sirolimus and Coronary-Stenosis

Very late stent thrombosis is an infrequent yet potentially fatal complication associated with drug-eluting stents. We report the case of an 88-year-old man who sustained an ST-segment-elevation myocardial infarction 11 years after initial sirolimus-eluting stent implantation. Optical coherence tomograms of the lesion showed that the focal incomplete endothelialization of the stent struts was the likely cause; neointimal formation, neoatherosclerosis, and late stent malapposition might also have contributed. To our knowledge, this is the longest reported intervening period between stent insertion and the development of an acute coronary event secondary to very late stent thrombosis. The associated prognostic and therapeutic implications are considerable, because they illuminate the uncertainties surrounding the optimal duration of antiplatelet therapy in patients who have drug-eluting stents. Clinicians face challenges in treating these patients, particularly when competing medical demands necessitate the discontinuation of antiplatelet therapy. In addition to the patient's case, we discuss factors that can contribute to very late stent thrombosis.

Topics: Aged, 80 and over; Anterior Wall Myocardial Infarction; Cardiovascular Agents; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Male; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The study sought to compare the acute gain and two-year follow-up late lumen loss (LLL) between the Absorb bioresorbable vascular scaffold (BVS) and the analogous everolimus-eluting metallic stent (EES). The current analysis included all the patients recruited in the ABSORB Cohort B and SPIRIT II trials implanted with a single 3.0×18 mm device (Absorb BVS or EES) who underwent serial angiographic examinations at baseline and at two-year follow-up. The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD). The in-stent/scaffold LLL was calculated as the difference in stent/scaffold segment between the post-procedural MLD and follow-up MLD. Thirty-three patients (33 lesions) implanted with the Absorb BVS, and 26 patients (28 lesions) implanted with the EES were studied. The acute gain was similar in the Absorb BVS group (1.23±0.38 mm) compared to the EES group (1.32±0.26 mm, p=0.29). The in-stent/scaffold LLL at two-year follow-up in the Absorb BVS group (0.26±0.19 mm) was also similar compared to the EES group (0.22±0.22 mm, p=0.29). Although the two groups had similar two-year clinical outcomes (major adverse cardiac events: Absorb BVS: 6.1% vs. EES: 0.0%), patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to the EES (2.02±0.26 mm vs. 2.22±0.34 mm, p=0.01). Although BVS and EES demonstrated similar two-year clinical outcomes, patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to patients treated with the EES. Appropriately powered randomised trials are necessary to confirm these exploratory results and evaluate their prognostic and clinical significance.

Topics: Absorbable Implants; Clinical Trials as Topic; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; Ultrasonography, Interventional

Incomplete stent apposition (ISA) is characterized by the lack of contact of at least 1 stent strut with the vessel wall in a segment not overlying a side branch; it is more commonly found in drug-eluting stents than bare-metal stents. The accurate diagnosis of ISA, initially only possible with intravascular ultrasound, can currently be performed with higher accuracy by optical coherence tomography, which also enables strut-level assessment due to its higher axial resolution. Different circumstances related both to the index procedure and to vascular healing might influence ISA occurrence. Although several histopathology and clinical studies linked ISA to stent thrombosis, potential selection bias precluded definitive conclusions. Initial studies usually performed single time point assessments comparing overall ISA percentage and magnitude in different groups (i.e., stent type), thus hampering a comprehensive understanding of its relationship with vascular healing. Serial intravascular imaging studies that evaluated vascular response heterogeneity recently helped fill this gap. Some particular clinical scenarios such as acute coronary syndromes, bifurcations, tapered vessels, overlapping stents, and chronic total occlusions might predispose to ISA. Interventional cardiologists should be committed to optimal stent choices and techniques of implantation and use intravascular imaging guidance when appropriate to aim at minimizing acute ISA. In addition, the active search for new stent platforms that could accommodate vessel remodeling over time (i.e., self-expandable stents) and for new polymers and/or eluting drugs that could induce less inflammation (hence, less positive remodeling) could ultimately reduce the occurrence of ISA and its potentially harmful consequences.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prognosis; Prosthesis Failure; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Survival Rate; Tomography, Optical Coherence

The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS).. Clinical outcomes of diabetic patients after BVS implantation have been unreported.. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up.. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group).. In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Clinical Trials as Topic; Coronary Stenosis; Coronary Thrombosis; Diabetic Angiopathies; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Propensity Score; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stents (DES) have transformed interventional cardiology over the past decade. Whilst their efficacy has rarely been called into question, there have been concerns over the safety of the early devices, which has prompted the development of new coronary stents. Many of these new devices have entered clinical practice, however questions remain as to whether they offer the improvements in clinical outcomes that were originally anticipated. In addition, there is a debate whether the reported high efficacy of these devices enables percutaneous coronary intervention (PCI) to be performed in patient and lesion sub-groups previous entirely the domain of the cardiac surgeon. This review paper addresses these outstanding questions.

Topics: Biocompatible Materials; Clinical Trials as Topic; Combined Modality Therapy; Comorbidity; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Complications; Disease-Free Survival; Drug-Eluting Stents; Humans; Meta-Analysis as Topic; Multicenter Studies as Topic; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Polymers; Postoperative Complications; Sirolimus; Thrombolytic Therapy; Treatment Outcome

Despite drug eluting stents (DES), as compared to bare metal stents, have reduced in-stent restenosis, complex and long lesions remains a challenge for interventional cardiologist. Their treatment is often associated with an unfavorable outcome, related to in-stent restenosis, stent thrombosis, and target lesion revascularization. These complications may derive from the contact between metallic structures and coronary artery endothelium, and consequent overexpression of platelet activating factors, growth factors, and inflammatory cytokines. Recently, an additional mechanism has emerged as new cause of these complications: "stent fracture." Several factors are involved in this phenomenon including material and stent platform, target vessel features, stent implantation technique, and implant duration. We reported a case of 69 years old man with rare early and complex DES fractures on right coronary that caused acute coronary syndrome 36 hr after a previous percutaneous coronary intervention.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Device Removal; Drug-Eluting Stents; Follow-Up Studies; Humans; Italy; Male; Myocardial Infarction; Prosthesis Failure; Retreatment; Risk Assessment; Sirolimus; Treatment Outcome

The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents.. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted.. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up.. In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomised trials, represents a paradigm shift.. The Cardiovascular Research Foundation.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Evidence-Based Medicine; Female; Humans; Incidence; Italy; Male; Paclitaxel; Prognosis; Prosthesis Failure; Radiography; Randomized Controlled Trials as Topic; Risk Assessment; Sirolimus; Stents; Survival Analysis; Thrombosis

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prognosis; Prosthesis Failure; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sex Factors; Sirolimus; Treatment Outcome

First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at one year. It is unclear whether these differences endure over the medium- to long-term. We compared the five-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients.. The patient cohorts of the ISAR-DESIRE, ISAR-DIABETES, and ISAR-SMART-3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five-year follow-up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years.. A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44-0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80-1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02-1.34; P = 0.12).. In high-risk patient subsets the lower rate of 12-month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Since its introduction, the cobalt chromium alloy MULTI-LINK VISION stent (MLV) has been extensively investigated thus leading to the largest amount of data so far available for a bare metal stent. Aim and. Systematic review and meta-analysis (according to Cochrane collaboration guidelines) aiming at summarizing the real world safety and efficacy of MLV stent. Endpoints of interest were: major adverse events [(MAE) combination of overall death and non-fatal myocardial infarction, MI], and target vessel revascularization (TVR). Rate of stent thrombosis was also assessed.. Eleven studies finally retrieved totalling 5539 patients [7 study registries, 4243 patients and 4 randomized controlled trials (RCTs) comparing MLV vs. first generation of drug-eluting stent (DES) (paclitaxel or sirolimus eluting), (RCTs) 1296 patients]. Across study registries, at a mean follow-up of 11.1 months, MLV was associated with a 5.3% risk of MAE, 3% of death, 2.3% of MI and a 9% of TVR. Risk of ST was 0.5%. Compared to first generation of DES in RCTs, at a mean follow-up of 10.5 months, MLV achieved similar results in terms of MAE, death and MI. On the other hand, MLV was associated with a double risk of TVR [OR 2.01 (1.34-3.01), P < 0.001, number needed to treat 18 (13-40)]. Overall, in stent late loss with MLV was 0.81 mm (±0.51), while the in segment late loss was 0.61 mm (±0.5). Risk of stent thrombosis was equivalent. Of note, performance of MLV in terms of safety, efficacy and risk of repeat revascularization was quite consistent across all the published studies, despite inherent differences in study design, clinical setting, complexity of the lesions and ethnicity.. Compared to first-generation DES, MLV showed substantial equivalence with respect to hard clinical endpoints. Data are consistent in study registries and RCTs meaning that the overall performance of MLV is quite predictable and reproducible into the wide spectrum of clinical settings.

Topics: Chromium Alloys; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Stents; Thrombosis; Treatment Outcome; Tubulin Modulators

The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES).. Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention.. Patient-level data were pooled from the randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) trials. Quantitative angiographic core laboratory data were available for 6,183 patients randomized to EES (n = 3,944) or PES (n = 2,239). Long lesions and small vessels were defined as LL >median (13.4 mm) and RVD ≤median (2.65 mm), respectively. Major adverse cardiac events (MACE) (consisting of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed at 2 years, according to stent type in 3 groups: short lesions in large vessels (group A, n = 1,297); long lesions or small vessels but not both (group B, n = 2,981); and long lesions in small vessels (group C, n = 1,905).. The pooled 2-year MACE rates were 5.6%, 8.2%, and 10.4% in Groups A, B, and C, respectively (p < 0.0001). There was no significant interaction between lesion group and stent type (p = 0.64), indicating lower MACE with EES compared with PES regardless of LL and RVD. However, the absolute difference was largest in Groups B and C. In Group A, 2-year MACE rates were not significantly different between EES and PES (4.8% vs. 7.0%, respectively, p = 0.11). In contrast, EES was associated with lower 2-year rates of MACE in Group B (6.6% vs. 11.2%, p < 0.01) and in Group C (9.1% vs. 12.7%, p = 0.008) as well as lower rates of myocardial infarction, target lesion revascularization, and stent thrombosis. Multivariable analysis confirmed EES versus PES as an independent predictor of freedom from MACE in Groups B and C.. Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Recent data on drug-eluting stents have shown improved clinical outcomes in patients with diabetes mellitus. However, the relative efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) remains controversial. Therefore, a meta-analysis of randomized trials was performed to compare SES with PES exclusively in patients with diabetes. The published research was scanned by formal searches of electronic databases (PubMed, EMBASE and the Cochrane Central Register of Controlled Trials) from January 2001 to April 2009. All randomized trials involving head-to-head comparison of SES versus PES in patients with diabetes were examined for analysis. A total of 5 randomized trials were included in the present meta-analysis, involving 1,173 patients (594 in the SES group, 579 in the PES group). SES were significantly more effective in the reduction of target lesion revascularization (5.1% vs 11.4%, odds ratio [OR] 0.41, 95% confidence interval [CI] 0.26 to 0.64, p <0.001) and angiographic binary (> or =50%) restenosis (5.6% vs 16.4%, OR 0.30, 95% CI 0.19 to 0.48, p <0.001) compared to PES. In contrast, the differences between SES and PES were not statistically significant with respect to cardiac death (2.2% vs 2.9%, OR 0.71, 95% CI 0.34 to 1.47, p = 0.35), myocardial infarction (1.5% vs 2.6%, OR 0.58, 95% CI 0.26 to 1.31, p = 0.19), and stent thrombosis (0.6% vs 1.2%, OR 0.57, 95% CI 0.18 to 0.84, p = 0.35). In conclusion, SES are superior to PES in reducing the incidences of restenosis and target lesion revascularization in patients with diabetes, with nonsignificant differences in terms of cardiac death, myocardial infarction, and stent thrombosis.

Topics: Antineoplastic Agents, Phytogenic; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

To assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the TAXUS paclitaxel-eluting stent (PES) in women at two years.. In this pooled analysis, a cohort of 395 women and 906 men was studied by using patient level and lesion level clinical data from SPIRIT II and SPIRIT III studies. Women enrolled in these two studies had higher demographic and lesion risk characteristics than their male counterparts. In-stent and in-segment late loss (LL) was significantly less in the women in the EES group compared to the women in the PES group (in-stent 0.15+/-0.44 mm vs. 0.45+/-0.51 mm; P<0.01, in-segment 0.09+/-0.46 mm vs. 0.29+/-0.40 mm; P<0.01). In women, EES compared to PES resulted in significant reductions in major adverse cardiac events (MACE) (8.5% vs 16.4%; p=0.02) and in target vessel failure (TVF) (11.2% vs 19.5%; p=0.02) at two years. In men, a significant difference was seen in in-stent LL and in-stent % diameter stenosis (DS) favouring EES (in-stent LL 0.14+/-0.33 mm vs. 0.28+/-0.47 mm; P<0.01, in-stent %DS 9.28+/-13.86 vs. 13.64+/-18.31; P<0.01). MACE rates at two years were lower in males treated with EES compared to PES (6.7% vs. 10.9%; p=0.03). The interaction between gender and stent type was not found to be significant for MACE at two years.. In this pooled analysis of two randomised trials, at two years, EES compared to PES resulted in reduced angiographic LL, fewer MACE and TVF events in women and reduced angiographic LL and %DS and fewer MACE events in men.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This meta-analysis was undertaken to assess the efficacy and safety of drug-eluting stents (DESs) compared to bare metal stents (BMSs) in saphenous vein graft (SVG) interventions. DESs decrease the risk of target vessel revascularization in native coronary arteries compared to BMSs. The ideal treatment strategy in patients with SVG disease is unknown. A search of the published reports was conducted to identify studies that compared DESs and BMSs in SVG intervention with a minimum follow-up of 6 months. A total of 19 studies (2 randomized trials and 17 registries), including 3,420 patients who had undergone SVG intervention (DESs, n = 1,489 and BMS, n = 1,931), met the selection criteria. The mean length of follow-up was 20 + or - 12 months. Using the fixed effect model, target vessel revascularization was less frequently performed in patients who had undergone SVG intervention with a DES than with a BMS (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.72). The incidence of myocardial infarction was lower in patients with a DES than in those with a BMS (OR 0.69, 95% CI 0.49 to 0.99). No differences were found in the risk of death (OR 0.78, 95% CI 0.59 to 1.02) or stent thrombosis (OR 0.41, 95% CI 0.15 to 1.11) between the 2 groups. In conclusion, these findings support the use of DESs in SVG lesions.

Topics: Antineoplastic Agents, Phytogenic; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Incidence; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Saphenous Vein; Sirolimus; Treatment Outcome; United States

Coronary stent thrombosis is a serious problem in the drug-eluting stent era. Despite aggressive antiplatelet therapy during and after percutaneous coronary intervention (PCI), the incidence of sub-acute stent thrombosis remains approximately 0.5%-2%, which may represent a catastrophic clinical situation. Both procedural factors and discontinuation of antiplatelet therapy are normally associated with this event. We report on simultaneous stent thromboses of two drug-eluting stents implanted in two different vessels, which resulted in a life-threatening clinical condition. Possible contributing factors that led to synergistic thrombotic effects are discussed.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Female; Humans; Medication Adherence; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; Ticlopidine; Treatment Outcome

Coronary angiography, despite its inherent invasiveness and need for contrast media and radiographic exposure, is still routinely employed every year for the diagnostic and therapeutic management of millions of patients with or at risk for coronary artery disease. Whereas approximate visual estimation is the most common way to evaluate coronary angiography findings, since the late 1980s a number of investigators have developed and investigated methods of quantitative coronary angiography (QCA) analysis exploiting automated or semi-automated edge detection. Despite the inherent drawback of QCA due to its focus on the contrast-filled lumen of the vessel, QCA has offered and continues to offer important insights for clinical research and, in selected cases, clinical practice. This review aims thus to provide a comprehensive and updated viewpoint on the actual role of QCA.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Disease Progression; Drug-Eluting Stents; Humans; Image Interpretation, Computer-Assisted; Immunosuppressive Agents; Sirolimus; Tomography, Optical Coherence

The authors analysed the data concerning sirolimus- and paclitaxel-eluting stents used for treatment of stenoses and chronic occlusions of coronary arteries. Also discussed herein are clinical outcomes following stenting of bifurcation stenoses, stenoses of the main trunk of the left coronary artery, diffuse stenoses and chronic occlusions. The authors concluded that introduction into clinical practice of stents with an antiproliferative coating made it possible to considerably improve the results of coronary angioplasty in the above-mentioned lesions of coronary arteries. At the same time, the incidence rate of restenoses, secondary revascularizations and unfavourable outcomes for drug-eluting stents in various lesions of the coronary bed remains sufficiently rather high and is 2-3 times greater than similar indices in focal stenoses.

Topics: Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Neovascularization, Pathologic; Paclitaxel; Prosthesis Design; Sirolimus; Treatment Outcome

In-stent restenosis (ISR) caused by neointimal hyperplasia is the major drawback after percutaneous coronary intervention (PCI) for obstructive coronary disease, occurring in up to 40% of lesions. Recently, one of the most intriguing new therapies developed is drug-eluting stents (DES) that target the central phenomenon of cellular proliferation that causes ISR. The benefits of stent-based drug delivery include maximizing the local tissue levels of therapeutic agents while minimizing systemic toxicity. Numerous DES using different thin-film polymeric drug carrier have been developed and tested, those eluting either antimitotic or antimicrotublar agents such as sirolimus and paclitaxel have been shown effective in clinical trials. Two DES, the J&J Cypher (sirolimus-eluting) and the Boston Scientific Taxus (paclitaxel-eluting) stents, are commercially available in the U.S. after a number of randomized trials demonstrated reductions in late lumen loss, binary restenosis rate, and need for repeat revascularization compared with bare-metal stents (BMS). Because ISR is multifactorial, ideal agents for DES should inhibit thrombus formation, inflammation and cellular proliferation as well as enhance re-endothelialization. The next generation of DES currently undergoing preclinical studies includes new technology, new stent designs and materials, biological polymers, bioabsorbable stents coated with new drugs including stent based gene, as well as cell delivery. The current paper will review and discuss the current and future status of DES.

Topics: Animals; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Humans; Molecular Structure; Paclitaxel; Prosthesis Design; Sirolimus; Stents

Little is known about the impact of treating bifurcations on the overall outcome of multivessel coronary artery disease treated with stenting. This analysis was made to investigate the 1 year clinical outcome of the treatment of bifurcation lesions using sirolimus-eluting stents (SES) in patients with multivessel disease.. Among a total of 607 patients (2160 lesions) in the Arterial Revascularization Therapies Study part II (ARTS II), there were 324 patients in whom at least one bifurcation lesion was treated (465 lesions). Patients with bifurcations were compared with those without bifurcations in terms of baseline characteristics and major adverse cardiac and cerebrovascular events (MACCE). Patients with 'true' (200 patients) vs. 'partial' bifurcations (124 patients) and usage of a one- (263 patients) vs. two-stent strategy (61 patients) were also evaluated. The bifurcation group was associated with more complex lesion and procedural characteristics than the non-bifurcation group. However, there was no significant difference in 1 year MACCE rates between the bifurcation group and the non-bifurcation group (13.3 vs. 11.0%, P=0.46). MACCE in patients with true bifurcations was 13.0 vs. 13.7% for partial bifurcations (P=0.87) and 14.1 vs. 9.8% for one- vs. two-stent strategy (P=0.53).. In this trial without angiographic follow-up, the presence of bifurcations did not affect 1 year outcomes after SES implantation. The outcomes in true vs. partial bifurcations and using one vs. two stents were similar when the treatment strategies were left to the operator's discretion.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug Implants; Female; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Myocardial Revascularization; Sirolimus; Stents; Treatment Outcome

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Stenosis; Humans; Paclitaxel; Quality of Life; Risk; Sirolimus; Stents

Patients with stenosis of the left main coronary artery present difficult challenges. The risks associated with this lesion have been known since the early days of angiography when patients were found to have increased mortality during follow-up. This information led to the general guidelines that surgical revascularization should be considered the treatment of choice in patients with significant left main coronary artery stenosis. Current advances in invasive cardiology have brought important information to the field. Intravascular ultrasound is now used routinely to evaluate angiographically indeterminate lesions with criteria now set forward as to what constitutes an indication for revascularization. Stents have even further dramatically changed the landscape. There are substantial issues, however, that need to addressed. These include the following: (1) the effect of specific lesion location on outcome - it is known that patients with distal bifurcation left main disease have worse outcome; (2) the potential for subacute thrombosis of the left main coronary artery; (3) the impact of left ventricular function and patient comorbidities irrespective of the degree and location of left main coronary artery stenosis; and (4) the risk-benefit ratio of stenting versus coronary artery bypass graft surgery. These issues are currently being addressed in two seminally important trials including the SYNTAX trial, which randomizes patients with left main and/or three-vessel disease to either coronary artery bypass graft surgery or a TAXUS drug-eluting stent. This trial is in the final stages of patient recruitment and will have important implications for the field. The other trial is the COMBAT trial, which is focused exclusively on left main coronary artery stenosis and randomizes patients with left main coronary artery disease either to a Sirolimus-eluting stent (Cypher, Johnson and Johnson Cordis, USA) or to coronary artery bypass graft surgery. The field of left main coronary artery disease continues to expand in terms of the evidence available for optimal patient evaluation and selection of treatment modalities.

Topics: Aged; Biomarkers; C-Reactive Protein; Catheter Ablation; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Echocardiography, Transesophageal; Exercise Test; Female; Humans; Immunosuppressive Agents; Leukocyte Count; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Sirolimus; Stents; Thallium Radioisotopes; Tomography, X-Ray Computed; Treatment Outcome; Tubulin Modulators

Polymer-based sirolimus- (Cypher) and paclitaxel-eluting (Taxus) drug eluting stents have become the treatment of choice for patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention (PCI). Although these stents reduce rates of restenosis compared with bare metal stents (BMS), late thrombosis, a life threatening complication, has emerged as a major safety concern. Our understanding of the pathophysiology of late DES thrombosis is derived from animal and human pathologic samples taken after implantation of these devices. These data indicate that both DES cause substantial impairment in arterial healing characterized by lack of complete reendothelialization and persistence of fibrin when compared with BMS. This delayed healing is the primary substrate underlying all cases of late DES thrombosis at autopsy. Several additional risk factors for late stent thrombosis such as penetration of necrotic core, malapposition, overlapping stent placement, excessive stent length, and bifurcation lesions represent additional barriers to healing and should be avoided if DES are to be used to minimize the risk of late thrombosis. Because the time course of complete healing with DES in man is unknown, the optimal duration of antiplatelet treatment remains to be determined.

Topics: Aged; Angioplasty, Balloon, Coronary; Animals; Biopsy, Needle; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease Models, Animal; Endothelium, Vascular; Humans; Immunohistochemistry; Middle Aged; Paclitaxel; Prognosis; Prosthesis Design; Rabbits; Risk Factors; Sensitivity and Specificity; Sirolimus; Stents; Time Factors; Wound Healing

The implantation of coronary stents is a relevant part of interventional procedures for percutaneous revascularization. The wide acceptance of coronary stenting was based on the results of two highly significant trials which have shown the superiority of stenting over balloon angioplasty in terms of reduction of angiographic restenosis and need for repeated intervention in focal lesions and large coronary arteries. Since then, the growing use of stent market was impressive. A rapidly increasing number of different stent type with different material and designs has been introduced in the market both for bare metal stent and drug eluting stent. This review will summarize the different components of stent design that are important in term of biological response of the arterial wall and clinical outcome. In addition, new stent platforms, mainly represented by the biodegradable stent will be shortly reviewed since it may provide in the near future a more "physiological" answer to stent implantation, reducing vascular injury and accelerating vessel healing with consequent improving in clinical outcome.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Stenosis; Drug Implants; Equipment Design; Humans; Multicenter Studies as Topic; Paclitaxel; Sirolimus; Stents; Treatment Outcome

This review presents the current data on drug release from drug-eluting stents and the effects of the release profiles on animal and human data for coronary stenosis. Data for the two most important drugs, sirolimus (rapamycin) and paclitaxel, are presented, the polymers used are described and the observed release profiles are discussed for various polymer carriers. The current literature on the tissue compatibility of the polymers commonly used in drug-eluting stents is also discussed. The range of release rates from stents studied to date is limited for sirolimus, but somewhat broader for paclitaxel. Animal and human data comparing the different release profiles are limited to about 6 months for animals and 2-4 years for humans. From the data available, it appears that for both sirolimus and paclitaxel, a slow-releasing drug-eluting stent leads to slightly more favorable angiographic outcomes than more rapid release. Most of the complications arising from the use of drug-eluting stents are attributed to incomplete healing; one possible clinical consequence of this delay in healing is that anti-platelet therapy needs to be maintained over a much longer period than is the case for bare metal stents.

Topics: Animals; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Follow-Up Studies; Humans; Immunosuppressive Agents; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Stents; Time Factors; Uncertainty

The advent of intravascular stenting dramatically reduced the incidence of restenosis among patients undergoing percutaneous transluminal coronary angioplasty. However, a substantial percentage of patients, particularly those with risk factors such as diabetes mellitus or complicated lesions, remain at risk for restenosis. Drug-eluting stents overcome this problem by releasing bioactive agents from a polymeric coating directly into the vessel wall, inhibiting the cellular mechanisms of restenosis while avoiding systemic toxicity. Recent data indicate that local targeting of the proliferative process with drug-eluting stents dramatically reduces the risk for restenosis, even among high-risk patients. A range of bioactive coatings are currently available or in late clinical trials. Both sirolimus- and paclitaxel-eluting stents have demonstrated efficacy in a broad range of patient types; early data from clinical trials of second-generation stent coatings, such as everolimus and ABT-578 (zotarolimus), suggest that these agents are also effective in preventing restenosis. This article reviews the pathophysiology of in-stent restenosis and surveys recent key clinical trials of drug-eluting stents.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Stents; Treatment Outcome; Tubulin Modulators

The author presented a review of clinical research works conducted and completed in 2001 - 2005. The review contains data on clinical trials of sirolimus-eluting stents in patients with coronary artery disease. The author analyzed experimental data on the mechanism of action of rapamycin on the cell and also analyzed data of clinical trials of sirolimus-containing stents in the treatment of coronary artery stenosis and chronic occlusion. Results of clinical trials of coated stents in diabetic patients with coronary artery stenosis, as well as data on the use sirolimus-containing stents in the treatment in stent restenosis were also discussed.

Topics: Anti-Bacterial Agents; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Sirolimus; Treatment Outcome

The goal of this study was to use angioscopy to investigate the amount of neointimal coverage after sirolimus-eluting stent (SES) implantation.. Sirolimus-eluting stents reduce intimal hyperplasia.. We used angioscopy to evaluate 37 consecutive stented coronary artery lesions (15 SES and 22 bare-metal stents [BMS]) in 25 patients (18 men, 7 women) at 3 to 6 months after stent implantation. Angioscopic evaluation focused on: 1) neointimal coverage of stent struts, and 2) the existence of thrombi. The degree of neointimal coverage was classified as grade 0 when there was no neointimal coverage (similar to immediately after the implantation); grade 1 when stent struts bulged into the lumen, but were covered and still translucently visible; grade 2 when stent struts were visible but not clearly seen (not translucent); and grade 3 when stent struts were not visible because they were embedded in the neointima.. Thrombi were identified in eight stented segments, tended to be more common with SES (p = 0.14), but were not seen on angiography. Three of the 15 SES (20%) had grade 0 neointimal coverage, and only 2 SES (13.3%) had complete coverage (grades 2/3). In contrast, all 22 BMS showed complete intimal coverage (grades 2/3). Thrombi were more common in stents with incomplete neointimal coverage (p = 0.09).. The SES had incomplete neointimal coverage three to six months after implantation, and this was associated with subclinical thrombus formation.

Topics: Aged; Angioscopy; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Delayed-Action Preparations; Female; Humans; Hyperplasia; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Tunica Intima; Wound Healing

Drug-eluting stents have been shown to be superior to bare metal stents in reducing restenosis rates. Recently head-to-head trials comparing sirolimus-eluting stents and paclitaxel-eluting stents have been reported. An early combined analysis of these comparative trials is needed. The present meta-analysis was carried out to compare the effects of sirolimus-eluting stents with paclitaxel-eluting stents on the restenosis rate, major adverse cardiac events and late loss of arterial lumen diameter in patients with obstructive coronary artery disease.. Electronic (Medline, Cochrane and Embase) and manual search (Index Medicus and cross references of retrieved articles) were carried out for all the relevant articles up till March 2005. Only randomized trials with adequate data for calculation of odds ratio for restenosis rates and major adverse cardiac events using the method of DerSimonian & Laird and standardized mean difference for late loss of arterial lumen diameter were included.. Four studies were found to be eligible for inclusion in the meta-analysis. Restenosis rate and late loss of arterial lumen diameter were significantly reduced by sirolimus-eluting stents as compared with paclitaxel-eluting stents (OR 0.598, 95% CI 0.400, 0.893, pooled mean difference -0.414, 95% CI -0.492, 0.336, respectively). The incidence of major adverse cardiac events was less with sirolimus-eluting stents as compared with paclitaxel-eluting stents (OR 0.727, 95% CI 0.518-1.018) but the results were not statistically significant.. Sirolimus-eluting stents are superior to paclitaxel-eluting stents in decreasing restenosis rate and late loss of arterial lumen diameter. However, no statistically significant difference in major adverse cardiac events was noted between the two stents.

Topics: Coronary Stenosis; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

The purpose of this research was to determine the relative safety and efficacy of multiple (> or =2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey).. Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents.. All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent-treated patients were compared by stent type and with single-stent-treated patients for the same stent device.. In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent-treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent-treated patients. Overlapped SES was not associated with an increase in myocardial infarction.. The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Creatine Kinase; Humans; Metals; Middle Aged; Sirolimus; Stents

Despite considerable benefits associated with current drug-eluting stents (DES), continued attention to the safety, efficacy, and deliverability of first-generation DES has led to the development of new antiproliferative agents with alternative stent platforms and different drug carrier systems. Zotarolimus is a recently developed pharmacologic agent with both antiproliferative and anti-inflammatory properties. The Endeavor drug-eluting stent (Medtronic Vascular, Santa Rosa, CA) represents the combination of zotarolimus, a low-profile cobalt alloy stent platform, and a biocompatible phosphorylcholine drug carrier system. At present, four clinical trials examining the safety and efficacy of the Endeavor stent have been performed. Although these studies have enrolled patients with similar clinical and angiographic characteristics, they have differed in trial design and study population size and have been performed across a broad geographic and physician distribution. Despite these differences, the results of these trials demonstrate consistently low rates of angiographic restenosis and repeat revascularization in addition to a favorable safety profile, with no occurrences of late stent thrombosis through 1 year of follow-up. This review describes the pharmacology and design on the Endeavor stent, summarizes results from recent clinical trials evaluating the Endeavor stent, and provides an overview of ongoing and future directions for clinical investigation.

Topics: Anti-Inflammatory Agents; Blood Vessel Prosthesis Implantation; Clinical Trials as Topic; Coated Materials, Biocompatible; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Humans; Phosphorylcholine; Prosthesis Design; Sirolimus; Stents

Restenosis after percutaneous intervention in the left main coronary artery may present as sudden cardiac death. Although drug-eluting stents have demonstrated promising results, there remains the question about appropriate length of the left main artery to be covered with the stent. We describe a patient who received two drug-eluting stents with the balloon crushing technique in the distal left main coronary artery. Three months later, this patient presented with a new lesion in the segment of the left main artery not covered with stent, but instead at the site where the balloon was inflated in the initial procedure.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug Delivery Systems; Female; Humans; Middle Aged; Retreatment; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Treatment Outcome

Drug-eluting stents, most commonly sirolimus-eluting stents and polymer-based paclitaxel-eluting stents, are now widely used during percutaneous coronary interventions, and have largely replaced bare-metal stents to treat a variety of native coronary artery and saphenous vein graft lesions. Stent thrombosis, a complication of both bare-metal and drug-eluting stents, is associated with significant morbidity and mortality including high rates of myocardial infarction and death. Recently, several studies in the literature have raised concern about increased rates of overall stent thrombosis and late stent thrombosis in drug-eluting stents in the so-called 'real world' where off-label uses of drug-eluting stents are common. Hypersensitivity reactions to the polymers used in drug-eluting stents, delayed endothelialization of the stents, and discontinuation of dual antiplatelet therapy have all been implicated in the pathophysiology of drug-eluting stents stent thrombosis. The incidence of total stent thrombosis as well as late stent thrombosis, however, does not seem to be significantly higher in drug-eluting stents than in bare-metal stents. An important risk factor for stent thrombosis in both types of stents appears to be the premature discontinuation of dual antiplatelet therapy, and physicians should educate their patients about the importance of adhering to dual antiplatelet therapy, given the dire clinical consequences of stent thrombosis.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coated Materials, Biocompatible; Coronary Stenosis; Coronary Thrombosis; Humans; Immunosuppressive Agents; Incidence; Paclitaxel; Prognosis; Prosthesis Failure; Sirolimus; Stents; Survival Rate

This meta-analysis was conducted to compare the effects of drug (paclitaxel and sirolimus)-eluting stents with bare metal stents on major adverse cardiac events, restenosis rates and late loss of arterial lumen diameter in patients with obstructive coronary artery disease.. Randomized, controlled clinical trials comparing sirolimus- and paclitaxel-eluting stents with bare metal stents were identified through electronic and manual search. Fixed effects method of Mantel-Haenszel and random effects method of DerSimonian and Laird were used for computing the pooled odds ratio (OR) and 95% confidence intervals (CI) for major adverse cardiac events and restenosis rates. Standardized mean difference with 95% CI was calculated for late-loss of arterial lumen diameter.. A total of 13 studies were included in the meta-analysis. As compared with bare metal stents, the use of sirolimus- and paclitaxel-eluting stents significantly reduced the major adverse cardiac events (pooled OR 0.35; 95% CI 0.24-0.50), restenosis rates (pooled OR 0.27; 95% CI 0.15-0.47), and late loss of arterial lumen diameter (mean difference 0.57 mm, 95% CI 0.49-0.68).. Paclitaxel- and sirolimus-eluting stents significantly reduced the incidence of major adverse cardiac events, restenosis rates, and late loss of arterial lumen diameter as compared with bare metal stents.

Topics: Cell Proliferation; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Drug Implants; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome; Tunica Intima

Topics: Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Follow-Up Studies; Humans; Observation; Randomized Controlled Trials as Topic; Sirolimus; Stents; Surface Properties

We conducted a meta-analysis on 6 studies in 2,963 patients who had coronary artery disease and received a sirolimus-eluting stent or a bare metal stent for revascularization. Compared with bare metal stents, sirolimus-eluting stents did not appear to increase the risk for thrombosis up to 13.5 months after coronary intervention (risk ratio 0.49, 95% confidence interval 0.22 to 1.12, p = 0.09).

Topics: Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Disease; Coronary Stenosis; Coronary Thrombosis; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Postoperative Complications; Radiography; Randomized Controlled Trials as Topic; Registries; Retrospective Studies; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

The introduction of drug-eluting stents (DES) to interventional cardiology practice has resulted in a significant improvement in the long-term efficacy of percutaneous coronary interventions. DES successfully combine mechanical benefits of bare-metal stents and stabilizing the lumen, with direct delivery and the controlled elution of a pharmacologic agent to the injured vessel wall to suppress further neointimal proliferation. The dramatic reduction in restenosis has resulted in the implementation of DES in clinical practice, and has rapidly expanded the whole spectrum of successfully treatable coronary conditions, particularly in high-risk patients and complex lesions. In this review the authors present current data on DES. Currently, two types of DES are available in the USA: sirolimus-eluting stents (SES) CYPHER (Cordis Corp., FL, USA) and paclitaxel-eluting stents (PES) TAXUS (Boston Scientific, MA, USA), and many more are on the way to approval. In addition to sirolimus and paclitaxel, several other drugs have been successfully used in DES. Everolimus and ABT-578 are both analogs of sirolimus that also have immunosuppressive and antiproliferative properties. Another approach in the development of DES is to use drugs that can accelerate re-endothelialization and restore normal endothelial function following vascular injury. Recent advances in vascular gene transfer have also demonstrated potential new treatment modalities for cardiovascular disease, particularly in the treatment of vascular restenosis.

Topics: Clinical Trials as Topic; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Fibrinolytic Agents; Humans; Paclitaxel; Prosthesis Design; Sirolimus; Stents

To compare the safety, effectiveness and cost-effectiveness of drug-eluting coronary stents used in Australia with bare-metal stents and determine whether the benefits are greater for high-risk subgroups.. MEDLINE, Pre-Medline, EMBASE, Current Contents, CINAHL and the Cochrane Library database were searched to identify eligible randomised controlled trials and systematic reviews published in English between January 1966 and June 2004.. Seven randomised controlled trials that assessed polymer-based paclitaxel- or sirolimus-eluting stents versus bare-metal stents in patients with coronary atherosclerosis and reported on stent thrombosis, mortality, myocardial infarction, coronary artery bypass grafting or target lesion revascularisation.. Two independent reviewers appraised eligible studies and extracted data. Relative risks (RRs) were calculated for each outcome and pooled using the Mantel-Haenszel method.. Rates of stent thrombosis, mortality, myocardial infarction and bypass grafts did not differ by stent type. Drug-eluting stents (DESs) resulted in a 71%-80% lower risk of revascularisation at 12 months (RR 0.29 [95% CI, 0.20-0.43] for paclitaxel-eluting stents [n = 1593 patients]; RR 0.20 [95% CI, 0.13-0.29] for sirolimus-eluting stents [n = 1296 patients]). Similar benefits were seen in several high-risk subgroups of patients: those with diabetes, lesion length > 20 mm and target-vessel diameter < or = 2.5 mm. The benefits of DESs in these high-risk groups over lower-risk groups were inconclusive because of low numbers. The cost per revascularisation avoided by using DESs was 3,750-6,100 Australian dollars, with an estimated cost per quality-adjusted-life-year (QALY) gained of 46,829-76,467 Australian dollars. In sensitivity analyses, estimates varied from DESs being cost-saving to costing an additional 314,385 Australian dollars per QALY gained.. DESs are effective in reducing revascularisation. Estimates of cost-effectiveness are very sensitive to changes in estimates of their true effects in clinical practice, market price and the number of stents used per patient. Decisions to limit DESs to only patients at the highest risk of restenosis may improve their cost-effectiveness but will need to be reassessed when evidence is available to compare absolute benefits between patient groups.

Topics: Australia; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Equipment Design; Humans; Immunosuppressive Agents; Metals; Paclitaxel; Patient Selection; Polymers; Risk; Sirolimus; Stents; Treatment Outcome

Coronary angiography is often inadequate for estimating the severity of ambiguous left main coronary artery (LMCA) stenoses. Our assessment of these lesions can be improved by the techniques of intravascular ultrasound and fractional flow reserve which provide indices of stenosis severity to enable the prediction of future events and planning of treatment. For patients requiring LMCA revascularization, coronary artery bypass graft (CABG) surgery has been gold standard for decades. However, this technique continues to be limited by factors such as periprocedural mortality, prolonged hospital stay and rehabilitation, and long-term graft patency. LMCA stenosis remains one of the few serious challenges for the interventional cardiologists and, in the bare metal stent era, the long-term results were not sufficient to replace CABG surgery, mainly because of the high restenosis rate. Drug-eluting stents (DES) have dramatically reduced the restenosis rate and early results in small series (approximately 300 patients in total) treated with DES in LMCA have been encouraging, especially for lesions at the ostium and in the left main shaft. Before changes are made in the guidelines for treatment, we must wait for a refinement in the technique and stent design used for bifurcational left main lesion and the results of randomized, specific multicenter studies (SYNTAX trial). It is likely that, for selected patients, LMCA stenosis will be regarded as an indication for PCI.

Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Blood Vessel Prosthesis Implantation; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Sirolimus; Stents

The efficacy of drug-eluting stents measured as the late loss, percentage neointimal volume, restenosis, target lesion revascularization and major cardiac events is significantly better than that of bare metal stents. The incidence of thrombosis and aneurysms is similar. Although there is a slight increase in late apposition, this is not followed by an increase in cardiac events. Despite the arguments against the routine use of drug-eluting stents, their cost is the only limiting factor for their widespread use.

Topics: Arterial Occlusive Diseases; Clinical Trials as Topic; Combined Modality Therapy; Coronary Stenosis; Drug Delivery Systems; Humans; Paclitaxel; Sirolimus; Stents

Antiproliferative drug-eluting stents represent a miles tone in advances in interventional cardiology. The amount and quality of the scientific evidence now show these new stents to be highly effective in reducing neointimal proliferation, and hence the process of restenosis. Their clinical impact can be expected to become relevant in terms of both increased indications for angioplasty and the extent of stent usage. However, at this time the systematic use of drug-eluting stents for all patients is not considered justified, because of their limited availability, gaps in our knowledge of their safety, and because their unquestioned clinical benefits have been magnified by exaggerated reports of the clinical problem restenosis represents. Currently, the cost of these stents remains high, and the cost/benefit ratio for certain patients is unfavorable. For these reasons selective use of these new stents is considered more reasonable: they should be used only for those patients who will obtain, in absolute terms, the greatest clinical benefit.

Topics: Clinical Trials as Topic; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Costs and Cost Analysis; Drug Delivery Systems; Humans; Paclitaxel; Registries; Sirolimus; Stents

The inhibitory action of the sirolimus-like agent everolimus on smooth muscle cell proliferation, evidenced in animal models, has triggered the interest in everolimus as stent coating for local inhibition of in-stent restenosis. For preclinical and clinical evaluation of safety and efficacy of an everolimus-eluting stent design, a new stent has recently been introduced by Biosensors International Inc, covered by a resorbable "composite" coating, that contains the immunosuppressive drug within a polyhydroxyacid biodegradable polymer matrix with roughly equal resorption rates. FUTURE I, the feasibility trial of this new stent concept, revealed a 30-day MACE (major adverse cardiac events) rate of 0% as well as a restenosis rate of 0% at 6-month follow-up in a total of 32 patients included. The more sensitive QCA (quantitative computerized analysis) and IVUS (intravascular ultrasound) parameters showed an 88% reduction of in-stent late loss and an 87% reduction of the neointimal volume. Adding a second feasibility trial including diabetics, the multicenter trial FUTURE II confirmed the initial beneficial findings of FUTURE I in a total of 64 patients in a 1 : 2 randomization to a bare metal control stent. Based on these results, the FUTURE program has now been expanded by Guidant with two large-scale multicenter studies, FUTURE III and IV, which evaluate this stent design in a larger patient population. Furthermore, FUTURE IV is addressed to demonstrate the non-inferiority of this stent concept in a head-to-head comparison to an approved drug-eluting stent (DES) concept. In contrast to everolimus, tacrolimus is a well-known potent antiproliferative agent, already used in various therapeutic areas. Preclinical studies on tacrolimus-eluting stents for treatment of native coronary artery lesions demonstrated safety and efficacy of this stent concept with significant reduction of neointimal proliferation within the implanted study stents. However, the clinical trial program of the first tacrolimus-eluting stent system in the treatment of native coronary lesions (PRESENT I, II) and saphenous vein graft lesions (EVIDENT) failed to prove the clinical benefit of the stent systems tested and demonstrated the impact of specific stent designs, especially the drug carrier characteristics, on the patient outcome. The progressive PRESET study, evaluating a directly coated tacrolimus-eluting stent, will provide important insights, that will clarify the potential of tacrolim

Topics: Angioplasty, Balloon, Coronary; Animals; Antibiotics, Antineoplastic; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Everolimus; Feasibility Studies; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus; Stents; Structure-Activity Relationship; Tacrolimus; Treatment Outcome

ABT-578 is a new synthetic analog of rapamycin, designed to inhibit smooth muscle cell proliferation-a key contributor to restenosis-by blocking the function of the mTOR cell cycle regulatory protein. Given these pharmacodynamics, ABT-578 was considered beneficial for intracoronary delivery to arrest the process responsible for neointimal hyperplasia after angioplasty and stenting. Consequently, the ABT-578-eluting ENDEAVOR stent system has been created, representing a potential new alternative for treating patients with coronary heart disease. In order to evaluate safety, feasibility and efficacy of this stent design, the ENDEAVOR clinical program has been started, including three randomized clinical trials. ENDEAVOR I is the first-in-man trial including 100 patients with native de novo coronary lesions. The 4-month follow-up data, recently presented, demonstrated safety and feasibility of this new drug-eluting stent (DES) concept with a 4-month MACE (major adverse cardiac events) rate of 2.0%. In order to evaluate this stent system in a larger patient population as well as more complex lesion subsets, the multicenter study ENDEAVOR II has been started including a total of 1,200 patients. The enrollment of this study was completed in January 2004. The aim of the US multicenter study ENDEAVOR III is a head-to-head comparison of the ENDEAVOR ABT-578-eluting stent system with the already approved sirolimus-eluting Cypher stent in 369 patients. If the results of both pivotal studies ENDEAVOR II and III confirm the efficacy of the ENDEAVOR stent design observed so far, the ENDEAVOR stent will be established as a new and promising contender in the field of DES.

Topics: Administration, Topical; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Feasibility Studies; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Sirolimus has been shown to inhibit vascular smooth muscle cell proliferation and migration. Stents coated with a mixture of polymer and active drug achieved near total inhibition of neointimal hyperplasia in patients with de novo coronary lesions. Larger, randomized trials confirmed these initial results to a large extent; late luminal loss was not only reduced by > 70% in patients with type A lesions, but also in complex situations such as diabetic patients, long lesions, and small vessels < 2.5 mm. Registries containing several thousand patients, however, indicate that under realistic conditions the flawless results of the initial studies could not be reproduced in all patient groups.

Topics: Administration, Topical; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Humans; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stents

Coronary stent implantation is currently performed in > 80% of percutaneous coronary interventions. Its main late complication is the development of in-stent restenosis (ISR), occurring in 10-80% of lesions treated in daily practice. The classification by Mehran et al. is most commonly used. Current therapeutic options to treat ISR include repeat balloon angioplasty, repeat stenting, cutting balloon angioplasty, directional coronary atherectomy, rotational coronary atherectomy, brachytherapy, and drug-eluting stents (DES). DES have been effective in reducing binary restenosis in de novo lesions in randomized controlled trials. The novel use of DES to treat ISR has been shown to be safe and effective in multiple studies involving sirolimus- and paclitaxel-eluting stents. As DES implantation becomes more widespread, ISR in DES is emerging as a new problem. The use of debulking techniques to treat ISR in DES is to be cautioned against. In this new era, the optimal treatment of this new problem is currently unknown. We await further data to see whether repeat DES implantation may help solve this vexing clinical problem.

Topics: Administration, Topical; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Humans; Paclitaxel; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

The number of surgical coronary revascularization procedures is static and even declining. Since the introduction of drug eluting stents the question arose whether this will have an impact on the spectrum of surgical coronary revascularization procedures.. Bypass surgery is a routine procedure for the treatment of coronary artery disease with good results. Studies have shown that there is a benefit in favor of surgery compared to interventional cardiologic procedures. DRUG-ELUTING STENTS: In recent studies a new generation of stents, drug-eluting stents, have proven to have a significant better patency rate than common stents. However, to date there are no studies which show a benefit compared to surgery given the same indication for treatment.. Therefore, the question whether drug-eluting stents have an impact on the spectrum of bypass surgery cannot be fully answered at present.

Topics: Administration, Topical; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Coated Materials, Biocompatible; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Equipment Failure Analysis; Humans; Microscopy, Electron, Scanning; Paclitaxel; Sirolimus; Stents; Treatment Outcome

Topics: Clinical Trials as Topic; Coronary Stenosis; Drug Carriers; Humans; Paclitaxel; Sirolimus; Stents

Antiproliferative drug-coated stents are a possible solution for post-angioplasty coronary restenosis. Here we analyze their efficacy, effectiveness and safety, and estimate the economic impact of their use in Spain.. Systematic review (meta-analysis) of the scientific evidence available up to January 2004, and analysis of hospital costs within a 1-year time horizon.. We identified 12 published studies (5 clinical series and 7 RCTs) comparing coated stents (sirolimus or paclitaxel) with conventional stents in patient with de novo single lesions < 30 mm in 2.5-3.5 mm vessels. In nearly all cases the rates of angiographic restenosis and major adverse cardiac events were lower in the coated stent group after 6-12 months. Meta-analysis showed a 69% decrease in revascularization rate (RR=0.31; 95%CI, 0.19-0.51). For every 1000 patients with de novo lesions, the use of a coated stent involved an additional average cost of Euro 818718. The estimated neutral price of a new stent was Euro 1448 at a market price per unit of Euro 2000.. At 12-month follow-up, sirolimus- or paclitaxel-eluting stents were effective and safe in patients with de novo lesions and low or medium risk of restenosis. At current market prices, the widespread use of these stents would involve an increase in health care expenditure for the different sensitivity scenarios we evaluated. More studies are needed to specify the type of patients and lesions likely to obtain the greatest clinical benefit.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug Delivery Systems; Drug Implants; Humans; Paclitaxel; Sirolimus; Spain; Stents

Data accrued to date indicate that stent placement in small vessels (< 3.0 mm reference diameter) suffers from the same disadvantage as other non-stent interventional devices in that the restenosis rate is significantly higher than observed following intervention involving large vessels. Randomized trials comparing systematic bare metal stenting versus conventional balloon angioplasty in the setting of small coronary arteries, however, show that the former therapeutic modality is probably superior to the latter treatment in its acute and mid-term angiographic and clinical results. Balloon angioplasty, even if performed optimally with resultant stent-like luminal outcome, yields a restenosis rate that is at best equivalent to that observed with stent placement. Stent performance is influenced profoundly by stent design and configuration. Tubular and corrugated stents are better than coil or meshwire stent design. Stents with thin struts appear to yield a lower restenosis rate compared with thick-strut stents. Coating the surface of stents with gold, phosphorylcholine or heparin does not appear to confer any additional long-term benefit compared with bare stainless-steel stents. On the other hand, impregnation of stents with anti-proliferative drugs, with or without a carrier polymer, has produced a significantly lower risk of restenosis, without an increase in stent thrombosis rate, compared with uncoated metal stents in multiple randomized trials. However, whether the clinico-anatomic benefits of drug-eluting stents can be sustained for several years and whether there are any long-term deleterious effects from the antiproliferative drug or carrier polymer remains unclear at this stage.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug Delivery Systems; Equipment Design; Humans; Paclitaxel; Sirolimus; Stents

Percutaneous treatment of coronary bifurcation lesions remained challenging in the stent era, with restenosis rates greater than 30% and no advantage from the routine use of kissing stents. Drug eluting stents (DES) have dramatically reduced the restenosis rates (RR) in the main vessel, but with conventional T-stenting double digits figures are still reported for the side-branch because of poor ostial coverage. The techniques of kissing stenting able to provide full lesion coverage (Culotte, V-stenting, Crush) have the potential to improve these results but the development of dedicated DES is probably needed to obtain consistently high procedural and long-term success.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Restenosis; Coronary Stenosis; Drug Therapy, Combination; Equipment Design; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Percutaneous treatment of coronary bifurcation lesions, pose a number of technical challenges to the interventional cardiologist. Each lesion has to be approached with its own, targeted solution in the context of the clinical picture, anatomy, and pathology. To achieve acceptable clinical outcomes a number of established techniques are available. The exact anatomy of the lesion determines the technique used. The most common approach is to stent the main vessel across the ostium of the side branch. The side branch can be additionally treated with a second stent or balloon angioplasty depending on the severity of the ostial lesion and/or evidence of active ischemia. Other techniques involve stenting the main branch up to the carina but sparing the side branches, multiple 'kissing stent' approaches ('Y','T', and 'V') or the 'culottes' technique. Follow-up data demonstrates a high (over 90%) technical success rate. Clinical outcome is variable but with conventional stents restenosis rates higher than 30% have been reported in most studies and there is no added advantage in routine stenting of both main vessel and side branch. Recent introduction of drug-eluting stents has resulted in a lower event rate and reduction of main vessel restenosis in comparison with historical controls. Side branch ostial restenosis remains a problem, which may require the development of novel 'bifurcate' stent designs to allow complete coverage with a single stent.

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Stenosis; Drug Carriers; Humans; Sirolimus; Stents; Treatment Outcome

Although the restenosis rate of coronary stenting is generally 10% to 20%, it can go as high as 60% in patients with diabetes or complex lesions. Currently, the only effective treatment for restenosis is brachytherapy. Drug-eluting stents may be the way to prevent restenosis that cardiologists have been seeking: the drug-coated stents are simple to use and help prevent negative remodeling and the intimal hyperplasia caused by stenting. In studies comparing sirolimus-coated and bare-metal stents, the sirolimus-coated stents resulted in less smooth muscle cell colonization, minimal intimal hyperplasia, and no edge effect; moreover, no adverse clinical events were reported. Currently ongoing, multicenter clinical trials of drug-eluting stents may soon come up with the answers that cardiologists have been hoping for.

Topics: Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Equipment Design; Equipment Safety; Female; Humans; Male; Secondary Prevention; Sensitivity and Specificity; Sirolimus; Stents; Vascular Patency

The aim of this study is to demonstrate the non-inferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the XIENCE stent regarding the patient-oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA).. The POLBOS LM study is a single-arm, prospective, multicentre study enrolling 260 patients (SYNTAX score ≤32) with a pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrolment will comply with objective inclusion criteria of diameter stenosis ≥50% in the LMCA based on off-line quantitative coronary angiography (QCA) analysed by an independent core laboratory using dedicated bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the same specific technical classification as for the BiOSS LIM (modified MADS classification) and the stent implantation is optimised by using pre-specified intravascular ultrasound criteria. The primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularisation) at 12 months.. The POLBOS LM study will indicate the efficacy of the BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.

Topics: Chromium; Cobalt; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

The novel sirolimus-eluting ultra-high molecular weight APTITUDE bioreabsorbable vascular scaffold (BRS) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to other BRS technologies. RENASCENT II is a prospective, multicentre first-in-human clinical study evaluating the clinical performance of the APTITUDE BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention.. The APTITUDE BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR) at 9 and 24 months. A total of 60 patients were enrolled. All patients underwent lesion predilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100%, respectively. Angiographic late lumen loss was 0.19±0.26 mm at 9 months and 0.3±0.41 mm at 24 months. At 9 months, TVF occurred in 2/59 patients (3.4%) due to TV-MI but there was no TLR. No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.. In this multicentre prospective study, the APTITUDE BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-month clinical follow-up.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (p

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus

Topics: Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Treatment Outcome

To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial.. The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient.. Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months.. In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.. These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Aged; Angina, Stable; Angina, Unstable; Antineoplastic Agents; Case-Control Studies; Coronary Stenosis; Diabetes Complications; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Polymers; Sirolimus; ST Elevation Myocardial Infarction; Treatment Outcome

The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, P

Topics: Absorbable Implants; Aftercare; Aged; Coronary Stenosis; Delayed-Action Preparations; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus; Thrombosis; Treatment Outcome

Dual antiplatelet therapy (DAPT) with aspirin and thienopyridine is required after placement of coronary stents to prevent thrombotic complications. However, current recommendation for duration of DAPT remains controversial. Firehawk is a biodegradable polymer applied to recessed abluminal grooves, sirolimus target-eluting stent associated with early excellent healing response and almost complete strut coverage, as well as possibly reduced myocardial ischaemic events. But the optimal DAPT duration for such a new generation stent is less known. Therefore, the present trial seeks to evaluate the safety and efficacy of 3-month versus 12-month DAPT in broad patients receiving Firehawk stents.. The TARGET DAPT study is designed to access the benefits and risks of short-term (3 months) versus long-term (12 months) DAPT in preventing stent thrombosis or major adverse cardiovascular and cerebrovascular events in subjects undergoing percutaneous coronary intervention for the treatment of coronary artery obstructive lesions. The TARGET DAPT trial is a large, prospective, multicentre, randomised (1:1) non-inferiority clinical trial that will enrol 2446 subjects treated with Firehawk stents. The primary endpoint is net adverse clinical and cerebral events, a composite of all-cause death, myocardial infarction, cerebral vascular accident and major bleeding (BARC 2,3 or 5) at 18 months clinical follow-up postindex procedure.. Ethics approval was obtained from the Ethics Committee of Zhongshan Hospital, Shanghai. The reference number is B2018-146R. Study findings will be made available to interested participants. Study results will be submitted for publication in a peer-reviewed journal. Also the protocol will be submitted and approved by the institutional Ethics Committee at each participating clinical centre.. NCT03008083.

Topics: Absorbable Implants; Aspirin; China; Clinical Trials, Phase IV as Topic; Coronary Angiography; Coronary Stenosis; Drug Administration Schedule; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Equivalence Trials as Topic; Hemorrhage; Humans; Multicenter Studies as Topic; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Sirolimus; Thrombosis

New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up.. Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients.. The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES.. In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Coronary bifurcations are encountered in about 15% to 20% of percutaneous coronary interventions (PCIs). They are considered technically challenging and associated with worse clinical outcomes than nonbifurcation lesions. The BiOSS LIM C is a dedicated bifurcation balloon expandable stent made of cobalt-chromium alloy (strut thickness 70 μm) releasing sirolimus (1.4 μg/mm) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids.. The aim of the randomized, multicenter, open-label, controlled POLBOS III trial is to compare BiOSS LIM C with limus second-generation drug-eluting stents (DES) in the treatment of non-left main stem coronary bifurcations (ClinicalTrials.gov NCT03548272).

Topics: Acute Coronary Syndrome; Chromium; Cobalt; Coronary Stenosis; Drug-Eluting Stents; Humans; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Research Design; Self Expandable Metallic Stents; Sirolimus; Treatment Outcome

In patients with increased bleeding risk during dual antiplatelet therapy, the biolimus A9-coated BioFreedom, a stainless steel drug-coated stent devoid of polymer, has shown superiority compared to a bare-metal stent. The aim of this study was to investigate whether the polymer-free biolimus A9-coated BioFreedom is noninferior to a modern thin-strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.. The multicenter SORT OUT IX trial (NCT02623140) randomly assigned all-comers patients to treatment with the BioFreedom drug-coated stent or the biodegradable polymer Orsiro stent in 4 Danish University Hospitals. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection based on Danish registries will be used and continue through 5 years. Assuming an event rate of 4.2% in each stent group, 1,563 patients in each treatment arm will provide 90% power to detect noninferiority of the drug-coated BioFreedom stent with a noninferiority margin of 2.1%.. A total of 3,150 patients have been randomized and enrolled in the study.. The SORT OUT IX trial will determine whether the drug-coated BioFreedom stent is noninferior to a modern biodegradable polymer Orsiro stent.

Topics: Absorbable Implants; Cause of Death; Chromium Alloys; Coronary Stenosis; Denmark; Drug-Eluting Stents; Equipment Design; Humans; Immunosuppressive Agents; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus; Time Factors

To show non-inferiority of the 67- or 87 µm thick, sirolimus-eluting Orsiro drug eluting stent (DES) to the 122 µm thick, biolimus-eluting Nobori DES regarding size of vessel lumen outside the stent at 13-month follow-up.. This study was a substudy to the SORT-OUT VII trial, a prospective, 1:1-randomized, comparison of the two stents in patients with stable coronary artery disease or acute coronary syndrome. Optical coherence tomography was acquired after percutaneous coronary intervention and at 13-month follow-up. The substudy was powered to access non-inferiority (Δ = 0.60 mm2) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro (n = 60) or Nobori (n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.26 mm2, but increased to 0.82 mm2 after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-inferiority limit. Testing for superiority, Orsiro had a significantly larger mean ESL at follow-up (Orsiro: 0.11 mm2 [0.02;0.30] mm2, Nobori: 0.03 mm2 [0.00;0.17] mm2, P = 0.04). Stent strut coverage was, Orsiro: 97.6 % [93.8;99.4]%, and Nobori: 96.3 % [90.5;98,6]% (P = 0.13).. Orsiro DES had a significantly larger mean ESL at follow-up and it could not be excluded that Orsiro exceeded the limit for non-inferiority. Nobori DES had a more heterogeneous distribution of neointima but stent strut coverage did not differ significantly between the two stents.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Neointima; Normal Distribution; Polymers; Prospective Studies; Prosthesis Design; Reference Values; Risk Assessment; Severity of Illness Index; Sirolimus; Statistics, Nonparametric; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Patency

The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents.. BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating.. Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients.. The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; p. The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).

Topics: Absorbable Implants; Aged; Cardiac Catheterization; Cardiovascular Agents; China; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polyesters; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent.. The BIONYX trial (ClinicalTrials.gov-no.NCT02508714) is an investigator-initiated, prospective, randomized, patient- and assessor-blinded, international, multicenter study in all-comer patients with all types of clinical syndromes and lesions who require percutaneous coronary interventions with DES. Patients at 7 study sites in the Netherlands, Belgium, and Israel were randomly assigned (1:1, stratified for gender and diabetes mellitus) to treatment with the novel, zotarolimus-eluting, durable polymer-coated Resolute Onyx stent that has a radiopaque, thin-strut, CoreWire stent platform versus the sirolimus-eluting, bioresorbable polymer-coated Orsiro stent (reference device) that has a very thin-strut, cobalt-chromium stent backbone. The primary end point is the 1-year incidence of the composite clinical end point target vessel failure consisting of cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. A power calculation, assuming a target vessel failure rate of 6.0% (noninferiority margin 2.5%), revealed that 2,470 study patients would give the study 80% power (α level 5%), allowing for up to 3% loss to follow-up. The first patient was enrolled on October 7, 2015; on December 23, 2016, the last patient entered the study.. BIONYX is a large-scale, prospective, randomized, international, multicenter trial comparing a novel DES with durable coating versus a reference DES with biodegradable coating in all-comers. The study is the first randomized assessment of the Resolute Onyx stent, which is an often-used DES outside the United States.

Topics: Absorbable Implants; Aged; Belgium; Coated Materials, Biocompatible; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Internationality; Israel; Kaplan-Meier Estimate; Male; Middle Aged; Netherlands; Patient Safety; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Risk Assessment; Single-Blind Method; Sirolimus; Statistics, Nonparametric; Survival Rate; Treatment Outcome

The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD).. Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established.. In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis.. Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72).. In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial.. Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI).. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years.. The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients.. Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prevalence; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

The primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device.. The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns.. In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post-scaffold implantation at 6 and 12 months.. Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was -0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = -0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: d. At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage.

Topics: Absorbable Implants; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Humans; Indonesia; Malaysia; Male; Middle Aged; Multimodal Imaging; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Our aim was to report the long-term safety and efficacy of the biodegradable polymer-coated biolimus- eluting Nobori stent compared to the durable polymer-coated sirolimus-eluting CYPHER stent.. SORT OUT V randomised 2,468 patients 1:1 to the Nobori (n=1,229) versus the CYPHER stent (n=1,239). Clinically driven event detection based on Danish registries was used. The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation). Individual components of the primary endpoint comprise the secondary endpoints. At five-year follow-up, the composite endpoint rate was found to be similar in patients treated with the two study stents (Nobori 182/1,229 [14.8%] vs. CYPHER 197/1,239 [15.8%]; odds ratio [OR] 0.93, 95% CI: 0.75-1.16; p=0.53). The rates of definite stent thrombosis were also found to be similar in patients treated with the two study stents (Nobori 23/1,229 [1.9%] vs. CYPHER 18/1,239 [1.5%]; OR 1.31, 95% CI: 0.70-2.47; p=0.40), as were the other secondary endpoints.. At five-year follow-up, the Nobori stent with a biodegradable polymer coating provided a similar safety and efficacy profile when compared to the durable polymer first-generation CYPHER stent.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We have recently seen the introduction of newer generation drug-eluting stents with ultrathin struts that use advanced polymer technologies. However, the efficacy and safety of these newest stents have not yet been fully explored. In addition, there are still controversies over the optimal duration of dual antiplatelet therapy (DAPT) after stent implantation, particularly for ultrathin stents with the newest polymer technologies.. The HOST-IDEA trial is a randomised, open-label, multicentre, non-inferiority trial and the first study to directly compare two of these ultrathin sirolimus-eluting stents: Orsiro stent with biodegradable polymer, and polymer-free Coroflex ISAR (CX-ISAR) stent. This study has a scheme of 2×2 factorial design according to the stent type and DAPT duration (3 vs 12 months). A total of 2152 patients will be randomised and stratified to demonstrate the non-inferiority of CX-ISAR to Orsiro, or of the abbreviated DAPT duration to the conventional 12 months (both in 1:1 ratio). For the comparison of stent type, the primary endpoint is target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction and clinically driven target lesion revascularisation. For the comparison of DAPT duration, the net adverse clinical event is the coprimary endpoint, which is defined as a composite of TLF, definite/probable stent thrombosis and major bleeding.. All the institutions involved in this study are required to have ethical approval prior to patient enrolment. This multicentre study will recruit patients through competitive registration, but institutions that have not yet obtained ethical approvals have made it impossible to enrol patients in a centralised web database. The final results will be presented at relevant international conferences and will be materialised in the form of papers.. NCT02601157; Pre-results.

Topics: Absorbable Implants; Clinical Protocols; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Equipment Design; Female; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Sirolimus; Thrombosis

Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution.. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization.. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison.

Topics: Absorbable Implants; Bayes Theorem; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Myocardial Revascularization; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions.. The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level.. Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate.. Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P < 0.001). Device success was obtained in 164 (99.5%) patients in the Axxess group and in all in the Control group (P = 1.00). Angiographic success was obtained in all patients. Inaccurate Axxess™ stent position occurred in 21 (13%) patients, and was more often associated with moderate-to-severe calcifications and distal lesion site. Procedural success was obtained in 91.5% patients in the Axxess group and in 90% patients in the Control group (P = 0.72).. The present registry suggests that the Axxess™ stent (1) may represent a valid alternative approach for the treatment of bifurcation lesions and (2) should be avoided in moderate-to-severe calcifications and/or in distal lesions. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Propensity Score; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Ultrasonography, Interventional

Incomplete neointimal coverage and malapposed struts after stenting are associated with increased risk of stent thrombosis. We aimed to evaluate neointimal coverage early after Resolute zotarolimus-eluting stent (R-ZES) implantation using optical coherence tomography (OCT). A total of 20 patients with de novo native coronary lesions with R-ZES were enrolled. Among these patients, 20 stented lesions in 19 patients were evaluated at 1, 2, and 3 months after R-ZES implantation. The strut apposition and neointimal coverage were evaluated by OCT. Neointimal hyperplasia (NIH) thickness and percentage of covered struts and the proportion of incompletely apposed struts were measured at 1-mm intervals. The mean percentages of covered stent struts were over 85 % within 3 months (88.4 ± 6.3 % at 1 month, 95.5 ± 5.5 % at 2 months, 93.6 ± 3.5 % at 3 months). The percentages of incompletely apposed struts were not significantly different among the groups (4.4 ± 4.2 % at 1 month, 1.9 ± 1.9 % at 2 months, 3.1 ± 2.2 % at 3 months, p = 0.51). Mean NIH thickness (38.9 ± 8.1 μm at 1 month, 70.6 ± 18.8 μm at 2 months, 54.1 ± 5.9 at 3 months, p = 0.0016) was thickest in the 2 months group. Most of all OCT findings within 2 months demonstrated neointimal coverage with low signal intensity. The neointimal coverage of ZES-R was over 85 % within 3 months. These data may support shorter requirement of dual antiplatelet therapy duration with R-ZES.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

This study aimed at comparing the mid-term clinical outcome of everolimus-eluting (EES) with sirolimus-eluting (SES) stents in the provisional bifurcation stenting guided by intravascular ultrasound (IVUS). We compared the clinical outcome up to 9-month follow-up results of the prospective J-REVERSE registry of 300 non-left main bifurcation lesions in 298 patients treated with EES (n = 240) and SES (n = 60). The SB dilation with the kissing balloon technique (KBT) was performed in 54 %. The patient and lesion characteristics of the groups were similar. The incidences of SB dissections, occlusions, stenting, and slow flow were similar. A greater luminal volume gain was achieved in the proximal MV after KBT compared in non-KBT treated lesions in the EES group (7.9 ± 2.4 versus 7.0 ± 2.0 mm(3)/mm, p = 0.002), though not in the SES group. The SB diameter stenosis in the non-KBT treatment at 9 months was greater than the KBT in both groups. The incidence of target lesion revascularisation (TLR) was 5.0 % in the EES versus 8.3 % in the SES group (p = 0.35), and the incidence of major adverse cardiac events, including TLR, myocardial infarction, stent thrombosis, and death was 5.4 % in the EES versus 11.7 % in the SES group (p = 0.15). IVUS-guided provisional stenting with EES achieved a greater luminal gain after than without KBT, and similar clinical outcomes as with SES up to 9-month follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Registries; Sirolimus; Thrombosis; Ultrasonography, Interventional

This study evaluated coronary endothelial function after the implantation of sirolimus-eluting stents (SESs), everolimus-eluting stents (EESs), and zotarolimus-eluting stents (ZES) by a different methodology, and also analyzed whether optical coherence tomography (OCT) findings represent endothelial healing after stenting.. It is unclear whether OCT assessment of stent strut coverage represents endothelial healing after drug-eluting stent implantation.. Thirty patients with a left anterior descending artery lesion were randomized 1:1:1 to receive an SES, EES, or ZES. The vascular response was evaluated 6 months after stenting by three methods: the functional response by acetylcholine infusion, the morphological response by OCT, and the biological response by measuring vascular endothelial growth factor (VEGF) levels.. The proportion of uncovered struts by OCT at 6 months was significantly higher in both SES and EES than in ZES. However, the vasomotor response was impaired and the VEGF level of the coronary sinus was significantly lower in SES than in EES and ZES. There were no relationships between the OCT findings and vasomotor response to acetylcholine and VEGF levels in all cohorts.. The vascular response at 6 months was more preserved in ZES and EES than in SES. Our results suggest that the morphological assessment with OCT may not always be used as a surrogate for functional and biological healing response after stenting. © 2015 Wiley Periodicals, Inc.

Topics: Acetylcholine; Aged; Aged, 80 and over; Biomarkers; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Endothelial Growth Factor A; Vasodilation; Vasodilator Agents; Wound Healing

The aim of the POLBOS II randomised trial was to compare any regular drug-eluting stents (rDES) with the dedicated bifurcation sirolimus-eluting stent BiOSS LIM for the treatment of coronary bifurcation lesions. The secondary aim was to study the effect of final kissing balloon inflation (FKBI) on clinical outcomes.. Between December 2012 and December 2013, 202 patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with an rDES (n=100). Coronary re-angiography was performed at 12 months. The primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target lesion revascularisation (TLR) at 12 months. The target vessel was located in the left main in one third of the cases (35.3% in BiOSS and 38% in rDES). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p<0.05).. MACE rates as well as TLR rates were comparable between the BiOSS LIM and rDES. At 12 months, cumulative MACE incidence was similar in both groups (11.8% vs. 15%), as was the TLR rate (9.8% vs. 9%). Significantly lower rates of restenosis were observed in the FKBI subgroup of the BiOSS group.

Topics: Acute Coronary Syndrome; Adult; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Sirolimus; Treatment Outcome

To assess performance of new, bioresorbable polymer sirolimus-eluting stent (BP-SES), in patients with long coronary lesions (LL) and to compare it to permanent polymer everolimus-eluting stent (PP-EES).. LL have been associated with worse clinical outcomes in percutaneous coronary interventions (PCI). The impact of lesion length on the outcomes of drug eluting stent (DES) implantations is not as clear.. In the frame of a randomized, multicentre CENTURY II study, out of 1119 patients enrolled, 182 patients had LL (defined as ≥25 mm), and were assigned randomly to treatment with BP-SES (101) or PP-EES (81). Primary endpoint was target lesion failure (TLF, composite of cardiac death, target vessel related myocardial infarction [MI], and target lesion revascularization [TLR]) at 9 months. All data were 100% monitored and adverse events were adjudicated by an independent clinical event committee.. The baseline patient and lesion characteristics were similar in the 2 study arms. At 9-months, the rates of cardiac death (2.0% vs 1.2%; P = 0.70), MI (3.0% vs 4.9%; P = 0.49) and clinically driven TLR (2.0% vs 3.7%; P = 0.48) and TLF (6.9% vs 8.6%; P = 0.67) were similar for BP-SES and PP-EES, respectively. There was no stent thrombosis (ST) in BP-SES group up to 9 months, while 1 case (1.2%) of ST was recorded in PP-EES group (P = 0.44).. Patients with LL showed similar clinical outcomes when treated with Ultimaster BP-SES and Xience PP-EES.

Topics: Absorbable Implants; Aged; Antineoplastic Agents; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Postoperative Complications; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Treatment Outcome

Our aim is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.. The EBC MAIN study is a prospective, multinational, randomised clinical study of left main stem true bifurcation lesions (type 1,1,1 or 0,1,1: both left anterior descending and circumflex artery >2.75 mm diameter). The study hypothesis is that left main coronary bifurcation lesions are best treated with a planned single-stent strategy rather than a planned dual-stent strategy, with respect to death, target lesion revascularisation and myocardial infarction at one year. A total of 450 patients will be enrolled and treated either with a planned single or a planned dual zotarolimus-eluting stent strategy according to randomisation. The primary study endpoint is a composite of death, myocardial infarction and target lesion revascularisation at 12 months. Secondary endpoints are: death, myocardial infarctions, and target lesion revascularisation, each at 12 months; angina status, stent thrombosis, death, myocardial infarction, target lesion revascularisation at three- and five-year clinical follow-up.. EBC MAIN will be the first randomised clinical trial to compare single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

To compare the efficacy and safety of the MiStent absorbable polymer sirolimus-eluting stent (APSES) with a zotarolimus-eluting stent (ZES).. The trial was a 2:1 randomisation at 26 sites of 184 patients implanted with an APSES (n=123) versus a ZES (n=61). Following stent implantation, all patients underwent quantitative coronary angiography at baseline and at nine months of follow-up, while a select subgroup also underwent optical coherence tomography (OCT). The primary efficacy hypothesis was superiority of in-stent late lumen loss (LLL) of APSES compared to ZES. At nine months, the primary endpoint was met, with a mean in-stent LLL of 0.27±0.46 mm in 103 APSES patients versus 0.58±0.41 mm in 52 ZES patients (p<0.001). The proportion of uncovered stent struts by OCT at nine months was very low in both groups. The mean neointimal thickness of covered struts (p=0.002) and percent net volume obstruction (p≤0.003) were significantly lower in the APSES than in the ZES group. Major adverse cardiac event and stent thrombosis rates were low and comparable between groups.. The DESSOLVE II trial demonstrated superiority in the primary efficacy endpoint of nine-month mean LLL for APSES compared to ZES. Strut coverage by OCT was high with both stents and the clinical safety endpoints including stent thrombosis were equally low in both groups. ClinicalTrials.gov Identifier: NCT01294748.

Topics: Absorbable Implants; Aged; Antibiotics, Antineoplastic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Single-Blind Method; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce.. The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.6% were diabetics, 70.1% had complex B2 or C lesions and 77.4% had "off-label" indications for DES use. Three-year follow-up data were obtained in 1,381 patients (99.3%; 10 withdrawals). Adverse clinical events were independently adjudicated. The primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically indicated target vessel revascularisation, was 12.1% for Resolute ZES and 13.4% for XIENCE V EES (p=0.50). Cardiac death rates were 1.9% vs. 3.5% (p=0.06); the other individual components of TVF also showed no significant between-group differences. The rates of definite-or-probable stent thrombosis (1.4% vs. 1.6%, p=0.82) and very late stent thrombosis (0.6% vs. 0.4%, p=1.0) did not differ between the groups.. Three-year follow-up data of patients included in the randomised TWENTE trial demonstrated similar and sustained safety and efficacy of Resolute ZES and XIENCE V EES.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Antineoplastic Agents; Cardiovascular Diseases; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Reoperation; Sirolimus; Thrombosis; Treatment Outcome

The aim of the present study was to evaluate the natural course of acute incomplete stent apposition (ISA) after second-generation everolimus-eluting stent (EES) when compared with first-generation sirolimus-eluting stent (SES) by using optical coherence tomography (OCT).. From the OCT substudy of the RESET trial, we identified 77 patients (EES = 38 and SES = 39) who successfully underwent serial OCT examination at post-stenting and 8-12-month follow-up. The presence of ISA was assessed in the OCT images, and ISA distance was measured from the centre of the strut blooming to the adjacent lumen border. Incomplete stent apposition was observed in all EES and SES at post-stenting, and it was persistent in 26% of EES and 38% of SES at 8-12-month follow-up. Maximum ISA distance was significantly decreased during the follow-up period in both EES (315 ± 94-110 ± 165 μm, P < 0.001) and SES (308 ± 119-143 ± 195 μm, P < 0.001). Receiver-operating curve analysis identified that the best cut-off value of OCT-estimated ISA distance at post-stenting for predicting late-persistent ISA at 8-12-month follow-up in EES and SES was >355 and >285 μm, respectively.. The second-generation EES showed better healing of acute ISA in comparison with the first-generation SES. Optical coherence tomography can predict late-persistent ISA after DES implantation and provide useful information to optimize PCI.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Monitoring, Physiologic; Predictive Value of Tests; Prospective Studies; Prosthesis Failure; Risk Assessment; ROC Curve; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

The aim of this analysis was to assess the 7-year long-term safety and effectiveness of a randomized comparison of percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of isolated proximal left anterior descending lesions.. Long-term follow-up data comparing PCI by SES and MIDCAB surgery for isolated proximal left anterior descending lesions are sparse.. Patients were randomized either to PCI with SES (n = 65) or MIDCAB (n = 65). Follow-up data were obtained after 7 years with respect to the primary composite endpoint of death, myocardial infarction, and target vessel revascularization. Angina was assessed by the Canadian Cardiovascular Society classification and quality of life with Short Form 36 and MacNew quality of life questionnaires.. Follow-up was conducted in 129 patients at a median time of 7.3 years (interquartile range: 5.7, 8.3). There were no significant differences in the incidence of the primary composite endpoint between groups (22% PCI vs. 12% MIDCAB; p = 0.17) or the endpoints death (14% vs. 17%; p = 0.81) and myocardial infarction (6% vs. 9%, p = 0.74). However, the target vessel revascularization rate was higher in the PCI group (20% vs. 1.5%; p < 0.001). Clinical symptoms and quality of life improved significantly from baseline with both interventions and were similar in magnitude between groups.. At 7-year follow-up, PCI by SES and MIDCAB in isolated proximal left anterior descending lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint and quality of life. Target vessel revascularization was more frequent in the PCI group. (MIDCAB Versus DES in Proximal LAD Lesions; NCT00299429).

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Quality of Life; Risk Factors; Sirolimus; Surveys and Questionnaires; Time Factors; Treatment Outcome

Stents with a passive coating of titanium-nitride-oxide (TiNO) have been compared with Endeavor® zotarolimus-eluting stents (E-ZES) with regard to the primary endpoint of in-stent late lumen loss at six to eight months. The objective of the present analysis was to compare the long-term outcomes of TiNO stents with E-ZES up to five years of clinical follow-up.. A total of 302 patients had been randomly allocated to treatment with TiNO or E-ZES. Up to five years of follow-up, major adverse cardiac events (MACE), the composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularisation (TLR), were observed in 27.6% of patients treated with TiNO stents and 25.3% of patients treated with E-ZES (RR 1.13, 95% CI: 0.72-1.75, p=0.60), with the majority of events related to clinically indicated TVR (TiNO 21.7% versus E-ZES 20.7%, RR 1.10, 95% CI: 0.67-1.81). There were no differences with respect to individual events including cardiac death, myocardial infarction or stent thrombosis between the two treatment arms up to five years of follow-up. A majority of patients remained free from angina throughout the entire study duration (TiNO 77.3% versus E-ZES 76.1%, p=0.92).. Final five-year outcomes of the TIDE trial comparing TiNO stents with E-ZES revealed increased rates of MACE driven primarily by clinically indicated TVR. The TIDE trial is registered at ClinicalTrials.gov: NCT00492908.

Topics: Aged; Antibiotics, Antineoplastic; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Proportional Hazards Models; Reoperation; Sirolimus; Titanium; Treatment Outcome

We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.. There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.. We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.. At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).. EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Denmark; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Incomplete struts coverage is a predictor of late stent thrombosis after implantation of the drug-eluting stents (DES) in atherosclerotic lesions. The process of struts coverage in DES implanted for bare-metal stent (BMS) restenosis has never been described. Thirty-two patients with stable coronary artery disease were consecutively selected, 11 with BMS restenosis (group A) and 21 with de novo atherosclerotic lesions (group B). All patients underwent everolimus-eluting stent implantation; coronary angiography and optical coherence tomography were performed at 6 months follow-up. Percentage difference in struts coverage between the 2 groups was the primary end point. A total of 85,773 struts (17,891 in group A and 67,882 in group B) were analyzed: compared with group B, the percentage of uncovered stent struts was significantly lower in group A (2.6% vs 4.8%; p <0.0001). In group A, DES struts protruding out of BMS were more uncovered (5.0% vs 1.9%; p <0.0001) and malapposed (4.1% vs 2.1%; p <0.0001) compared with overlapping struts. In conclusion, when DES are implanted to treat BMS restenosis, struts coverage at 6 months follow-up is more complete compared with DES implanted in atherosclerotic lesions.

Topics: Antineoplastic Agents; Atherosclerosis; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Electrocardiography; Everolimus; Follow-Up Studies; Immunosuppressive Agents; Prosthesis Design; Reproducibility of Results; Retrospective Studies; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence

In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year.. This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis.. We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis.. At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012).. During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).

Topics: Aged; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome

There has not been sufficient data to evaluate the serial vascular healing pattern after everolimus-eluting stent (EES) implantation. Using optical coherence tomography, we compared serial changes in strut coverage of the EES and the first-generation sirolimus-eluting stent (SES).. Sixty patients were randomly assigned to receive either EES (n = 30) or first-generation SES (n = 30) for coronary artery disease. Serial optical coherence tomography evaluation immediately after the procedure, and 3- and 12-month follow-ups were performed in 50 patients with 54 stents (25 patients with 28 EES vs. 25 patients with 26 SES). The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts. The primary end point was the percentage of uncovered struts at 12-month follow-up. The secondary primary end point was the percentage of uncovered struts at the 3-month follow-up and the comparative percentage change (Δ) of uncovered struts at 3- and 12-month follow-ups of EES vs SES.. The percentage of uncovered struts was significantly lower in the EES group compared with the SES group (median value, 6.9%; interquartile range [IQR], 3.9-10.6% vs. 11.1%; IQR, 5.5-29.4%, respectively) at the 3-month follow-up (P = 0.03), and at the 12-month follow-up (median value, 1.3%; IQR, 0.3-3.5% vs. 3.6%; IQR, 1.0-9.4%; P = 0.02). The percentage Δ of uncovered struts from the 3- to the 12-month follow-up was similar (-7.0 ± 6.9% in EES vs. -10.5 ± 13.6% in SES; P = 0.24).. The EES group showed more favourable stent strut coverage than the first-generation SES group at the early and late periods after stent implantation. These findings suggest that EES have a more beneficial effect for vascular healing.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Multivariate Analysis; Prognosis; Prospective Studies; Prosthesis Design; Regression Analysis; Risk Assessment; Severity of Illness Index; Sex Factors; Sirolimus; Survival Analysis; Treatment Outcome

The purpose of the present study was to investigate the relationship between in-stent neoatherosclerosis (NA) and native atherosclerosis progression of untreated coronary segments.. In-stent NA was assessed by optical coherence tomography (OCT) among patients included in the SIRTAX-LATE OCT study 5 years after drug-eluting stent (DES) (sirolimus-eluting and paclitaxel-eluting stents) implantation. Neoatherosclerosis was defined as the presence of fibroatheroma or fibrocalcific plaque within the neointima of stented segments with a longitudinal extension >1.0 mm. Atherosclerosis progression in untreated native coronary segments was evaluated by serial quantitative coronary angiography (QCA). The change in minimal lumen diameter (MLD) was serially assessed within matched segments at baseline and 5-year angiographic follow-up. The key clinical endpoint was non-target lesion (non-TL) revascularization throughout 5 years. A total of 88 patients with 88 lesions were available for OCT analysis 5 years after DES implantation. In-stent NA was observed in 16% of lesions with the majority of plaques being fibroatheromas (11.4%) followed by fibrocalcific plaques (5.7%). A total of 704 non-TL segments were serially evaluated by QCA. Between baseline and 5-year follow-up, the reduction in MLD was significantly more pronounced in patients with NA (-0.25 mm, 95% CI -0.36 to -0.17 mm) when compared with patients without NA (-0.13 mm, 95% CI -0.17 to -0.10 mm, P = 0.002). Similarly, non-TL revascularization was more frequent in patients with NA (78.6%) when compared with patients without NA (44.6%, P = 0.028) throughout 5 years.. In-stent NA is more common among patients with angiographic and clinical evidence of native atherosclerosis progression suggesting similar pathophysiological mechanisms.SIRTAX trial is registered at http://www.clinicaltrials.gov/ct2/show/NCT00617084.

Topics: Aged; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease Progression; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Neointima; Paclitaxel; Prosthesis Failure; Sirolimus; Tomography, Optical Coherence; Tubulin Modulators

The aim of this substudy of the SORT OUT IV trial was to compare clinical outcomes among patients with acute coronary syndromes (ACS) and stable angina pectoris (SAP) treated with everolimus-eluting stents (EES) or sirolimus-eluting stents (SES).. We performed a post hoc subgroup analysis of data from SORT OUT IV. Of 2,705 patients, 1,178 (43.5%) patients had ACS and were treated with EES (n=580) or SES (n=598), and 1,527 (56.5%) patients had SAP and were treated with EES (n=773) or SES (n=754). The primary composite endpoint was major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI), stent thrombosis, or target vessel revascularisation within 18 months. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated for the endpoints. At 18-month follow-up, patients with ACS had higher rates of MACE compared to patients with SAP (8.1% versus 6.7%; HR=1.23, 95% CI: 0.93-1.62). MACE did not differ significantly between ACS patients treated with EES or SES (7.3% versus 8.9%; HR=0.81, 95% CI: 0.54-1.22) nor between SAP patients treated with EES or SES (6.9% versus 6.5%; HR=1.05, 95% CI: 0.71-1.55).. EES and SES performed similarly with respect to MACE at 18-month follow-up in patients with ACS and SAP.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Chi-Square Distribution; Coronary Stenosis; Coronary Thrombosis; Denmark; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Persistence of stent polymer coating has been associated with incomplete endothelialization, expansive vessel remodeling, neoatherosclerosis, and delayed healing associated with inflammation that may contribute to late adverse events.. The BICARE (Lepu Medical, Beijing, China) stent is a novel polymer-free, nanotechnology-based stent eluting sirolimus and probucol. As a first in human feasibility study, patients with a single de novo native coronary stenosis <30 mm in length and with reference vessel diameter from 2.5 to 4.0 mm underwent revascularization with the BICARE stent. The primary endpoint of target lesion failure (TLF) was assessed at 30 days. Secondary endpoints included in-stent late lumen loss and proportion of uncovered or malapposed stent struts by optical coherence tomography at 4-month angiographic surveillance.. Among 32 consecutive patients (age, 55.7 ± 8.7 years; men, 62.5%; diabetes, 18.8%), the average baseline reference vessel diameter and lesion length were 2.85 ± 0.48 mm and 15.0 ± 5.6 mm, respectively. At 30 days there was no occurrence of TLF. At 4 months (angiographic follow-up, N=32), angiographic in-stent late loss was 0.14 ± 0.19 mm, and the in-stent binary restenosis rate was 3.1%. Complete strut coverage was 98.2% with 0.2% malapposition among 16,751 analyzed struts. At 18 months, TLF occurred in 3 (9.4%) patients related to repeat revascularization with no adverse safety events identified.. The preliminary feasibility and safety of a polymer-free, dual-drug eluting stent are demonstrated by absence of early adverse safety events and favorable angiographic suppression of neointimal hyperplasia. Stent imaging suggests favorable healing with extensive stent strut coverage and very low malapposition. These findings further inform comparison with biopermanent polymer DES.

Topics: Cardiovascular Agents; China; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Combinations; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Probucol; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Different approaches of local intravascular drug delivery may influence endothelial and microvascular function. The aim of this trial was to study the influence of a paclitaxel coated balloon in combination with a bare metal stent (DCB + BMS) versus a bare metal stent (BMS) or a sirolimus-eluting stent (DES) on coronary restenosis and endothelial function.. This prospective trial included 77 patients with coronary de novo lesions. The patients were assigned to either one of the treatment groups. After 9 months, patients underwent angiographic follow-up including invasive measurement of coronary endothelial function. After 9 months, late lumen loss in-stent was highest in the BMS group (0.85 ± 0.73 mm), lower in DCB + BMS (0.36 ± 0.46 mm); and lowest in the DES group (0.25 ± 0.34 mm; P = 0.001 [ANOVA]). When compared to the BMS group, in-segment late lumen loss was significantly reduced in the DCB + BMS group (0.27 ± 0.43 mm vs. 0.60 ± 0.55 mm, P = 0.029) and the DES group (0.28 ± 0.40 mm, P = 0.045). Coronary flow reserve was significantly higher with the DCB + BMS treatment (3.16 ± 0.97 vs. 2.42 ± 0.99 [BMS], P = 0.036) whereas the increase in the DES group did not reach the significance level (3.06 ± 1.39, P = 0.144 vs. BMS). Parameters of endothelial function like intracoronary flow velocity and vessel diameter distal to the stented area showed similar patterns of response to adenosine, acetylcholine, and nitro in all groups.. DES and the combination of DCB + BMS showed a significant reduction of late lumen loss as compared to a BMS alone. Furthermore, both types of local drug delivery were not associated with a deterioration of microvascular function at 9 months [ClinicalTrials.gov Identifier: NCT00473499].

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endothelium, Vascular; Female; Hemodynamics; Humans; Male; Metals; Microcirculation; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Vasodilator Agents

This study sought to evaluate the impact of anatomic and procedural variables on the outcome of the unprotected left main coronary artery (uLMCA) itself after drug-eluting stent (DES) implantation.. There is a controversial debate regarding when and how to perform percutaneous coronary intervention (PCI) for an uLMCA stenosis.. This analysis is based on a randomized study of 607 patients undergoing PCI for uLMCA, randomized 1:1 to receive paclitaxel- or sirolimus-eluting stents. We evaluated the impact of the SYNTAX score, uLMCA anatomy, and stenting technique on in-stent restenosis (ISR), target lesion revascularization (TLR), and the 3-year outcomes.. The 3-year cardiac mortality rate was 5.8%; 235 (39%) patients had a true bifurcation lesion (TBL), and the median SYNTAX score was 27. TBL was associated with a higher need for multiple stents (72% vs. 37%, p < 0.001). TBL was a significant predictor of ISR (23% vs. 14%, p = 0.008) and for TLR (18% vs. 9%, p < 0.001). The need for multiple stents was a predictor of ISR (22% vs. 13%, p = 0.005) and for TLR (16% vs. 9%, p = 0.005). Culotte stenting showed better results compared with T-stenting for ISR (21% vs. 56%, p = 0.02) and for TLR (15% vs. 56%, p < 0.001). We observed a significant association between uLMCA-TLR and SYNTAX scores (9.2% for scores ≤ 22, 14.9% for scores 23 to 32, and 13.0% for scores ≥ 33, p = 0.008).. PCI of uLMCA lesions with DES is safe and effective out to 3 years. TBL and multiple stents were independent predictors for ISR. In the multivariate analysis, independent predictors for TLR were TBL, age, and EuroSCORE (European System for Cardiac Operative Risk Evaluation). (Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT-MAIN]; NCT00133237).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention (PCI). This study aimed to elucidate the relative efficacy of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) according to diabetic status.. Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. Among a total of 6,524 patients, 2,404 (36.8%) had diabetes mellitus. Patients with diabetes were shown to have a higher rate of TLF after PCI, which was mainly driven by differences in cardiac death and myocardial infarction, while the rate of repeat revascularisation and stent thrombosis did not differ significantly. TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status (interaction p=0.384). In addition, no significant interactions were present with regard to any pre-specified clinical endpoints. The results were corroborated by analysis with inverse probability of treatment weighting (interaction p=0.329). We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI.. Despite the recent advances in drug-eluting stent technology, diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus. Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI.

Topics: Aged; Case-Control Studies; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR).. Treatment of patients with ISR remains a challenge.. This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up.. A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups.. In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Prosthesis Failure; Risk Assessment; Severity of Illness Index; Sirolimus; Spain; Survival Rate; Treatment Outcome

The aims of this study were to compare strut tissue coverage at six-month follow-up after Nobori biolimus-eluting stent (N-BES) versus sirolimus-eluting stent (SES) implantation.. A total of 120 patients with a single stenotic lesion requiring revascularisation were randomly assigned to either N-BES (n=60) or SES (n=60). Baseline optical coherence tomography (OCT) was performed post stent implantation, and follow-up OCT was scheduled at six months. Post-intervention and follow-up OCT analyses were available in 51 (85.0%) and 52 (86.7%) patients, respectively. The primary endpoint was the percentage of uncovered struts at follow-up OCT in all cross-sections with analysis of 0.2 mm longitudinal intervals. In addition, an OCT contour plot analysis was constructed to investigate the distribution patterns of uncovered struts. The percentage of uncovered struts of N-BES was significantly lower versus SES (15.9±12.2% versus 25.1±18.3%, respectively, p=0.003). N-BES showed a greater NIH thickness than SES (median [interquartile range] 52.4 μm [41.9-74.9] versus 42.1 μm [30.6-56.0], p=0.005). Contour plot analyses showed a lower incidence of a diffuse distribution pattern of uncovered struts (46.8% versus 75.0%, respectively, p=0.022).. This randomised OCT study showed that N-BES had a significantly lower percentage of uncovered struts, and less common diffuse distribution pattern of uncovered struts versus SES.

Topics: Aged; Cardiovascular Agents; Coronary Stenosis; Coronary Vessels; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

In the TARGET I randomized controlled trial, the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent FIREHAWK proved non-inferior to the everolimus-eluting stent in nine-month in-stent late loss in single de novo coronary lesions. This study was aimed at evaluating clinical safety and effectiveness of FIREHAWK in a moderately complex population (including patients with small vessels, long lesions and multi-vessels), and at validating the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with this latest generation drug-eluting stent.. TARGET II was a prospective, multicenter, single-arm study with primary outcome of 12-month target lesion failure (TLF), including cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (TLR). Stent thrombosis was defined according to the Academic Research Consortium (ARC) definition. Patients were grouped by tertiles of SS (≤6, >6 to ≤12, and >12). All patients were exclusively treated with the FIREHAWK stent and were followed up at 1, 6, and 12 months, and annually thereafter up to five years.. A total of 730 patients were included in this registry study. The 12-month incidence of TLF was 4.4% and the incidence of TLF components were, cardiac death 0.5%, TV-MI 3.2%, and TLR 2.2%. One definite/probable stent thrombosis was observed at 12-month follow-up. Mean SS was 10.87±6.87. Patients in the SS >12 tertile had significantly higher TLF (P = 0.02) and TLR (P < 0.01) rates than those in lower SS groups. In COX proportional-hazards regression analyses, TLF incidence was strongly related to lesion length (long lesion vs. non-long lesion patients; HR 3.416, 95% CI, 1.622-7.195), but unrelated to diabetic, small vessel, and multivessel subgroups.. The low TLF incidence in this study indicates that FIREHAWK is safe and effective in the treatment of moderately complex coronary disease. SS is also able to predict adverse clinical outcomes in FIREHAWK treated patients.

Topics: Adolescent; Adult; Aged; Biocompatible Materials; Cardiovascular Agents; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Sirolimus; Young Adult

Many studies have reported comparable risk of hard end points between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for unprotected left main coronary artery (ULMCA) stenosis. However, there are limited data regarding the morbidity associated with ULMCA revascularization. This study sought to compare the cause and risk of readmissions after PCI and CABG for ULMCA stenosis. We evaluated the unadjusted and adjusted risk of readmissions in 1,352 patients (783 PCI treated and 569 CABG treated) who were consecutively enrolled in a multicenter registry of patients with ULMCA stenosis, named the Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease trial. Overall, 206 PCI-treated patients (26.3%) experienced at least 1 readmission after the index procedure during 48.7 ± 16.0 months of follow-up compared with 84 CABG-treated patients (14.8%, p <0.001). The most frequent causes of readmission were repeat revascularization after PCI (41%) and noncardiac readmissions after CABG (48%). Through repeated events analysis, PCI was associated with more frequent readmissions than CABG (hazard ratio 2.037, 95% confidence interval 1.542 to 2.692, p <0.001), being an independent predictor of readmission (hazard ratio 1.820, 95% confidence interval 1.420 to 2.331, p <0.001). Except for the acute period, defined as the first 3 months, when there was no significant difference in readmission rate, a higher readmission rate after PCI was consistently observed over the remainder of the follow-up period. In conclusion, PCI was shown to be associated with a higher risk of readmission than CABG in treating ULMCA disease. This higher risk was attributable to more frequent revascularization in the PCI group.

Topics: Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Patient Readmission; Percutaneous Coronary Intervention; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy.. This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis.. Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Long-term clinical outcomes of everolimus-eluting stent (EES) compared with sirolimus-eluting stent (SES) have not been evaluated fully yet, especially whether EES implantation could positively affect late adverse events reported after SES implantation occurring >1 year.. In this all-comer prospective multicenter randomized open-label trial, 3196 patients were assigned randomly to implant either EES (n=1596) or SES (n=1600). At 3 years, EES was noninferior to SES on the primary safety end point (all-cause death or myocardial infarction; 10.1% versus 11.5%; noninferiority P <0.001; and superiority P=0.19). Cumulative incidence of definite stent thrombosis was low and was not significantly different between the 2 groups (0.5% versus 0.6%; P=0.81). There was no significant difference in the efficacy end point of target-lesion revascularization between the EES and SES groups (6.6% versus 7.9%; P=0.16). However, the cumulative incidence of target-lesion failure (cardiac death/target-vessel myocardial infarction/ischemia-driven target-lesion revascularization) was significantly lower in the EES group than in the SES group (8.8% versus 11.4%; P=0.01). By a landmark analysis at 1 year, the cumulative incidence of very late stent thrombosis and late target-lesion revascularization was not significantly different between the 2 groups (0.2% versus 0.2%; P=0.99 and 2.2% versus 2.9%; P=0.21, respectively).. The efficacy and safety outcomes for this trial after EES implantation remained comparable with those after SES implantation through 3-year follow-up. However, improvement of clinical outcome after EES implantation compared with SES implantation was suggested by the significantly lower cumulative incidences of target-lesion failure, which has been the most widely used primary end point in the stent-versus-stent trials.. http://www.clinicaltrials.gov. Unique identifier: NCT01035450.

Topics: Aged; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Thrombosis; Treatment Outcome

This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI).. PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents.. We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD.. At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352).. At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).

Topics: Antineoplastic Agents; Chromium Alloys; Chromium Compounds; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platinum Compounds; Prospective Studies; Prosthesis Design; Republic of Korea; Single-Blind Method; Sirolimus; Treatment Outcome

Paclitaxel drug-eluting balloons (pDEB) could be an attractive option to minimise side branch (SB) restenosis in bifurcated coronary lesions. We compared angiographic and clinical outcomes with pDEB plus bare metal stent (BMS) versus drug-eluting stents (DES) in de novo bifurcated lesions.. This multicentre randomised trial included 108 patients. Sequential main branch (MB)/SB dilatation with pDEB, with provisional T-stenting with BMS in the MB was performed in the pDEB group, and with everolimus DES in the DES group. The primary endpoint was late lumen loss (LLL) at nine months. The secondary endpoint was the incidence of major adverse cardiac events (MACE: death, myocardial infarction, or target lesion revascularisation). In-segment MB LLL was 0.31±0.48 mm in the pDEB group, and 0.16±0.38 mm in the DES group (p=0.15); mean difference was 0.15 mm (upper limit one-sided 95% CI: 0.27 mm; p=0.001; non-inferiority test). LLL in SB was -0.04±0.76 mm in the pDEB group and -0.03±0.51 mm in the DES group (p=0.983). MACE and TLR were higher in the pDEB group (17.3% vs. 7.1%; p=0.105, and 15.4% vs. 3.6%; p=0.045), due to higher MB restenosis (13.5% vs. 1.8%; p=0.027).. pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL (ns) and increased incidence of MACE compared to everolimus DES. Both strategies showed similar results in the SB.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Aspirin; Clopidogrel; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Stents; Ticlopidine; Treatment Outcome; Tubulin Modulators

The aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan.. The CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months-TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]-was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively.. The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up.. UMIN000006940.

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Myocardial Ischemia; Percutaneous Coronary Intervention; Prospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome

The systematic pro-inflammatory responses after percutaneous coronary intervention with drug-eluting stents (DES) remain poorly defined. Therefore, we compared the systematic pro-inflammatory state of circulating mononuclear cells (MNCs) between DES and bare metal stent (BMS) implantation.. Patients with indications for treatment with stents were randomized in a 1:1 ratio to placement of DES or BMS. The primary endpoint was a change of pro-inflammatory state at 12 weeks post-procedure.. Thirty-six consecutive patients received DES or BMS. At 12 weeks after stent implantation, the lipid profile and high-sensitivity C-reactive protein (hs-CRP) improved significantly in both groups. The mRNA levels and plasma concentrations of interleukin-6, tumor necrosis factor-α and matrix metalloproteinase-9 were significantly elevated in the DES group, which was not observed in the BMS group. An increase in NF-κB binding activity and a decrease in PPAR-γ expression in MNCs were observed in the DES group, along with increases in IκB phosphorylation and p50 expression. However, similar changes were not observed in the BMS group.. Systematic inflammatory responses were accentuated after the patients were treated percutaneously with DES, despite their improved lipid profile and hs-CRP. These data may provide fundamental information for optimizing therapeutic strategy in the era of DES.

Topics: Analysis of Variance; C-Reactive Protein; Coronary Stenosis; Drug-Eluting Stents; Enzyme-Linked Immunosorbent Assay; Everolimus; Humans; Immunosuppressive Agents; Interleukin-4; Interleukin-6; Leukocytes, Mononuclear; Matrix Metalloproteinase 9; RNA, Messenger; Sirolimus; Stents; Systemic Inflammatory Response Syndrome; Tumor Necrosis Factor-alpha

To our knowledge, no randomised study has compared rates of uncovered stent struts in everolimus (EES) vs. new-generation zotarolimus-eluting (ZES-R) stents in acute coronary syndrome (ACS). The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography (OCT) in ACS patients treated with drug-eluting stents (DES) comparing EES versus new-generation ZES-R.. All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R. The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography (OCT) at six months. Secondary endpoints were the percentage of malapposed stent struts, percent neointimal hyperplasia cross-sectional area (CSA) and major adverse cardiac events (MACE) at six months. A total of 60 patients were randomised to EES (n=29) or ZES-R (n=31). No differences were observed in baseline characteristics between the two groups. Overall, 31.7% presented with STEMI, of which 68.4% were anterior. The other patients comprised 41.7% NSTEMI and 26.7% troponin-negative ACS. A mean of 1.3±0.6 lesions were treated per patient, with a mean of 1.3±0.5 stents per lesion. At 30 days there was one sudden death. Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group. There was no difference in the primary endpoint of uncovered stent struts between groups (EES 6.42% [3.27, 9.57] vs. ZES-R 7.07% [3.22, 10.92]; p=0.80). Furthermore, there were no differences between groups in the percentage of malapposed stent struts, either with (EES 1.19% [0.34, 2.04] vs. ZES-R 0.85% [0.40, 1.30]; p=0.49) or without coverage (EES 1.06% [0.12, 2.01] vs. ZES-R 0.24% [0.05, 0.44]; p=0.09). Percent neointima CSA was similar in both groups (EES 37.0% [18.6, 55.3] vs. ZES-R 26.6% [18.4, 34.8]; p=0.31). At six-month clinical follow-up, no additional patients died or suffered MI. There were four MACE in the EES group and one in the ZES-R group.. In our study, in patients presenting with ACS, both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis.

Topics: Acute Coronary Syndrome; Aged; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Single-Blind Method; Sirolimus; Tomography, Optical Coherence

Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first real-life human experience with the rapamycin-eluting biodegradable polymer-coated Rapstrom stent.. All consecutive patients with single de novo native coronary stenosis (<30 mm and between 2.5 and 4.0 mm) were enrolled. Major adverse cardiac events (MACE) at 1 year (cardiac death, myocardial infarction [Q and non-Q], or ischemia-driven target lesion revascularization) were the primary end-point.. A total of 123 patients were enrolled. The stent was implanted without complications in all patients, and no MACE were recorded at 30 days. At 12-month follow-up 9 patients (7.3%) experienced a MACE and 4 (3.2%) required a target lesion revascularization, while 1 (1%) stent thrombosis was recorded. A planned angiographic follow-up (FU) was performed in 73 patients (59%) at 9.4 ± 2.6 months following the index procedure. In-stent late loss was 0.16 ± 0.09 mm, and in-segment late loss was 0.18 ± 0.8 mm.. The Rapstrom biodegradable polymer rapamycin-eluting stent appeared safe and efficacious in this first real-life human experience, due to a low late lumen loss. Larger randomized studies are required to confirm these preliminary results.

Topics: Absorbable Implants; Coronary Angiography; Coronary Stenosis; Delayed-Action Preparations; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Revascularization; Prospective Studies; Sirolimus; Thrombosis

To investigate the outcomes of percutaneous coronary intervention (PCI) in bifurcation versus non-bifurcation lesions using the next-generation Resolute zotarolimus-eluting stent (R-ZES).. We analyzed 3-year pooled data from the RESOLUTE All-Comers trial and the RESOLUTE International registry. The R-ZES was used in 2772 non-bifurcation lesion patients and 703 bifurcation lesion patients, of which 482 were treated with a simple-stent technique (1 stent used to treat the bifurcation lesion) and 221 with a complex bifurcation technique (2 or more stents used). The primary endpoint was 3-year target lesion failure (TLF, defined as the composite of death from cardiac causes, target vessel myocardial infarction, or clinically-indicated target lesion revascularization [TLR]), and was 13.3% in bifurcation vs 11.3% in non-bifurcation lesion patients (adjusted P=.06). Landmark analysis revealed that this difference was driven by differences in the first 30 days between bifurcation vs non-bifurcation lesions (TLF, 6.6% vs 2.7%, respectively; adjusted P<.001), which included significant differences in each component of TLF and in-stent thrombosis. Between 31 days and 3 years, TLF, its components, and stent thrombosis did not differ significantly between bifurcation lesions and non-bifurcation lesions (TLF, 7.7% vs 9.0%, respectively; adjusted P=.50).. The 3-year risk of TLF following PCI with R-ZES in bifurcation lesions was not significantly different from non-bifurcation lesions. However, there was an increased risk associated with bifurcation lesions during the first 30 days; beyond 30 days, bifurcation lesions and non-bifurcation lesions yielded similar 3-year outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cause of Death; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Recurrence; Registries; Retrospective Studies; Sirolimus

Intimal hyperplasia appears to differ after implanting a drug-eluting stent (DES) with a biodegradable or a permanent polymer. The aim of the present study was to compare biodegradable with permanent polymer DES, since the available data are limited. One hundred patients with de novo coronary artery stenosis were included in this study. The patients were classified into 2 groups: DES with a biodegradable polymer (n=50) and DES with a permanent polymer (n=50). Optical coherence tomography (OCT) examination was performed before and after stent implantation. A follow‑up OCT, performed 1 year after stent implantation, compared the morphologies of intimal hyperplasia in the 2 groups. The frequencies of uncovered stent struts (2.27 vs. 1.87%, P=0.145) and stent strut malapposition (1.9 vs. 2.02%, P=0.655) upon the first-year follow-up were not significantly different. Average neointimal thickness was lower in the biodegradable compared with the permanent polymer group (106.12±80.65 vs. 181.20±146.96 µm, P<0.001). The frequencies of neointimal thickness <100 µm were significantly higher in the biodegradable compared with the permanent polymer group (62.1 vs. 35.9%, P<0.001). The average intimal thickness was also lower in the biodegradable compared with the permanent polymer group (57.7±24.6 vs. 67.6±22.4 µm, P<0.001). In conclusion, biodegradable polymer DES resulted in significantly lower intimal hyperplasia and had well-proportioned intimal coverage compared with permanent polymer DES.

Topics: Aged; Biodegradable Plastics; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Polymers; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial.

Topics: Antineoplastic Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

The DIABETES (DIABETes and sirolimus-Eluting Stent) trial is a prospective, multicentre, randomised, controlled trial aimed at demonstrating the efficacy of sirolimus-eluting stent (SES) as compared to bare metal stent (BMS) implantation in diabetic patients. The aim of the present analysis was to assess the five-year clinical follow-up of the patients included in this trial.. One hundred and sixty patients (222 lesions) were included: 80 patients were randomised to SES and 80 patients to BMS. Patients were eligible for the study if they were identified as non-insulin-dependent diabetics (NIDDM) or insulin-dependent diabetics (IDDM), with significant native coronary stenoses in ≥1 vessel. There was a sub-randomisation according to diabetes status. Clinical follow-up was extended up to five years. Five-year clinical follow-up was obtained in 96.2%. Overall, MACE at five years was significantly lower in the SES group as compared with the BMS arm, mainly due to a significant reduction in TLR. There were no significant differences in cardiac death or myocardial infarction (MI). This was also observed in both prespecified subgroups IDDM and NIDDM. In the SES group, the incidence density of definite/probable stent thrombosis was 0.53 per 100 person-years, whereas in the BMS group it was 0.8 per 100 person-years. Independent predictors of MACE were: SES implantation (p<0.001), multivessel stent implantation (p=0.04), and creatinine levels (p=0.001).. Five-year follow-up of the DIABETES trial suggests the effect of SES in reducing TLR is similar in both IDDM and NIDDM. No major safety concerns in terms of ST, MI or mortality were observed.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Spain; Stents; Time Factors; Treatment Outcome

This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months.. Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations.. One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events.. The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group.. In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.

Topics: Aged; Antibodies; Antigens, CD34; Asia; Australia; Brazil; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Endothelial Cells; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Stem Cells; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years.. In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28).. After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc.

Topics: Aged; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; New Zealand; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS).. Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain.. Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596).. Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p < 0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p < 0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES.. Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Paclitaxel-eluting stents (PESs) have been shown to inhibit neointimal hyperplasia after percutaneous coronary intervention. Coroflex Please (B Braun, Melsungen, Germany) is a newly developed PES. We compared the clinical and angiographic efficacy of Coroflex Please with Taxus Liberte (Boston Scientific, Natick, MA) in a real-world practice.. We performed a prospective, open-label, randomized, controlled study that enrolled 945 patients undergoing percutaneous coronary interventions in 18 centers in Korea. The primary end point was clinically driven target vessel revascularization at 9 months. The baseline characteristics were mostly similar and comparable between 2 groups. At 9 months, the incidence of clinically driven target vessel revascularization was 14.6% for Coroflex and 6.4% for Taxus, which was significantly different (hazard ratio 2.43, 95% CI 1.50-3.94, noninferiority P value = 1.000). This is well corroborated by the difference of in-stent late loss between 2 stents (0.71 ± 0.64 mm vs 0.52 ± 0.50 mm, P < .001) by 9-month follow-up angiography (n = 415 vs 215). Among secondary clinical end points, stent thrombosis (definite and probable) for 1 year was 2.2% in Coroflex and 1.3% in Taxus (P = .317). Also, myocardial infarction for 9 months was higher in Coroflex group than that in Taxus (4.9% vs 1.6%, P = .012), which was partly contributed by the higher incidence of periprocedural myocardial infarction in Coroflex arm (2.2% vs 0.3%, P = .028).. Coroflex Please was inferior to Taxus Liberte with regard to clinical and angiographic efficacy.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent (EES) XIENCE V.. A total of 458 patients with single de novo native coronary lesions ≤24 mm in length and a coronary artery ≥2.25 to ≤4.0 mm in diameter were enrolled in the TARGET I study, a prospective, randomised, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), or ischaemia-driven target lesion revascularisation (iTLR). Patients were centrally randomised to treatment with either biodegradable polymer SES (n=227) or durable polymer EES (n=231). The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm, p=0.94; difference and 95% confidence interval 0.00 [-0.04, 0.04] mm; p for non-inferiority <0.0001). Cardiac death (0.4% vs. 0.0%), TVMI (1.3% vs. 1.7%), iTLR (0.4% vs. 0.4%) and TLF (2.2% vs. 2.2%) were similar between the biodegradable polymer SES and durable polymer EES groups at 12-month follow-up (all p>0.05). No definite/probable stent thrombosis was observed in both of these groups.. In the multicentre TARGET I trial, the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions. The incidences of clinical endpoints were low in both of the stents at 12-month follow-up. (ClinicalTrials.gov identifier: NCT01196819).

Topics: Absorbable Implants; Aged; Analysis of Variance; Antineoplastic Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Least-Squares Analysis; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

We investigated clinical outcomes after treatment of coronary bifurcation lesions with second generation drug eluting stents (DES).. Post hoc analysis of a randomised, multicentre, non-inferiority trial.. Multicentre study.. All comers study with minimal exclusion criteria.. Patients were treated with either zotarolimus or everolimus eluting stents. The patient population was divided according to treatment of bifurcation or non-bifurcation lesions and clinical outcomes were compared between groups.. Clinical outcomes within 2-year follow-up.. A total of 2265 patients were included in the present analysis. Two-year follow-up data were available in 2223 patients: 1838 patients in the non-bifurcation group and 385 patients in the bifurcation group. At 2-year follow-up the bifurcation and the non-bifurcation lesion groups showed no significant differences in terms of cardiac death (2.3 vs 2.1, p=0.273), target lesion failure (9.7% vs 13.8%, p=0.255), major adverse cardiac events (11.5% vs 15.1%, p=0.305), target lesion revascularisation (4.7% vs 6.0%, p=0.569), and definite or probable stent thrombosis (1.6% vs 1.8%, p=0.419).. The use of second generation DES for the treatment of coronary bifurcation lesions was associated with similar long term mortality and clinical outcomes compared with non-bifurcation lesions.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Sirolimus; Treatment Outcome

Histologic experimental studies have reported incomplete neointimal healing in overlapping with respect to nonoverlapping segments in drug-eluting stents (DESs), but these observations have not been confirmed in human coronary arteries hitherto. On the contrary, angiographic and optical coherence tomography studies suggest that DES overlap elicits rather an exaggerated than an incomplete neointimal reaction.. Optical coherence tomography studies from 2 randomized trials including sirolimus-eluting, biolimus-eluting, everolimus-eluting, and zotarolimus-eluting stents were analyzed at 9- to 13-month follow-up. Coverage in overlapping segments was compared versus the corresponding nonoverlapping segments of the same stents, using statistical pooled analysis.. Forty-two overlaps were found in 31 patients: 11 in sirolimus-eluting stents, 3 in biolimus-eluting stents, 17 in everolimus-eluting stents, and 11 in zotarolimus-eluting stents. The risk ratio of incomplete coverage was 2.35 (95% CI 1.86-2.98) in overlapping versus nonoverlapping segments. Thickness of coverage in overlaps was only 85% (95% CI 81%-90%) of the thickness in nonoverlaps. Significant heterogeneity of the effect was observed, especially pronounced in the comparison of thickness of coverage (I(2) = 90.31).. The effect of overlapping DES on neointimal inhibition is markedly heterogeneous: on average, DES overlap is associated with more incomplete and thinner coverage, but in some cases, the overlap elicits an exaggerated neointimal reaction, thicker than in the corresponding nonoverlapping segments. These results might help to understand why overlapping DES is associated with worse clinical outcomes, both in terms of thrombotic phenomena and in terms of restenosis and revascularization.

Topics: Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Follow-Up Studies; Humans; Hyperplasia; Immunosuppressive Agents; Male; Middle Aged; Neointima; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To evaluate the atherosclerotic evolution in coronary bifurcations located proximally and distally to a bioresorbable scaffold.. Thirty bifurcations located >5 mm beyond the scaffolded segment, being investigated with serial intravascular ultrasound virtual histology (IVUS-VH) examinations, at baseline and 2-years, in patients enrolled in the ABSORB cohort B1 study were included in this analysis. In each bifurcation, the frames portraying the proximal rim, in-bifurcation, and distal rim of the ostium of the side branch were analyzed. The geometric parameters and plaque types were evaluated at baseline and 2-years follow-up.. There were no significant differences in the geometrical parameters such as lumen, vessel and plaque areas as well as in the composition of the atheroma between baseline and 2-years follow-up.When we separately examined the bifurcations located proximally and distally to the scaffolded segment, no changes were found at the distal bifurcations, while at the proximal bifurcations there was a statistical significant decrease in the plaque burden (36.67 ± 13.33% at baseline vs. 35.06 ± 13.20% at 2 years follow-up, p = 0.04).Ten necrotic core rich plaques were found at baseline, of which 2 regressed to either fibrotic plaque or to intimal thickening at 2 years follow-up. The other 8 did not change. Disease progression was noted in 3 plaques (1 adaptive intimal thickening, 1 fibrotic and 1 fibrocalcific plaque) that evolved to necrotic rich plaques.. Plaque regression was noted at the bifurcations located proximally to the bioresorbable scaffold but not at these located distally. Additional studies are required to confirm this finding and examine further the effect of drug elution on atherosclerotic evolution.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Echocardiography; Everolimus; Female; Humans; Image Enhancement; Image Interpretation, Computer-Assisted; Immunosuppressive Agents; Male; Reproducibility of Results; Sensitivity and Specificity; Sirolimus; Subtraction Technique; Treatment Outcome; Ultrasonography, Interventional; User-Computer Interface

The initial enthusiasm caused by the potent antirestenotic effect of early generation drug-eluting stents was recently plagued by concerns regarding their safety profile. Investigators worldwide were stimulated, therefore, to seek for improvement in drug-eluting stent technology, such as eliminating their permanent polymer blamed for vascular inflammation and delayed healing. Optical coherence tomography (OCT) assessments of stent-vessel interactions are used as a surrogate for vessel healing after DES implantation. Herewith, we report serial OCT assessments of vascular reactions to the implantation of a novel absorbable polymer sirolimus-eluting stent (MiStent). In total, 30 patients were included. At 4-, 6-, and 8-month follow-up, different groups of 10 patients underwent OCT imaging, whereas all the patients had OCT assessments scheduled at 18-month follow-up. A total of 13,569 stent struts were analyzed. Low rates of uncovered (14.34 ± 15.35%, 6.62 ± 10.93%, 3.51 ± 2.87%, and 0.84 ± 1.15%, respectively, p <0.05 for 8- vs 18-month follow-up) and malapposed (3.74 ± 7.35%, 3.15 ± 6.13%, 0.48 ± 0.56%, and 0.09 ± 0.28%, respectively, p = NS) stent struts coupled with thin and increasingly homogenous neointimal proliferation were demonstrated. Neointimal area increased from 4- to 8-month follow-up (0.46 ± 0.29 and 1.12 ± 0.73 mm(2), respectively, p <0.05), whereas no "late catch up" was demonstrated at 18-month follow-up (1.28 ± 0.66 mm(2), p = NS vs 8-month follow-up). Early tissue maturation and reduction of low signal intensity tissue covering stent struts (8.8%, 3.1%, 0.3%, and 0%, respectively, p <0.05 for 4- vs 8-month follow-up comparison) were revealed by optical density analysis. In addition, high rates of strut coverage overlying the ostia of side branches without proliferative pattern were demonstrated. In conclusion, this comprehensive OCT analysis depicted favorable absorbable polymer sirolimus-eluting stent-vessel interactions up to 18-month follow-up.

Topics: Absorbable Implants; Coronary Angiography; Coronary Circulation; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Follow-Up Studies; Humans; Prospective Studies; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent.. Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events.. We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up.. The median (range) in-stent late lumen loss (LLL) was 0.03 mm (-0.22 to 0.21 mm), 0.10 mm (-0.03 to 1.2 mm), and 0.08 mm (-0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (-0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range: 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction.. At 18 months of follow-up, this absorbable polymer-coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428).

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Angina, Stable; Angina, Unstable; Australia; Belgium; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; New Zealand; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Small vessels represent a risk factor for restenosis in percutaneous coronary angioplasty (PCA). The Sparrow® self-expanding drug-eluting stent, which has a lower profile than the current systems, has never been tested in this scenario.. To evaluate the late effectiveness of the Sparrow® drug-eluting stent, regarding in-stent late lumen loss (LLL).. Patients with ischemia, symptomatic or documented, were submitted to PCA in vessels with reference diameter < 2.75 mm, divided into two groups regarding Sparrow® stent type: group 1: Sparrow® drug-eluting stent (DES), group 2: Sparrow® bare metal stent (BMS). Clinical follow-up duration was 12 months. Evaluation using quantitative coronary angiography (QCA) was performed immediately and at 8 months. A decrease of over 65% of in-stent LLL with DES was estimated to calculate sample size. IBM® SPSS software, release 19 (Chicago, Illinois, USA) was used for the statistical analysis.. A total of 24 patients were randomized, 12 in each group. The DES and BMS groups were similar in age (63.25 ± 10.01 vs. 64.58 ± 11.54, p = 0.765), male gender (58.3% vs. 33.3%, p = 0.412), risk factors and all angiographs aspects. Immediate results were satisfactory in both groups. At 8 months in-stent late lumen loss was significantly lower in DES than in BMS group (DES vs. BMS 0.25 ± 0.16 0.97 ± 0.76, p = 0.008).. In small-vessel PCA, the Sparrow® DES determined significant reduction in in-stent LLL, when compared to Sparrow® BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Miniaturization; Sirolimus; Stents; Treatment Outcome

Paclitaxel-eluting balloons (PEBs) are a promising alternative to drug-eluting stent (DES) in the treatment of coronary stenoses. The aim of our study was to compare the 9-month restenosis rates of a strategy of predilatation with PEB followed by bare-metal CoCr stent (PEB + BMS group) versus implantation of everolimus DES (DES group).. This randomized, single-center study planned to enroll 366 patients with stable angina (183 patients per arm) undergoing percutaneous coronary intervention of a de novo, native coronary artery stenosis ≤ 15 mm in length. Primary end point, in a noninferiority study design, was 9-month binary angiographic restenosis. A frequency-domain optical coherence tomography substudy investigated the percentage of uncovered stent struts per lesion, the percentage of malapposed/uncovered struts per lesion, and the percentage of net volume obstruction at 9-month follow-up among the first consecutive 30 patients enrolled in the PEB + BMS group.. The study was prematurely halted after enrollment of 125 patients, 59 in the PEB + BMS group and 66 in the DES group, because of excess of ischemia-driven target lesion revascularization in the PEB + BMS group. When all the enrolled patients completed their follow-up, IDLTR rates were 14% in the PEB + BMS versus 2% in DES group (P = .001). Binary restenosis, either in-stent or in-segment, was significantly higher in the PEB + BMS compared with DES group (17% vs 3% [P = .01] and 25% vs 4% [P = .009] respectively). Frequency-domain optical coherence tomography demonstrated important neointimal regrowth in the PEB + BMS group, similar to historical BMS data.. In the treatment of de novo coronary stenosis, a strategy of predilatation with PEB before BMS implantation was significantly inferior to implantation of an everolimus DES stent in terms of 9-month target lesion revascularization. Frequency-domain optical coherence tomography data confirm the lack of efficacy of this strategy.

Topics: Aged; Aged, 80 and over; Angina, Stable; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

Limited evidence exists regarding the long-term performance of polymer-free (PF) drug-eluting stents (DES) in comparison to permanent polymer DES. This study investigated the 5-year efficacy and safety of a PF sirolimus-eluting stent (PF-SES) versus a permanent polymer paclitaxel-eluting stent (PES) in the setting of the Intracoronary Stenting and Angiographic Restenosis-Test Equivalence Between Two Drug-Eluting Stents (ISAR-TEST) randomized trial.. A total of 450 patients undergoing percutaneous coronary intervention were randomized to receive either PF-SES (Yukon, Translumina; n = 225) or PES (Taxus, Boston Scientific; n = 225). Clinical follow-up was performed to 5 years after enrollment. The endpoints were major adverse cardiac events (MACE), target lesion revascularization (TLR), the composite of death or any myocardial infarction (MI) and stent thrombosis (ST). The incidence of MACE at 5 years was 27.3% (57 patients) in the PF-SES group and 31.7% (65 patients) in the PES group [hazard ratio (HR) = 0.87 [95% confidence interval (95% CI) = 0.61-1.24]; P = 0.40]. The combined incidence of death or MI was 16.6% (34 patients) in the PF-SES group and 20.0% (39 patients) in the PES group (HR = 0.86 [95% CI = 0.54-1.36]; P = 0.52). The incidence of TLR was 16.5% (34 patients) in the PF-SES group and 16.4% (33 patients) in the PES group (HR = 1.03 [95% CI = 0.64-1.66]; P = 0.89). ST occurred in 0.5% (one patient) in the PF-SES group and 1.6% (three patients) in the PES group (HR = 0.33 [95% CI = 0.03-3.14]; P = 0.32).. Overall there was no significant difference in clinical outcomes between PF-SES and PES to 5 years. Extended follow-up supports the durability of efficacy and safety of PF-SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Confidence Intervals; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Failure; Risk Assessment; Sirolimus; Statistics, Nonparametric; Survival Rate; Time Factors; Treatment Outcome

Despite the known effects of drug-eluting stents (DES), other cofactors attributed to patient characteristics affect their success. Interest focused on designing a study minimizing these factors to answer continuing concerns on the heterogeneity of response to different DESs. The study's aim was to investigate the feasibility and impact of an intra-individual comparison design in patients (pts) with two coronary artery stenosis treated with a Sirolimus- (SES) and a Paclitaxel- (PES) eluting stent.. The study was conducted as a prospective, randomized, multi-center trial in 112 pts who consented to treatment with a SES and a PES. Pts were eligible if they suffered from the presence of two single primary target lesions in two different native coronary arteries. Lesions were randomized to either SES or PES treatment. The primary endpoint was in-stent luminal late loss (LLL), as determined by quantitative angiography at 8 months; clinical follow up was obtained at 1, 8, and 12 months additionally. The LLL (0.13 ± 0.28 mm SES vs. 0.26 ± 0.35 mm PES, p=0.011) showed less neointima in SES. With a predefined cut-off criterion of 0.2mm difference in LLL, 53/87 pts SES and PES were similar effective. 34/87 pts had a divergent result, 26 pts had greater benefit from SES while 8 pts had greater benefit from PES. Overall, MACE (MI, TLR, and death) occurred in 19 (17%) pts. Based on lesion analysis of 108 lesions treated with SES and 110 lesions treated with PES, 5 (4.6%) lesions with SES and 3 (2.7%) lesions with PES required repeated TLR.. An intra-individual comparison design to assess differences in efficacy of different DESs is feasible, safe and achieves similar results to inter-individual studies. This study is among the first to show that failure of one DES does not necessarily implicate failure of another DES and vice versa.

Topics: Adult; Aged; Aged, 80 and over; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Observer Variation; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus

There have been no optical coherence tomographic (OCT) data directly comparing the pattern of strut coverage between the 2 second-generation drug-eluting stents in the early period. The aim of this prospective study was to evaluate early strut coverage using optical coherence tomography 3 months after Resolute zotarolimus-eluting stent (ZES-R) or everolimus-eluting stent (EES) implantation in de novo coronary artery lesions. A total of 40 patients who were suitable for the OCT procedure and consented to the study protocol were randomized 1:1 to receive either ZES-R or EES. Among these patients, 35 stented lesions (18 ZES-R, 17 EES) in 34 patients were evaluated by optical coherence tomography immediately and 3 months after stent implantation. Neointimal hyperplasia thickness, percentage of uncovered struts, and the proportion of malapposed struts were measured at 1-mm intervals. An uncovered strut was defined as having a neointimal hyperplasia thickness of 0 μm. At the 3-month OCT evaluation, mean neointimal hyperplasia thickness (ZES-R vs EES 74 ± 41 vs 75 ± 35 μm, p = 0.89) and mean percentage of uncovered struts (ZES-R vs EES 6.2 ± 6.9 vs 4.7 ± 5.1%, p = 0.62) were not significantly different between the groups. The percentage of malapposed struts was also similar between the groups (0.7 ± 2.2% for ZES-R and 0.7 ± 1.7% for EES, p = 0.64). Thrombi were documented in 3 stents (1 [5.6%] in a ZES-R vs 2 [11.8%] in EES, p = 0.60). In conclusion, early stent strut coverage on the basis of serial OCT evaluation was comparable between ZES-R and EES 3 months after stent implantation.

Topics: Aged; Antineoplastic Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Neointima; Prospective Studies; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

The Nobori stent is a new drug-eluting stent (DES) with biodegradable polymer coating limited to the abluminal side of stents. Biolimus A9 is a novel sirolimus derivative specifically developed for DES, and polymer load 15.6 μg of biolimus A9 per 1 mm of stent. A non-randomized multicenter trial was conducted in Japan. Twenty-two de novo lesions were treated by Nobori stents and biolimus A9 concentration in whole blood was serially measured at 14 predetermined time points using a validated chromatography-tandem mass spectrometry (LC-MS/MS) assay. The C max was 85.3 ± 37.9 pg/mL (min-max 46.7-169 pg/mL) in the 18 mm cohort and 198 ± 81 pg/mL (min-max 82.5-365 pg/mL) in the ≥ 28 mm cohort and no early or late bursts of biolimus A9 release were documented. After 4 weeks, no measurable concentration of biolimus A9 was observed in any patient. Estimated AUC0-t was 1.12 ± 1.16 ng/mL h in the 18 mm group, and 5.93 ± 4.41 ng/mL h for the ≥ 28 mm group. A significant association between loaded biolimus A9 dose adjusted by patient weight and pharmacokinetic parameters was observed. The systemic exposure of biolimus A9 eluting from the Nobori stent was low and proportional to the loaded amount of biolimus A9, and clearance from the blood was rapid. These findings suggest that the Nobori stent is feasible and safe. Systemic lower exposure of biolimus A9 after Nobori stent implantation may have beneficial effects on stent endothelialization.

Topics: Aged; Angina Pectoris; Angina, Unstable; Angioplasty, Balloon, Coronary; Area Under Curve; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome

The purpose of this prospective, randomized, single-blind controlled clinical trial was to compare the effectiveness of a zotarolimus-eluting stent (ZoMaxx™) with a paclitaxel-eluting coronary stent (Taxus™ Express(2)™) in patients with angina pectoris and a single native coronary artery lesion between 10-28 mm in length and 2.5-3.75mm in diameter.. Patients were enrolled at 75 international institutions between June 2005 and November 2006.. 1099 (1672 originally planned) patients received 557 ZoMaxx and 542 Taxus stents: cohorts were well-matched for diabetes (27% vs. 27%), reference vessel diameter (2.73 ± 0.46mm vs. 2.74 ± 0.45mm) and lesion length (14.8 ± 6.7mm vs. 14.3 ± 6.4mm). Nine month clinical and angiographic follow-up was available in 1052/1099 (96%) and 649/836 (78%) patients, respectively. The safety profiles for the two stents (myocardial infarction (MI), cardiac death and/or target vessel revascularization (TVR)) were similar (ZoMaxx 8.7% vs. Taxus 6.9%, p=NS). The primary endpoint of 9-month TVR occurred more frequently after treatment with ZoMaxx (6.8%) as compared with Taxus (4.2%), therefore the primary clinical endpoint was not met. However, the 9-month in-segment late lumen loss for ZoMaxx (0.29 ± 0.47mm) and Taxus (0.22 ± 0.41mm, p=NS) were similar, thus satisfying the primary angiographic endpoint. Secondary endpoints of the rates of in-segment and in-stent binary restenosis were also similar (5.9% vs. 5.8%, 7.8% vs. 7.9%, respectively).. At 9months, the ZoMaxx stent failed to achieve the primary endpoint of non-inferiority in TVR to the Taxus stent, but safety endpoints were equal between the two stent systems.

Topics: Angina Pectoris; Cohort Studies; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Paclitaxel; Prospective Studies; Radiography; Single-Blind Method; Sirolimus; Treatment Outcome

The aim of this randomized-controlled trial is to compare biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher).. The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent.. We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months.. At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P < 0.001). As main secondary endpoints, the in-stent late loss was 0.12 ± 0.30 mm and 0.14 ± 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient.. Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Japan; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Polymers; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Because a delayed arterial healing response after drug-eluting stent implantation has raised concerns about safety in diabetic patients, long-term effects of treatment with sirolimus-eluting stent (SES), as compared with bare-metal stent (BMS), have to be established. The aim of the 5-year follow-up of the randomized, controlled, open-label multicenter SCORPIUS study was to assess long-term safety and efficacy of the CYPHER (Cordis, Johnson & Johnson, Bridgewater, NJ) SES in percutaneous coronary intervention of diabetic patients.. A total of 190 patients with type 2 diabetes mellitus were randomized to receive either a SES (n = 95) or a BMS (n = 95). Dual-antiplatelet therapy (aspirin plus clopidogrel) was prescribed for at least 6 months. Clinical follow-up data were scheduled at 1, 8, and 12 months and 5 years.. Treatment with SES resulted in a 16% decrease in the rate of major adverse cardiac events (36% vs 52%; hazard ratio 0.6, 95% CI 0.4-0.9; P = .02). This reduction in major adverse cardiac events with SES at 5 years was mostly attributable to a lower number of repeat target lesion revascularization (13% vs 29%; hazard ratio 0.4, 95% CI 0.2-0.7; P = .003). No differences between groups were observed for safety end points (all-cause mortality 21% vs 21%, cardiac death 15% vs 13%, repeat myocardial infarction 8% vs 9%, and stent thrombosis 5% vs 6%) at 5 years.. The 5-year follow-up of the SCORPIUS trial demonstrates the long-term antirestenotic efficacy of SES in diabetic patients with significantly reduced target lesion revascularization and comparable rates of mortality, myocardial infarction, and stent thrombosis compared with BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus, Type 2; Double-Blind Method; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Immunosuppressive Agents; Male; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.. In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.. The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.. ClincalTrials.gov number NCT01267734.

Topics: Angioplasty, Balloon, Coronary; Chromium; Chromium Alloys; Coronary Stenosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Humans; Platelet Aggregation Inhibitors; Platinum; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Early generation drug-eluting stents (DESs) reduce restenosis and repeat revascularization procedures. However, the long-term safety and efficacy of early generation DES according to diabetic status are poorly established.. A total of 1,012 patients were randomly assigned to treatment with sirolimus-eluting (n = 503) or paclitaxel-eluting stents (n = 509). Serial angiographic follow-up at baseline, 8 months, and 5 years was available in 293 patients with 382 lesions. The primary end point was a composite of major adverse cardiac events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization). Clinical and angiographic outcomes through 5-year follow-up were compared between diabetic and nondiabetic patients.. Major adverse cardiac events were more common among diabetic than nondiabetic patients at 5 years (25.9% vs 19.2%, hazard ratio [HR] 1.45, 95% CI 1.06-1.99, P = .02). The difference in disfavor of diabetic patients was largely determined by a higher rate of cardiac mortality (11.4% vs 4.3%, HR 2.86, 95% CI 1.69-4.84, P < .0001), whereas the risk of myocardial infarction (6.5% vs 6.8%, HR 1.00, 95% CI 0.55-1.84, P = .99) and ischemia-driven target lesion revascularization (14.4% vs 14.1%, HR 1.09, 95% CI 0.73-1.64, P = .67) was comparable. The risk of stent thrombosis was similar among diabetic and nondiabetic patients (definite or probable: 6.0% vs 4.6%, HR 1.36, 95% CI 0.71-2.67, P = .35). Among 293 patients undergoing serial angiography, very-late lumen loss amounted to 0.42 ± 0.63 mm in diabetic patients and 0.44 ± 0.68 mm in nondiabetic patients (P = .79).. Diabetic patients remain at increased risk for mortality after revascularization with early generation DES during long-term follow-up. Conversely, diabetes is no longer associated with an increased risk of clinical and angiographic restenosis after revascularization with early generation DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Reference Values; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Analysis; Time; Time Factors; Treatment Outcome

The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation.. There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation.. We randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n=1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n=1,058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\\vessel revascularization, or bleeding) at 1 year.. The primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES+3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference: 0.0%; 95% confidence interval [CI]: -2.5 to 2.5; p=0.84; p<0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI: -1.5 to 0.5; p=0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference: -0.1%; 95% CI: -0.5 to 0.3; p=0.65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference: 0.2%; 95% CI: -2.3 to 2.6; p=0.70).. E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079).

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome; Withholding Treatment

We retrospectively analyzed the midterm clinical and angiographic outcomes after the implantation of paclitaxel- (PES, TAXUS Express) and sirolimus- (SES, Cypher Bx Velocity) eluting stents in Japanese patients with complex coronary lesions.. From August 2004 to May 2009, 1,335 nonrandomized de novo native complex coronary lesions treated with either a PES (357 cases) or SES were included. The inclusion criteria for patients with complex lesions were those with diabetes, those undergoing hemodialysis, and those with a low ejection fraction, as well as subjects who had lesions with severe calcification, ostiums of the right coronary and left circumflex arteries, and who underwent the side-branch bifurcation 2-stent technique. The subjects were evaluated for consistent predictors of cardiac events, binary restenosis and target lesion vascularization of the SES. The composite primary endpoint percentage (900-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after PES placement was 0.6%, which was not significantly different from that after SES placement (0.12%; p=0.290). The incidence of the secondary endpoint (binary restenosis; stenosis >50% of the diameter at the secondary angiographic examination performed within 550 days after the procedure) after PES placement (15.0%) was also not significantly different than that after SES placement (13.3%; p=0.498). There was no relationship between PES placement and binary restenosis upon angiographic follow-up of 989 lesions (odds ratio of 1.14; 95% confidence interval, 0.73-1.77; p=0.57).. For de novo native complex coronary stenosis, the midterm safety and efficacy of PES placement was statistically equivalent to that of SES placement in a clinical setting in Japan.

Topics: Aged; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

This was designed to assess the outcomes of side branch (SB) stenosis after implantation of three drug-eluting stents (DES). From 2,645 patients in the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Trial, 788 patients had 923 bifurcation lesions with SB ≥ 1.5 mm were included. SB was treated in 150 lesions, including 35 (3.8%) receiving SB stenting. Of untreated SB with baseline stenosis < 50%, the incidences of periprocedural SB compromise was similar in the zotarolimus (15.8%), sirolimus (17.2%), and paclitaxel (16.6%) stent groups (P = 0.92). At follow-up angiography, delayed SB compromise occurred in 13.9%, 3.2%, and 9.4% (P = 0.010) of these groups. When classified into four groups (< 50%, 50%-70%, 70%-99%, and 100%), 9.0% of untreated SB were worsened, whereas improvement and stationary were observed in 9.6% and 81.4%. In a multivariable logistic regression model, main branch (MB) stenosis at follow-up (%) was the only independent predictor of SB stenosis worsening (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < 0.001). After MB stenting in bifurcation lesions, a minority of SB appears to worsen. DES with strong anti-restenotic efficacy may help maintain SB patency.

Topics: Acute Disease; Aged; Blood Vessels; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Paclitaxel; Predictive Value of Tests; Sirolimus; Thrombosis; Treatment Outcome

The purpose of this randomized study was to compare sirolimus-eluting stenting with coronary artery bypass grafting (CABG) for patients with unprotected left main (ULM) coronary artery disease.. CABG is considered the standard of care for treatment of ULM. Improvements in percutaneous coronary intervention (PCI) with use of drug-eluting stents might lead to similar results. The effectiveness of drug-eluting stenting versus surgery has not been established in a randomized trial.. In this prospective, multicenter, randomized trial, 201 patients with ULM disease were randomly assigned to undergo sirolimus-eluting stenting (n = 100) or CABG using predominantly arterial grafts (n = 101). The primary clinical end point was noninferiority in freedom from major adverse cardiac events, such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months.. The combined primary end point was reached in 13.9% of patients after surgery, as opposed to 19.0% after PCI (p = 0.19 for noninferiority). The combined rates for death and myocardial infarction were comparable (surgery, 7.9% vs. stenting, 5.0%; noninferiority p < 0.001), but stenting was inferior to surgery for repeat revascularization (5.9% vs. 14.0%; noninferiority p = 0.35). Perioperative complications including 2 strokes were higher after surgery (4% vs. 30%; p < 0.001). Freedom from angina was similar between groups (p = 0.33).. In patients with ULM stenosis, PCI with sirolimus-eluting stents did not show noninferiority [corrected] to CABG at 12-month follow-up with respect to freedom from major adverse cardiac events, which is mainly influenced by repeated revascularization, whereas for hard endpoints, [corrected] PCI results are favorable. A longer follow-up is warranted. [corrected]

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Radiography; Sirolimus; Treatment Outcome

The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 12 months in patients with coronary bifurcation lesions after double kissing double crush (DK crush) or provisional stenting (PS) techniques.. Provisional side branch (SB) stenting is preferable to DK crush because it has been associated with fewer complications. It is unknown which strategy would provide the best results.. From April 2007 to June 2009, 370 unselected patients with coronary bifurcation lesions from 7 Asian centers were randomly assigned to either the DK or the PS group. Additional SB stenting in PS was required if final results were suboptimal. The primary end point was the occurrence of MACE at 12 months, including cardiac death, myocardial infarction, or target vessel revascularization (TVR). Secondary end point was the angiographic restenosis at 8 months.. There were 3 procedural occlusions of SB in the PS group. At 8 months, angiographic restenosis rates in the main vessel and SB were significantly different between the DK (3.8% and 4.9%) and the PS groups (9.7% and 22.2%, p = 0.036 and p < 0.001, respectively). Additional SB stenting in the PS group was required in 28.6% of lesions. TVR was 6.5% in the DK group, occurring significantly less often than in the PS group (14.6%, p = 0.017). There were nonsignificant differences in MACE and definite stent thrombosis between the DK (10.3% and 2.2%) and PS groups (17.3%, and 0.5%, p = 0.070 and p = 0.372, respectively).. DK crush was associated with a significant reduction of TLR and TVR in this unselected patient population. However, there was no significant difference in MACE between DK and the PS groups. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChicTR-TRC-00000015).

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; China; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Hospital Mortality; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Failure; Risk Assessment; Severity of Illness Index; Sex Factors; Sirolimus; Survival Analysis; Time Factors; Treatment Outcome

The ABSORB cohort A trial using the bioresorbable everolimus-eluting scaffold (BVS revision 1.0, Abbott Vascular) demonstrated a slightly higher acute recoil with BVS than with metallic stents. To reinforce the mechanical strength of the scaffold, the new BVS scaffold (revision 1.1) with modified strut design was developed and tested in the ABSORB cohort B trial. This study sought to evaluate and compare the in vivo acute scaffold recoil of the BVS revision 1.0 in ABSORB cohort A and the BVS revision 1.1 in ABSORB cohort B with the historical recoil of the XIENCE V® everolimus-eluting metal stent (EES, SPIRIT I and II).. In the ABSORB cohort B trial, 101 patients with one or two de-novo lesions were enrolled at 10 sites. In ABSORB cohort A, 27 patients treated with a BVS 1.0 were analyzed and compared with EES. Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage.. Out of 101 patients enrolled in the ABSORB cohort B trial, 88 patients are available for complete analysis of acute recoil. Absolute recoil of BVS 1.1 (0.19 ± 0.18 mm) was numerically higher than metallic EES (vs. 0.13 ± 0.21 mm) and similar to BVS 1.0 (0.20 ± 0.21 mm) but the differences did not reach statistical significance (P = 0.40). The acute percent recoil demonstrated the same trend (EES: 4.3% ± 7.1%, BVS 1.0: 6.9% ± 7.0%, BVS 1.1: 6.7% ± 6.4%, P = 0.22). In the multivariate regression model, high balloon/artery ratio (>1.1) (OR 1.91 [1.34-2.71]) was the predictive for high absolute recoil (>0.27 mm) while (larger) preprocedural MLD was protective (OR 0.84 [0.72-0.99]). The stent/scaffold type was not a predictor of acute recoil.. The average in vivo acute scaffold recoil of the BVS 1.1 is slightly higher than the metallic EES. However, the scaffold/stent type was not predictive of high acute recoil, while implantation in undersized vessels or usage of oversized devices might confound the results.

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Biocompatible Materials; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Logistic Models; Male; Metals; Middle Aged; New Zealand; Odds Ratio; Pressure; Prosthesis Design; Sirolimus; Stress, Mechanical; Treatment Outcome

We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).. Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner.. This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR).. The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE.. Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabetic patients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice.. We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups.. The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02).. In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Diseases; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Ischemia; Prospective Studies; Sirolimus

The objective of the study was to assess noninferiority of the polymer-free sirolimus-eluting Yukon Choice stent (Translumina GmbH, Hechingen, Germany) compared with the polymer-based Taxus Liberté stent (Boston Scientific, Natick, Massachusetts) with regard to the primary endpoint, in-stent late lumen loss, at 9 months in patients with diabetes mellitus.. The Yukon Choice stent has been evaluated in several randomized controlled trials before, albeit to date, there has been no trial that exclusively enrolled patients with diabetes mellitus.. Patients with diabetes mellitus undergoing percutaneous coronary intervention for clinically significant de novo coronary artery stenosis were randomized 1:1 to receive either the polymer-free sirolimus-eluting Yukon Choice stent or the polymer-based paclitaxel-eluting Taxus Liberté stent.. A total of 240 patients were randomized. Quantitative coronary angiography was available for 79% of patients. Mean in-stent late lumen loss was 0.63 ± 0.62 mm for the Yukon Choice stent and 0.45 ± 0.60 mm for the Taxus Liberté stent. Based on the pre-specified margin, the Yukon Choice stent failed to show noninferiority for the primary endpoint. During follow-up, there were no significant differences between groups regarding death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, or nontarget vessel revascularization.. Compared with the Taxus Liberté stent, the polymer-free sirolimus-eluting Yukon Choice stent failed to show noninferiority with regard to the primary endpoint, in-stent late lumen loss, in patients with diabetes mellitus after 9-month follow-up. Both stents showed comparable clinical efficacy and safety. (Yukon Choice Versus Taxus Liberté in Diabetes Mellitus; NCT00368953).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS).. IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10 ± 0.46 mm2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57 ± 1.3 mm2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external elastic membrane area (y=0.68x-0.1; r=0.58, p=0.03).. Based on 6-months IVUS-VH analysis, the BVS 1.1 appears to have a different backscattering signal compared to the BVS 1.0, which may reflect differences in the speed of chemical and structural alteration.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Australia; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Image Interpretation, Computer-Assisted; Male; Middle Aged; Necrosis; New Zealand; Polyesters; Prosthesis Design; Sirolimus; Time Factors; Tissue Scaffolds; Treatment Outcome; Ultrasonography, Interventional

Previous studies have demonstrated endothelial dysfunction after sirolimus-eluting stent (SES) implantation. The present study evaluated the effect of pioglitazone on endothelial dysfunction after SES implantation in nondiabetic patients. A total of 50 nondiabetic patients who had undergone SES implantation were randomly assigned to the pioglitazone group (n = 25) or the control group (n = 25). Endothelial function was estimated by measuring the coronary vasoreactivity in the reference segment within 15 mm proximal and distal to the SES in response to intracoronary acetylcholine infusion (10(-8) and 10(-7) mol/L) at 9 months of follow-up. Endothelium-independent vasomotion was assessed after an intracoronary bolus of nitroglycerin. Changes in the coronary diameter in response to 10(-8) and 10(-7) mol/L acetylcholine in the segment proximal to the SES were not significantly different between the pioglitazone and control groups. In contrast, in the segment distal to the SES, vasoconstrictions to 10(-8) (-3.0 ± 2.8% vs -7.1 ± 4.5%, p <0.01) and 10(-7) mol/L acetylcholine (-6.2 ± 8.0% vs -13.1 ± 8.9%, p <0.01) were attenuated in the pioglitazone group compared to the control group. Endothelium-independent vasodilation to nitrate did not differ between the 2 groups. Multivariate analysis showed that pioglitazone was an independent predictor improving endothelial dysfunction after SES implantation. In conclusion, pioglitazone might improve endothelial dysfunction after SES implantation in nondiabetic patients.

Topics: Acetylcholine; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Hypoglycemic Agents; Male; Multivariate Analysis; Pioglitazone; Prospective Studies; Sirolimus; Thiazolidinediones; Vasodilator Agents

The aim of this study was to investigate the impact of patient and lesion complexity on outcomes with newer-generation zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES).. Clinical and angiographic outcomes of newer-generation stents have not been described among complex patients.. Patients enrolled in the RESOLUTE All Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) were stratified into "complex" and "simple.". Of 2,292 patients, 1,520 (66.3%) were complex and treated with ZES (n = 764) or EES (n = 756). Event rates were higher among complex patients, and results did not differ between ZES and EES, regardless of complexity. At 1 year, target lesion failure was 8.9% in ZES- and 9.7% in EES-treated complex patients (p = 0.66) and 6.8% in ZES- and 5.7% in EES-treated simple patients (p = 0.55). Rates of cardiac death (1.3% vs. 2.2%, p = 0.24), target-vessel myocardial infarction (4.3% vs. 4.4%, p = 0.90), and clinically indicated target lesion revascularization (4.4% vs. 4.0%, p = 0.80) were similar for both stent types among complex patients. Definite or probable stent thrombosis occurred in 20 (1.3%) complex patients with no difference between ZES (1.7%) and EES (0.9%, p = 0.26). Angiographic follow-up showed similar results for ZES and EES in terms of in-stent percentage diameter stenosis (22.2 ± 15.4% vs. 21.4 ± 15.8%, p = 0.67) and in-segment binary restenosis (6.6% vs. 8.0%, p = 0.82) in the complex group.. In this all-comers randomized trial, major adverse cardiovascular events were more frequent among complex than simple patients. The newer-generation ZES and EES proved to be safe and effective, regardless of complexity, with similar clinical and angiographic outcomes for both stent types through 1 year. (RESOLUTE-III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084).

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Sirolimus; Treatment Outcome

To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers' population of patients, in order to clarify the mechanism of eventual differences in the biocompatibility and thrombogenicity of the devices.. Patients randomized to angiographic follow-up in the RESOLUTE All Comers trial (NCT00617084) at pre-specified OCT sites underwent OCT follow-up at 13 months. Tissue coverage and apposition were assessed strut by strut, and the results in both treatment groups were compared using multilevel logistic or linear regression, as appropriate, with clustering at three different levels: patient, lesion, and stent. Fifty-eight patients (30 ZES and 28 EES), 72 lesions, 107 stents, and 23 197 struts were analysed. Eight hundred and eighty-seven and 654 uncovered struts (7.4 and 5.8%, P= 0.378), and 216 and 161 malapposed struts (1.8 and 1.4%, P= 0.569) were found in the ZES and EES groups, respectively. The mean thickness of coverage was 116 ± 99 µm in ZES and 142 ± 113 µm in EES (P= 0.466). No differences in per cent neointimal volume obstruction (12.5 ± 7.9 vs. 15.0 ± 10.7%) or other areas-volumetric parameters were found between ZES and EES, respectively.. No significant differences in tissue coverage, malapposition, or lumen/stent areas and volumes were detected by OCT between the hydrophilic polymer-coated ZES and the fluoropolymer-coated EES at 13-month follow-up.

Topics: Aged; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polymers; Prospective Studies; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Tubulin Modulators

Telmisartan is a peroxisome proliferator-activated receptor-γ activator with potent anti-inflammatory and antiatherogenic effects. The authors compared the effects of telmisartan and valsartan on neointima volume, atherosclerosis progression and brachial-ankle pulse wave velocity (baPWV) after stenting in hypertensive type 2 diabetes.. This was a prospective, randomised, 8-month follow-up study that included patients with significant coronary stenosis who received telmisartan (n=36) or valsartan (n=37).. University hospital.. Neointima volume and atherosclerosis progression 10 mm proximal and distal to the stented segment were analysed using repeat intravascular ultrasonography. baPWV and inflammatory markers such as interleukin 6, tumour necrosis factor α, C-reactive protein and adiponectin were compared.. Neointima volume at 8 months was significantly lower in the telmisartan group than the valsartan group (1.9±1.0 vs 2.6±1.4 mm(3)/1 mm, p=0.007, respectively). Total plaque volumes 10 mm proximal (7.1±1.5 vs 7.8±1.6 mm(3)/1 mm, p=0.032, respectively) and distal (3.5±1.4 vs 4.1±1.3 mm(3)/1 mm, p=0.028, respectively) to the stent were significantly lower in the telmisartan group than the valsartan group at 8 months. The decrease from baseline in baPWV was significantly greater in the telmisartan group than the valsartan group (-52±104 vs 30±113 cm/s, p=0.002, respectively). The increase from baseline in adiponectin levels and the decreases from baseline in interleukin 6 and tumour necrosis factor α levels were significantly greater in the telmisartan group at 8 months. Retinol-binding protein-4, homeostasis model of assessment index, hemoglobin A(1c) and low-density lipoprotein cholesterol levels decreased significantly in both groups without differences in changes from baseline between the two groups.. Telmisartan reduced neointima volume; atherosclerosis progression 10 mm proximal and distal to the stented segment and baPWV independent of blood pressure, glucose and lipid control in hypertensive type 2 diabetes. Clinical trial no NCT00599885 (clinicaltrials.gov.).

Topics: Adiponectin; Aged; Ankle Brachial Index; Anti-Inflammatory Agents; Benzimidazoles; Benzoates; C-Reactive Protein; Coronary Stenosis; Diabetes Mellitus, Type 2; Disease Progression; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hypertension; Interleukin-6; Male; Middle Aged; Neointima; Prospective Studies; Single-Blind Method; Sirolimus; Telmisartan; Tetrazoles; Time Factors; Treatment Outcome; Tumor Necrosis Factor-alpha; Ultrasonography, Interventional; Valine; Valsartan

We assessed the in vivo vascular response to a new generation of zotarolimus-eluting stents (ZES) with prolonged drug release (Resolute ZES-SR, Medtronic Vascular, Santa Rosa, California) compared with ZES with faster kinetics (Endeavor ZES-FR, Medtronic Vascular) by optical coherence tomography.. Local drug release kinetics has been implicated with antirestenosis efficacy of drug-eluting stents. However, the impact of different release kinetics on vascular response of diseased human coronary arteries remains to be investigated.. The study population consisted of 43 patients with long lesions in native coronary vessels treated with multiple overlapping ZES. Twenty-one patients treated with ZES-SR were compared with 22 patients treated with ZES-FR from the ODESSA (Optical coherence tomography for DES SAfety) study. The primary endpoint was in-stent neointimal hyperplasia as assessed by optical coherence tomography at 6-month follow-up. Coprimary endpoints were the percentage of uncovered and malapposed struts.. Strut-level median neointimal thickness was 0.11 mm (interquartile range [IQR]: 0.07 to 0.15 mm) in ZES-SR and 0.31 mm (IQR: 0.27 to 0.42 mm) in ZES-FR, respectively (p < 0.001). The 6-month rate of uncovered struts per patient was 7.38% (IQR: 3.06% to 12.72%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001); rate of malapposed and uncovered struts was 1.47% (IQR: 0.32% to 4.23%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001).. This study demonstrated the impact of different release kinetics on human in vivo vascular response to ZES implantation. The new generation of ZES-SR compared with ZES-FR had better suppression of the neointimal response but higher proportion of uncovered and malapposed struts at 6-month optical coherence tomography follow-up. (Optical Coherence Tomography in Long Lesions [LongOCT]; NCT01133925).

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prognosis; Prospective Studies; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

To investigate the ability of SYNTAX score and Clinical SYNTAX score (CSS) to predict very long-term outcomes in an all-comers population receiving drug-eluting stents.. The SYNTAX score was retrospectively calculated in 848 patients enrolled in the SIRolimus-eluting stent compared with pacliTAXel-Eluting Stent for coronary revascularization (SIRTAX) trial. The CSS was calculated using age, and baseline left ventricular ejection fraction and creatinine clearance. A stratified post hoc comparison was performed for all-cause mortality, cardiac death, myocardial infarction (MI), ischaemia-driven target lesion revascularization (TLR), definite stent thrombosis, and major adverse cardiac events (MACE) at 1- and 5-year follow-up. Tertiles for SYNTAX score and CSS were defined as SS(LOW) ≤ 7, 7< SS(MID) ≤ 14, SS(HIGH) >14 and CSS(LOW) ≤ 8.0, 8.0 17.0, respectively. Major adverse cardiac events rates were significantly higher in SS(HIGH) compared with SS(LOW) at 1- and 5-year follow-up, which was also seen at 5 years for all-cause mortality, cardiac death, MI, and TLR. Stratifying outcomes across CSS tertiles confirmed and augmented these results. Within CSS(HIGH), 5-year MACE increased with use of paclitaxel- compared with sirolimus-eluting stents (34.7 vs. 21.3%, P = 0.008). SYNTAX score and CSS were independent predictors of 5-year MACE; CSS was an independent predictor for 5-year mortality. Areas-under-the-curve for SYNTAX score and CSS for 5-year MACE were 0.61 (0.56-0.65) and 0.62 (0.57-0.67), for 5-year all-cause mortality 0.58 (0.51-0.65) and 0.66 (0.59-0.73) and for 5-year cardiac death 0.63 (0.54-0.72) and 0.72 (0.63-0.81), respectively.. SYNTAX score and to a greater extent CSS were able to stratify risk for very long-term adverse clinical outcomes in an all-comers population receiving drug-eluting stents. Predictive accuracy for 5-year all-cause mortality was improved using CSS.. NCT00297661.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Predictive Value of Tests; Prospective Studies; Retrospective Studies; ROC Curve; Severity of Illness Index; Sirolimus; Treatment Outcome; Tubulin Modulators

The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev.1.1, Abbott Vascular, Santa Clara, California) was sustained and not simply delayed by a few months.. With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months.. Fifty-six patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up.. Overall the scaffold area remained unchanged with IVUS as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27 ± 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two patients experienced peri-procedural and iatrogenic myocardial infarction, respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56).. The 12-month performance of the second-generation ABSORB bioresorbable everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856).

Topics: Absorbable Implants; Aged; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Treatment Outcome

This study sought to compare the neointimal response of metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) by optical coherence tomography at 1 year.. DES decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. BVS may overcome the risk of stent/scaffold thrombosis when completely resorbed. It is unknown if, during the bioresorption process, the neointimal response of the everolimus BVS (Absorb, Abbott Vascular, Santa Clara, California) differs from that of the metallic everolimus DES (Xience, Abbott Vascular).. A total of 19 lesions were treated with a single everolimus DES, and 31 lesions were treated with everolimus BVS and imaged with optical coherence tomography at 1 year. Neointimal response was assessed as percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima.. At 1 year, no significant differences in the angiographic lumen loss were seen for the everolimus DES and everolimus BVS (0.18 ± 0.20 mm vs. 0.29 ± 0.36 mm; p = 0.42). optical coherence tomography analysis of 951 cross sections and 8,385 struts demonstrated similar rates of uncovered struts (5.3% everolimus DES vs. 4.5% everolimus BVS; p = 0.11), mean neointimal thickness (120.6 ± 46.0 μm vs. 136.1 ± 71.4 μm; p = 0.82) and in-stent/scaffold area obstruction (12.5 ± 7.1% vs. 13.6 ± 9.7%; p = 0.91), respectively. There was a trend of higher heterogenic tissue pattern of neointima (21.1% vs. 6.5%; p = 0.12) and less intraluminal masses (0% vs. 12.9%; p = 0.10) with everolimus DES than with everolimus BVS.. The everolimus BVS (Absorb) demonstrated a similar neointimal response as the everolimus DES (Xience). However, the presence of intraluminal masses at 12 months in a small proportion of patients warranted watchful follow-up of these cases.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

Although oxidative stress plays an important role in the pathophysiology of restenosis, its role following the implantation of sirolimus-eluting stents (SES) is unknown.. We examined the relation between total peroxides (TP), a marker of oxidative stress, and in-stent late luminal loss over a 6-month follow-up in patients with stable coronary artery disease and compared the results from SES with those from bare metal stents (BMS). We enrolled 75 consecutive patients, who underwent successful PCI and were randomly allocated to SES (n=37) or BMS (n=38). Blood samples were taken 24 h before, at 24 h, 48 h and 1 month after angioplasty; levels of TP were determined on each occasion. Follow-up coronary angiography was performed 6-8 months later.. TP levels in the BMS group were significantly higher at 24 h and 48 h compared to baseline (p=0.006 for both). At one month there was a significant decline from the 48 h levels (p=0.029) to levels slightly, but not significantly higher than baseline. In contrast, in SES TP levels showed no significant changes during the first 48 h, while they declined to levels somewhat lower than baseline at 30 days. A significant correlation was found between TP changes and in-stent late luminal loss at 6 months in both groups.. Our study showed that patients with stable coronary artery disease who received SES have a different behavior of oxidative stress after stenting compared with BMS, and this could contribute to the difference in restenosis rate between these 2 types of stents.

Topics: Aged; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Oxidative Stress; Sirolimus; Stents; Treatment Outcome

This study evaluates the safety and efficacy of the XIENCE V 4.0 mm stent for the treatment of de novo native coronary artery lesions.. In the SPIRIT III trial, the XIENCE V everolimus-eluting stent (EES), compared with the TAXUS EXPRESS(2) paclitaxel-eluting stent (PES) in 2.5-3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE).. The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Registries; Risk Assessment; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

In the ISAR-TEST-2 (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents) randomized trial, a new-generation sirolimus- and probucol-eluting stent (Dual-DES) demonstrated a 12-month efficacy that was comparable to sirolimus-eluting stents (SES) (Cypher, Cordis Corp., Warren, New Jersey) and superior to zotarolimus-eluting stents (ZES) (Endeavor, Medtronic CardioVascular, Santa Rosa, California). The aim of the current study was to investigate the comparative clinical and angiographic effectiveness of SES, Dual-DES, and ZES between 1 and 2 years.. Long-term polymer residue is implicated in adverse events associated with delayed vessel healing after drug-eluting stent therapy. The second-generation ZES utilizes an enhanced biocompatibility polymer system whereas a new-generation Dual-DES employs a polymer-free drug-release system.. A total of 1,007 patients undergoing coronary stenting of de novo lesions in native vessels were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). Clinical follow-up was performed to 2 years. Angiographic follow-up was scheduled at 6 to 8 months and 2 years.. There were no significant differences between groups regarding death/myocardial infarction (SES: 10.2% vs. Dual-DES: 7.8% vs. ZES: 9.2%; p = 0.61) or definite stent thrombosis (SES: 0.9% vs. Dual-DES: 0.9% vs. ZES: 0.6%; p = 0.87). Two-year target lesion revascularization (TLR) was 10.7%, 7.7%, and 14.3% lesions in the SES, Dual-DES, and ZES groups, respectively (p = 0.009). Incident TLR between 1 and 2 years in the Dual-DES group (0.9%) was significantly lower than in the Cypher SES group (3.6%) (p = 0.009), but comparable to the Endeavor ZES group (0.7%) (p = 0.72). These findings mirrored those observed for binary restenosis.. At 2 years, there was no signal of a differential safety profile between the 3 stent platforms. Furthermore, the antirestenotic efficacy of both Dual-DES and ZES remained durable between 1 and 2 years, with Dual-DES maintaining an advantage over the entire 2-year period. (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents [ISAR-TEST-2]; NCT00332397).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Polymers; Probability; Prospective Studies; Prosthesis Design; Prosthesis Failure; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Survival Analysis; Time Factors; Treatment Outcome

We designed a randomized trial exploiting optical coherence tomography (OCT) to assess coverage and apposition of overlapping bare-metal stents (BMS) and drug-eluting stents (DES) in human coronary arteries.. Overlapping DES impair healing in animals. Optical coherence tomography allows accurate in vivo assessment of stent strut coverage and apposition.. Seventy-seven patients with long coronary stenoses were randomized to overlapping sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), or BMS. The primary goal of the study was to determine the rate of uncovered/malapposed struts in overlap versus nonoverlap segments, according to stent type, at 6-month follow-up with OCT.. A total of 53,047 struts were analyzed. The rate of uncovered/malapposed struts was 1.5 +/- 3.4% and 0.6 +/- 2.7% in overlap versus nonoverlap BMS (p = NS), respectively, and 4.3 +/- 11% and 3.6 +/- 8% in overlap versus nonoverlap DES (p = NS), respectively. There were no differences in the rates of uncovered/malapposed struts between overlapping BMS and DES, likely due to low frequency of uncovered/malapposed struts in ZES (0.1 +/- 0.4%), which offset the higher rates observed in SES (6.7 +/- 9.6%) and PES (6.7 +/- 16.5%, p < 0.05). Overlap segments showed greater neointimal volume obstruction versus nonoverlap segments in all DES (p < 0.05 for all DES types). Strut-level neointimal thickness at overlap and nonoverlap segments were lowest in SES (0.16 +/- 0.1 mm and 0.12 +/- 0.1 mm, respectively) compared with PES (0.27 +/- 0.1 mm and 0.20 +/- 0.1 mm, respectively), ZES (0.40 +/- 0.16 mm and 0.33 +/- 0.13 mm, respectively), and BMS (0.55 +/- 0.31 mm and 0.53 +/- 0.25 mm, respectively, p < 0.05).. As assessed by OCT the impact of DES on vascular healing was similar at overlapping and nonoverlapping sites. However, strut malapposition, coverage pattern, and neointimal hyperplasia differ significantly according to DES type. (Optical Coherence Tomography for Drug Eluting Stent Safety [ODESSA]; NCT00693030).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Male; Metals; Middle Aged; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long-term follow-up data are scarce and only available for sirolimus- and paclitaxel-eluting stents.. To assess the feasibility and performance of the XIENCE V everolimus-eluting stent (EES) versus an identical bare metal stent after a 5-year follow-up period.. SPIRIT FIRST was a First in Man, multicentre, prospective, single-blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent.. At 5-year clinical follow-up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1- and 5-year follow-up. The 5-year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2- and 5-year follow-up. No additional clinically driven TVR events were observed between 3- and 5-year follow-up. The 5-year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years.. The favorable 5-year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Single-Blind Method; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This was a single centre registry study on clinical efficacy and safety of drug-eluting stent (DES) in diabetic patients undergoing percutaneous coronary intervention (PCI) for complex coronary lesions.. A total of 288 diabetic patients who underwent elective PCI between September 2003 and June 2006 in our centre were enrolled and followed-up for 18 months. Among them, 79 (27.4%) patients received sirolimus-eluting stent (SES), 138 (47.9%) paclitaxel-eluting stent (PES) and 71 (24.7%) zotarolimus-eluting stent (ZES). The endpoints were major adverse cardiac events (MACE) and stent thrombosis rates.. Baseline demographics were comparable among the 3 DES groups (median age was 60 years; 69% men). Complex lesions (defined as ACC/AHA type C stenosis) accounted for 55.6% of the total lesions: SES (50.6%), PES (65.2%) and ZES (43.7%), P = 0.005. At 18 months follow-up, the composite endpoint of MACE was found in 12.7% in SES group, 8.7% in the PES group, 12.7% in ZES group and (P = 0.55). Stent thrombosis (ST) occurred in 1 patient (1.3%) in the SES group, 2 patients (1.4%) in PES group and 1 patient (1.4%) in ZES group, respectively (P = 1.00).. The use of DES for elective PCI in diabetic patients was associated with favourable intermediate-term clinical outcomes with no significant differences in efficacy among the 3 groups. Stent thrombosis had low event occurrence rate.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Sirolimus; Survival Analysis; Treatment Outcome

Previous reports have shown the advantage of paclitaxel compared to limus-derivative drugs for the treatment of diabetics. A total of 109 diabetics (115 lesions) treated with everolimus-eluting stents (EESs, n = 58) or paclitaxel-eluting stents (PESs, n = 55) undergoing 8 to 9 months of follow-up 3-dimensional intravascular ultrasound examinations were enrolled. In addition to the standard intravascular ultrasound parameters, the percentage of neointimal volume (neointimal volume/stent volume) and maximum percentage of cross-sectional narrowing (neointimal area/stent area) was calculated. EESs showed a lower percentage of neointimal volume (7.2 +/- 7.1% vs 11.7 +/- 11.0%; p = 0.01) and maximum percentage of cross-sectional narrowing (22.5 +/- 16.3% vs 29.4 +/- 19.2%; p = 0.04) than PESs. One case of severe narrowing (lesions with maximum percentage of cross-sectional narrowing >60%) in the EES group developed and 6 cases in the PESs group (p = 0.05). The EESs showed no serial changes for vessel or peri-stent plaque during the follow-up period, and PESs showed significant increases in vessel and peri-stent plaque. PESs showed significantly greater peri-stent plaque increase, with a tendency toward greater vessel enlargement than EESs. Late acquired incomplete stent apposition was observed in 2 PES cases. The major adverse cardiac event rate was comparable < or =2 years. In conclusion, EESs showed greater neointimal suppression without significant vessel expansion than PESs in diabetic patients. In this small cohort, no significant differences were observed in the major adverse cardiac event rate < or =2 years.

Topics: Aged; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Ultrasonography, Interventional

The purpose of this study is to assess jailing of side branches (SB) by the everolimus-eluting, bioresorbable vascular scaffold (BVS) with 3-dimensional (3D) optical coherence tomography (OCT) reconstruction.. Because BVS struts at the SB orifice are suspected of being bioresorbed and/or forming a neointimal bridge, OCT has been used to evaluate the struts in detail at that particular site. Our understanding of the 3D relationship of the strut and the SB orifice is limited by the use of 2-dimensional OCT images. Fourier-domain OCT enables reliable 3D reconstruction of coronary vessels.. The ABSORB Cohort B (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trial is a multicenter single-arm trial to assess the safety and performance of the BVS. Fourier-domain OCT pullbacks (C7-XR system, LightLab Imaging Inc., Westford, Massachusetts) are obtained at pullback speed of 20 mm/s and 3D renderings are performed. The orifices of the SB are assessed visually. The area of SB orifice and the number of strut-free compartments delineated by the BVS struts are evaluated.. Fifty-one OCT pullbacks were acquired: 33 pullbacks were imaged with Fourier-domain OCT and 27 treated segments had 46 side branches. Three-dimensional assessment was feasible in 87% (40 of 46) of pullbacks. The mean area of the SB orifice was 1.16 +/- 1.02 mm(2). The mean number of strut-free compartments was 2.0 +/- 1.1. The classification of the overhanging struts is proposed.. This study demonstrates that 3D OCT reconstruction is feasible to evaluate the orifices of SB jailed with BVS. (ABSORB Clinical Investigation, Cohort B; NCT00856856).

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Feasibility Studies; Female; Fourier Analysis; Humans; Image Interpretation, Computer-Assisted; Imaging, Three-Dimensional; Male; Middle Aged; New Zealand; Predictive Value of Tests; Prosthesis Design; Sirolimus; Terminology as Topic; Tomography, Optical Coherence; Treatment Outcome

Three-year follow-up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation have not been reported.. Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES.. Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three-year follow-up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25-22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07-29.44, P < 0.001) during the three-year follow-up.. The rates of MACEs, TVR, and stent thrombosis during the three-year follow-up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three-year follow-up after either SES or PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The increased frequency of very late (>1 year) stent thrombosis (VLST) has raised concerns with regard to the safety of sirolimus-eluting stents and paclitaxel-eluting stents (PES).. Experimental and preliminary clinical findings with the zotarolimus-eluting stent (ZES) have suggested a favorable safety profile.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial is a single-blind randomized ZES versus PES clinical trial in 1,548 patients with de novo native coronary lesions; the primary end point-9-month target vessel failure-was previously reported, annual clinical follow-up is planned for 5 years, and this report describes the 3-year outcomes.. The ZES compared with PES reduced target vessel failure (12.3% vs. 15.9%, hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.58 to 1.00, p = 0.049), myocardial infarctions (MI) (2.1% vs. 4.9%, HR: 0.44, 95% CI: 0.25 to 0.80, p = 0.005), and cardiac death plus MI (3.6% vs. 7.1%, HR: 0.52, 95% CI 0.32 to 0.82, p = 0.004). Although the overall 3-year rate of Academic Research Consortium definite/probable stent thrombosis did not differ significantly (1.1% vs. 1.7%, HR: 0.67, 95% CI 0.28 to 1.64, p = 0.380), VLST (between 1 and 3 years) was significantly reduced in ZES patients (1 event vs. 11 events; 0.1% vs. 1.6%, HR: 0.09, 95% CI: 0.01 to 0.71, p = 0.004). Ischemia-driven target lesion revascularization at 3 years was similar with ZES versus PES (6.5% vs. 6.1%, HR: 1.10, 95% CI: 0.73 to 1.65, p = 0.662).. Three-year follow-up results from the ENDEAVOR IV trial indicate similar antirestenosis efficacy but improved clinical safety associated with ZES compared with PES, due to significantly fewer peri-procedural and remote MIs associated with fewer VLST events. (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

We compared the degree of systemic inflammation and its relation to the angiographic outcomes after drug-eluting stent (DES) implantations.. We implanted a single DES in 79 stable angina patients (50 men; 60.4 (9.5) years of age; sirolimus-eluting stent (SES), n = 38; paclitaxel-eluting stent (PES), n = 41). The high-sensitivity C-reactive protein (hs-CRP) and interleukin 6 (IL-6) levels were determined before and at 24 hours, 72 hours, and 4 weeks after the percutaneous coronary intervention (PCI). An angiography and intravascular ultrasound (IVUS) were performed.. The hs-CRP and IL-6 levels at baseline did not differ between the two groups. The hs-CRP increased significantly from baseline at 24 hours and 72 hours after the PCI in both groups and there was a significant increase in the IL-6 level at 24 hours after the PCI in both groups. However, there was no significant difference between the two groups in any of the hs-CRP or IL-6 measurements. At follow-up, the late lumen loss was significantly higher in the PES group than in the SES group (0.57 (0.56) mm vs 0.28 (0.58) mm, respectively, p = 0.020). The neointimal hyperplasia (NIH) volume in the PES group was significantly higher than that in the SES group (23.1 (22.7) vs 3.8 (7.1) mm(3), respectively, p = 0.000). The percentage luminal volume reduction was higher in the PES group than in the SES group (18.9 vs 3.9%, p = 0.002). The absolute values or change in the inflammatory markers did not correlate with the NIH or stent volume reduction.. Our study showed that the benefits obtained from the SES, which reduce neointimal proliferation, are not probably mediated by the attenuation of the systemic inflammatory markers hs-CRP or IL-6.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; C-Reactive Protein; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Inflammation Mediators; Interleukin-6; Male; Middle Aged; Paclitaxel; Prognosis; Prospective Studies; Sirolimus; Systemic Inflammatory Response Syndrome; Treatment Outcome; Tubulin Modulators; Ultrasonography

To assess the efficacy of the AXXESS stent on the treatment of left main coronary artery (LMCA) bifurcation lesions using IVUS.. The treatment of LMCA bifurcation lesions remains challenging even with the use of drug-eluting stents. The AXXESS system is a biolimus A9-eluting self-expanding stent, dedicated to the treatment of bifurcation lesions.. Data were obtained from the AXXENT trial, a prospective, single-arm, multicenter study designed to evaluate the efficacy of the AXXESS stent on the treatment of LMCA bifurcation lesions. IVUS was available in 26 cases at 6-months follow-up. Volumetric and cross-sectional analyses within the AXXESS stent, and cross-sectional analyses at the ostia of left anterior descending (LAD) and left circumflex coronary arteries (LCX) were performed.. Within the AXXESS stent, percent neointimal volume obstruction was (3.0 +/- 4.1)% with a minimal lumen area of 10.3 +/- 2.6 mm(2). AXXESS stent volume showed an 12.4% increase at follow-up compared with postprocedure (P = 0.04). Lumen area was significantly smaller in the LCX ostium compared with the LAD ostium at follow-up (3.6 +/- 1.3 mm(2) vs. 5.5 +/- 2.0 mm(2), P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 +/- 1.20 mm(2) vs. 0.30 +/- 0.36 mm(2), P = 0.0003).. The AXXESS stent in the LMCA showed enlargement through 6-months follow-up and significant neointimal suppression. Greater neointimal formation and relatively inadequate stent expansion may contribute to luminal narrowing in the LCX ostium.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; United States

The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Sirolimus

Long-term polymer residue in the coronary milieu is a consequence of current drug-eluting stent (DES) therapy and has been implicated in late adverse events. We developed a novel polymer-free rapamycin- and probucol-eluting stent (Dual-DES) and compared its efficacy against commercially available permanent polymer-based sirolimus-eluting (SES; Cypher) and zotarolimus-eluting (ZES; Endeavor) stents.. Between March 2006 and July 2007, a total of 1007 patients undergoing coronary stenting of de novo lesions, in native vessels, were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). The primary endpoint was binary angiographic restenosis at 6-8 month follow-up angiography. Secondary endpoints were angiographic in-stent late loss; and target lesion revascularization (TLR), death/myocardial infarction and stent thrombosis at 12 months. Follow-up angiographic data were available for 828 (82.2%) patients. There was a significant difference in both binary restenosis and TLR across treatment groups (P = 0.003 and P < 0.001, respectively). Binary restenosis in the Dual-DES group (11.0%) was significantly lower than that in the ZES group (19.3%; P = 0.002) but comparable with that in the SES group (12.0%; P = 0.68). Similarly, TLR with Dual-DES (6.8%) was significantly lower than ZES (13.6%; P = 0.001) but not different to that of SES (7.2%; P = 0.83). These differences were mirrored in the extent of late loss across the groups. No differences were observed between stent groups in terms of death/myocardial infarction or stent thrombosis.. A novel polymer-free Dual-DES is associated with high anti-restenotic efficacy without recourse to carrier polymer. Potential long-term clinical advantage of this platform remains subject to investigation. Study registered at ClinicalTrials.gov. Identifier number: NCT00332397.

Topics: Aged; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Male; Myocardial Infarction; Myocardial Revascularization; Polymers; Probucol; Prospective Studies; Sirolimus; Treatment Outcome; Tubulin Modulators

Percutaneous coronary intervention (PCI) with bare metal stent (BMS) deployment causes plaque disruption and a rise in systemic levels of C-reactive protein (CRP), interleukin (IL)-6, and monocyte chemoattractant protein (MCP)-1. Our aim is to study whether PCI with sirolimus-eluting stent (SES) use attenuates this response.. Patients with stable angina undergoing single-vessel PCI were enrolled in a randomized, open-label fashion into a BMS group or an SES group. Blood samples were drawn pre-PCI, 24 hours post-PCI, and 30 days post-PCI. Systemic concentrations of CRP, IL-6, and MCP-1 were measured at all time points.. In total, 41 patients were enrolled (21 in the BMS group and 20 in the SES group). The baseline plasma concentrations of all markers were comparable between groups. At 24 hours, the mean plasma CRP concentration in the SES group was 20.21 mg/dL versus 8.95 mg/dL in the BMS group (P = 0.15). The mean plasma IL-6 concentration at 24 hours was 25.41 pg/mL in the SES group versus 17.44 pg/mL in the BMS group (P = 0.17). The mean plasma MCP-1 concentration at 24 hours was 382.38 pg/mL in the SES group versus 329.04 pg/mL in the BMS group (P = 0.2). At 30 days, plasma concentrations of all three markers decreased to similar values between groups.. The use of SES did not inhibit the rise in systemic concentrations of CRP, IL-6, and MCP-1 at 24 hours or 30 days post-PCI, compared with BMS. Moreover, at 24 hours, there was a trend for higher systemic levels of all proinflammatory markers in the SES group compared with the BMS cohort.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; C-Reactive Protein; Chemokine CCL2; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Interleukin-6; Male; Middle Aged; Sirolimus; Stents

This study sought to assess the safety and performance of the Axxess (Devax Inc., Lake Forest, California) self-expanding drug-eluting stent in coronary bifurcation lesions.. Percutaneous treatment of coronary bifurcations is a predictor of adverse late outcomes, in part because of the lack of dedicated devices.. Patients with de novo bifurcation lesions were prospectively enrolled in a multicenter study. The Axxess stent was deployed at the level of the carina followed by additional sirolimus-eluting stents in the distal parent vessel (PV) and/or side branch (SB). All patients underwent clinical follow-up at 9 months; 150 were to receive control angiography and 76 were to receive intravascular ultrasound. The primary end point was the rate of major adverse cardiac events (MACE): a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Secondary end points included in-segment restenosis, late loss, and percent neointimal volume obstruction.. Overall, 302 patients were treated with 299 Axxess stents (99%). Additional stenting of 1 branch was performed in 21.7% of patients (17.7% PV, 4% SB), and of both branches in 64.7%. At 9 months, 99.3% of patients returned for clinical follow-up; from the angiographic and IVUS substudies, 93.3% and 89.4% returned. The cumulative 9-month MACE rate was 7.7% (0.7% death, 3.3% non-Q-wave MI, 1.0% Q-wave MI, 4.3% TLR). Subacute and late stent thrombosis occurred in 0.7% and 0.3% of patients. Total restenosis was 6.4% (3.6% PV, 4.3% SB), late loss was 0.20 +/- 0.41 mm in the PV and 0.17 +/- 0.34 mm in the SB. In the Axxess stent segment, percent neointimal volume obstruction was 4.3 +/- 5.2%.. This prospective multicenter study confirms the safety and performance of the Axxess stent in bifurcation lesions. (Drug-Eluting Stent Intervention for Treating Side Branches Effectively; ACTRN12606000259549).

Topics: Aged; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

We compared 1-year outcomes in patients treated with paclitaxel-eluting stents (PESs) or sirolimus-eluting stents (SESs) in "real-world" clinical practice. Clinical outcomes were evaluated in 1,558 consecutive, unselected, retrospectively collected patients treated with drug-eluting stents (DESs; PES = 816, SES = 742) at 19 United States centers. The primary end point was 1-year target vessel revascularization (TVR). The study included a prespecified diabetic cohort (PES = 289, SES = 247), for which efficacy comparisons between DESs were analyzed according to vessel diameter and presence of chronic kidney disease. Baseline demographic, angiographic, and procedural characteristics were similar between patients treated with PESs and those treated with SESs. At 1 year, there were no overall statistical differences in death, myocardial infarction, TVR, or stent thrombosis. In the diabetic cohort, however, the cumulative incidence of TVR was significantly lower for patients treated with PESs (3%) compared with SESs (9%, p <0.01), which persisted after adjustment for baseline differences (hazard ratio 0.29, 95% confidence interval 0.12 to 0.67). This decrease in TVR with PES was similar in insulin- and noninsulin-requiring diabetic patients. In multivariate analysis, independent predictors of TVR included diabetes, bifurcation stenting, and overlapping stents; in the diabetic cohort, treatment with SESs was also a multivariate predictor of TVR. In conclusion, in this observational, retrospective analysis of DES-treated patients, PESs and SESs demonstrated similar overall safety and efficacy, but PESs were associated with a significant decrease in 1-year TVR rates in diabetic patients.

Topics: Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Postoperative Complications; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome; United States

The everolimus-eluting stent (EES) is a newly developed drug-eluting stent using the MULTILINK VISION stent platform combined with the drug everolimus contained in a polymer coating. Recently reported randomized trials have shown the noninferiority and subsequent superiority of the EES compared with the paclitaxel-eluting stent regarding in-stent late loss (LL) at 180 days. However, there have been no studies comparing head to head the EES with the sirolimus-eluting stent (SES), which has shown the least amount of LL among the previously released drug-eluting stent (DES). In addition, adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite the recommendation of the American Heart Association/American College of Cardiology to maintain 12 months of dual antiplatelet therapy, there have been no prospective randomized trials comparing the efficacy and safety of different durations.. In the Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial, approximately 1,400 patients are being prospectively and randomly assigned in a 2 x 2 factorial design according to the type of stent (EES vs SES) and the duration of dual antiplatelet therapy (6 vs 12 months). The primary end point is in-segment LL at 9 months for comparison of type of stent, and the coprimary end point is target vessel failure at 12 months for comparison of dual antiplatelet therapy duration.. The EXCELLENT trial is the largest study yet performed to directly compare the efficacy and safety of the EES versus the SES. In addition, this study will also address the issue of a 6- versus 12-month duration of dual antiplatelet therapy for post-percutaneous coronary intervention management.

Topics: Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Incidence; Korea; Male; Myocardial Revascularization; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Stent length is a major predictor of restenosis in stable patients undergoing percutaneous coronary intervention (PCI) with bare metal stents (BMS). The effect of stent length is decreased by using drug eluting stents, however, this association had not been previously determined in patients with acute myocardial infarction (AMI). We sought to determine the impact of stent length on restenosis in patients who undergo primary PCI for AMI.. Three-hundred and fifty-seven and 355 patients with AMI were included respectively in the BMS and SES (sirolimus eluting stents) arms of the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON). Patients were divided into four subgroups based on the total length of the culprit lesion stented segment (in mm) : <18, >or=18 and <23, >or=23 and < 28, and >or=28 (groups 1 - 4 respectively). Target lesion revascularisation (TLR) and angiographic late loss were used to assess the restenotic process. Despite similar lesion length, average stent length was longer in patients treated with SES as compared to BMS 22.1+/-8.6 and 20.3+/-8.2 mm respectively, p=0.005. The rate of 12m death and AMI was similar in SES and BMS. There was no significance influence of stent length on % TLR neither in BMS (12.6, 10.1, 17.4 and 12.3 - subgroups 1-4 respectively) nor in SES (3.9, 5, 2.2 and 2.7 respectively). There was also no significant impact of stent length on angiographic late loss (mm) neither in BMS (0.7, 0.87, 0.84 and 0.92 respectively) nor in SES (0.32, 0.0, 0.11 and 0.3 respectively).. Physicians tend to choose longer SES than BMS for a similar lesion length during primary PCI for AMI. Interestingly, stent length did not affect clinical or angiographic restenosis neither in BMS nor in SES in this group of patients who underwent primary PCI for acute MI. This data challenges current practice concerning the chosen stent length in patients with AMI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Israel; Male; Metals; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

To evaluate the vascular response at 9 months after zotarolimus-eluting stent (ZES; Endeavor) implantation using optical coherence tomography (OCT). These findings were compared with those after implantation of a sirolimus-eluting stent (SES; Cypher Select).. Cross-sectional observational study with prospective OCT registry.. Nine months after ZES or SES implantation.. A total of 68 patients (32 ZES and 36 SES) underwent OCT at 9 months after stent implantation. The neointima hyperplasia (NIH) thickness inside each strut and percentage of NIH area at every 1 mm cross section were measured.. The degree of neointimal coverage and the prevalence of malapposition at 9 months after ZES and SES implantation using OCT.. The mean (SD) NIH thickness (251.2 (110.0) mum vs 85.5 (53.3) mum, p<0.001) and percentage of NIH area (27.9 (9.1)% vs 11.2 (7.1)%, p<0.001) were significantly greater in ZES than in SES. The prevalence of uncovered strut as well as malapposed strut was significantly lower in ZES than in SES (0.3% vs 12.3%, p<0.001 and 0.08% vs 2.6%, p<0.001). Thrombus was not observed in ZES (0.0% in ZES vs 27.8% in SES, p = 0.001).. Neointimal coverage in ZES was almost complete and malapposition was very rare at 9-months' follow-up.

Topics: Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Observer Variation; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

The purpose of this randomized study was to compare sirolimus-eluting stenting (SES) with minimally invasive direct coronary artery bypass (MIDCAB) surgery for patients with isolated proximal left anterior descending (LAD) coronary artery disease.. Bare-metal stenting is inferior to MIDCAB surgery in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. SES are effective in restenosis reduction.. A total of 130 patients with significant proximal LAD coronary artery disease were randomized to either SES (n = 65) or MIDCAB surgery (n = 65). The primary clinical end point was noninferiority in freedom from major adverse cardiac events (MACE), such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months.. Follow-up was completed for all patients. MACE occurred in 7.7% of patients after stenting, as compared with 7.7% after surgery (p = 0.03 for noninferiority). The individual components of the combined end point revealed mixed results. Although noninferiority was revealed for the difference in death and myocardial infarction (1.5% vs. 7.7%, noninferiority p < 0.001), noninferiority was not established for the difference in target vessel revascularization (6.2% vs. 0%, noninferiority p = 0.21). Clinical symptoms improved significantly in both treatment groups in comparison with baseline, and the percentage of patients free from angina after 12 months was 81% versus 74% (p = 0.49).. In isolated proximal LAD disease, SES is noninferior to MIDCAB surgery at 12-month follow-up with respect to MACE at a similar relief in clinical symptoms.

Topics: Aged; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Exercise Tolerance; Female; Humans; Male; Middle Aged; Minimally Invasive Surgical Procedures; Prosthesis Implantation; Quality of Life; Sirolimus; Treatment Outcome

We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).. The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel.. Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months.. Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups.. Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Cardiovascular Diseases; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to evaluate long-term clinical outcomes after implantation of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) among patients with unprotected left main coronary artery (LMCA) disease.. There have been few comparisons of long-term outcomes among currently available drug-eluting stents (DES) for the treatment of LMCA disease.. A total of 858 consecutive patients with unprotected LMCA stenosis were treated with SES (n = 669) or PES (n = 189) between May 2003 and June 2006. Primary outcome was the composite of death, myocardial infarction (MI), or target vessel revascularization (TVR).. Baseline clinical and angiographic characteristics were similar in the 2 groups. During 3 years of follow-up, the adjusted risk of primary composite outcome was similar among the groups (SES vs. PES: 25.8% vs. 25.7%, hazard ratio [HR]: 0.95, 95% confidence interval [CI]: 0.64 to 1.41, p = 0.79). The 2 groups also showed a comparable adjusted rate of each component of outcome: death (9.1% vs. 11.0%, HR: 0.92, 95% CI: 0.47 to 1.80, p = 0.82), MI (8.1% vs. 8.0%, HR: 0.80, 95% CI: 0.43 to 1.48, p = 0.47), and TVR (12.1% vs. 10.6%, HR: 1.10, 95% CI: 0.53 to 2.29, p = 0.81). The 3-year rates of definite or probable stent thrombosis were 0.6% in the SES group and 1.6% in the PES group (adjusted p = 0.18).. In consecutive patients with unprotected LMCA disease undergoing DES implantation, SES and PES showed similar long-term clinical outcomes in terms of death, MI, repeat revascularization, and stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Treatment Outcome; Tubulin Modulators

Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions.. A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography).Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32+/-0.69 vs 0.24+/-0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group.. BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We assessed the impact of vessel size on outcomes of stenting with biolimus-eluting degradable polymer stent (BES) and sirolimus-eluting permanent polymer stent (SES) within a randomized multicenter trial (LEADERS).. Stenting of small vessels might be associated with higher rates of adverse events.. "All-comer" patients (n = 1,707) were randomized to BES and SES. Post-hoc-stratified analysis of angiographic and clinical outcomes at 9 months and 1 year, respectively, was performed for vessels with reference diameter 2.75 mm.. Of 1,707 patients, 429 patients in the BES group with 576 lesions and 434 patients in the SES group with 557 lesions had only small vessels treated (50.6% of the patient cohort). In patients with small vessels there was no significant difference in overall major adverse cardiac events (MACE) rate (12.1% vs. 11.8%; p = 0.89) or target lesion revascularization (TLR) rate (9.6% vs. 7.4%; p = 0.26) between BES and SES. The MACE and TLR rates in the small-vessel patient population were higher than in the large-vessel population. The TLR rate was 9.6% versus 2.6%, and MACE rate was 12.1% versus 7.1% for small versus large vessels in the BES arm (TLR: hazard ratio [HR] = 3.724, p = 0.0013; MACE: HR = 1.720, p = 0.0412). In the SES arm, TLR was 7.4% versus 5.1%, and MACE was 11.8% versus 10.3% in small versus large vessels (TLR: HR = 1.435, p = 0.2594; MACE: HR = 1.149, p = 0.5546).. Prevalence of small vessel disease is high in an "all-comer" population with higher TLR and MACE rates. The BES and SES seem equivalent in treatment outcomes of small vessels in this "all-comer" patient population.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to examine outcomes related to the use of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) compared with the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific Corp., Natick, Massachusetts) in the 477 patients with diabetes mellitus (DM) enrolled in the randomized ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial.. Percutaneous coronary intervention (PCI) in diabetic patients is associated with increased rates of restenosis-related end points compared with PCI in nondiabetic patients. Although ZES has been associated with similar clinical efficacy compared with PES in the overall trial population of the ENDEAVOR IV trial, whether these results are maintained in the higher-risk restenosis subgroup of patients with DM has not been determined.. Clinical and angiographic outcomes were compared according to randomized treatment assignment to either ZES or PES.. Baseline characteristics were similar among ZES (n = 241) and PES (n = 236) diabetic patients, with slightly longer lesion lengths in PES-treated patients (12.9 mm vs. 14.0 mm, p = 0.041). Among the 86 DM patients assigned to routine angiographic follow-up (18% of the overall DM cohort), in-stent percent diameter stenosis at 8 months was greater among ZES-treated patients (32.9 vs. 21.1, p = 0.023), with a trend toward higher in-stent late loss. One-year clinical outcomes were similar among DM patients treated with either ZES or PES (target vessel failure: 8.6% vs. 10.8%, p = 0.53; target lesion revascularization: 6.9% vs. 5.8%, p = 0.70; target vessel revascularization: 8.6% vs. 9.4%, p = 0.87). There were no significant interactions between DM status and stent type with respect to the outcomes measured, and the relative efficacy/safety of ZES and PES were similar among insulin- and noninsulin-requiring subgroups.. One-year clinical outcomes were similar among DM patients treated with ZES and PES in the ENDEAVOR IV trial. These findings parallel the overall trial results, which demonstrated similar efficacy and safety of ZES and PES for single de novo coronary lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Severity of Illness Index; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California).. Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.. The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters > or =2.5 and < or =3.5 mm and lesion length > or =14 and < or =27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.. The 9-month in-stent late lumen loss was 0.22 +/- 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 +/- 7.83 mm(3), and percent NIH volume obstruction was 3.73 +/- 4.05%.. In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

To evaluate the 5-year clinical outcomes of patients treated with the Endeavor zotarolimus-eluting stent (ZES) in the ENDEAVOR I first-in-human study.. ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries.. Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have > or = 50% stenosis, be < or = 15 mm in length, and located in a vessel with a reference diameter of 3.0-3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation.. The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non-Q-wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%.. Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Massachusetts; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation.. We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11+/-0.30 mm versus 0.32+/-0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (P<0.001) and the secondary hypothesis of superiority (P=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (P=0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5+/-7.2% in Taxus to 1.8+/-5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm.. The NOBORI 1 clinical trial confirmed its primary hypothesis--noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population.

Topics: Angioplasty, Balloon, Coronary; Asia; Australia; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Hyperplasia; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The E-Five registry was designed to evaluate the safety and effectiveness of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) for the treatment of coronary artery stenosis across a wide range of patients treated in real-world clinical practice settings.. Early clinical trials with the Endeavor ZES have demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 4 years of follow-up. A clinical registry was designed to complement controlled trial data by examining a large patient population, including high-risk patient subsets.. The E-Five registry is a prospective, nonrandomized, multicenter global registry conducted at 188 centers worldwide. Adult patients (n = 8,314) with coronary artery disease who underwent single-vessel or multivessel percutaneous coronary intervention were enrolled. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. A secondary analysis stratified patients by standard versus extended-use clinical and lesion characteristics.. Overall 12-month outcome rates were MACE 7.5%; cardiac death 1.7%; myocardial infarction (all) 1.6%; target lesion revascularization 4.5%; and stent thrombosis (Academic Research Consortium definite and probable) 1.1%. The 12-month MACE rates were 4.3% and 8.6% for standard- and extended-use patients, respectively (p < 0.001).. This large, international multicenter registry provides important information regarding the long-term safety and efficacy of the Endeavor ZES across standard and extended-use patients in the real-world setting. Rates of MACE and measures of safety including cardiac death, myocardial infarction, and stent thrombosis were low and consistent with pooled results of clinical trials. (E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent [eFive Registry]; NCT00623441).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Stenosis; Europe; Female; Humans; Israel; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Sirolimus; South America; Thrombosis; Time Factors; Treatment Outcome; United States

The long-term impact of treating bifurcation lesions on the overall outcome of patients with multivessel coronary disease treated percutaneously with drug-eluting stents is unknown. This analysis determined the influence of bifurcation treatment using sirolimus-eluting stents on 3-year clinical outcomes.. Of the 607 patients (2,160 lesions) in the ARTS II study, 324 patients underwent revascularisation procedures involving treatment of at least one bifurcation (465 lesions). Three-year outcomes were compared to those without bifurcations. Despite more diffuse and complex disease in the bifurcation group, survival free of adverse events was equivalent in the two groups. At 3-years, there was no difference in rate of overall MACCE (20.2% vs. 18.5%, p=NS) or any of the component events between the bifurcation and the non-bifurcation group. There was a trend for a higher rate of definite stent thrombosis in the bifurcation group (4.6 vs 2.1%, p=0.1), but in multivariate analysis the CK value post-procedure served as the only independent predictor of definite stent thrombosis (p=0.015), with the presence of a bifurcation lesion of borderline significance (p=0.056).. In multivessel disease treated by PCI with DES, the presence of bifurcation disease had no adverse influence on 3-year clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cerebrovascular Disorders; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The objective of this study was to assess the non-inferiority, in terms of anti-restenotic efficacy, of both biodegradable-polymer (BP) and polymer-free (PF) stents compared with permanent-polymer rapamycin-eluting (PP; Cypher) stent.. Patients with de novo coronary lesions in native vessels were randomly assigned to receive a BP stent, a PF stent or a PP stent. The primary endpoint was in-stent late lumen loss at follow-up angiogram. A total of 605 patients were enrolled: 202 patients received BP stents, 202 were treated with PP stents, and 201 received PF stents. Repeat angiography was available for 492 patients (81.3%). Mean late lumen loss at 6-8-month angiographic follow-up was 0.17 +/- 0.45 mm in the BP stent group, 0.23 +/- 0.46 mm in the PP cohort, and 0.47 +/- 0.56 mm in the PF stent group. The BP stent met pre-specified criteria for non-inferiority (P < 0.001), whereas the PF stent did not (P = 0.94). There were no differences in safety outcomes.. Both BP and PF stents have a 1-year safety profile similar to that of the PP stent. Whereas the PF stent provided an inferior efficacy, the BP stent is at least as effective as the PP stent in terms of anti-restenotic efficacy.

Topics: Aged; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Polymers; Prospective Studies; Radiography; Sirolimus; Stents; Treatment Outcome; Tubulin Modulators

The clinical significance of early inflammatory response after coronary stent implantation has been controversial. Sirolimus-eluting stent (SES) has been shown to be better outcomes compared with bare metal stent (BMS). We prospectively investigated the early inflammatory response after SES or BMS implantation in patients with single-vessel lesion, and evaluated the relationship between inflammation and late clinical outcomes in a randomized design.. Forty-eight patients with single-vessel disease were randomized into SES or BMS implantation group (n=24 respectively). Blood samples were taken before stenting, 1 h, 24 h and 8 months afterward. The plasma concentrations of C-reactive protein (CRP) and interleukin-6 (IL-6) were determined by ELISA. The clinical and angiographic follow-up were performed at 8 months after stenting.. There was no difference in baseline characteristics, plasma CRP and IL-6 concentrations between the 2 groups. However, plasma IL-6 concentrations at 1 h after stenting were higher in both groups than in baseline (p<0.01). In addition, the plasma CRP and IL-6 concentrations at 24 h after stenting were significantly higher in both groups compared with baseline (p<0.01 respectively). Likewise, plasma CRP and IL-6 concentrations were significantly higher in BMS group compared with SES group at 24 h after stenting (p<0.05 respectively). At the follow-up (mean 8 months after stenting), the rate of in-stent restenosis (ISR) and target lesion revascularization (TLR) were higher in BMS group than in SES group (p<0.05 respectively) although the plasma CRP and IL-6 concentrations are similar between the groups.. Single coronary stenting could trigger an early inflammatory response. However, patients undergoing SES implantation has less augmentation of early inflammatory markers after stenting compared to patients treated with BMS, which was positively related the incidence of ISR and TLR at follow-up. This may reflect the potential impact of SES implantation on the early inflammatory response and late clinical outcomes.

Topics: Angioplasty; Biomarkers; Coronary Stenosis; Female; Follow-Up Studies; Humans; Inflammation; Male; Middle Aged; Myocardial Revascularization; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this study was to compare the effectiveness of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).. Drug-eluting stent implantation significantly improved the angiographic and clinical outcomes compared with bare-metal stent implantation in diabetic patients. However, comparison of SES with PES in diabetic patients has not been sufficiently evaluated.. This prospective, multicenter, randomized study compared SES (n = 200) and PES implantation (n = 200) for diabetic patients (n = 400). The primary end point was in-segment restenosis at 6 months according to intention-to-treat principle.. The 2 groups had similar baseline clinical and angiographic characteristics. Six-month in-stent (3.4% vs. 18.2%, p < 0.001) and in-segment restenosis (4.0% vs. 20.8%, p < 0.001) and 9-month target lesion revascularization (2.0% vs. 7.5%, p = 0.017) were significantly lower in the SES versus the PES group. The incidence of death (0% in SES vs. 0.5% in PES, p = 0.999) or myocardial infarction (0.5% in SES vs. 0.5% in PES, p = 0.999) at 9-month follow-up was not statistically different between the 2 groups. Major adverse cardiac events including death, myocardial infarction, and target lesion revascularization at 9 months (2.0% vs. 8.0%, p = 0.010) were lower in the SES versus the PES group.. Sirolimus-eluting stent implantation is superior in reducing angiographic restenosis and improving 9-month clinical outcomes in patients with DM and coronary artery disease compared with PES implantation.

Topics: Aged; Blood Vessel Prosthesis Implantation; Cohort Studies; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Radiography; Sirolimus; Treatment Outcome; Tubulin Modulators

Topics: Adult; Aged; Aged, 80 and over; Angioscopy; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Tunica Intima

We investigated whether routine T-stenting reduces restenosis of the side branch as compared with provisional T-stenting in patients with de novo coronary bifurcation lesions.. Our randomized study assigned 101 patients with a coronary bifurcation lesion to routine T-stenting with sirolimus-eluting stents (SES) in both branches and 101 patients to provisional T-stenting with SES placement in the main branch followed by kissing-balloon angioplasty and provisional SES placement in the side branch only for inadequate results. Primary endpoint was per cent diameter stenosis of the side branch at 9 month angiographic follow-up. Angiographic follow-up in 192 (95%) patients revealed a per cent stenosis of the side branch of 23.0 +/- 20.2% after provisional T-stenting (19% with side-branch stent) and of 27.7 +/- 24.8% (P = 0.15) after routine T-stenting (98.2% with side-branch stent). The corresponding binary restenosis rates were 9.4 and 12.5% (P = 0.32), prompting re-intervention in 5.0 and 7.9% (P = 0.39), respectively. In the main branch, binary restenosis rates were 7.3% after provisional and 3.1% after routine T-stenting (P = 0.17). The overall 1 year incidence of target lesion re-intervention was 10.9% after provisional and 8.9% after routine T-stenting (P = 0.64).. Routine T-stenting with SES did not improve the angiographic outcome of percutaneous coronary intervention of coronary bifurcation lesions as compared with stenting of the main branch followed by kissing-balloon angioplasty and provisional side-branch stenting.

Topics: Aged; Angioplasty, Balloon; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Sirolimus; Treatment Outcome

To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions.. In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few.. This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months.. Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006).. In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Fibrinolytic Agents; Humans; Male; Metals; Middle Aged; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; United States

A novel zotarolimus-eluting coronary stent system (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) was compared with a paclitaxel-eluting coronary stent (Taxus Express2) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. The primary end point was defined as noninferiority of in-segment late lumen loss after 9 months.. The ZoMaxx stent system elutes 10 microg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum.. Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent.. After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 +/- 0.57 mm vs. 0.45 +/- 0.48 mm; p < 0.001; in-segment 0.43 +/- 0.60 mm vs. 0.25 +/- 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups).. After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Logistic Models; Male; Middle Aged; New Zealand; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Wall shear stress (WSS) has been associated with neointimal hyperplasia (NIH) following bare metal stent (BMS) implantation. Drug-eluting stents (DES) almost abolish NIH. Conversely, diabetes mellitus amplifies NIH response. The association between WSS and arterial wall response following DES and BMS implantation in diabetic patients remains to be evaluated.. The study involved 20 diabetic patients randomized to BMS (n = 9) or sirolimus-eluting stent (SES; n = 11) implantation in native coronary arteries. A computational fluid dynamic model applied 3D intravascular ultrasound (IVUS) and two-plane angiographic to measure WSS (Pa). IVUS assessments were performed post-procedure and at 9-months follow-up. The target segment encompassed the stent plus 5 mm distal and proximal edges. A total of 93 subsegments were evaluated: in-stent segments divided in three subsegments (proximal, mid and distal; n = 60) and proximal and distal edges (n = 33).. Stent length was similar between BMS (17.4 +/- 7.3 mm) and SES (19.8 +/- 6.8 mm) groups. NIH was observed in all BMS subsegments (n = 27) versus one subsegment in the SES group (n = 33). WSS ranged from 0.52 to 4.20 Pa in the BMS and from 0.42 to 3.06 Pa in the SES group. There was no correlation between WSS and NIH in either stent group. In addition, there were no correlation between the change of external elastic membrane (EEM) or plaque growth at the edges and WSS.. WSS was not associated with NIH after implantation of SES or BMS in diabetic patients. Plaque growth or the change of EEM at the edges were not associated with WSS either.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Computer Simulation; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Diabetic Angiopathies; Drug-Eluting Stents; Female; Hemorheology; Humans; Hyperplasia; Image Interpretation, Computer-Assisted; Imaging, Three-Dimensional; Male; Metals; Middle Aged; Models, Cardiovascular; Pulsatile Flow; Sirolimus; Stents; Stress, Mechanical; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The purpose of this study was to investigate the vascular response of zotarolimus-eluting stent (ZES) and sirolimus-eluting stent (SES) using serial intravascular ultrasound (IVUS).. Data were obtained from the Endeavor Drug-Eluting Coronary Stent System Versus the Center Siromlimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (ENDEAVOR) III trial, a randomized study comparing ZES and SES for the treatment of de novo native coronary artery lesions. Serial (baseline and 8-month follow-up) IVUS was available in 258 patients (190 ZES, 68 SES).. At 8 months, ZES had greater percentage of neointimal volume index (ZES 1.1 +/- 0.8 mm3/mm vs SES 0.2 +/- 0.1 mm3/mm, P < .01), resulting in smaller lumen volume index (6.0 +/- 2.0 mm3/mm vs 7.0 +/- 2.1 mm3/mm, P < .05). Zotarolimus-eluting stents showed larger IVUS-detectable neointimal coverage over stent surface (50.2% vs 10.5%, P < .01) and greater mean neointimal thickness (0.19 +/- 0.07 mm vs 0.10 +/- 0.06 mm, P < .01). Zotarolimus-eluting stents had a significantly lower incidence of late-acquired incomplete stent apposition.. Zotarolimus-eluting stent is associated with a significantly greater amount of neointimal hyperplasia compared with SES. This amount of hyperplasia in ZES is distributed throughout the stent at 8-month follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Probability; Reference Values; Risk Assessment; Sensitivity and Specificity; Single-Blind Method; Sirolimus; Survival Rate; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; Vascular Patency

With the introduction of drug-eluting stents (DES), the angiographic rates of restenosis have reduced dramatically but less prominently in diabetic patients. We compared the effects of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) on 6-month angiographic and clinical outcomes in Korean diabetic patients.. Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned to either SES or PES in six different cardiovascular centers from April 2005 to January 2006. Patients with vessel size >2.0 mm and < or =2 vessel diseases requiring < or =2 DES implantation were included in the study.. Baseline clinical and angiographic characteristics were similar between the two groups. At 6-month follow-up, the late lumen loss (0.26 +/- 0.76 in the SES group vs. 0.39 +/- 0.92 mm in the PES group, P = 0.356) and the rate of binary restenosis (2.8%[n = 2] in the SES group vs. 6.9%[n = 5] in the PES group, P = 0.441) showed no significant differences. Rates of death (1.2%[n = 1] in the SES group vs. 1.2%[n = 1] in the PES group, P = 1.000), myocardial infarction (1.2%[n = 1] in the SES group vs. 1.2%[n = 1] in the PES group, P = 1.000), and target lesion revascularization (2.4%[n = 2] in the SES group vs. 4.8%[n = 4] in the PES group, P = 0.443) were similar in both groups during 6 months of follow-up.. The use of either SES or PES demonstrated similar 6-month angiographic and clinical outcomes in Korean diabetic patients with coronary artery disease.

Topics: Aged; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Korea; Male; Middle Aged; Paclitaxel; Prospective Studies; Secondary Prevention; Sirolimus; Treatment Outcome

Few studies directly compared drug-eluting stents and bare-metal stents (BMSs) in diabetic patients. DESSERT was an Italian multicenter randomized trial to show the efficacy of sirolimus-eluting stents (SESs) compared with BMSs in de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for > or =3 months on top of glycoprotein IIb/IIIa inhibitors. The primary end point was in-stent late lumen loss, assessed using centralized quantitative coronary angiography at 8-month follow-up. Centrally adjudicated composite major adverse cardiac events (MACEs) and target-vessel failure (TVF; death, treated vessel-related acute myocardial infarction, and target-vessel revascularization) at 30 days and 9 and 12 months were secondary end points. Seventy-five patients were randomly assigned to an SES (109 lesions), and 75 (109 lesions), to a BMS. The 2 groups were well balanced for clinical, anatomic, and procedural characteristics. In-stent late lumen loss decreased from 0.96 +/- 0.61 mm for BMSs to 0.14 +/- 0.33 for SESs (p <0.001), and in-segment binary restenosis was 38.8% versus 3.6%, respectively (p <0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACEs 22.1% versus 40% (p = 0.023), target-lesion revascularization 5.9% versus 30% (p <0.001), and TVF 14.7% versus 34.3% (p = 0.008). At multivariate analysis, stent type was confirmed as an independent predictor of in-segment late loss (p <0.001), binary restenosis (p <0.001), 12-month TVF (p = 0.010), and 12-month MACEs (p = 0.037). In conclusion, the randomized DESSERT showed SESs to be safe and effective in decreasing both angiographic parameters of restenosis and incidence of MACEs compared with BMSs in diabetic patients with de novo 1- or 2-vessel coronary stenoses.

Topics: Aged; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Electrocardiography; Female; Follow-Up Studies; Humans; Incidence; Italy; Male; Metals; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Risk Factors; Single-Blind Method; Sirolimus; Stents; Survival Rate; Time Factors; Treatment Outcome

The goal of this work was to verify whether the superiority of the sirolimus-eluting stent (SES) in inhibiting neointimal hyperplasia could be demonstrated in complex coronary lesions.. Both the SES (Cypher, Cordis, Miami Lakes, Florida) and the paclitaxel-eluting stent (PES) (Taxus, Boston Scientific, Natick, Massachusetts) have shown a marked reduction in neointimal hyperplasia compared with bare-metal stents. Intravascular ultrasound (IVUS) is the best method to assess arterial response to stent deployment, but few IVUS data are available comparing complex lesions treated with SES or PES.. We prospectively randomized patients with complex lesions to SES or PES implantation. Intravascular ultrasound and quantitative angiography were performed post-procedure and at 9 months. Mean neointimal hyperplasia area (NIHA), percent of NIHA (NIHA%), mean peristent plaque area (PSPA), and percent of PSPA (PSPA%) were calculated. The primary end point was NIHA% at follow-up. Secondary end points included change in PSPA% and angiographic late luminal loss at follow-up.. Of the 100 patients enrolled, 42 receiving the SES and 43 receiving the PES had adequate IVUS assessment. Vessel, plaque, and lumen areas were comparable at follow-up, but NIHA% was significantly lower with SES than PES (7.4 +/- 4.2% vs. 15.4 +/- 8.1%; p < 0.001). A significant reduction in PSPA% was observed with SES (-4 +/- 10% vs. 0 +/- 8%; p = 0.01). Late loss was significantly lower with SES (0.16 +/- 0.19 mm vs. 0.32 +/- 0.33 mm; p = 0.003).. The SES shows a significantly higher inhibition of neointimal hyperplasia compared with PES in complex lesions. However, both stents have excellent IVUS and angiographic results at 9 months. A significant reduction in peri-stent plaque is observed only with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Female; Follow-Up Studies; Humans; Hyperplasia; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Radiography; Sirolimus; Stents; Tubulin Modulators; Tunica Intima; Ultrasonography, Interventional

The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months.. Patients (n =1,197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer-coated stent (n= 598) or the same bare metal stent but without the drug or the polymer coating (n=599).. The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P=0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P=0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P=0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03+/-0.58 to 0.61+/-0.46 (P<0.001) in stent and from 0.72+/-0.61 to 0.36+/-0.46 (P<0.001) in segment. The rate of in-segment restenosis was reduced from 35% to 13.2% with Endeavor (P<0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P<0.0001).. Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.

Topics: Aged; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Double-Blind Method; Drug Delivery Systems; Equipment Design; Europe; Female; Humans; Israel; Male; Middle Aged; New Zealand; Pacific Islands; Phosphorylcholine; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Although complete coverage of diffuse long coronary lesions has warranted the use of overlapping drug-eluting stents (DESs), the effect of stent overlap with different DESs on the neointimal hyperplasia and whether it would result in dose-related side effects are unknown.. Forty-seven consecutive patients, from June 2003 to August 2004, underwent percutaneous coronary intervention (PCI) with 2 of the same or different overlapping DESs for diffuse long lesions. Out of the total of 47 patients, a nine-month angiographic examination and IVUS were performed in 40 (85.1%) patients. Of the 47 overlapping DESs utilized, 14 were overlapped using sirolimus- and paclitaxel-eluting stents (S-P group), 13 using two sirolimus-eluting stents (S-S group) and 20 using two paclitaxel-eluting stents (P-P group). In the follow-up, there was no difference between the three groups in the late loss or area of neointimal hyperplasia. All restenoses were noted at non-overlapping sites (2 at the proximal edge of the proximal stent, and 3 at the distal in-stent). There were no stent thromboses documented or aneurysmal formations at the overlapping site in any of the three groups. One late stent malapposition was observed not at an overlapping site, but in the distal single stent area.. In conclusion, compared with using the same overlapping DESs, PCI with different overlapping DESs exhibited similar effects on the suppression of neointimal hyperplasia and did not increase the side effects of the DES.

Topics: Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Diagnosis, Differential; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Ultrasonography, Interventional

To see whether use of a sirolimus-eluting stent (SES) is superior to a third-generation thin-strut, cobalt-chromium stent (CCS) in terms of in-segment late loss at 9 months in patients with symptomatic coronary artery disease.. Stent-strut thickness has been shown to be strictly related with risk of in-stent restenosis, but available demonstrations of the angiographic efficacy of SES have been based on comparisons with thick-strut bare metal control stents.. The primary outcome measure of this single-center, single-blind randomized comparative trial was 9-month in-segment late loss. Eligibility criteria were symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3-mm stent. Based on a power calculation, 104 patients were randomly assigned to receive a SES (Cypher) or a CCS (Vision).. In-segment late loss was significantly lower in the SES group (0.18 +/- 0.40 mm vs 0.58 +/- 0.51 mm, P < 0.001). Regarding subsidiary outcome measures, in-segment restenosis (at 9 months) was recorded in 10% (5/50) patients treated with SES and 23% (11/48) receiving CCS (P = 0.14). No clinical difference between the two groups was apparent at 12 months. Freedom from target vessel failure at 12 months was 72% for SES patients and 68% for CCS patients (P = 0.65).. In patients with de-novo coronary lesions at medium risk of restenosis the anti-proliferative effect of SES is greater than that of a thin-strut CCS. Nevertheless, the angiographic results of the CCS were rather good. It remains to be seen whether the angiographic superiority of SES can translate into clinical superiority.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prosthesis Design; Research Design; Risk Factors; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

The drug-eluting stent (DES) has been proven its efficacy in randomized trials. But the difference of efficacy between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in unselected patients is in controversy. Therefore, we investigated the clinical and angiographic outcomes of these two types of the DES.. All consecutive patients treated with DES from March 2003 to March 2004 at two centers were analyzed.. We analyzed 440 patients with 519 lesions who were treated with the two types of DES (SES 353 lesions/296 patients, PES 166 lesions/144 patients). PES group had more acute myocardial infarction (AMI) patients. Angiographically, the number of stents per lesion, maximal deployment pressure, stent diameter and the percent residual stenosis after procedure were different between the two groups. Angiographic follow-up was available in 103 patients (71.5%) in the PES group and 208 patients (70.3%) in the SES group. PES showed the higher binary restenosis rate (PES 17.9%, SES 4.5%, p<0.0001) and the larger late loss (PES 0.60x0.83 mm vs. SES 0.16x0.40 mm, p<0.001) than SES. PES was the predictor of binary restenosis at six months (OR 4.67, CI 2.20-9.91). At one year follow-up, PES also had more cardiac events (composites of death of all cause, MI, and target lesion revascularization) than SES (PES 13.9% vs. SES 6.1%, p<0.001). PES was a significant predictor of cardiac events at one year (OR 2.47, CI 1.23-4.95).. SES showed better clinical and angiographic outcomes compared to PES in a daily routine practice of coronary intervention in Koreans.

Topics: Anti-Bacterial Agents; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Korea; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Paclitaxel; Sirolimus; Stents; Treatment Outcome

This study aimed to assess the efficacy of a rapamycin plus 17-beta-estradiol-eluting stent versus a rapamycin-eluting stent in patients with coronary artery disease.. Estradiol promotes rapid re-endothelialization of coronary stents in animal models, but it is not known whether combining this drug with rapamycin represents an improved drug-eluting stent technology in terms of reduced lumen renarrowing.. In this randomized study, we enrolled 502 patients with de novo lesions in native coronary arteries who were randomly assigned to receive either a polymer-free, estradiol plus rapamycin-eluting stent (ERES) (n = 252) or a polymer-free, rapamycin-eluting stent (RES) (n = 250). The primary end point was in-stent late lumen loss in the follow-up angiography. Secondary end points were binary angiographic restenosis, target lesion revascularization, combined incidence of death and myocardial infarction, and incidence of stent thrombosis during 1 year after randomization. The study was designed to test for the superiority of the ERES compared with the RES with respect to in-stent late lumen loss.. Late lumen loss (0.52 +/- 0.58 mm vs. 0.51 +/- 0.58 mm, p = 0.83), the incidence of binary angiographic restenosis (17.6% vs. 16.9%, p = 0.85), the incidence of target lesion revascularization (14.3% vs. 13.2%, p = 0.72), the combined incidence of death and myocardial infarction (7.9% vs. 8.0%, p = 0.98), and the incidence of stent thrombosis (0.8% vs. 1.2%, p = 0.99) were not significantly different between the ERES group and the RES group.. No apparent beneficial effect is obtained by adding estradiol to a polymer-free rapamycin-eluting stent during the first year after the procedure. (The ISAR-PEACE trial; http://clinicaltrials.gov/ct/show/NCT00402636?order=1; NCT00402636).

Topics: Aged; Coronary Stenosis; Drug Therapy, Combination; Estradiol; Female; Follow-Up Studies; Humans; Male; Middle Aged; Radiography; Sirolimus; Stents

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Phosphorylcholine; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Sirolimus stent implantation has been demonstrated to be safe and effective in diabetics; however, the long-term outcomes in this high-risk population remain unknown. The aim of this study was to determine the long-term safety and efficacy of the sirolimus-eluting stent (SES) when compared with the bare metal stent (BMS) in patients included in the DIABETES (DIABETes and sirolimus Eluting Stent) trial.. The prospective multicentre DIABETES trial randomized 160 diabetic patients with one or more significant coronary stenoses in one, two, or three vessels to either SES or BMS implantation. One-year dual antiplatelet therapy (aspirin plus clopidogrel) was routinely prescribed. Clinical follow-up was scheduled at 1, 9, 12, and 13 months and 2 years. Baseline clinical and angiographic characteristics were comparable between groups. At 2 years, the rate of target lesion revascularization was significantly lower in the SES group compared with the BMS group (7.7 vs. 35.0%, P < 0.001). However, the total revascularization rate at 2 years increased in both groups due to progression of atherosclerosis in coronary segments remote from the target lesion (rate of atherosclerosis progression: 7.7% in SES group vs. 10% in BMS group; P = 0.7). During dual antiplatelet treatment (1 year), there was no stent thrombosis in the SES group, whereas two patients presented it in the BMS group. However, after clopidogrel withdrawal, three patients allocated to the SES group presented stent thromboses vs. none in the BMS group.. SES implantation in diabetic patients remains effective at 2-year follow-up. However, clinical efficacy appeared to be reduced by the occurrence of stent thrombosis between 1 and 2 years.

Topics: Aged; Aspirin; Blood Vessel Prosthesis; Clopidogrel; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Myocardial Revascularization; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Failure; Reoperation; Sirolimus; Ticlopidine; Treatment Outcome

We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial.. We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES.. A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization.. Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29% [95% confidence interval (CI) 17% to 45%]) versus 0 after BMS (0% [95% CI 0% to 9%]) with an absolute difference of 29% ([95% CI 14% to 45%], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18% and 34% after SES, respectively, versus 5% and 38% after BMS, respectively (p = 0.15 and p = 0.74, respectively).. In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up. (RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Double-Blind Method; Drug Delivery Systems; Female; Follow-Up Studies; Graft Rejection; Humans; Male; Metals; Probability; Prosthesis Design; Retreatment; Risk Assessment; Saphenous Vein; Sirolimus; Statistics, Nonparametric; Stents; Survival Rate; Time Factors; Treatment Outcome

We assessed the impact of vessel size on angiographic and long-term clinical outcome after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) within a randomized trial (SIRTAX [Sirolimus-Eluting Stent Compared With Paclitaxel-Eluting Stent for Coronary Revascularization]).. Percutaneous coronary intervention in small-vessel disease is associated with an increased risk of major adverse cardiac events (MACE).. A total of 1,012 patients were randomly assigned to treatment with SES (n = 503) or PES (n = 509). A stratified analysis of angiographic and clinical outcome was performed up to 2 years after PCI according to size of the treated vessel (reference vessel diameter < or =2.75 vs. >2.75 mm).. Of 1,012 patients, 370 patients (37%) with 495 lesions underwent stent implantation in small vessels only, 504 patients (50%) with 613 lesions in large vessels only, and 138 patients (14%) with 301 lesions in both small and large vessels (mixed). In patients with small-vessel stents, SES reduced MACE by 55% (10.4% vs. 21.4%; p = 0.004), mainly driven by a 69% reduction of target lesion revascularization (TLR) (6.0% vs. 17.7%; p = 0.001) compared with PES at 2 years. In patients with large- and mixed-vessel stents, rates of MACE (large: 10.4% vs. 13.1%; p = 0.33; mixed: 16.7% vs. 18.0%; p = 0.83) and TLR (large: 6.9% vs. 8.6%; p = 0.47; mixed: 16.7% vs. 15.4%; p = 0.86) were similar for SES and PES. There were no significant differences with respect to death and myocardial infarction between the 3 groups.. Compared with PES, SES more effectively reduced MACE and TLR in small-vessel disease. Differences between SES and PES appear less pronounced in patients with large- and mixed-vessel disease. (The SIRTAX trial; http://clinicaltrials.gov/ct/show/NCT00297661?order=1; NCT00297661).

Topics: Aged; Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Double-Blind Method; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Paclitaxel; Probability; Proportional Hazards Models; Prospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Treatment Outcome

To assess the safety and efficacy of direct stenting using the sirolimus-eluting BX Velocitytrade mark stent in patients with coronary lesions.. Although direct coronary stenting has become a widespread practice, there have been no systematic assessments of direct stenting with drug-eluting stents.. Total of 225 patients with identical inclusion and exclusion criteria as the original SIRIUS trial were enrolled in this prospective single-arm study. They were compared in a no-inferiority design with 412 similar patients from the SIRIUS trial who had sirolimus-eluting stents deployed after predilatation and were preassigned to angiographic follow-up evaluation.. Direct stenting was successful in 85.8% of the patients. Compared with the predilatation group, direct stenting was associated with shorter median procedure duration (33 min vs. 45 min, P < 0.001). Angiographic follow-up at 8 months revealed similar late loss (in-stent-0.19 +/- 0.47 mm vs. 0.17 +/- 0.44 mm, and in-lesion-0.23 +/- 0.41 mm vs. 0.24 +/- 0.47 mm) and similar frequency of binary restenosis (in-stent-4.6% vs. 3.2% and in-lesion-6.1% vs. 8.9%) between the two treatment strategies. However, stent-edge restenosis was lower with direct stenting than in the predilatation control group (2.1% vs. 6.9%, P = 0.02). At 12-months, there were no significant differences in target lesion revascularization (3.7% vs. 5.1%, P = ns) or composite major adverse cardiac events (7.0% vs. 8.3%, P = ns).. In patients similar to those treated in the SIRIUS trial, direct stenting using sirolimus-eluting stents achieves excellent short- and long-term clinical and angiographic results with shorter procedure time and less frequent stent edge restenosis compared with predilation stent implantation techniques.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Prospective Studies; Research Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

This study examined the clinical outcomes at 5 years in RAVEL (A Randomized Comparison of a Sirolimus-Eluting Stent With a Standard Stent for Coronary Revascularization), the first controlled trial of drug-eluting stents.. The 6-month rate of angiographic coronary restenosis has been markedly lowered by sirolimus-eluting stents (SES). The long-term performance of drug-eluting stents, however, is under close scrutiny.. The trial included 238 patients (mean age 60.7 +/- 10.4 years, 76% men) with a single, de novo native coronary artery lesion, randomly assigned to treatment with SES versus bare-metal stents (BMS). Rates of major adverse cardiac events (MACE), defined as all-cause mortality, myocardial infarction, and percutaneous or surgical revascularization up to 5 years of follow-up, and rates of stent thrombosis were compared between the 2 treatment groups.. Complete datasets were available in 92.5% of patients treated with SES and 89.1% of patients assigned to BMS. The 1-, 3-, and 5-year rates of survival free from target lesion revascularization (TLR) were, respectively, 99.2%, 93.8%, and 89.7% in the SES group versus 75.9%, 75.0%, and 74.0% in the control group (p < 0.001; log-rank). Rates of all MACE at 5 years were 25.8% in patients treated with SES versus 35.2% in patients assigned to BMS (p = 0.03; log-rank). Rates of stent thrombosis, per protocol or by the Academic Research Consortium definitions, were similar in both groups.. The 5-year rate of TLR associated with SES was significantly lower than that with BMS. There was no apparent adverse effect associated with the use of SES, although the trial was not powered to examine uncommon complications.

Topics: Aged; Aged, 80 and over; Blood Vessel Prosthesis; Coronary Restenosis; Coronary Stenosis; Double-Blind Method; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Outcome Assessment, Health Care; Sirolimus; Stents; Survival Analysis; Treatment Outcome

This study examined whether sirolimus-eluting stent (SES) implantation may affect endothelial vasomotor dysfunction in resistance and epicardial infarct-related coronary arteries in acute myocardial infarction (AMI).. Myocardial ischemia-reperfusion causes endothelial injury entirely in the vasculature of the infarct-related coronary artery. Sirolimus-eluting stent implantation inhibits re-endothelialization at the site of stenting.. This study included 29 patients with a first AMI due to occlusion of the left anterior descending coronary artery (LAD) and successful reperfusion therapy using a SES (n = 13) or bare-metal stent (BMS) (n = 16). The diameter of the epicardial segment distal to the site of SES deployment and coronary blood flow in the LAD in response to an intracoronary infusion of acetylcholine were measured at 2 weeks after AMI. Levels of vascular endothelial growth factor (VEGF) were measured by enzyme-linked immunoadsorbent assay in plasma obtained from the aortic root (AO) and the anterior interventricular vein (AIV) in all patients.. The epicardial coronary artery was more severely constricted in response to acetylcholine in the SES than in the BMS group. The increase in coronary blood flow in response to acetylcholine was lower in the SES than in the BMS group. Vascular endothelial growth factor levels in the AIV were significantly lower than in the AO in the SES group but not in the BMS group.. During the course of AMI, SES implantation adversely affects endothelium-dependent vasomotor function in resistance and epicardial coronary arteries after the ischemia-reperfusion in association with a reduction in myocardial VEGF secretion.

Topics: Aged; Blood Vessel Prosthesis Implantation; Coronary Stenosis; Endothelium, Vascular; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Risk Factors; Sirolimus; Stents; Vascular Endothelial Growth Factor A; Vasomotor System

This study sought to analyze the effectiveness of drug-eluting stents in a high-risk group of diabetic patients. Previously, this had been analyzed only in substudies of larger trials or in clinical investigations enrolling a small number of patients.. Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis.. Two hundred patients with diabetes and de novo coronary artery lesions were enrolled in 16 centers: 98 were randomly assigned to sirolimus-eluting stents (SES) and 102 received bare-metal stents (BMS). The primary end point was in-segment late luminal loss. Major adverse cardiac events (MACE) rate was analyzed at 30 days and 8 and 12 months.. The extent of in-segment late luminal loss in the SES group was 0.18 mm compared with 0.74 mm in the BMS group. In-segment restenosis was identified on follow-up angiography in 8.8% of the patients in SES and in 42.1% in BMS (p < 0.0001). Target lesion revascularization was performed in 5.3% of the patients in SES and in 21.1% of the patients in BMS (p = 0.002). The SES was effective in the treatment group with oral diabetic medication as well as in the insulin-dependent treatment group (3.6% SES vs. 38.8% BMS). There was no subacute stent thrombosis in the SES group up to 1 year. The MACE rate was not significantly different at 30 days. At 12 months, MACE rate was 14.7% in SES versus 35.8% in BMS.. The SES is safe and highly effective in patients with diabetes mellitus and coronary artery disease and associated with a significant decrease in the extent of late luminal loss.

Topics: Aged; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug Delivery Systems; Female; Follow-Up Studies; Germany; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Sirolimus; Stents; Thrombosis; Treatment Outcome

We compared the effects of telmisartan and valsartan on late lumen loss and inflammatory markers after sirolimus-eluting stent implantation in hypertensive patients. This was a prospective, randomized, single-blinded, 8-month follow-up study that included hypertensive patients with significant coronary artery stenosis treated with telmisartan (n=79) or valsartan (n=80). Risk factors such as diabetes, hyperlipidemia, smoking, and obesity were similar between groups. After 8 months of follow-up, only the telmisartan group showed significant decreases in interleukin-6 and tumor necrosis factor-alpha. The decreases from baseline level in total cholesterol and low-density lipoprotein cholesterol concentrations were significantly greater in the telmisartan group. The increase in adiponectin concentrations from baseline measurements was significantly greater in the telmisartan group than in the valsartan group (1.9+/-2.7 vs 0.4+/-2.0 microg/ml, respectively, p<0.05). Moreover, late lumen loss was significantly lower in the telmisartan group than in the valsartan group (0.1+/-0.4 vs 0.3+/-0.5 mm, respectively, p=0.001). Major adverse cardiac events were similar between groups. In conclusion, compared with valsartan, telmisartan was associated with a significant decrease in late lumen loss and inflammatory markers after sirolimus-eluting stent implantation in hypertensive patients with significant coronary narrowing.

Topics: Adiponectin; Adult; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Benzimidazoles; Benzoates; Biomarkers; Cholesterol; Cholesterol, LDL; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Hypertension; Immunosuppressive Agents; Interleukin-6; Male; Middle Aged; Single-Blind Method; Sirolimus; Telmisartan; Tetrazoles; Tumor Necrosis Factor-alpha; Valine; Valsartan

The purpose of this study was to assess the role of oral rapamycin in decreased restenosis after bare metal stent implantation.. Small observational studies suggest that the administration of oral rapamycin reduces angiographic restenosis after bare metal stent implantation.. Between September 2003 and September 2004, 100 patients were randomized to either oral rapamycin (6-mg loading dose given 2.7 h before intervention followed by 3 mg/day for 14 days) plus diltiazem 180 mg/day or no therapy after the implantation of a coronary bare metal stent design. The primary study end point was incidence of angiographic binary restenosis and late loss at nine months. The secondary end points were target lesion revascularization, target vessel revascularization, and incidence of major adverse cardiovascular events at 1 year.. Angiographic follow-up was completed in 87% of patients. In the rapamycin group, the drug was well tolerated (26% minor side effects) and was maintained in 96% of patients. At 9 months, the in-segment binary restenosis was reduced by 72% (11.6% rapamycin vs. 42.8% no-therapy group, p = 0.001) and the in-stent binary restenosis was reduced by 65% (12% rapamycin vs. 34.6% no-therapy group, p = 0.009). The in-segment late loss was also significantly reduced with oral therapy (0.66 vs. 1.13 mm, respectively; 43% reduction, p < 0.001). At 1 year, patients in the oral rapamycin group also showed a significantly lower incidence of target vessel revascularization (8.3% vs. 38%, respectively, p < 0.001), target lesion revascularization (7.6% vs. 37.2%, respectively, p < 0.001), and major adverse cardiovascular events (20% vs. 44%, respectively, p = 0.018).. This randomized, controlled, and unblinded study showed that the administration of oral rapamycin during 14 days after stent implantation significantly reduces angiographic and clinical parameters of restenosis.

Topics: Administration, Oral; Aged; Angiogenesis Inhibitors; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Sirolimus; Stents; Treatment Outcome

Sirolimus-eluting stents (SES) have demonstrated low target vessel revascularizations and low incidence of angiographic restenosis in several clinical scenarios. The aim of the present study was to assess the efficacy and safety of SES for the treatment of proximal left anterior descending coronary artery (pLAD) lesions.. Ninety-six patients with severe pLAD stenosis were enrolled. Angiographic and clinical follow-up were performed at 6 and 24 months, respectively. Death, myocardial infarction (MI), new target lesion revascularization (TLR), and target vessel failure (TVF) were registered. Clinical, angiographic, and procedural variables were analyzed to identify predictors of restenosis.. Mean clinical follow-up was 858+/-158 days (26.5+/-8.3 months). Angiographic procedural success was 100%. Angiographic follow-up showed 8.4% of binary restenosis without edge-restenosis phenomenon. Late loss was 0.15+/-0.65 mm; 15.6% of patients had an adverse cardiac event, with 1% of death, 5.2% of MI, 6.3% of TLR, and 9.4% of TVF. At 2 years, the probabilities of cumulative TVF- and TLR-free survival were 90.6% and 93.7%, respectively. Interestingly, no adverse cardiac events were registered between the first and second years. Female gender (OR 10.7 CI 95%[1.7-66.7]) and in-stent restenosis (OR 8.2, CI 95%[1.2-56.4]) were found as independent predictors of binary restenosis. Advanced chronic renal failure showed a strong trend toward worse outcome in terms of binary restenosis (P=0.063).. SES for the treatment of pLAD stenosis proved safe and effective in a long-term follow-up with low incidence of adverse cardiac events and restenosis. Female gender and in-stent restenosis were predictors of binary restenosis.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Radiography; Severity of Illness Index; Sirolimus; Spain; Stents; Treatment Outcome

Although clinical outcomes after sirolimus-eluting stents (SESs) have been previously described ("primary" success rates), the fate of patients whose SES implantation fail and who require ischemia-driven target lesion revascularization is poorly understood. The SIRIUS trial is a prospective, randomized, clinical trial that includes 533 evaluable patients with SESs. Twenty-two of these patients had adjudicated ischemia-driven target lesion revascularization (4.1%) within the first year of follow-up and comprised the study population of this analysis. Of these patients, 11 (50%) had diabetes, and restenotic lesions were focal and located at the proximal stent edge in 91% and 73% of patients, respectively. Restenosis was treated with bare metal stent implantation, balloon dilatation, or intravascular brachytherapy in 82%, 13.5%, and 4.5% of patients, respectively. At 1-year follow-up after the first recurrence (2-year follow-up after the index procedure), only 5 of these patients (23%) required a second repeat revascularization procedure. Risk factors for a second recurrence after treatment of SES restenosis were female gender, long lesions that required long stents at the index procedure, and an early first recurrence. In conclusion, SES failure treated with traditional percutaneous coronary intervention yielded good outcome at 1-year follow-up (secondary failure rate only 23%), perhaps due to the focal nature of the SES restenotic lesion. Future studies should evaluate other methods, including drug-eluting stents, to further optimize the outcome of treatment of SES failures.

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Risk Factors; Sirolimus; Stents; Survival Rate; Treatment Failure

The aim of this study was to investigate the physiologic parameters: fractional flow reserve (FFR), hyperaemic trans-stent gradient (HTG), and wall shear stress (WSS) at implantation and at 6-month follow-up in the drug-eluting sirolimus stent and in its bare metal counterpart implanted in pairs within the same patient.. Twenty patients, accepted for percutaneous coronary intervention of at least two coronary arteries with comparable vessel and stenosis characteristics, received at random one sirolimus-eluting stent and one bare metal stent (BMS). Coronary pressure, FFR, HTG, and WSS were measured just after stent implantation and at 6-month follow-up. At 6-month follow-up, FFR was significantly higher in the sirolimus group compared with the bare metal group (0.91+/-0.05 vs. 0.83+/-0.10, P=0.027) and HTG was significantly lower (1.2+/-1.2 vs. 7.5+/-8.1 mmHg, P<0.001). In-stent WSS at 6 months remained normal in the sirolimus group but was elevated in the bare metal group (1.6+/-0.7 vs 3.9+/-3.1 Pa, respectively, P=0.003).. The physiologic characteristics of the drug-eluting sirolimus stents were superior to those of the equivalent BMS. Six months after implantation, FFR was significantly higher, HTG was significantly lower in arteries treated by a sirolimus stent, and normal WSS was maintained within the drug-eluting stent.

Topics: Angina Pectoris; Blood Pressure; Coronary Stenosis; Drug Implants; Female; Follow-Up Studies; Fractional Flow Reserve, Myocardial; Humans; Hyperemia; Immunosuppressive Agents; Male; Sirolimus; Stents; Stress, Mechanical; Tunica Intima

This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronary lesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, < or = 24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n = 80, 82 lesions) or the control uncoated stent (n = 40). Baseline lesion and angiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 +/- 0.43 vs 0.74 +/- 0.45 mm, p < 0.001) and in the segment (0.14 +/- 0.45 vs 0.40 +/- 0.41 mm, p = 0.004). In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p = 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Feasibility Studies; Follow-Up Studies; Humans; Immunosuppressive Agents; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions.. In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n = 100) were randomly assigned to receive bare metal BxVelocity stents and half (n = 100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P < 0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P < 0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P < 0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events.. In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.

Topics: Aged; Anti-Bacterial Agents; Coronary Angiography; Coronary Stenosis; Equipment Design; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Ischemia; Risk Factors; Single-Blind Method; Sirolimus; Stents

The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents.. A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P=NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis >50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MV+SB group (P=NS).. Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique.

Topics: Coronary Angiography; Coronary Stenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

Routine drug-eluting stent (DES) implantation has recently improved outcome in patients undergoing percutaneous treatment of left main (LM) coronary artery. However, even in the DES era, distal LM treatment remains an independent predictor of poor outcome. Whether single-vessel stenting (SVS) or bifurcation stenting (BS) should be performed to optimize treatment of such a lesion is unclear.. From April 2002 to June 2004, 94 patients affected by distal LM disease underwent percutaneous intervention at our institution either with SVS (n = 48) or BS (n = 46). The 2 groups were well balanced for all baseline characteristics but the extension of disease in the LM carina.. After a median follow-up of 587 days (range, 328-1179), the cumulative incidence of MACE was similar between the 2 groups (31% in the BS vs 28% in SVS group, HR 0.96, 95% CI 0.46-1.49, P = .92), with no difference for the composite death/myocardial infarction or target vessel revascularization. After adjustment for confounders, the technique of stenting was not a predictor of either major adverse cardiac events or target vessel revascularization. Angiographic analysis--performed in 81% of eligible patients in SVS and 87% in the BS group--confirmed the equivalency between SVS versus BS.. In consecutive patients undergoing catheter-based distal LM intervention, SVS or BS may perform equally under both clinical and angiographic perspective in current DES era.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Registries; Sirolimus; Stents

This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES).. Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined.. A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length > or =14 mm and < or =27 mm. The primary end point was 8-month angiographic in-segment late lumen loss.. Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 +/- 0.44 mm vs. 0.13 +/- 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly.. Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).

Topics: Aged; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Treatment Outcome

We sought to define the incidence of late clinical events and late stent thrombosis in patients treated with drug-eluting (DES) versus bare-metal stents (BMS) after the discontinuation of clopidogrel as well as their timing and outcome.. There is growing concern that delayed endothelialization after DES implantation may lead to late stent thrombosis and related myocardial infarction (MI) or death. However, event rates and outcomes after clopidogrel discontinuation versus BMS are unknown.. A consecutive series of 746 nonselected patients with 1,133 stented lesions surviving 6 months without major events were followed for 1 year after the discontinuation of clopidogrel. Patients were assigned randomly 2:1 to DES versus BMS in BASKET (Basel Stent Kosten Effektivitäts Trial). The primary focus of this observation was cardiac death/MI.. Rates of 18-month cardiac death/MI were not different between DES and BMS patients. However, after the discontinuation of clopidogrel (between months 7 and 18), these events occurred in 4.9% after DES versus 1.3% after BMS implantation. Target vessel revascularization remained lower after DES, resulting in similar rates of all clinical events for this time period (DES 9.3%, BMS 7.9%). Documented late stent thrombosis and related death/target vessel MI were twice as frequent after DES versus BMS (2.6% vs. 1.3%). Thrombosis-related events occurred between 15 and 362 days after the discontinuation of clopidogrel, presenting as MI or death in 88%.. After the discontinuation of clopidogrel, the benefit of DES in reducing target vessel revascularization is maintained but has to be balanced against an increase in late cardiac death or nonfatal MI, possibly related to late stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Stenosis; Coronary Thrombosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Stents; Ticlopidine

Direct stenting without balloon predilatation has been shown to be feasible and safe with drug-eluting stents, but no randomized comparisons between the two strategies exist. This study was designed to compare direct stenting with balloon predilatation followed by stent placement using only drug-eluting stents.. One hundred and sixty-six consecutive coronary lesions in 95 consenting patients (mean age 59 +/- 11 years; 12 women) were randomly assigned to direct stenting (n = 88), or balloon predilatation followed by stenting (n = 78), using sirolimus- or paclitaxel-eluting stents.. All procedures were uneventful. Crossover to balloon predilatation was necessary in 6 (7%) lesions randomized to direct stenting. During a 12-month follow up period, ischemia-driven angiography was performed in 13 patients. By intention to treat analysis, target lesion revascularization was required in 4 lesions, all of which were randomized to the predilatation group (p = 0.04).. Direct stenting was feasible in up to 93% of attempted lesions. A strategy of direct stenting resulted in a significantly lower rate of target lesion revascularization over a 12-month follow-up period compared to balloon predilatation followed by stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Middle Aged; Probability; Prospective Studies; Risk Assessment; Sirolimus; Statistics, Nonparametric; Stents; Survival Rate; Treatment Outcome; Vascular Patency

The purpose of this study was to report the angiographic findings of the first human evaluation of the everolimus-eluting stent (EES) for the treatment of noncomplex coronary lesions. Forty-two patients with de novo coronary lesions (2.75 to 4.00 mm vessels; lesion length, <18 mm) were prospectively randomized in a 2:1 ratio to receive either the EES (n = 27) or a metallic stent (n = 15). Baseline clinical and angiographic characteristics were similar among both groups. At 6-month follow-up, EES had a lower in-stent late lumen loss (0.10 +/- 0.22 vs 0.85 +/- 0.32 mm, p <0.0001) and in-segment diameter stenoses (20.7 +/- 12.3% vs 37.0 +/- 15.8%, p = 0.002). There was no in-stent restenosis with EES; however, 1 focal distal edge restenosis was present. There was 1 in-stent and 1 in-segment (proximal edge) restenosis in the metallic stent group. There was no stent thrombosis or aneurysm formation at follow-up in either group.

Topics: Aged; Combined Modality Therapy; Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Everolimus; Female; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Stents

Renal impairment is an important predictor of mortality after percutaneous coronary intervention and may increase the restenosis rate. However, the relation between restenosis and the risk of death in patients who have renal impairment remains unclear. We evaluated the incidences of repeat revascularization and mortality in patients who had renal impairment and those who did not and who received sirolimus-eluting stents or bare stents. A total of 1,080 consecutive patients treated for 1 year had available data to calculate baseline creatinine clearance. Patients received bare stents (first 6 months, n = 543) or sirolimus-eluting stents (last 6 months, n = 537) and were grouped according to the presence or absence of renal impairment (creatinine clearance <60 ml/min). Patients who had renal impairment had a higher mortality rate at 1 year (7.6% vs 2.5%, hazard ratio 3.14, 95% confidence interval 1.68 to 5.88, p <0.01), with no differences in mortality between patients who received bare stents and those who received sirolimus-eluting stents (hazard ratio 0.91, 95% confidence interval 0.49 to 1.68, p = 0.8). The incidence of target vessel revascularization decreased significantly in patients who were treated with sirolimus-eluting stents and did not have renal impairment (hazard ratio 0.59, 95% confidence interval 0.39 to 0.90, p = 0.01) and in those who had decreased renal function (hazard ratio 0.37, 95% confidence interval 0.15 to 0.90, p = 0.03). Thus, sirolimus-eluting stents compared with conventional stents decreased clinical restenosis in patients who had renal impairment. However, this benefit was not paralleled by a decrease in the risk of death in this population. It seems unlikely that restenosis could be a contributing factor that influenced the increased mortality of patients who had impaired renal function.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Kidney Failure, Chronic; Kidney Function Tests; Male; Middle Aged; Netherlands; Radiography; Severity of Illness Index; Sirolimus; Stents; Treatment Outcome

The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term.. This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months.. Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.

Topics: Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Revascularization; Sirolimus; Stents; Time

To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study.. Multicentre, double blind, randomised trial.. Percutaneous coronary intervention for single de novo coronary lesions.. 238 patients with stable or unstable angina.. Randomisation to sirolimus eluting stent or bare stent implantation.. Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs.. At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at 166.. The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined.

Topics: Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Disease-Free Survival; Double-Blind Method; Female; Humans; Immunosuppressive Agents; Male; Metals; Netherlands; Sirolimus; Stents; Surface Properties

Sirolimus systemic administration has shown marked inhibition of neointimal hyperplasia (NIH) after balloon angioplasty in porcine models. In this pilot study, we tested the hypothesis that oral sirolimus is safe and effective to inhibit in-stent NIH and therefore to prevent and treat in-stent restenosis (ISR). Twelve patients (18 lesions) with high risk for ISR, including 8 ISR lesions, were admitted. One day before the procedure, patients were given a 15 mg loading dose of oral sirolimus, followed by 5 mg daily for 28 days, with weekly whole blood level measurements. The daily dose was adjusted to keep the concentration at 10-15 ng/ml. Sirolimus was well tolerated by all patients but one, who died at the end of the third week of treatment. The 4- and 8-month follow-up revealed an angiographic late loss of 0.40 +/- 0.24 and 0.67 +/- 0.45 mm (P < 0.01), respectively. At the same time points, the intravascular ultrasound in in-stent relative volumetric obstruction was 14.4% +/- 9.1% and 23.2% +/- 10.1% (P < 0.01), respectively. At 24-month clinical follow-up, adverse events were one (8.3%) death, two (11.1%) target lesion, and four (22.2%) target vessel revascularizations. In conclusion, in this small group of high-risk ISR patients, oral sirolimus inhibited NIH and therefore may be an effective strategy for the prevention and treatment of ISR.

Topics: Administration, Oral; Adult; Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pilot Projects; Probability; Risk Assessment; Severity of Illness Index; Sirolimus; Statistics, Nonparametric; Stents; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

To investigate the relationship between coronary artery remodelling and glycaemic and lipid profiles in diabetic patients.. Intravascular ultrasound analyses of 131 angiographically non-significant coronary stenoses in 80 diabetic patients were performed. The remodelling index (RI) was calculated as the ratio between total vessel area at target site and total vessel area at proximal reference, and was assessed in two ways: as a continuous variable, and as a binary categorical variable: RI<1 namely, negative remodelling (group I), or RI> or =1 (group II). Percentage cross-sectional narrowing was 57+/-13%. On average, RI was 0.93+/-0.13. Coronary shrinkage was found in 94 (71.7%) lesions. Significant inverse correlations were demonstrated between RI and total cholesterol (r=-0.26, P=0.003), apolipoprotein-B (r=-0.23, P=0.01) and LDL-cholesterol (r=-0.3, P=0.001) levels. Multivariable lineal regression analysis identified LDL-cholesterol as the only independent predictor of RI (P=0.001).. Negative remodelling is a frequent finding in diabetics and it is associated with LDL-cholesterol levels. This may contribute to the diffuse coronary artery disease observed in diabetic patients.

Topics: Aged; Blood Glucose; Cholesterol, LDL; Coronary Stenosis; Coronary Vessels; Diabetic Angiopathies; Female; Humans; Immunosuppressive Agents; Insulin Resistance; Male; Prospective Studies; Sirolimus; Stents; Ultrasonography

The purpose of this research was to evaluate the long-term outcomes after implantation of drug-eluting stents (DES) in bifurcation lesions with the "crush" technique.. The long-term outcome of "crush" stenting technique has yet to be determined.. We identified 181 consecutive patients who were treated with DES with the "crush" stent technique from April 2002 to April 2004. Based on the usage of final kissing balloon post-dilation (FKB), the patients were divided into an FKB group (n = 116) and a non-FKB group (n = 65).. Clinical follow-up at nine months was available in all patients, and angiographic follow-up in 80% of patients. Three cases (1.7%) of intraprocedural stent thrombosis and five (2.8%) cases of postprocedural stent thrombosis occurred. Restenosis rate of the main branch in the entire cohort lesions was 11.5%. Restenosis rate of the side branch was lower in the FKB group than that in the non-FKB group (11.1% vs. 37.9%, p < 0.001). The target lesion revascularization (TLR) rate for all patients was 14.9%. The lack of FKB was a predictor for TLR (hazard ratio [HR] 4.17; 95% confidence interval [CI] 1.30 to 14.3, p = 0.02). Diabetes was also a predictor for TLR (HR 1.79; 95% CI 1.14 to 2.80, p = 0.01). Premature discontinuation of dual antiplatelet therapy (odds ratio [OR] 16.8; 95% CI 1.31 to 159.5, p = 0.03) and age (OR 1.10; 95% CI 1.00 to 1.21, p = 0.048) was associated with the occurrence of postprocedural stent thrombosis.. Compared to the absence of FKB, the "crush" stenting technique with FKB appears to be associated with more favorable long-term outcomes. When utilizing the "crush" stenting technique, FKB is mandatory.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Risk Factors; Sirolimus; Stents; Treatment Outcome

This study was designed to evaluate the clinical and angiographic outcomes of sirolimus-eluting stent (SES) implantation for ostial left anterior descending (LAD) lesions compared with bare-metal stent (BMS) implantation.. The effectiveness of SES implantation for ostial LAD lesions is currently unknown.. Sirolimus-eluting stents were implanted in 68 consecutive patients with ostial LAD stenoses. The control group was composed of 77 patients treated with BMS during the preceding two years. In the SES group, for complete lesion coverage, stent positioning was intentionally extended into the distal left main coronary artery (LMCA) in 23 patients (34%) with intermediate LMCA narrowing.. Compared with the BMS group, the SES group had more multivessel involvement, received fewer debulking atherectomies, underwent more direct stenting, had a greater number of stents, and had more segments stented. The procedural success rate was 100% in both groups. The six-month angiographic restenosis rate was significantly lower in the SES group than in the BMS group (5.1% vs. 32.3%, p < 0.001). During the one-year follow-up period, neither death nor myocardial infarction occurred in either group, but target lesion revascularization was less frequent in the SES group than in the BMS group (0% vs. 17%, p < 0.001). In the SES group, there were no restenoses in cases with LMCA coverage, compared with three restenoses (7.9%) in cases with precise stent positioning (p = NS).. Sirolimus-eluting stent implantation in ostial LAD lesions achieved excellent results regarding restenosis and clinical outcomes compared with BMS implantation. This finding may be associated with reduced neointimal hyperplasia and complete lesion coverage.

Topics: Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Delayed-Action Preparations; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Ultrasonography

Outcomes after percutaneous coronary interventions in diabetic patients are shadowed by the increased rate of recurrence compared with nondiabetic patients.. We conducted a multicenter, randomized trial to demonstrate the efficacy of sirolimus-eluting stents compared with standard stents to prevent restenosis in diabetic patients with de novo lesions in native coronary arteries. The primary end point of the trial was in-segment late lumen loss as assessed by quantitative coronary angiography at 9-month follow-up. The trial was stratified by diabetes treatment status. One hundred sixty patients were randomized to sirolimus-eluting stents (80 patients; 111 lesions) or standard stent implantation (80 patients; 110 lesions). On average, reference diameter was 2.34+/-0.6 mm, lesion length was 15.0+/-8 mm, and 13.1% of lesions were chronic total occlusions. In-segment late lumen loss was reduced from 0.47+/-0.5 mm for standard stents to 0.06+/-0.4 mm for sirolimus stents (P<0.001). Target-lesion revascularization and major adverse cardiac event rates were significantly lower in the sirolimus group (31.3% versus 7.3% and 36.3% versus 11.3%, respectively; both P<0.001). Non-insulin- and insulin-requiring patients demonstrated similar reductions in angiographic and clinical parameters of restenosis after sirolimus-eluting stent implantation. During the 9-month follow-up, stent thrombosis occurred in 2 patients after standard stent implantation. Conversely, this phenomenon was not seen in the sirolimus stent group.. This randomized trial demonstrated that sirolimus stent implantation is safe and efficacious in reducing both angiographic and clinical parameters of restenosis compared with standard stents in diabetic patients with de novo coronary stenoses.

Topics: Aged; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Equipment Design; Female; Humans; Male; Middle Aged; Sirolimus; Stents

The effect of lesion characteristics on neointimal hyperplasia after sirolimus-eluting stent implantation was examined in 45 patients who underwent successful preinterventional intravascular ultrasound. There were no differences in neointimal hyperplasia between the moderate/severe calcified lesion group (calcium arc >120 degrees ) and the non/mild calcified lesion group or between the positive vessel remodeling group (external elastic membrane area at the minimal lumen area site larger than that at the proximal reference site) and negative vessel remodeling group. No correlation between preinterventional plaque burden and neointimal hyperplasia was found. In patients who have coronary artery disease, sirolimus-eluting stents continue to demonstrate striking suppression of neointimal proliferation, irrespective of lesion characteristics previously associated with greater restenotic risk.

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Disease Progression; Double-Blind Method; Female; Follow-Up Studies; Humans; Hyperplasia; Immunosuppressive Agents; Male; Middle Aged; Postoperative Complications; Prospective Studies; Prosthesis Failure; Risk Factors; Severity of Illness Index; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

Topics: Administration, Oral; Aged; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Double-Blind Method; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Prosthesis Failure; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

To assess whether asymmetric stent expansion affects suppression of neointimal hyperplasia after sirolimus-eluting stent implantation, 64 patients in the SIRolImUS-coated Bx Velocity stent trial who underwent single 18-mm stent implantation and 3-dimensional intravascular ultrasonography at 8-month follow-up were enrolled. To assess the longitudinal stent asymmetric expansion, 2 cross sections with a maximal/minimal stent area were chosen in each patient. To assess for tomographic stent asymmetric expansion, stent eccentricity was determined by dividing the minimum stent diameter by the maximum stent diameter. At the 2 cross sections with a maximal/minimal stent area, a sirolimus-eluting stent reduced neointimal hyperplasia significantly with no interaction between the treatment and stent areas. A sirolimus-eluting stent also significantly reduced neointimal hyperplasia in the concentric and eccentric stent groups.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Stenosis; Double-Blind Method; Follow-Up Studies; Humans; Hyperplasia; Immunosuppressive Agents; Postoperative Complications; Prospective Studies; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007). Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.

Topics: Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Disease-Free Survival; Female; Follow-Up Studies; Humans; Hyperplasia; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Tunica Intima

Sirolimus-eluting stents have been shown to be effective in de-novo coronary lesions, reducing restenosis strikingly in a subset of lesions with a low or moderate risk of restenosis. We decided to assess their usefulness in lesions with a high risk of restenosis.. We included consecutive patients with lesions that met at least one of the following criteria: a) in-stent restenosis; b) diffuse lesion (>20 mm); c) small vessel (< or =2.5 mm), and d) total occlusion.. Between June 2002 to December 2002, 100 patients were included (61 [11] years, 84% men, 21% with diabetes). In all, 154 lesions were treated (34% diffuse lesions, 36% in small vessels, 20% in-stent restenosis and 20% occlusions). An average of 1.6 (0.7) stents were implanted per patient. Mean diameter was 2.74 (0.26) mm, mean length was 21 (8.5) mm and total stent length per patient was 33 (16) mm. The acute success rate was 98%. After the procedure 2 (2%) non-Q-wave infarctions were diagnosed. No episodes of acute or subacute thrombosis occurred. During a follow-up period of 8.5 (2) months (range 6-12 months) there were two (2%) late thromboses, one of which caused an infarction. Target lesion revascularization was required in 3 patients (3%), two of whom were the patients with late thrombosis.. Sirolimus-eluting stents can be used in lesions with a high risk of restenosis. The rate of thrombosis was low, and the use of these stents was associated with a strikingly low rate of target lesion revascularization during follow-up.

Topics: Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Middle Aged; Risk Factors; Sirolimus; Stents; Time Factors

A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied.. This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%).. These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

Topics: Aged; Anticoagulants; Aspirin; Catheterization; Clopidogrel; Combined Modality Therapy; Comorbidity; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Death, Sudden; Diabetes Mellitus; Disease-Free Survival; Drug Implants; Female; Follow-Up Studies; Humans; Life Tables; Male; Middle Aged; Pilot Projects; Postoperative Complications; Prospective Studies; Safety; Sirolimus; Stents; Survival Analysis; Ticlopidine; Treatment Outcome

Long-length stenting has a poor outcome when bare metal stents are used. The safety and efficacy of the sirolimus-eluting stent (SES) in long lesions has not been evaluated. Therefore, the aim of the present study was to evaluate the clinical and angiographic outcomes of SES implantation over a very long coronary artery segment. Since April 2002, all patients treated percutaneously at our institution received a SES as the device of choice as part of the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. During the RESEARCH registry, stents were available in lengths of 8, 18, and 33 mm. The present report includes a predefined study population consisting of patients treated with >36-mm-long stented segments. Patients had a combination of >or=2 overlapping stents at a minimum length of 41 mm (i.e., one 33-mm SES overlapping an 8-mm SES) to treat native de novo coronary lesions. The incidence of major cardiac adverse events (death, nonfatal myocardial infarction, and target lesion revascularization) was evaluated. The study group comprised 96 consecutive patients (102 lesions). Clinical follow-up was available for all patients at a mean of 320 days (range 265 to 442). In all, 20% of long-stented lesions were chronic total occlusions, and mean stented length per lesion was 61.2 +/- 21.4 mm (range 41 to 134). Angiographic follow-up at 6 months was obtained in 67 patients (71%). Binary restenosis rate was 11.9% and in-stent late loss was 0.13 +/- 0.47 mm. At long-term follow-up (mean 320 days), there were 2 deaths (2.1%), and the overall incidence of major cardiac events was 8.3%. Thus, SES implantation appears safe and effective for de novo coronary lesions requiring multiple stent placement over a very long vessel segment.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Drug Implants; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome

Percutaneous coronary intervention in patients with a history of previous coronary artery bypass grafting (CABG) is associated with an increased rate of subsequent adverse events compared to those without prior CABG. We evaluated the impact of utilizing the sirolimus-eluting stent (SES) in this high-risk population.. Since April 2002, SES implantation was utilized as the default strategy for all percutaneous procedures in our hospital. Consecutive patients with a history of previous CABG and de novo lesions (n=47) treated exclusively with SES, were compared to 66 patients who received bare stents in the 6-month period just before SES introduction.. There were no significant differences between the groups (SES and bare stent) with respect to baseline clinical or lesion characteristics. The only difference between the groups related to the nominal diameter of stent utilized, which was smaller in the SES group than the bare stent group. (The maximum diameter of SES available was 3.0 mm). At 1 year, the cumulative incidence of major adverse events (defined as death, myocardial infarction, or target vessel revascularization) was significantly lower in the SES group than the bare stent group [8.5 versus 30.3%, hazard ratio 0.37 (95% confidence interval 0.15-0.91); P=0.03].. The utilization of the sirolimus-eluting stent for percutaneous intervention in a high-risk population with a history of previous CABG surgery is associated with a significant reduction in the rate of major adverse cardiac events at 1 year.

Topics: Aged; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Male; Netherlands; Sirolimus; Stents; Treatment Outcome

Randomized clinical trials have shown that a sirolimus-eluting stent significantly reduces restenosis after percutaneous coronary revascularization. Diabetic patients are known to have a higher risk of restenosis compared with nondiabetic patients. The purpose of this analysis was to determine the impact of sirolimus-eluting stents on outcomes of diabetic compared with nondiabetic patients.. The SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) trial is a randomized, double-blind study that compared sirolimus-eluting and bare metal stent implantation in 1058 patients with de novo native coronary artery lesions. Diabetes mellitus was present in 279 (26%) patients (diabetes mellitus group, 131 patients received sirolimus-eluting stents and 148 patients received bare metal stents) and was absent in 778 patients (no-diabetes mellitus group, 402 patients received sirolimus-eluting stents and 376 patients received bare metal stents). At 270 days, target lesion revascularization was reduced in diabetic patients from 22.3% with bare metal stents to 6.9% with sirolimus-eluting stents (P<0.001) and in nondiabetic patients from 14.1% to 2.99% (P<0.001), respectively. Major adverse cardiac events were reduced in diabetic patients from 25% with bare metal stents to 9.2% with sirolimus-eluting stents (P<0.001) and from 16.5% to 6.5% (P<0.001) in nondiabetic patients, respectively.. Implantation of sirolimus-eluting stents compared with bare metal stents in de novo coronary lesions reduces major adverse cardiac events in patients with and without diabetes mellitus. However, among patients receiving sirolimus-eluting stents, there remains a trend toward a higher frequency of repeat intervention in diabetic patients compared with nondiabetic patients, particularly in the insulin-requiring patients.

Topics: Aged; Anticoagulants; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Diabetes Mellitus; Disease-Free Survival; Double-Blind Method; Drug Implants; Female; Follow-Up Studies; Growth Inhibitors; Humans; Hypertension; Immunosuppressive Agents; Incidence; Insulin; Male; Middle Aged; Mortality; Myocardial Infarction; Sirolimus; Stents; Treatment Outcome

Everolimus, an active immunosuppressive and antiproliferative agent of the same family as sirolimus (rapamycin), has demonstrated significant reduction of neointimal proliferation in animal studies. The First Use To Underscore restenosis Reduction with Everolimus (FUTURE) I trial was the first in-human experience to evaluate the safety and efficacy of everolimus-eluting stents (EES), coated with a bioabsorbable polymer, compared with bare metal stents (BMS).. FUTURE I was a prospective, single-blind, randomized trial that enrolled 42 patients with de novo coronary lesions (EES 27, BMS 15). Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low at 30 days and 6 months, without any early or late stent thrombosis for either group (P=NS). Between 6 and 12 months, there were no additional reports of major adverse cardiac events. The 6-month angiographic in-stent restenosis rate was 0% versus 9.1% (1 patient) (P=NS), with an associated late loss of 0.11 mm versus 0.85 mm (P<0.001), and the in-segment restenosis rate was 4% (1 patient) and 9.1% (1 patient) (P=NS) for EES and BMS, respectively. Intravascular ultrasound analysis revealed a significant reduction of percent neointimal volume in EES compared with BMS (2.9+/-1.9 mm3/mm versus 22.4+/-9.4 mm3/mm, P<0.001). There was no late stent malapposition in either group. The safety and efficacy of the EES appeared to be sustained at 12 months.. In this initial clinical experience, EES with bioabsorbable polymer demonstrated a safe and efficacious method to reduce in-stent neointimal hyperplasia and restenosis.

Topics: Aged; Anticoagulants; Catheterization; Cineangiography; Coated Materials, Biocompatible; Comorbidity; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Implants; Everolimus; Female; Follow-Up Studies; Growth Inhibitors; Humans; Hyperplasia; Immunosuppressive Agents; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Polyesters; Polymers; Prospective Studies; Single-Blind Method; Sirolimus; Stainless Steel; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Revascularization strategies often hinge on the presence and degree of left anterior descending coronary artery (LAD) stenosis. A decision for bypass surgery is often based on the durability of surgical LAD revascularization compared with percutaneous approaches. By decreasing restenosis, drug-eluting stents may have reduced the "reintervention gap" between surgery and percutaneous intervention, making the percutaneous route preferable.. Of the 1101 patients in the SIRIUS trial, 459 with an LAD stenosis were randomized to percutaneous intervention with either sirolimus-eluting or bare-metal stents. Baseline demographic, clinical, and angiographic data were obtained. Patients had 1-year clinical and 8-month angiographic follow-up. Baseline characteristics were similar in both groups. The majority of lesions were tubular type B lesions (69.7%) with a mean diameter of 2.73 mm and a mean length of 14.0 mm. The binary in-stent restenosis rate was 2% for the sirolimus stent group and 41.6% for the bare-metal arm (relative risk, 0.05; 95% CI, 0.02 to 0.1; P<0.001). One-year major adverse events (defined as cardiac death, Q-wave and non-Q-wave myocardial infarction, or target vessel revascularization) was decreased 59% in the sirolimus-stent group (9.8% versus 24.9%; relative risk, 0.39; 95% CI, 0.26 to 0.61; P<0.001). Subgroup analysis of 135 patients with proximal LAD lesions showed similar benefits. In-stent restenosis was 0 in the proximal LAD sirolimus-eluting group (n=67), compared with 38% in the bare-metal arm (n=68), and major adverse events demonstrated a similar trend, with a 50% decrease compared with control patients (10.4% versus 20.6%, P=NS).. Sirolimus-eluting stents significantly decrease revascularization rates in LAD lesions. At 1 year, sirolimus-eluting stent revascularization rates are comparable to historic single vessel bypass surgery revascularization rates.

Topics: Aged; Angioplasty, Balloon, Coronary; Anticoagulants; Aspirin; Clopidogrel; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Double-Blind Method; Drug Implants; Female; Humans; Life Tables; Male; Middle Aged; Myocardial Infarction; Premedication; Sirolimus; Stents; Survival Analysis; Ticlopidine; Treatment Outcome; Ultrasonography

Despite recent advances in interventional cardiology, including the introduction of drug-eluting stents for de novo coronary lesions, the treatment of in-stent restenosis (ISR) remains a challenging clinical issue. Given the efficacy of systemic sirolimus administration to prevent neointimal hyperplasia in animal models and to halt and even reverse the progression of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was to evaluate the efficacy of a 10-day oral sirolimus treatment with 2 different loading regimens for the prevention of recurrent restenosis in patients with ISR.. Three hundred symptomatic patients with ISR were randomly assigned to 1 of 3 treatment arms: placebo or usual-dose or high-dose sirolimus. Patients received a cumulative loading dose of 0, 8, or 24 mg of sirolimus 2 days before and the day of repeat intervention followed by maintenance therapy of 2 mg/d for 7 days. Angiographic restenosis at 6-month angiography was the primary end point of the study. Restenosis was significantly reduced from 42.2% to 38.6% and to 22.1% in the placebo, usual-dose, and high-dose sirolimus groups, respectively (P=0.005). Similarly, the need for target vessel revascularization was reduced from 25.5% to 24.2% and to 15.2% in the placebo, usual-dose, and high-dose groups, respectively (P=0.08). The sirolimus blood concentration on the day of the procedure correlated significantly with the late lumen loss at follow-up (P<0.001).. In patients with ISR, an oral adjunctive sirolimus treatment with an intensified loading regimen before coronary intervention resulted in a significant improvement in the angiographic parameters of restenosis.

Topics: Administration, Oral; Aged; Angioplasty, Balloon, Coronary; Biomarkers; Comorbidity; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Creatine Kinase; Creatine Kinase, MB Form; Diabetes Mellitus; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Hypertension; Isoenzymes; Male; Middle Aged; Myocardial Infarction; Retreatment; Sirolimus; Stents; Treatment Outcome; Tunica Intima

Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis.. Angiographic follow-up at 240 days was obtained in 701 patients with long (15- to 25-mm) lesions in small-diameter (2.5- to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (>50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; P<0.001) and within the stent (3.2% versus 35.4% with the BMS; P<0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all P<0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups.. Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.

Topics: Aged; Aspirin; Clopidogrel; Coronary Aneurysm; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Double-Blind Method; Drug Implants; Drug Therapy, Combination; Female; Follow-Up Studies; Heparin; Humans; Incidence; Male; Middle Aged; Randomized Controlled Trials as Topic; Sirolimus; Stents; Ticlopidine; Treatment Outcome

Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization.. We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days.. The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined.. In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Disease-Free Survival; Double-Blind Method; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Sirolimus; Stents; Thrombosis; Treatment Outcome; Ultrasonography, Interventional

The objective of study was to compare effects of rapamycin-eluting single and double stenting on serum markers like high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α), interleukin 6 (IL-6), interleukin 8 (IL-8) and monocyte chemoattractant protein-1 (MCP-1) in patients with coronary bifurcation lesions. It was an experimental study carried out from April 2016 to July 2017. One hundred and twenty-six patients were divided into two equal groups according to different treatment regimens. Group A was treated with rapamycin-eluting single stenting and group B with rapamycin-eluting double stenting. Three months after operation, hs-CRP, TNF-α, IL-6, IL-8 and MCP-1 levels in group B were lower than those in group A (p=0.010, p <0.001, p <0.001, p <0.001 and p <0.001, respectively). After one year of follow-up, rate of intrasegmental restenosis of branch vessels was higher in group A than in group B (p=0.011). Compared with rapamycin-eluting single stenting, rapamycin-eluting double stenting may regulate more effectively the above serum markers levels, reduce the incidence of intrasegmental restenosis of branch vessels.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; C-Reactive Protein; Chemokine CCL2; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Cytokines; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus

Supraflex (Sahajanand Medical Technologies Pvt. Ltd, Surat, India) is the latest generation of biodegradable polymer-coated sirolimus-eluting coronary stent designed on ultra-thin (60 µm) cobalt-chromium platform with flexible 'S-link.' The present study was designed to establish the safety and clinical performance of Supraflex in real-world Indian patients with coronary artery disease.. The study included 839 consecutive patients with coronary artery disease who were implanted with Supraflex from January 2014 to August 2017 at six different tertiary care centers in India. Follow-up was performed at 30 days, 6 months, and 12 months after the index procedure. The primary end-point of the study was the incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at the 12-month follow-up. The occurrence of stent thrombosis was analyzed as safety end-point.. A total of 1025 lesions were treated by implantation of 1098 Supraflex stents. At the 12-month follow-up, MACE was 4.92%, including 7 (0.86%) cardiac deaths, 16 (1.97%) MI, and 17 (2.09%) TLR. Only three incidences of stent thrombosis were found at the 12-month follow-up.. The study results showed excellent safety and clinical effectiveness of Supraflex in a high proportion of high-risk real-world Indian patients with coronary artery disease.

Topics: Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; India; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; Survival Analysis; Tertiary Care Centers; Treatment Outcome

Edge restenosis has gained attention as a main cause of restenosis after first-generation drug-eluting stent (DES) implantation. The aim of this study was to assess the incidence of edge restenosis and identify the predictors of edge restenosis after second-generation DES implantation. Data were obtained from several postmarketing surveillance (PMS) studies on a cobalt-chromium everolimus-eluting stent (CoCr-EES; Xience V/PROMUS, Xience Prime, Xience Prime SV, and Xience Expedition SV), a second-generation DES, in Japan. Angiographic analysis was conducted at the baseline and after eight months on the following subsegments: in-stent region, proximal edge, and distal edge. Restenosis was defined as ≥ 50% diameter stenosis (DS) at follow-up. We used multivariate logistic regression (with lesions as a random effect) to compare the instances of restenosis between the proximal and the distal edges. Univariate and multivariate analyses of the risk factors for restenosis were performed for each subsegment. We analyzed 1,966 lesions in 1,687 patients. The restenosis rates at the in-stent region, proximal edge, and distal edge were 4.4%, 3.0%, and 1.1%, respectively. The risk of restenosis at the distal edge was significantly lower than that at the proximal edge, when adjusted for 13 variables. The predictors of restenosis were postprocedural % diameter stenosis (%DS), postprocedural reference diameter, ≥ 45° bending, stent overlap at the proximal edge, and postprocedural %DS at the distal edge. Our analysis of eight-month angiographic outcomes from CoCr-EES PMS demonstrated that postprocedural %DS is a major predictor of edge restenosis. Edge restenosis is more likely attributable to postprocedural angiographic results than to the patient's background.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Chromium; Cobalt; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure Analysis; Female; Hospitals, University; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Multivariate Analysis; Product Surveillance, Postmarketing; Prognosis; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sex Factors; Sirolimus; Survival Analysis; Treatment Outcome

The BiOSS LIM stent is a dedicated device for the treatment of bifurcation lesions that present a proximal and distal part with two different diameters and a middle zone with two connecting struts facilitating side branch rewiring. In this study, after implanting the BiOSS LIM stent in the left main, rewiring to the side branch was easier compared to standard metallic stent. The device may be very useful in the treatment of bifurcation lesions for provisional stenting strategies or for two-stent strategies such as T-stenting or T-and-Protruding (TAP).

Topics: Constriction, Pathologic; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Stents; Treatment Outcome

Background Guidelines recommend heart team discussion and coronary artery bypass graft consideration in patients with proximal left anterior descending (LAD) artery stenosis. Evidence suggests that outcomes of proximal LAD angioplasty might not differ from treatment of nonproximal LAD locations. We aim to determine clinical outcomes of patients undergoing percutaneous coronary intervention in the proximal LAD segment in comparison with nonproximal LAD angioplasty, using a thin-strut drug-eluting stent. Methods and Results In this analysis of the e-Ultimaster registry, patients undergoing angioplasty in the proximal LAD territory were compared with those treated in nonproximal LAD locations. Multivariate analysis and propensity score were used to adjust for differences among the groups. The primary outcome was target lesion failure: a composite of cardiac death, target-lesion-related myocardial infarction, and/or clinically driven target lesion revascularization at 1-year follow-up. Of the 17 805 patients (mean age, 64.2±11; 76% male), 5452 (30.6%) underwent proximal LAD and 12 353 (69.4%) nonproximal LAD percutaneous coronary intervention. Patients in the proximal LAD group had more multivessel disease (48.7% versus 43.5%;

Topics: Absorbable Implants; Aged; Angioplasty; Coated Materials, Biocompatible; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Polymers; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Stenosis; Humans; Inferior Wall Myocardial Infarction; Male; Percutaneous Coronary Intervention; Predictive Value of Tests; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Background Polymer-free drug-eluting stents are based on different technologies for drug binding and release without the use of polymer coatings. It is unknown whether different polymer-free drug-eluting stents are comparable in terms of safety and efficacy profiles. Methods and Results Polymer-free BioFreedom biolimus-eluting stents (BES) and polymer-free Cre8 amphilimus-eluting stents (AES) were investigated in 2 recent multicenter registries including 2320 all-comer patients undergoing percutaneous coronary interventions at 22 Italian centers. Using propensity score matching, safety and efficacy outcomes were compared among 1280 patients (640 matched pairs) treated with BioFreedom BES or Cre8 AES. The primary end point was target lesion failure-a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR). At 1 year, target lesion failure occurred in 4.0% of BES and 4.2% of AES-treated patients (hazard ratio [HR] 0.98, 95% CI, 0.57-1.70). Risks of cardiac death (2.0% versus 2.1%; HR, 1.03; 95% CI, 0.47-2.26), target vessel myocardial infarction (0.8% versus 0.3%; HR, 1.89; 95% CI, 0.50-6.80), TLR (1.5% versus 2.2%; HR, 0.74; 95% CI, 0.34-1.62), and definite/probable stent thrombosis (0.9% versus 0.8%; HR, 1.17; 95% CI, 0.36-3.81) were comparable in patients treated with BioFreedom BES and Cre8 AES. A differential treatment effect by diabetes mellitus status was observed, indicating a benefit of AES in patients with diabetes mellitus ( P interaction=0.003). Conclusions The present study shows that BioFreedom BES and Cre8 AES have favorable and comparable safety and efficacy profiles in all-comer patients undergoing percutaneous coronary intervention. Further evaluation in large-scale, randomized trials are necessary to confirm our findings.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Italy; Male; Middle Aged; Observational Studies as Topic; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Proximal optimization technique (POT) has been proposed to adapt the conventional drug-eluting stent (DES) with the fractal anatomy of the bifurcation. However, only few DES are labeled for post-expansion beyond 5.0 mm. Furthermore, recrossing in the side branch (SB) through the main vessel (MV) stent cells may be challenging.. To compare the sirolimus-eluting, balloon-expandable dedicated bifurcation stent BiOSS LIM DES versus the second generation DES in the treatment of distal unprotected left main coronary arteries (ULMCAs) lesions.. Forty-two consecutive patients with distal ULMCA lesions were treated with the BiOSS LIM (BiOSS LIM group) in our center. A matched-group of patients treated with second-generation DES was selected from our database (Control group). The primary endpoint was the procedural complication rate, including (a) SB occlusion, defined as intraprocedural TIMI flow grade <3 immediately after MV stenting; and/or (b) trouble in SB access, defined as the need of ≥2 guidewires or a failure to recross in the SB trough the MV stent cells. The need of POT in the two groups was also analyzed.. The primary endpoint occurred in four (9.5%) patients in the BiOSS LIM group and in 13 (31%) in the Control group (p = 0.028; OR = 4.25; 95% confidence interval: 1.25-14.43). POT was performed more often in the Control group (71% vs. 35%; p = 0.004).. Compared to conventional DES, the BiOSS LIM stent (1) facilitates SB recrossing and (2) fits well with the fractal anatomy of the left main bifurcation.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Case-Control Studies; Coronary Stenosis; Databases, Factual; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Treatment Outcome

Background A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 µm, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population. Methods and Results The FANTOM II study (Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold - First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length ≤20 mm. Major adverse cardiac events through 12-month follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n=117) and 9 months (n=123). Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235/240), 95.8% (230/240), 99.1% (228/230), and 99.6% (227/228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25±0.40 mm and 0.33±0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Major adverse cardiac events and target lesion failure through 12 months occurred in 4.2% of 240 patients; scaffold thrombosis developed in only one patient (0.4%). Conclusions The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness performance at 12-month follow-up. Longer-term follow-up is ongoing to examine the late outcomes with this novel device. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02539966.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

We conducted propensity-score-matched comparisons of midterm angiographic follow-up outcomes of sirolimus- versus everolimus-eluting stents (SES, EES) after elective placements for de novo coronary stenosis in small vessels (SV) in patients with diabetes mellitus (DM), because the angiographic efficacy of EES over SES for those cohorts remained unclear. The study was a non-randomized, retrospective, lesion-based, multicenter study, examining lesions followed up angiographically within 550 days, extracted from the unified database of 6 institutes. The endpoint (binary restenosis) was defined as the percentage of subjects having >50% diameter stenosis at follow-up. Propensity-score-matched analyses were conducted in 3 different vessel-size cohorts, defined by a preprocedural reference diameter (RD) <2.10, <2.35, and <2.60 mm, yielding group sizes of n = 107, 183, and 312 baseline-adjusted lesions in each of the 2 stent arms. The frequency of binary restenosis decreased significantly with increasing vessel size, at 16.8, 12.6, and 12.2%, in the SES group. However, it remained almost the same across vessel-size groups in the EES group (8.0, 6.0, and 7.5%). The p values for the significance of the differences in binary restenosis between EES and SES in each vessel size increased with the decrease in vessel size [p = 0.002, 0.040, and 0.063 (the last still nearly significant)]. Thus, in patients with DM, EES showed increasingly superior efficacy over SES for SV stenosis as the vessel size became smaller, i.e., the risk for binary restenosis became greater.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Diabetes Mellitus; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Propensity Score; Retrospective Studies; Sirolimus; Treatment Outcome

In the distal left main (LM) atherosclerosis mainly develops within bifurcation or trifur-cation. The aim of this study was to analyze the strategy of distal LM stenosis treatment and associated clinical outcomes in a large hospital in Northern Poland.. The study population consisted of consecutive patients with stable coronary artery disease or acute coronary syndrome (ACS) and distal LM stenosis who were hospitalized between June 2012 and June 2013. Patients were treated with regular drug-eluting stents (rDES), including bioresorbable vascular scaffolds, or dedicated bifurcation stents (BiOSS LIM®). Clinical outcomes were analyzed at 12, 24 and 36 months. Primary endpoint was cumulative major adverse cardiovascular events (MACE) inducing rate of cardiac death, myocardial infarction, and target lesion revascularization (TLR) after 36 months.. One hundred and two patients were identified, 90 of whom were treated with percutaneous coronary intervention (56 rDES, including 9 Absorb, and 34 BiOSS) with no stent implantation fail-ure. In 15 (16.7%) patients rDES was required within side branch (SB). After 36 months MACE rate was 19.0% (BiOSS: 18.8% vs. rDES 19.2%), whereas TLR rate was 10.7% (BiOSS 12.5% vs. rDES 9.6%). In logistic regression for 36-month TLR rate proximal optimization technique (OR 0.311, 95% CI 0.211-0.644) was a prognostic factor of better clinical outcome, whereas non-ST-elevation ACS (OR 2.211, 95% CI 1.642-5.110), ST-elevation myocardial infarction (OR 2.771, 95% CI 1.325-7.209) and SB stenting (OR 1.141, 95% CI 1.002-1.881) were risk factors of poor outcome.. Regular drug-eluting stents as well as dedicated bifurcation BiOSS LIM® stents enabled a simple and fast distal LM treatment option with a single stent. Both resulted in comparable MACE and TLR rates.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Paclitaxel; Percutaneous Coronary Intervention; Poland; Postoperative Complications; Prosthesis Design; Retrospective Studies; Sirolimus; Survival Rate; Tissue Scaffolds; Treatment Outcome

Drug-eluting stents (DES) have evolved to using bioresorbable polymers as a method of drug delivery. The impact of bioresorbable polymer on long-term neointimal formation, inflammation, and healing has not been fully characterised. This study aimed to evaluate the biological effect of polymer resorption on vascular healing and inflammation.. A comparative DES study was performed in the familial hypercholesterolaemic swine model of coronary stenosis. Permanent polymer DES (zotarolimus-eluting [ZES] or everolimus-eluting [EES]) were compared to bioresorbable polymer everolimus-eluting stents (BP-EES) and BMS. Post implantation in 29 swine, stents were explanted and analysed up to 180 days. Area stenosis was reduced in all DES compared to BMS at 30 days. At 180 days, BP-EES had significantly lower area stenosis than EES or ZES. Severe inflammatory activity persisted in permanent polymer DES at 180 days compared to BP-EES or BMS. Qualitative para-strut inflammation areas (graded as none to severe) were elevated but similar in all groups at 30 days, peaked at 90 days in DES compared to BMS (p<0.05) and, at 180 days, were similar between BMS and BP-EES but were significantly greater in DES.. BP-EES resulted in a lower net long-term reduction in neointimal formation and inflammation compared to permanent polymer DES in an animal model. Further study of the long-term neointima formation deserves study in human clinical trials.

Topics: Absorbable Implants; Animals; Coronary Stenosis; Disease Models, Animal; Drug-Eluting Stents; Everolimus; Inflammation; Neointima; Percutaneous Coronary Intervention; Polymers; Sirolimus; Swine; Wound Healing

To report long-term results of a novel sirolimus-eluting stent with biodegradable polymer BACKGROUND: Newer generation drug-eluting stents are characterized by thin struts, improved platform design and highly biocompatible polymer carrying the antiproliferative drug. The RapstromTM stent, sharing these features, showed promising outcomes in preclinical models and in a first-in-man trial.. The present study is a multicenter, non-randomized post-market registry, including patients with de novo coronary artery disease treated with implantation of one or more Rapstrom stents. Primary endpoint of the study was the rate of major adverse cardiac events (MACE) at three-year follow-up.. 1073 patients were enrolled, with a high prevalence of diabetes (35%) and acute coronary syndrome at presentation (82%); at three-year follow up, MACE rate was 14.8%, with a low incidence of definite or probable stent thrombosis (0.75%).. These data confirm the good clinical performance of the Rapstrom stent, supporting the concept that the combination of thin struts and biodegradable polymer is associated with positive clinical outcomes.

Topics: Absorbable Implants; Acute Coronary Syndrome; Cardiovascular Agents; Comorbidity; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Incidence; Percutaneous Coronary Intervention; Prevalence; Product Surveillance, Postmarketing; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The optimal approach to coronary bifurcation treatment by percutaneous coronary intervention (PCI) is still a subject of debate, and dedicated bifurcation stents are one of the proposed solutions.. The aim of this report was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM C® (Balton, Poland) at the first three months of a 12-month registry.. This is a two-centre registry, which enrolled patients with non-ST elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting is the obligatory strategy of the treatment. Angiographic control is planned at 12 months. The primary endpoint is the cumulative rate of cardiac death, myocardial infarction (MI), and target lesion revas-cularisation (TLR) at 12 months.. A total of 48 patients with lesions in coronary bifurcations were enrolled (mean age 67.9 ± 8.9 years, 14.6% female). There were 20.8% of patients with NSTE-ACS, 93.8% with hypertension, 35.4% with diabetes, 52.1% had previous MI, and 47.9% and 14.6% underwent prior PCI and coronary artery bypass grafting, respectively. The device success rate was 100%. The side branch was treated with an additional classical drug-eluting stent implantation in 18.8% of cases. The periprocedural MI (MI type 4a) was observed in two (4.2%) cases. At three months there was one (2.1%) case of TLR. No death, MI, or stent thrombosis were observed in the follow-up period.. Bifurcation treatment with a single dedicated bifurcation stent (BiOSS LIM C®) is feasible and highly successful (100% implantation success rate). The short-term clinical outcomes are very promising, also in distal left main stenosis. The 12-month observations are pending.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Chromium; Cobalt; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Poland; Registries; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Sirolimus

The use of short-duration dual antiplatelet therapy (DAPT) remains controversial. To investigate efficacy and safety of short-duration DAPT, we performed a detailed comparison of intra-stent conditions by optical coherence tomography (OCT) after second-generation drug-eluting stent implantation with short-term and standard DAPT.. Eighty-two consecutive patients with stable angina pectoris who received Resolute zotarolimus-eluting stents (R-ZESs; Medtronic Cardiovascular, Santa Rosa, CA, USA) were enrolled. Patients were assigned to 3-month (3M group: 41 patients) and standard (standard group: 41 patients) DAPT. In the 3M group, clopidogrel was discontinued 3 months after stent implantation. In the standard group, DAPT was maintained until follow-up OCT. At 9 months, neointimal proliferation was significantly larger in the 3M group, but there were no significant between-group differences in the proportion of uncovered and malapposed strut. The prevalence of abnormal intra-stent tissue (AIT) at 9 months was equivalent between groups. A multiple regression analysis revealed malapposition at 9 months as the strongest independent predictor of AIT at 9 months, and the prevalence of AIT was not associated with DAPT duration. Over 2 years, cardiac events were equal between groups; however, major bleeding was higher tendency in the standard group than in the 3M group.. This OCT study indicated that reducing DAPT's duration may provide acceptable arterial healing in patients with implanted R-ZESs.

Topics: Aged; Angina Pectoris; Aspirin; Clopidogrel; Coronary Stenosis; Coronary Vessels; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Follow-Up Studies; Hemorrhage; Humans; Japan; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus; Thrombosis; Tomography, Optical Coherence

We conducted propensity-score matched comparisons of midterm angiographic outcomes of sirolimus (SES) versus either everolimus- (EES) or biolimus- (BES) eluting stents after placements for coronary stenosis in a daily practice environment since previous randomized trials did not demonstrate the superiority of EES and BES over SES in terms of midterm angiographic outcomes.The present study was a non-randomized, retrospective, and lesion-based study, recruiting angiographically followed-up lesions within 550 days after successful and elective SES (n = 1793), EES (n = 1303), or BES (n = 324) placement for de novo native coronary stenosis during the period from August 2004 to January 2014 at 6 institutes. The endpoint, as an angiographic surrogate marker of clinical efficacy, was the distribution of in-stent follow-up percent diameter stenosis (%DS) which comprised the percentages of 1) follow-up %DS < 20 and 2) follow-up %DS > 50. Propensityscore matched analyses were conducted to adjust 21 baselines.In 1215 baseline adjusted lesions, the endpoints in the EES group [1) 74.1%, and 2) 4.6%] were significantly different from those in the SES group [57.9%; P < 0.001, 7.2%; P = 0.006, respectively). In 307 baseline adjusted lesions, the endpoints in the BES group [1) 80.5%, 2) 2.0%] were significantly different from those in the SES group [59.3%; P < 0.001, 2) 8.1%; P = 0.001, respectively].The present study is the first to confirm the superiority of midterm angiographic outcomes after the placement of EES and BES over SES for de novo coronary stenosis in a clinical setting.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Propensity Score; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

The incidence and long-term clinical impact of stent fracture (SF) occurred beyond 1 year after sirolimus-eluting stent (SES) implantation remains unclear. From April 2004 to March 2008, 985 consecutive patients with 1,307 lesions were treated only with SES. Of these, 868 patients (88.1%) with 1,140 lesions underwent follow-up angiography within 1 year after the index procedure, and 646 patients (65.6%) with 872 lesions underwent it both within and beyond 1 year after the index procedure. According to the diagnosed timing of SF, we divided the patients into the 2 groups: early SF (<1 year after the index procedure) and late-acquired SF (>1 year after the index procedure). Early- and late-acquired SFs were observed in 64 of 868 patients (7.4%) and 66 of 1,140 lesions (5.8%); 12 of 646 patients (1.9%) and 12 of 872 lesions (1.4%), respectively. Cumulative 10-year incidence of clinically driven target lesion revascularization and definite stent thrombosis were numerically higher in the early- and late-acquired SF groups than in the non-SF group (41.6% vs 45.5% vs 19.0%; 8.0% vs 8.3% vs 2.0%, respectively). In conclusion, late-acquired SF after SES implantation occurred in 1.4% of lesions, which was lower than that of early SF. However, both early- and late-acquired SFs appeared to be associated with clinically driven target lesion revascularization and stent thrombosis during the long-term follow-up.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Japan; Male; Postoperative Complications; Prosthesis Failure; Retrospective Studies; Sirolimus; Time Factors

Although Nobori

Topics: Absorbable Implants; Animals; Aspirin; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Humans; Metals; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Swine

The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months.. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment.. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).. Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%).. The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Female; Humans; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study aimed to evaluate the efficacy and safety of limus-based drug-eluting stent (DES) implanted in medium or small coronary vessels during a very long-term follow-up period.. A total of 2383 patients treated with 2916 limus-based DES between April 2003 and March 2015 were evaluated. The enrolled patients were stratified into 3 groups according to the reference vessel diameter: group A: ≤2.5 mm; group B: 2.51 to 3.00 mm; group C: 3.01 to 3.50 mm.. Group A had a significantly higher loss index and binary restenosis rate than the other 2 groups at 9 months of angiographic follow-up. Group A also had a significantly higher rate of target lesion revascularization and a lower rate of major adverse cardiovascular event-free survival than the other 2 groups after a follow-up period of 68 ± 59 months. The long-term cardiovascular event-free survival curves based on a Cox regression model showed large vessel size, and second-generation DES had better outcomes.. An inverse relationship between vessel size (≤3.5 mm) and clinical outcomes was noted in patients who received limus-based DES implantation.

Topics: Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Diabetes Mellitus; Drug-Eluting Stents; Electrocardiography; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Registries; Risk Factors; Sirolimus; Survival Rate; Treatment Outcome

The second-generation drug-eluting absorbable magnesium scaffold Magmaris, recently introduced for the treatment of obstructive coronary atherosclerotic lesions, suggests a good safety profile, but preclinical assessment is important for predicting clinical performance. The aim of the present study was to assess subacute and long-term safety as well as pharmacokinetic properties of the Magmaris compared with a current-generation metallic DES and an approved BRS in porcine and rabbit animal models.. Ninety Magmaris scaffolds were implanted into non-diseased porcine and rabbit models. A bioresorbable vascular scaffold (Absorb) and a permanent drug-eluting stent (XIENCE Xpedition) served as controls. Scanning electron microscopy showed increased endothelialisation and decreased thrombus formation at three and 28 days in the Magmaris group compared with the Absorb group. In the XIENCE group, inflammation exceeded the level in the Magmaris group at 365 and 730 days. Neointimal growth was greater in the Magmaris group than in the XIENCE group. Late lumen loss decreased over time in both groups. Optical coherence tomography (OCT) showed stable luminal dimensions in both the Magmaris and XIENCE groups. Pharmacokinetic studies demonstrated a retarded elution profile in the Magmaris group with 69.4% of sirolimus released at 90 days.. Preclinical results suggest that the Magmaris has a favourable safety profile with advanced healing relative to benchmark, low acute thrombogenicity, and absence of excessive lumen loss up to two years. These results support clinical application of Magmaris for human use.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Magnesium; Percutaneous Coronary Intervention; Prosthesis Design; Rabbits; Sirolimus; Swine; Treatment Outcome

The aim of this study was to assess prospectively the effectiveness and safety of a new version of the dedicated bifurcation BiOSS stent, the sirolimus-eluting BiOSS LIM, for the treatment of distal left main (LM) stenosis.. This was a prospective international registry which enrolled patients with NSTE-ACS or stable angina. Provisional T-stenting was the mandated strategy. The primary endpoint was the cumulative rate of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at 12 months. Twelve-month quantitative coronary angiography endpoints included late lumen loss and percent diameter stenosis. A total of 74 patients with distal LM stenosis were enrolled. Seventy-three of the 74 patients (aged 67±9 years, 23% women, 20.3% NSTE-ACS, SYNTAX score 22.4±4.4) were successfully treated with the BiOSS LIM stent, with additional side branch placement of regular DES in 11 patients (14.9%). Periprocedural MI occurred in one (1.4%) patient. The 12-month MACE rate was 9.5% without cardiac death or definite stent thrombosis. TLR and MI rates were 6.8% (n=5) and 2.7% (n=2), respectively.. The use of the BiOSS LIM dedicated bifurcation stent for the treatment of distal LM stenosis was feasible and safe, with promising long-term clinical effectiveness.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Constriction, Pathologic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Registries; Sirolimus; Time; Treatment Outcome

Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions.. We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504.. Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed.. Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease.. Biotronik AG.

Topics: Absorbable Implants; Aged; Alloys; Antibiotics, Antineoplastic; Cohort Studies; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endosonography; Female; Humans; Magnesium; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Methods for intravascular assessment of the side-branch (SB) orifice after stenting are not readily available. The aim of this study was to assess the utility of an en-face projection processing for optical coherence tomography (OCT) images for SB evaluation.. Measurements of the SB orifice obtained using en-face OCT images were validated using a phantom model. Linear regression modeling was applied to estimated area measurements made on the en-face images. The SB orifice was then analyzed in 88 patients with bifurcation lesions treated with either Xience V (everolimus-eluting stent) or Resolute Integrity [zotarolimus-eluting stent (ZES)]. The SB orifice area (A) and the area obstructed by struts (B) were calculated, and the %open area was evaluated as (A-B)/A*100.. Linear regression modeling demonstrated that the observed departures of the intercept and slope were not significantly different from 0 (-0.12 ± 0.22, P=0.59) and 1 (1.01 ± 0.06, R(2)=0.88, P=0.87), respectively. In cases without SB dilatation, the %open area was significantly larger in the everolimus-eluting stent group (n=25) than in the ZES group [n=32; 89.2% (83.7-91.3) vs. 84.3% (78.9-87.8), P=0.04]. A significant difference in %open area between cases with and those without SB dilatation was demonstrated in the ZES group [91.4% (86.1-94.0) vs. 84.3% (78.9-87.8), P=0.04].. The accuracy of SB orifice measurement on an en-face OCT image was validated using a phantom model. This novel approach enables quantitative evaluation of the differences in SB orifice area free from struts among different stent types and different treatment strategies in vivo.

Topics: Biocompatible Materials; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Membranes, Artificial; Middle Aged; Phantoms, Imaging; Polyglactin 910; Prosthesis Design; Reproducibility of Results; Sirolimus; Tomography, Optical Coherence

Topics: Absorbable Implants; Antibiotics, Antineoplastic; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Sirolimus; Tissue Scaffolds

Topics: Adult; Coronary Aneurysm; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Humans; Male; Sirolimus; Time Factors; Ultrasonography, Interventional

We aimed to investigate short-term outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in human coronary artery.. Bioresorbable scaffolds are considered to be the fourth milestone in percutaneous coronary intervention.. Thirty patients with symptomatic ischemic coronary disease were enrolled and treated with the XINSORB scaffolds that were 3.0 × 12, 15, and 18 mm in size. The primary angiographic endpoint was late luminal loss (LLL), whereas the primary clinical endpoint was major adverse cardiac events (MACEs) at the 6 month follow-up. In a subset of 19 patients, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were performed at follow-up.. The success rates of the procedure and the device were both 100%. Twenty-seven patients received angiographic follow-up. All patients were clinically assessed. Neither MACEs nor stent thrombus-related events were recorded. The percentage of diameter stenosis at follow-up was similar to that at postprocedure. In-scaffold and periscaffold LLL were 0.17 ± 0.12 and 0.13 ± 0.24 mm, respectively. No in-stent restenosis was detected. IVUS showed that the mean areas of the lumen, scaffold, and neointima at follow-up were 6.27 ± 0.69, 6.48 ± 0.70, and 0.20 ± 0.09 mm(2) , while in-device stenosis was 3.1 ± 1.3%. OCT showed that 97.9% of the struts presented a preserved box, while 2.1% had an open box after 6 months. A total of 95.9% of the struts were covered by neointima.. This first-in-human study demonstrates the effectiveness and safety of the XINSORB scaffold in treating single de novo coronary lesions.

Topics: Absorbable Implants; Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing.. In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1% at three months to 98.6% at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2% and 0.0% at the two respective time points. Neointimal volume obstruction increased from 6.3% to 12.8%, and the HS decreased from a median of 28.1 at three months to 2.4 at six months.. In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Sirolimus; Tomography, Optical Coherence

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Registries; Retrospective Studies; Sirolimus; Treatment Outcome

A 78-year-old man with unstable angina showed 90% stenosis in the proximal left anterior descending artery. Pre-procedural intravascular ultrasound revealed ruptured plaque and attenuated plaque in the lesion. Under these conditions, two overlapping sirolimus-eluting stent (SES) implantation in this lesion resulted in slow flow which was recovered by intracoronary nitrates, nicorandil, and nitroprusside without further complications. When the patient showed up again 5 years later with recurrence of angina pectoris, angiography revealed a hazy ulcerated in-stent restenosis (ISR) at the site of the SES. Pre-procedural optical coherence tomography (OCT) imaging revealed multiple intimal ruptures, cavity formation behind the stent struts, a thin-cap fibroatheroma containing neointima surrounded by signal-poor, lipid-rich area in the proximal SES, suggesting the progression of neoatherosclerosis within SES. Importantly, there occurred slow flow again after balloon angioplasty for this lesion. We would suggest careful OCT examination is warranted to confirm development of neoatherosclerosis within the stent, and distal protection device should be considered to prevent slow flow phenomenon even in a patient with very late ISR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Denture, Partial, Temporary; Drug-Eluting Stents; Humans; Male; No-Reflow Phenomenon; Recurrence; Retreatment; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Arterial plaque rupture and thrombus characterise ST-elevation myocardial infarction (STEMI) and may aggravate delayed arterial healing following durable polymer drug-eluting stent (DP-DES) implantation. Biodegradable polymer (BP) may improve biocompatibility. We compared long-term outcomes in STEMI patients receiving BP-DES vs. durable polymer sirolimus-eluting stents (DP-SES).. We pooled individual patient-level data from three randomised clinical trials (ISAR-TEST-3, ISAR-TEST-4 and LEADERS) comparing outcomes from BP-DES with DP-SES at four years. The primary endpoint (MACE) comprised cardiac death, MI, or target lesion revascularisation (TLR). Secondary endpoints were TLR, cardiac death or MI, and definite or probable stent thrombosis. Of 497 patients with STEMI, 291 received BP-DES and 206 DP-SES. At four years, MACE was significantly reduced following treatment with BP-DES (hazard ratio [HR] 0.59, 95% CI: 0.39-0.90; p=0.01) driven by reduced TLR (HR 0.54, 95% CI: 0.30-0.98; p=0.04). Trends towards reduction were seen for cardiac death or MI (HR 0.63, 95% CI: 0.37-1.05; p=0.07) and definite or probable stent thrombosis (3.6% vs. 7.1%; HR 0.49, 95% CI: 0.22-1.11; p=0.09).. In STEMI, BP-DES demonstrated superior clinical outcomes to DP-SES at four years. Trends towards reduced cardiac death or myocardial infarction and reduced stent thrombosis require corroboration in specifically powered trials.

Topics: Absorbable Implants; Aged; Antibiotics, Antineoplastic; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Treatment Outcome

To investigate the extent and the circumferential distribution of the neointima tissue developed following an Absorb bioresorbable vascular scaffold (BVS) implantation.. Twenty-three patients who were treated with the Absorb BVS and had optical coherence tomographic examination after scaffold implantation, at six-month and at two-year follow-up, were included in the current analysis. The lumen and the scaffold borders were detected and the circumferential thickness of the neointima was measured at one degree intervals. The symmetry of the neointima was defined as: minimum/maximum thickness. The lumen area was decreased at six months compared to baseline but it did not change between six-month and two-year follow-up (baseline: 7.49 [6.13-8.00] mm², six months: 6.31 (4.75-7.06) mm², two years: 6.01 [4.67-7.11] mm², p=0.373). However, the mean neointima thickness (six months: 189 [173-229] m, two years: 258 [222-283] m, p<0.0001) and the symmetry index of the neointima (six months: 0.06 [0.02-0.09], two years: 0.27 [0.24-0.36], p<0.0001) were increased at two years. Full circumferential coverage of the vessel wall by neointima tissue was seen in 91% of the studied frames at two years.. This study demonstrates that after an Absorb BVS implantation neointima tissue develops that covers almost the whole circumference of the vessel wall. In contrast to the metallic stents, the neointima tissue does not compromise the luminal dimensions. Further research is required to evaluate the neointimal characteristics and assess the potential value of the device in passivating high-risk plaques.

Topics: Absorbable Implants; Adult; Aged; Antineoplastic Agents; Cohort Studies; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence

Topics: Angina Pectoris, Variant; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vasospasm; Drug-Eluting Stents; Everolimus; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Vasodilator Agents

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Sirolimus; Tomography, Optical Coherence

This study evaluated the safety and efficacy of the RESOLUTE(TM)zotarolimus-eluting stent (R-ZES; Medtronic, Inc, Santa Rosa, CA, USA) in Japanese patients for the treatment of de novo native coronary lesions.. Both RESOLUTE Japan (R-Japan) and RESOLUTE Japan Small Vessel Study (R-Japan SVS) were prospective, multicenter, single-arm observational studies. R-Japan enrolled 100 patients (reference vessel diameter, 2.5-3.5 mm) and R-Japan SVS enrolled 65 patients (at least 1 lesion suitable for 2.25-mm stent) treated with R-ZES. In R-Japan, in-stent late lumen loss (LLL; the primary endpoint) at 8 months was 0.12 ± 0.22 mm and volume obstruction on intravascular ultrasound was 2.33 ± 3.51%. At 4 years, there were no cases of clinically driven target lesion revascularization (TLR); the target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, and clinically driven TLR) was 5.6% (5/90). In R-Japan SVS, in-stent LLL at 9 months was 0.27 ± 0.33 mm, TLF (primary endpoint) was 4.6% (3/65), without incidence of TLR. At 3 years, TLF was 7.9% (5/63) and clinically driven TLR, 3.2% (2/63).. R-Japan and R-Japan SVS demonstrate substantial suppression of neointimal hyperplasia, low LLL, and excellent and sustained long-term clinical outcome with R-ZES in Japanese patients.

Topics: Combined Modality Therapy; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Heart Diseases; Humans; Incidence; Japan; Myocardial Infarction; Myocardial Revascularization; Neointima; Platelet Aggregation Inhibitors; Postoperative Complications; Prospective Studies; Risk Factors; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

We present a case of a bifurcation lesion treated with two dedicated sirolimus eluting bifurcation stents, BiOSS Lim in the setting of non-ST elevation myocardial infarction and poor left ventricular function. We demonstrate the feasibility of a new technique, a "simplified" culotte technique. The key differences of this new technique compared with conventional culotte are: better sizing of the stent due to the specific design of the stent with a larger proximal diameter and smaller distal diameter, direct stenting of the second stent without predilatation of the stent struts of the first deployed stent, and possibility to perform post-dilatation directly with properly sized balloons without additional predilatation.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Electrocardiography; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Sirolimus; Treatment Outcome; Ventricular Dysfunction, Left

To evaluate strut coverage after biolimus-A9 eluting stent (BES) implantation for unprotected left main artery (ULMA) stenosis during follow-up and identify features associated with the length of uncovered stent segment, as assessed by frequency domain-optical coherence tomography (FD-OCT).. Incomplete stent strut coverage is a risk factor for late stent thrombosis. Long-term interaction between vessel wall and BES in the context of ULMA stenting has not been investigated in depth.. We prospectively enrolled 32 patients with ULMA stenosis treated with BES. FD-OCT was performed at 9-month follow-up. Both malapposed and uncovered segment length were indexed for the segment between the distal and proximal cross-sections in which stent struts were circumferentially visible. Patients were divided into two groups according to the median value of maximal indexed uncovered segment length. Study endpoints were the rate of strut coverage and predictors of high uncovered segment length.. We analyzed 3622 struts. The rate of covered struts was 87%. A high correlation was found between malapposed and uncovered segment length (r = 0.82; P<.001). The median value of indexed-uncovered segment length was 0.308. On multivariable analysis, patients undergoing final kissing balloon were at lower risk of high uncovered segment length (odds ratio, 0.81; 95% confidence interval, 0.008-0.837; P=.04).. In patients undergoing BES implantation for treatment of ULMA stenosis, the rate of 9-month strut coverage is high. The use of final kissing balloon reduces the risk of high uncovered stent segment length.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Prospective Studies; Prosthesis Design; Sirolimus; Surgery, Computer-Assisted; Time Factors; Tomography, Optical Coherence; Treatment Outcome

We conducted a lesion-based retrospective sub-analyses of diabetes mellitus (DM), diffuse long lesions (stented segment ≥40 mm; LLs), and small vessels (SVs; reference diameter ≤2.6 mm) in patients who received sirolimus- (SESs) or paclitaxel-eluting stents (PESs) for nonrandom treatment of de novo native coronary stenosis in a clinical practice setting. During the period from May 2007 to February 2009, 490 of 682 PES-treated and 293 of 386 SES-treated lesions were angiographically followed up within 1500 days of PCI, and the retrospective investigation was conducted in April 2013. The frequencies of target lesion revascularization (TLR; any recurrent PCI including both marginal stent restenosis) and binary in-stent restenosis (percentage diameter of in-stent stenosis >50%) upon follow-up angiography, evaluated by adjusting 25 baseline variables using propensity score matching analysis, after placement of SESs and PESs were the following: DM (n = 124 per arm), 14.5 vs. 15.3% (p = 0.842), and 14.5 vs. 16.1% (0.856); LLs (n = 81), 16.0 vs. 21.0% (0.433), and 12.3 vs. 22.2% (0.117); SVs (n = 107), 11.2 vs. 29.9% (<0.001), and 11.2 vs. 30.8% (<0.001), respectively. The p values of log-rank tests for the cumulative TLR-free ratios after SES and PES placement were 0.504 in DM, 0.625 in LLs, and <0.001 in SVs group, respectively. Thus, compared to PES, SES showed the equivalent efficacy for DM, the tendency to be superior for LLs due to approximately 24-45% reductions in TLR and binary restenosis rates, and the promising superiority for SVs on the angiographic outcomes during a long-term observational interval.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Paclitaxel; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM® (Balton, Poland) in 12-month Registry.. The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions.. This was the international, 3-center registry, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.. A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE-ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug-eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow-up (11 ± 1 months) there was 1 non-cardiac death (1.7%), 1 non-ST-elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in-stent thrombosis. Overall TLR was 8.3% (clinically driven TLR - 1.7%, angiographically driven - 6.6%). Mean late lumen loss was as follows: In main vessel - 0.35 ± 0.33 mm, in main branch - 0.34 ± 0.27 mm and in side branch - 0.18 ± 0.38 mm.. Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long-term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis.

Topics: Acute Coronary Syndrome; Aged; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Male; Prosthesis Design; Registries; Sirolimus

Topics: Absorbable Implants; Angina Pectoris; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coronary Aneurysm; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Echocardiography, Stress; Humans; Male; Middle Aged; Monitoring, Physiologic; Platelet Aggregation Inhibitors; Sirolimus; Treatment Outcome

Coronary adventitia harbors a wide variety of components, such as inflammatory cells and vasa vasorum (VV). Adventitial VV initiates the development of coronary artery diseases as an outside-in supply route of inflammation. We have recently demonstrated that drug-eluting stent implantation causes the enhancement of VV formation, with extending to the stent edges in the porcine coronary arteries, and also that optical frequency domain imaging (OFDI) is capable of visualizing VV in humans in vivo. However, it remains to be fully validated whether OFDI enables the precise measurement of VV formation in pigs and humans.. In the pig protocol, a total of 6 bare-metal stents and 12 drug-eluting stents were implanted into the coronary arteries, and at 1 month, the stented coronary arteries were imaged by OFDI ex vivo. OFDI data including the measurement of VV area at the stent edge portions were compared with histological data. There was a significant positive correlation between VV area on OFDI and that on histology (R=0.91, P<0.01). In the human protocol, OFDI enabled the measurement of the VV area at the stent edges after coronary stent implantation in vivo.. These results provide the first direct evidence that OFDI enables the precise measurement of the VV area in coronary arteries after stent implantation in pigs and humans.

Topics: Adventitia; Aged; Aged, 80 and over; Animals; Aspirin; Clopidogrel; Coronary Stenosis; Coronary Vessels; Disease Progression; Drug-Eluting Stents; Everolimus; Female; Humans; Interferometry; Male; Middle Aged; Neointima; Neovascularization, Physiologic; Platelet Aggregation Inhibitors; Postoperative Period; Prosthesis Implantation; Sirolimus; Stents; Swine; Swine, Miniature; Ticlopidine; Tomography, Optical Coherence; Vasa Vasorum; Vasculitis

The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR).. The optimal treatment for drug-eluting in-stent restenosis remains controversial.. The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year.. The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES=14%, SES=18%, POBA=20%; p=0.65), death (EES=2.3%, SES=6.2%, POBA=6.1%; p=0.61), MI (EES=4.8%, SES=2.1%, POBA=2.5%; p=0.69), TLR (EES=11.9%, SES=12.1%, POBA=24%; p=0.78), and TVR (EES=11.9%, SES=24.8%, POBA=22.2%; p=0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p=0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE.. In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Confidence Intervals; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Multivariate Analysis; Patient Safety; Proportional Hazards Models; Retreatment; Retrospective Studies; Risk Assessment; Sirolimus; Statistics, Nonparametric; Survival Rate; Time Factors; Treatment Outcome

Topics: Adventitia; Animals; Coronary Stenosis; Coronary Vessels; Everolimus; Female; Humans; Male; Neovascularization, Physiologic; Prosthesis Implantation; Sirolimus; Stents; Tomography, Optical Coherence; Vasa Vasorum

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Combined Modality Therapy; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Electrocardiography; Follow-Up Studies; Humans; Male; Myocardial Infarction; Platelet Aggregation Inhibitors; Prosthesis Failure; Retreatment; Sirolimus; Stents; Thrombosis; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Unprotected left main coronary artery (ULMCA) stenosis has relatively high prevalence and exposes patients to a high risk for adverse cardiovascular events. The optimal revascularisation strategy (coronary artery bypass surgery [CABG] or percutaneous coronary intervention [PCI]) for patients with complex coronary artery disease is a topic of continuing debate. The introduction of the newer-generation drug-eluting stents (DES) -with documented improvements in both safety and efficacy- has prompted the interventional community to design two new dedicated randomised trials comparing CABG and PCI: the NOBLE (Coronary Artery Bypass Grafting Vs Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis) and EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trials. The aims of the present review are to describe the similarities and contrasts between these two trials as well to explore their future implications in ULMCA treatment.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

Topics: Alloys; Antibiotics, Antineoplastic; Coronary Stenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Self Expandable Metallic Stents; Sirolimus; Treatment Outcome

Topics: Alloys; Antineoplastic Agents; Coronary Stenosis; Drug-Eluting Stents; Humans; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Stents; Treatment Outcome

Topics: Antineoplastic Agents; Coronary Stenosis; Drug-Eluting Stents; Humans; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Stainless Steel; Treatment Outcome

Topics: Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Prosthesis Failure; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Absorbable Implants; Angina Pectoris; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Metals; Middle Aged; Percutaneous Coronary Intervention; Recurrence; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence; Tubulin Modulators

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Imaging, Three-Dimensional; Male; Middle Aged; Predictive Value of Tests; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Diabetes is associated with aggressive atherosclerosis, leading to an increased risk of in-stent restenosis and stent thrombosis. Bioresorbable scaffolds (BRS) are a new technology for the treatment of coronary lesions that might be beneficial due to their dissolving character, especially in diabetic patients.. This study was designed to evaluate feasibility and mid-term clinical outcome of the implantation of PLLA-based, everolimus-eluting BRS for the treatment of coronary lesions in a diabetic all-comers population.. All patients of an all-comers registry with diabetes eligible for BRS implantation were included. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), cardiac death, and myocardial infarction. Follow-up was conducted via telephone and/or office visit.. A total of 120 diabetic patients were included. Of all diabetics, 35.0% had insulin-dependent diabetes, and all other patients were treated with oral antidiabetics or dietary modification. The median age was 67 (59-72) years and 26.7% were female. Patients underwent coronary angiography due to acute coronary syndrome in 50.8%. Of 127 lesions, 60.6% were B2/C lesions according to ACC/AHA classification. The 6-month rates of TVF, TLR, and MACE were 8.9, 2.7, and 8.4%, respectively.. This evaluation confirms reasonable clinical outcome of bioresorbable vascular scaffold implantation in a high-risk diabetic population with predominately complex lesions during daily clinical practice. Nevertheless, long-term data are required for final evaluation.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Feasibility Studies; Female; Follow-Up Studies; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Registries; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Rate; Treatment Outcome

NOBORI biolimus A9-eluting stent (BES) is the third generation drug eluting stent (DES) with only abluminal biodegradable polymer. Recent clinical trials have indicated that the BES is non-inferior to the XIENCE V everolimus-eluting stent (EES). Meanwhile, potential superiority of biodegradable polymer BES over current generation DES has not been addressed. The aim of this preclinical study was to assess and compare the biocompatibility of both BES and EES in porcine coronary arteries.. BES with length of 24-mm (n=9) and EES with length of 23-mm (n=9) were both implanted in porcine coronary arteries. At 28 days endothelium-dependent vasomotion was assessed by acetylcholine (Ach) and subsequently measurements of endothelial superoxide production, histological evaluations and microarray gene analyses were performed.. Angiographic and histological in-stent stenoses were significantly suppressed in BES compared with EES. Histopathological assessment showed lower inflammatory score as well as fibrin and injury scores in BES as compared with EES. On the contrary, paradoxical vasoconstriction to Ach was frequently observed in EES-treated vessels compared with BES-treated vessels. Additionally, gene expressions of inflammatory cytokines and chemokines were upregulated in vessels treated with EES compared with BES in microarray pathway specific analyses.. Implantation of BES revealed less inflammation and foreign-body immunoreaction than EES, suggesting more enhanced biocompatibility of BES compared with EES at 28 days in porcine coronary arteries.

Topics: Animals; Biocompatible Materials; Coronary Stenosis; Disease Models, Animal; Drug-Eluting Stents; Everolimus; Immunosuppressive Agents; Materials Testing; Sirolimus; Swine; Treatment Outcome

This study compared safety and efficacy of first- and second-generation DES in an unrestricted, real-life population of diabetic patients undergoing PCI.. The study was a subanalysis of diabetic patients from the all-comer Katowice-Zabrze Registry of patients undergoing PCI with the implantation of either first- (Paclitaxel-, Sirolimus-eluting stents) or second-generation DES (Zotarolimus-, Everolimus-, Biolimus-eluting stents). Efficacy defined as major adverse cardiac and cerebrovascular events (MACCE: death, myocardial infarction, target vessel revascularization, stroke) and safety defined as stent thrombosis (ST) were evaluated at 1 year.. From the total of 1916 patients, 717 were diabetics. Among them, 257 (36%) were treated with first-generation DES (230 [89%] Paclitaxel-eluting stents, 27 [11%] Sirolimus-eluting stents), 460 with second-generation DES (171 [37%] Zotarolimus-eluting stents, 243 [53%] Everolimus-eluting stents, 46 [10%] Biolimus-eluting stents). Rate of MACCE was equal in both groups (p=0.54). Second-generation DES had a better safety profile than first-generation DES (log-rank for cumulative ST at 1 year p<0.001). First-generation DES was a risk factor for ST (HR 5.75 [1.16-28.47], p=0.03) but not for MACCE (HR 0.89 [0.6-1.32], p=0.57).. In a real-life setting of diabetic patients undergoing PCI, second-generation DES had lower risk of ST and similar MACCE rate compared to first-generation DES.

Topics: Aged; Angiography; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Percutaneous Coronary Intervention; Poland; Proportional Hazards Models; Registries; Retrospective Studies; Sirolimus; Stents; Thrombosis; Treatment Outcome

The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

To compare strut coverage patterns between everolimus-eluting stent (EES) and first-generation drug-eluting stents (DES) at more than 12 months after successful implantation, using optical coherence tomography (OCT).. No sufficient OCT data has been reported comparing late strut coverage patterns between EES and first-generation DES. The favorable late results after EES implantation could be related to lower rates of uncovered and malapposed struts.. A total of 66 DES (21 EES, 23 SES, and 22 PES) that were implanted at least 1 year in advance in 40 patients and met good late angiographic results were evaluated by OCT. The percentage of uncovered and malapposed struts, calculated as the ratio of uncovered or malapposed struts to total struts in all cross-sectional images per stent, was compared among the three groups.. A total of 35,061 struts were analyzed: 11,967 from EES, 11,855 from SES, and 11m239 from PES. The average tissue coverage thickness of the struts per stent was greater in EES than in SES and PES (109 ± 40 µm vs. 72 ± 27 µm and 83 ± 26 µm, respectively; P = 0.001). The percentage of uncovered struts (1.9 ± 4.1% in EES vs. 11.6 ± 12.7% in SES, P = 0.01 and vs. 7.1 ± 5.2% in PES, P < 0.001) and malapposed struts (0.1 ± 0.3% in EES vs. 1.8 ± 3.5% in SES, P = 0.01 and vs. 3.5 ± 5.1% in PES, P = 0.02) was much lower in EES than in first-generation DES, with no significant differences between SES and PES.. Late strut coverage patterns are not similar between EES and first-generation DES. EES showed a lower percentage of uncovered and malapposed struts.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Stenosis; Cross-Sectional Studies; Drug-Eluting Stents; Equipment Failure Analysis; Everolimus; Female; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Design; Prosthesis Failure; Sensitivity and Specificity; Sirolimus; Time Factors; Tomography, Optical Coherence

Ostial right coronary artery (RCA) lesions are associated with a high restenosis rate after bare-metal stent implantation. However, long-term outcomes after drug-eluting stent (DES) implantation for ostial RCA lesions have not been adequately evaluated. Among 12824 patients enrolled in the j-Cypher registry, 5-year outcomes were compared between 397 patients with ostial RCA lesions, and 3716 patients with non-ostial RCA lesions treated with sirolimus-eluting stents (SES). Through 5-year follow-up, patients with ostial RCA lesions had a significantly higher cumulative incidence of target lesion revascularization (TLR) (28.2 versus 13.7 %, P < 0.0001) than those with non-ostial RCA lesions. After adjusting for confounders, excess TLR risk of the ostial group relative to the non-ostial group was significant for both early TLR within 1-year and late TLR beyond 1-year (HR 2.14 [95 % CI 1.59-2.84], P < 0.0001, and HR 1.58 [95 % CI 1.06-2.26], P = 0.02, respectively). Although the cumulative incidence of death was also significantly higher in the ostial group than in the non-ostial group (25.7 versus 14.4 %, P < 0.0001), the excess risk of the ostial group relative to the non-ostial group was no longer significant after adjusting for confounders (HR 1.25 [95 % CI 0.99-1.57], P = 0.07). SES implantation for ostial RCA lesions was associated with higher risk for TLR as compared with that for non-ostial RCA lesions. Restenosis, both early and late, remains an issue in coronary DES implantation for ostial RCA lesions.

Topics: Aged; Aged, 80 and over; Calcinosis; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Registries; Risk Factors; Sirolimus; Treatment Outcome

Neointimal proliferation of bifurcation lesions after implantation of drug-eluting stents (DES) has not been well evaluated. Thus, we compared neointimal proliferation of bifurcation lesions among four DES using optical coherence tomography (OCT).. 8-month follow-up OCT was performed in 68 bifurcation lesions treated by 15 sirolimus-eluting stents (SES) and 17 paclitaxel-eluting stents (PES) as first-generation DES, and by 17 zotarolimus-eluting stents (ZES) and 19 everolimus-eluting stents (EES) as second-generation DES. Cross-sectional images of the bifurcation lesion using OCT were analyzed every 450 µm. All images were divided into three areas: inner wall of the bifurcation (IB), outer wall of the bifurcation (OB), and ostium of the side branch (SB). We compared the incidence of uncovered struts (IUS) among three areas and the averaged neointimal thickness (NIH) between IB and OB in each stent and also compared these OCT parameters among all DES.. There were no significant differences of IUS between IB and OB in second-generation DES, while in first-generation DES, IUS of IB and OB showed significant differences. The IUS of SES in both areas was significantly higher than in the other DES (all P < 0.001). PES had a significantly higher IUS in SB than the others (all P < 0.001). NIH of OB was significantly higher than that of IB in PES, ZES, and EES, but in SES the NIH was similar in the two areas.. OCT revealed different neointimal growth patterns among SES, PES, ZES, and EES in bifurcation lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Cross-Sectional Studies; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Neointima; Paclitaxel; Prosthesis Failure; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

This study sought to assess clinical significance of angiographic peri-stent contrast staining (PSS) after sirolimus-eluting stent (SES) implantation in a large multicenter study with 5-year follow-up. The j-Cypher PSS substudy is a multicenter study including 5712 patients (7838 lesions) who underwent follow-up angiographic study within 12 months after SES implantation. Late acquired PSS was observed in 184 patients (3.2 %) or 194 lesions (2.5 %). Independent risk factors of PSS were chronic total occlusion and left anterior descending artery lesion, while negative risk factors were in-stent restenosis, diabetes mellitus, ≥70 years of age, and left circumflex coronary artery lesion. Cumulative incidence of definite very late stent thrombosis (VLST) at 4 years after the index follow-up angiography in lesions with PSS was significantly higher than that in lesions without PSS (5.3 versus 0.7 %, P < 0.0001). Late target-lesion revascularization (TLR) was also more frequently observed in the PSS group (13 versus 6.9 %, P = 0.01), while late TLR for restenosis excluding those TLR procedures for VLST tended to be higher in the PSS group (9.9 versus 6.3 %; P = 0.15). PSS found in 2.5 % of lesions within 12 months after SES implantation was associated with higher risk for subsequent VLST.

Topics: Aged; Anti-Inflammatory Agents; Blood Vessel Prosthesis Implantation; Contrast Media; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Male; Registries; Retrospective Studies; Risk Factors; Sirolimus

Restenosis after drug eluting stent (DES) implantation in the distal/bifurcation left main (DBLM) remains challenging to manage. The aim of this study was to assess the in-stent restenosis (ISR) after DES implantation in DLM and to evaluate current management strategy.. The medical records of patients referred for LM distal/bifurcation percutaneous coronary interventions (PCI) from the same Cardiology Unit in the January 2007 to December 2012 period were reviewed for PCI technique, stent type, restenosis type, restenosis treatment and management (CABG, balloon angioplasty only, alternative DES implant, drug eluting balloon angioplasty).. Fourteen patients (5 females, mean age 75.1±8.3years) out of 89 (15.7%) having undergone a percutaneous coronary interventions on DBLM with DES, developed restenosis (everolimus stents in 10 patients, zotarolimus stents in 4 patients). Technique used at the first implant included stenting of the main branch in 4 patients, culottes stenting in 6 patients and T-stent in 4 patients. The mean time elapsed from the first angioplasty and ISR intervention was 7.6±3.6months. Restenosis treatments included: implantation of a different DES (in 3 patients), implantation of a bare-metal stent (in 2 patients), simple balloon angioplasty (in 4 patients), and drug-eluting balloon (5 patients). At 6-month angiographic control second restenosis rate was 14.2%. After a mean follow-up of 38.5±24.4months the target vessel revascularization was 14.3%: surgery was the final choice in two patients due to recurrent restenosis. Incidence of major adverse cardiac event was 28.5%.. The occurrence of restenosis after DBLM following DES implantation is not frequent but remains difficult to manage. In our small anecdotal series, all the different strategies including implantation of different DES, balloon angioplasty, bare-metal stent implantation and drug-eluting balloon angioplasty appeared equally effective in maintaining arterial patency.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Male; Middle Aged; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Detailed long-term changes of the neointima in sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) are still unclear.. We consecutively enrolled 14 patients (18 SES) and 12 patients (13 PES) who underwent optical coherence tomography (OCT) serially at eight months and 18 months after stent implantation. For 18 SES and 13 PES, OCT was used to visualise 2,486 and 1,361 stent struts at the eight-month and 2,199 and 1,309 stent struts at the 18-month follow-up, respectively. The OCT parameters, including incidence of uncovered and malapposed struts (uncovered and malapposed percentage), average neointimal hyperplasia thickness (NIH thickness) and %NIH volume obstruction, which was defined as ([mean NIH area*stent length]/[mean stent area*stent length])100, and qualitative analysis of the neointima were compared between SES and PES and also compared between the eight- and 18-month follow-up for SES and PES, respectively. The uncovered and malapposed percentage was significantly higher in SES than PES at the eight- and 18-month follow-up, and the NIH thickness and %NIH volume obstruction were lower in SES than PES at both follow-ups. The uncovered and malapposed percentage decreased in both SES and PES between the eight- and 18-month follow-up. Percent NIH volume obstruction and NIH thickness in SES significantly increased from the eight- to 18-month follow-up; however, those parameters significantly decreased in PES. The incidence of high signal with peri-strut low-intensity areas increased in SES but decreased in PES from the eight- to 18-month follow-up.. Uncovered and malapposed struts were reduced in both SES and PES, while the neointimal hyperplasia and qualitative changes showed different patterns.

Topics: Acute Coronary Syndrome; Aged; Antineoplastic Agents; Cohort Studies; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Disease Progression; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Sirolimus; Tomography, Optical Coherence

The SYNTAX score has been proposed as a valuable tool to characterise coronary anatomy prospectively based on its complexity. This study evaluated the prognostic value on adverse outcomes of the residual SYNTAX score (rSS) in patients with complex lesions treated with an everolimus-eluting stent (EES).. One thousand eight hundred and fifty-one patients with small vessel (reference diameter <2.75 mm), long lesion (length >25 mm), or multivessel (>2 target vessels) disease who underwent percutaneous coronary intervention (PCI) with EES in the prospective SEEDS (A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization) trial were categorised into low (<6), mid (>6-<12) and high (>12) baseline SYNTAX score (bSS) groups, and into low (=0), mid (>0-<5) and high (>5) rSS groups. Mean bSS and rSS were 10.87±7.26 and 2.18±3.97, respectively; 64% of patients had complete revascularisation (rSS=0). At 12 months the primary outcome of ischaemia-driven target vessel failure (TVF, composite of cardiac death, target vessel myocardial infarction and ischaemia-driven target vessel revascularisation) was significantly higher in the high bSS and rSS groups than in the respective lower groups (p<0.01 for both). In multivariable analysis, rSS was an independent predictor of TVF (hazard ratio: 1.403, 95% confidence interval: 1.081 to 1.820, p=0.01).. Twelve-month TVF was significantly higher in the highest rSS group; rSS with a cut-off of 5 might therefore allow the risk stratification of patients with complex lesions treated with a second-generation drug-eluting stent (Clinical-Trials.gov identifier: NCT 01157455).

Topics: Aged; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prognosis; Prospective Studies; Reproducibility of Results; Sirolimus; Treatment Outcome

Recent technological developments have led to the development of Absorb™ bioresorbable vascular scaffold (BVS) [Abbott Vascular, Santa Clara, USA] for percutaneous treatment of coronary artery disease by percutaneous coronary intervention (PCI). The BVS is now approved for use in many countries but experience in bifurcation lesions is limited and largely unreported and concerns still exist about its use across major side branches. We report for the first time, the successful use of the "T and Protrusion" (TAP) technique of deploying BVS into the side branch (SB) through the struts of main branch (MB) BVS to salvage a suboptimal result and threatened closure of a SB in three cases when treating bifurcation lesions with a planned single BVS strategy. The TAP technique was successful in all cases and there were no complications. All patients continue to do well at short-term follow-up. This case report provides information regarding the feasibility as well as technical and procedural insights when using BVS for bifurcation lesions.

Topics: Absorbable Implants; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Tissue Scaffolds

This study aimed to assess the long-term safety and clinical effectiveness of the Xience V everolimus-eluting stent (EES) compared to both Taxus paclitaxel-eluting stent (PES) and Cypher sirolimus-eluting stent (SES) in an unselected patient population.. There are limited long-term data comparing Xience V EES vs the first-generation Cypher SES.. This retrospective analysis included 6069 patients treated with Cypher SES, Taxus PES, or Xience V EES from 2003-2009 at our institution. Patients were followed by telephone contact or office visit up to 2 years after the index procedure.. Baseline characteristics were generally comparable, with the exception of a significantly higher prevalence of diabetes mellitus, systemic hypertension, history of angioplasty, and coronary bypass surgery among Xience V EES patients. At 2 years, the incidence of major adverse cardiovascular events was 13.3% (Xience V EES) vs 17.8% (Cypher SES) vs 22% (Taxus PES) (P<.001). The main drivers for the differences in event rates were lower mortality, the need for target vessel revascularization, and Q-wave myocardial infarction. Stent thrombosis was lowest in Xience V EES patients (0.2% vs 1.2% SES vs 0.7% PES, respectively; P=.01). A landmark analysis after 1 year showed that the benefits of Xience V EES continued in long-term follow-up.. In a contemporary clinical United States practice with an unselected patient population, Xience V EES use was associated with improved safety profile and reduction of all-cause mortality and stent thrombosis when compared to both first-generation drug-eluting stents. This superiority continues to widen from 1 to 2 years.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Postoperative Complications; Retrospective Studies; Sirolimus; Treatment Outcome

A left main stem bifurcation lesion (Medina 1,0,0) treated with a single Axxess stent through radial access is presented. Although the use of this stent in left main stenosis is off label, in selected cases it may simplify the technique, avoiding the use of additional overlapping stents and ensuring the bifurcation coverage with minimal amount of metal at the carina.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Echocardiography; Humans; Male; Radial Artery; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Angina Pectoris; Coronary Angiography; Coronary Occlusion; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Male; Middle Aged; Recurrence; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence

Topics: Cardiovascular Agents; Coronary Stenosis; Coronary Vessels; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus; Tomography, Optical Coherence

Premature antiplatelet therapy discontinuation (ATD) after drug-eluting stent (DES) implantation is known to predict stent thrombosis (ST). However, recent data suggest that a shorter antiplatelet therapy duration is safe with newer generation DESs. The study aimed to compare the impact of early and late clopidogrel ATDs on ST in a real-world registry of first- and second-generation DES use. A total of 6,236 patients who underwent DES implantation were analyzed retrospectively: 4,217 received first-generation DESs (sirolimus- and paclitaxel-eluting stents) and 2,019 received second-generation DESs (everolimus-eluting stents). Within each DES cohort, patients were categorized into timing of clopidogrel discontinuation within 1 year: early (<3 months), late (3 to 12 months), and continued. ST rates and clinical outcomes at 1 year were analyzed. There were 341 patients (8.1%) in the first-generation DES group and 126 patients (6.2%) in the second-generation DES group who discontinued clopidogrel within the first year. Definite and probable ST rates were 3.8% for early ATD, 2.5% for late ATD, and 0.5% for continued (p = 0.001) in the first-generation DES cohort, whereas there were no definite or probable ST events in early and late ATDs and 0.5% for continued in the second-generation DES cohort. Major adverse cardiac event rates were 9.9% for early ATD, 5.6% for late ATD, and 0.9% for continued (p <0.001) in the first-generation DES cohort and 5.5% for early ATD, 7.4% for late ATD, and 1.5% for continued (p <0.001) in the second-generation DES cohort. In conclusion, ATD within the first year is associated with increased ST events with first-generation DESs, whereas ATD appears safe with second-generation DESs with regard to ST. However, ATD is associated with greater mortality and major adverse cardiac events in both first- and second-generation DESs. Thus, this study supports ATD if required based on physician discretion with the use of second-generation DESs but cannot rule out potential benefit for longer duration of dual antiplatelet therapy even when second-generation DESs are used.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Clopidogrel; Cohort Studies; Combined Modality Therapy; Coronary Angiography; Coronary Stenosis; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Graft Occlusion, Vascular; Hospital Mortality; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Failure; Registries; Retrospective Studies; Severity of Illness Index; Sirolimus; Survival Analysis; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome; Withholding Treatment

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus

Topics: Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Sirolimus

We sought to perform a propensity score-matched lesion-based comparison of mid-term angiographic outcomes of sirolimus- (SES, Cypher Bx Velocity) and paclitaxel- (PES, TAXUS Liberté, the 2nd-generation TAXUS) eluting stents to treat de novo coronary stenosis and, particularly, in patients with diabetes mellitus (DM) in a daily practice environment.. The present study was a non-randomized, retrospective, lesion-based, single center study that included 1,287 de novo native coronary stenosis cases after successful SES or PES placement between February 2007 and April 2011. The primary endpoint was angiographic-based binary in-stent restenosis (% diameter stenosis >50 at secondary angiogram) within 550 days of placement. A propensity score-matched analysis was used to adjust the baselines.. Among 360 baseline-adjusted angiographic lesions followed up in each arm, the incidence of the primary endpoint in the PES group (11.7%, follow-up period: 350±76 days) was not significantly different from that in the SES group (10.3%, p=0.645, 354±81 days, p=0.912). PES was not associated with the primary endpoint by logistic regression analysis (odds ratio: 1.15, 95% confidence interval: 0.68-1.93, p=0.605). In the DM specific sub-analysis, the primary endpoint in the PES group (19.6%) was not significantly different from that in the SES group (12.8%, p=0.105) in 148 baseline-adjusted lesions in each arm.. The mid-term angiographic outcomes after TAXUS Liberté placement for all-comer de novo native coronary stenosis and in patients with DM were not significantly different from those of SES in a Japanese daily practice environment.

Topics: Aged; Antineoplastic Agents; Coronary Angiography; Coronary Stenosis; Diabetes Complications; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Propensity Score; Retrospective Studies; Sirolimus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Male; Metals; Paclitaxel; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Image Interpretation, Computer-Assisted; Imaging, Three-Dimensional; Predictive Value of Tests; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Although percutaneous coronary intervention with everolimus-eluting stent (EES) implantation for native coronary artery disease has favorable results compared to first-generation drug-eluting stents, outcomes with EES for the treatment of in-stent restenosis (ISR) are unknown.. The Xience V USA is a prospective multicenter registry evaluating outcomes in patients treated with EES. Here, we present the 12-month clinical outcomes in patients who received EES for the treatment of ISR and non-ISR. The primary outcome was the composite of target lesion failure (cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization). Secondary outcomes were MI, target lesion revascularization (TLR), and stent thrombosis (ST).. In this registry, a total of 383 patients (64.4 ± 11.4 years; 68.4% male) received revascularization for single-vessel ISR and 4832 patients (64.4 ± 11.0 years; 69.0% male) received revascularization for non-ISR lesions. At 1 year, target lesion failure was 10.9% in the ISR group and 4.9% in the non-ISR group. MI, TLR, and definite ST rates were higher in the ISR group (MI, 2.2% ISR group and 1.6% non-ISR group; TLR, 10.3% ISR group and 2.9% non-ISR group; definite/probable ST, 1.98% ISR group and 0.36% non-ISR group). However, these differences ceased to exist when case-control matched patients in the non-ISR group were studied (target lesion failure, 8.8% ISR vs 7.4% non-ISR; cardiac death or MI, 2.7% ISR vs 1.4% non-ISR; TLR, 7.8% ISR vs 7.1% non-ISR; and definite/probable ST, 1.03% ISR vs 0.69% non-ISR).. The treatment of ISR with EES appears to be safe and efficacious at 1 year. Compared to the non-ISR group, target lesion failure was much higher, indicating a higher risk profile of these patients. However, these differences ceased to exist with case-controlled matching.

Topics: Adult; Aged; Aged, 80 and over; Case-Control Studies; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States

Limited data exist on contemporary sex-related differences in long-term outcomes of coronary patients receiving drug-eluting stents. In this study we evaluate differences for males (M) and females (F) in 2-year target lesion failure (TLF) in an unselected consecutive series of patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) at a tertiary medical center.. Data on 348 consecutive patients (M 221, F 127) stented with EES and PES were retrospectively analyzed. The primary end point of the study was to compare sex-related outcomes in TLF, defined as the combined end point of cardiac death, nonfatal myocardial infarction, and target lesion revascularization (TLR). Secondary end points included TLR, target vessel failure, target vessel revascularization, acute stent thrombosis as defined by the Academic Research Consortium, and cardiac death. The cineangiograms of the first consecutive 162 patients (M 105, F 57) were independently reviewed by a cardiologist blinded to clinical outcome, and SYNTAX scoring was performed. Follow-up was achieved using medical records and/or phone calls and was censored at 2 years. Descriptive analysis was performed on all variables. Univariate analysis compared the M and F cohorts. Multivariate analysis using Cox regression was performed to determine independent predictors of TLF with time, including sex as an independent variable in the model.. M had more prior percutaneous coronary interventions and restenotic lesions and a higher prevalence of smoking. They also had longer length of disease and received more stents than F. F were older and had a higher prevalence of prior stroke. Angiographic complexity was not statistically different between the two groups, as judged by SYNTAX scoring (M 20.8±13.8, F 19.7±13.9, P=0.650). At 2-year follow-up, TLF was 27.4% and 24.8% (P=0.614) with no statistical difference between TLR (23.3% versus [vs] 21.6%), cardiac death (2.8% vs 3.2%), and definite and probable stent thrombosis (2.3% vs 0.0%) in M and F, respectively. Cox regression analysis using backward elimination showed that the number of stents per patient was the only independent predictor of TLF with time (hazard ratio 1.201, 95% confidence interval 1.126-1.280, P=0.001).. In this cohort of patients receiving EES and PES, M and F did not have statistically different outcomes at 2-year follow-up, consistent with recent reports in the current era of percutaneous coronary interventions.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Iowa; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Sex Factors; Sirolimus; Tertiary Care Centers; Time Factors; Treatment Outcome

We propose a modified simultaneous kissing stenting technique (MSKS) based on systematic implantation of a protective stent in the proximal main vessel (PMV) proximally to the bifurcation before simultaneous kissing stenting (SKS).. SKS has been proposed in large-size coronary vessel bifurcation lesions (BLs) when the PMV can accommodate two stents. SKS implies, however, low-pressure simultaneous final balloon inflations to avoid retrograde PMV dissection or rupture and therefore may not ensure optimal final stent apposition.. From January 2005 to May 2008, a total of 97 patients with 100 BLs (true bifurcation in 92%) who underwent MSKS were enrolled in a prospective registry. Drug-eluting stents were used for distal main vessel and side branch. Drug-eluting or large-size bare-metal stents were used as proximal protective stents.. Immediate procedural success rate was 100%. Global restenosis rate was 10% (5% in the main vessel and 8% in the side branch) at follow-up angiogram performed at 7 months in all patients (100%). No patient had early or late stent thrombosis. Two cases of non-fatal very late stent thrombosis occurred at 46 and 64 months. Over a mean 4.5-year follow-up period, target lesion revascularization rate was 11%, with only 3% driven by clinical ischemia.. Protective stent systematic implantation in the PMV represents a newly modified SKS technique that allows safe finalization of the procedure by high-pressure kissing balloon final inflation, ensuring optimal stent apposition with high immediate procedural success and low rates of long-term events.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Male; Metals; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

The aim of this study is to compare clinical outcomes for seven years, between sirolimus-eluting stent (SES) and bare metal stent (BMS). During the BMS and drug-eluting stent (DES) transition period (from April 2002 to April 2004), 434 consecutive patients with 482 lesions underwent percutaneous coronary intervention, using BMS or SES. Using propensity score matching, 186 patients with BMS and 166 patients with SES were selected. Seven year clinical outcomes of major adverse cardiac events (MACE), such as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization (TVR), and angiographic definite stent thrombosis (ST) were compared. At one-year follow up, patients with SES showed significantly lower MACE (9.1% in BMS vs 3.0% in SES, P = 0.024). However, cumulative MACE for 7 yr was not significantly different between two groups (24.7% in BMS vs 17.4% in SES, P = 0.155). There was no significant difference in MI, TVR, death and ST. The TVR were gradually increased from 1 to 7 yr in SES, on the contrary to that of BMS. In conclusion, although SES showed better clinical outcomes in the early period after implantation, it did not show significant benefits in the long-term follow up, compared with that of BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Databases, Factual; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Registries; Sirolimus; Stents; Thrombosis

Topics: Adult; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Male; Prosthesis Design; Prosthesis Failure; Sirolimus; Stress, Mechanical; Treatment Outcome; Ultrasonography, Interventional

Second-generation everolimus-eluting stents (EESs) have demonstrated superiority in efficacy and safety compared with first-generation drug-eluting stents (DESs) in the treatment of native coronary artery lesions. The present study evaluated and compared the safety and efficacy of EESs and first-generation DESs in saphenous vein graft lesions. The EES group consisted of 88 patients with 96 lesions, and the first-generation DES group consisted of 243 patients with 317 lesions (sirolimus-eluting stents, n = 212; paclitaxel-eluting stents, n = 105). The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (composite of all-cause death, myocardial infarction, and target vessel revascularization), and definite stent thrombosis at 2 years. The groups had similar baseline characteristics and graft ages (128.1 ± 77.5 vs 132.4 ± 90.8 months, p = 0.686). The EES group had more type C lesions and less embolic protection device use. The peak postprocedure values of creatinine kinase-MB and troponin I were similar between the 2 groups. Overall, major adverse cardiovascular events occurred in 18.2% of EES patients and 35.0% of first-generation DES patients (p = 0.003), mainly driven by a lower target vessel revascularization rate (6.8% vs 24.5%, p <0.001). The target lesion revascularization rate was lower in the EES group (1.1% vs 11.6%, p = 0.005). Stent thrombosis was low and similar between the 2 groups (0% vs 0.8%, p = 1.000). On multivariate analysis, the type of DES implanted and graft age were the only independent predictors of major adverse cardiovascular events. In conclusion, the superiority of EESs compared with first-generation DESs shown in native artery lesions has been extended to saphenous vein graft lesions and should be considered as the DES of choice for this lesion type.

Topics: Aged; Biomarkers; Coronary Stenosis; Drug-Eluting Stents; Electrocardiography; Everolimus; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Proportional Hazards Models; Retrospective Studies; Saphenous Vein; Sirolimus; Treatment Outcome

Data concerning the results of 2nd generation DES in the treatment of unprotected left main coronary artery (ULMCA) stenosis are limited. The aim of this study was to evaluate the efficacy and safety of stenting with everolimus- (EES) with sirolimus-eluting stent (SES) for the treatment of ULMCA stenosis in the "real world" setting.. In this multi-center all-comer registry, a total of 275 patients with ULMCA stenosis were analyzed; 160 receiving EES and 115 receiving SES. The primary endpoint was major adverse cardiac events (MACE), defined as death, myocardial infarction, and ischemia-driven target vessel revascularization at 1 year.. Baseline characteristics were similar between the two stent groups. At 1 year, the rate of MACE was comparable between the two groups (7.5% for EES vs. 13.9% for SES, HR: 0.55 [0.26-1.17], p = 0.117). However, after multivariable or propensity score adjustment, the risk of MACE was significantly lower for EES compared with that for SES (multivariable adjusted HR: 0.42 [0.19-0.92], p = 0.030; propensity score-adjusted HR: 0.43 [0.20-0.95], p = 0.037). These results were mainly driven from the numerically lower rate of repeat revascularization in the EES group (2.5% for EES vs. 7.0% for SES, p = 0.096). As for hard endpoint (death or myocardial infarction) and stent thrombosis, no differences were found between the 2 groups.. In a large cohort of patients receiving ULMCA stenting, the MACE rate was numerically lower in the EES compared with that in the SES (statistically significant only after adjustment), which was mainly driven by significantly lower rates of repeat revascularization.

Topics: Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Registries; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Antineoplastic Agents; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Polymers; Sirolimus

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Metals; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Stents

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Aged; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Prosthesis Failure; Sirolimus; Tomography, Optical Coherence

Long-term clinical outcomes were evaluated in long coronary artery stenosis treated with different types of drug-eluting stents.. Long-term follow-up data to compare clinical outcomes between Resolute™ zotarolimus-eluting stent (R-ZES) versus sirolimus-eluting stent (SES) implantation for long coronary artery stenosis is insufficient.. A total of 254 patients (307 lesions) treated with R-ZES and 265 patients (303 lesions) treated with SES for long coronary lesions (total stent length ≥ 30 mm) were enrolled, and long-term (3 years) clinical outcomes were compared between the 2 groups. Efficacy (target lesion revascularization [TLR]) and safety (the composite occurrence of cardiovascular death, target lesion-related myocardial infarction, or target lesion-related definite stent thrombosis) were assessed.. The 2 groups had similar baseline characteristics except for the duration of dual antiplatelet therapy (23.4 ± 11.2 months in R-ZES-treated patients vs. 27.4 ± 13.9 months in SES-treated patients, P<0.001). Total stent length was similar in R-ZES-treated patients (45.0 ± 19.0 mm) and SES-treated patients (45.4 ± 18.6 mm) (P=0.464). The cumulative TLR rate was 4.6% in R-ZES-treated patients versus 4.6% in SES-treated patients (P=0.911). For safety parameters, R-ZES-treated patients showed a significantly lower rate of the composite occurrence of cardiovascular death, target lesion-related myocardial infarction, or target lesion-related definite stent thrombosis than SES-treated patients (0.4% vs. 2.4%, P=0.042). Particularly, the occurrence of target lesion-related definite stent thrombosis was significantly lower in R-ZES-treated patients than in SES-treated patients (0.0% vs. 2.0%, P=0.028).. R-ZES stents showed superior long-term safety than SES for treating long coronary lesions, while maintaining a similar clinical efficacy.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Design; Prosthesis Implantation; Sirolimus; Treatment Outcome

Previous research suggests that the early benefit from revascularization with drug-eluting stents might diminish over time.. We performed an extended analysis of a previously identified cohort of 6440 patients who underwent percutaneous coronary intervention between April 1, 2003 and March 31, 2005 using a prospective provincial clinical registry in Alberta, Canada. We compared rates of death, and of death or repeat revascularization among the 6440 patients receiving either drug-eluting (sirolimus- and paclitaxel) stents or bare-metal stents. We determined risk-adjusted hazard ratios at moments in time with a spline analysis using Cox proportional hazards modelling.. During the 8 years of observation, the relative risks for death or the composite outcome of death or repeat revascularization varied over time. There was an early finding of better outcomes associated with drug-eluting stents in the first year after implantation. Thereafter, there was no significant benefit associated with drug-eluting stents compared with bare-metal stents with 8 years of follow-up. At 30 days, the adjusted hazard ratio was 0.38 (95% confidence interval [CI], 0.18-0.81) for death and 0.27 (95% CI, 0.14-0.54) for the composite outcome of death or repeat revascularization. By 8 years, the adjusted hazard ratio of death or the composite outcome was 1.15 (95% CI, 0.97-1.36) and 1.01 (95% CI, 0.87-1.17), respectively.. Revascularization with first-generation drug-eluting stents is associated with better outcomes within the first year only. Thereafter, the risk of death or repeat revascularization is similar between drug-eluting stents and bare-metal stents.

Topics: Acute Coronary Syndrome; Aged; Alberta; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Patient Outcome Assessment; Propensity Score; Proportional Hazards Models; Prospective Studies; Registries; Risk; Sirolimus; Stents; Survival Rate; Time Factors

New generation DES are effectively used in all spectrum of coronary artery diseases (CAD) and are replacing earlier DES and BMS. Biolimus A9™-eluting stent is a new generation DES containing the anti-proliferative drug biolimus A9™ incorporating a biodegradable abluminal coating that leaves a polymer-free stent after drug release enhancing strut coverage while preventing neointimal hyperplasia. A retrospective data analysis was done in patients treated with DES, with a major share of Biolimus A9™ (BA9™) drug-eluting stents (DES) at Bombay Hospital, Mumbai. A total of 158 patients with 219 lesions were treated with DES, comprising Biolimus A9-eluting stent and others and the major adverse cardiac events (MACE) rate and stent thrombosis (ST) at 1, 6, 12 months and 24 months were analyzed. Mace rate was 3.16% for average follow-up of 19 months. There were 3 cases of ST (2 of acute and 1 of subacute onset) and one non-cardiac death reported during this time. This retrospective data demonstrates good one- and two-year clinical safety and efficacy of DES, especially of BioMatrix stents in real world setting.

Topics: Absorbable Implants; Adult; Age Factors; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cause of Death; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; India; Male; Middle Aged; Myocardial Infarction; Polymers; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sex Factors; Sirolimus; Survival Rate; Treatment Outcome; Young Adult

Drug-eluting stents (DES) are more effective in reducing restenosis than bare-metal stents. Less certain is the relative performance of the two widely used DES-sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)-in diabetic patients undergoing percutaneous coronary intervention (PCI).. We studied the long-term effectiveness and safety of SES versus PES in diabetic patients, overall and grouped by the size of the stent placed in the native-stented vessel.. Data were obtained from an observational, multicenter registry of 2,429 consecutive patients with DM who underwent PCI between August 2003 and August 2009 with SES (n = 1,370) or PES (n = 1,059). Data were analyzed separately for patients with small stents (<3.0 mm, n = 1,274) vs. only large (≥3.0 mm, n = 1,155).. At Cox-adjusted analysis of the overall cohort, there was no significant difference between SES and PES with regard to death/myocardial infarction (D/MI) (P = 0.6) or target lesion revascularization (TLR) (P = 0.3) either in "small-stent" (D/MI, P = 0.8; TLR, P = 0.2) or "large stent" group (D/MI, P = 0.8; TLR, P = 0.4) throughout 1 to 5-year follow-up. These results were confirmed by sensitivity, propensity-score matched analysis (717 matched pairs) that failed to find differences in the safety and efficacy between SES and PES.. In this large observational study, PES and SES were equally safe and efficacious in diabetic patients undergoing PCI in clinical practice, regardless of the stent size.

Topics: Aged; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Patient Safety; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Registries; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

Our aim was to compare the outcomes of a same versus different drug-eluting stent (DES) implantation strategy for the treatment of DES instent restenosis (ISR).. The absence of clear data renders the treatment of DES ISR one of the most challenging situations in interventional cardiology.. We identified all cases of DES ISR treated with a second DES between January 2004 and January 2009. The lesions were divided into those treated with the same DES as the initial one that restenosed and those treated with a different DES. The main end-point was repeat target lesion revascularization (TLR).. We included 116 patients with a total of 132 lesions. The patient population was highly complex: 55.5% with diabetes, 56% with type-C lesions, 15.9% with lesions previously stented with BMS and 18.2% with fluoroscopic evidence of stent fracture. A same and different stent strategy was conducted in 41 lesions (31%) and 91 lesions (69%), respectively. Overall TLR was 31.1% and occurred in 46.3% of patients treated with the same stent and 24.4% of those with a different stent (P = 0.012). Multivariable analysis found same stent strategy (OR 2.84, 95%CI 1.23-6.57;P = 0.014) and occurrence of stent fracture (OR 4.03, 95%CI 1.33-12.01;P = 0.012) to be the only independent predictors of TLR after a median follow-up of 20.4 [12.1-30.2] months.. In highly complex lesions, DES implantation for DES ISR is linked to a high need of future revascularization. An association between implanting a DES type other than the original and lower rate of TLR is suggested.

Topics: Aged; Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Ontario; Paclitaxel; Patient Selection; Prosthesis Failure; Registries; Retreatment; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Analysis; Treatment Outcome

We evaluated, using quantitative coronary angiography, the natural history of change that occurred in target lesions after successful sirolimus-eluting stent (SES) implantation.. Percutaneous coronary intervention with drug-eluting stents (DES) has significantly reduced the rate of repeated target lesion revascularization. However, early studies have raised concerns regarding the "late catch-up" phenomenon of DES.. Between June 2004 and March 2007, consecutive 217 patients with 306 lesions without restenosis at early angiographic follow-up underwent late angiographic follow-up (early follow-up: 11.2 ± 2.1 months and late follow-up: 29.4 ± 5.2 months). Predictors of late catch-up were identified with univariate and multivariate regression analyses.. Although reference vessel diameter did not significantly change during follow-up [3.15 mm (interquartile range (IQR): 2.81-3.49 mm), 3.12 mm (IQR: 2.79-3.47 mm), and 3.08 mm (IQR: 2.76-3.46 mm) at postprocedure, and early and late angiographic follow-up, respectively; P = 0.2653], late loss (LL) significantly increased during follow-up [0.05 mm (IQR: 0.00-0.13 mm) and 0.08 mm (IQR: 0.01-0.19 mm) at early and late follow-up, respectively; P < 0.0001]. Univariate analysis showed previous intervention, adjunctive use of cutting balloon, lesion length, and progression of MLD, LL, %DS at early follow-up as predictors of late catch-up. Multivariate regression analysis identified %DS at early follow-up as a predictor of late catch-up (OR 1.076, CI 1.039-1.114, P < 0.0001).. Significant and continuous progression of neointima after SES implantation was observed in the present study. Larger LL may be a sign of late catch-up phenomenon.

Topics: Aged; Analysis of Variance; Cohort Studies; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Exercise Test; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Monitoring, Physiologic; Multivariate Analysis; Prosthesis Failure; Regression Analysis; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Analysis; Time Factors; Treatment Outcome

Drug-eluting stents (DES) have significantly improved the rate of target vessel revascularization in comparison with bare metal stents. DES fracture was not reported in multicenter randomized clinical trials, but several case reports of DES fracture have been published, mostly with sirolimus-eluting stents. DES fracture is associated with stent restenosis and thrombosis. We report a zotarolimus-eluting stent fracture in an aortocoronary saphenous vein graft (SVG) bypass. The patient presented with chest pain and a non-ST-elevation myocardial infarction. He underwent cardiac catheterization that showed a complete fracture of a zotarolimus-eluting stent in the ostium of a sequential SVG to the diagonal and obtuse coronary arteries. His management included coronary angioplasty and retrieval of the proximal fractured segment. We discuss the potential causes for this stent fracture and suggest caution when using a DES in an ostial location of a SVG bypass, especially in a highly mobile vessel.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Humans; Male; Myocardial Infarction; Prosthesis Failure; Retreatment; Risk Assessment; Saphenous Vein; Severity of Illness Index; Sirolimus; Treatment Outcome

We evaluated healing responses with optical coherence tomography (OCT), and clinical and angiographic outcome after bifurcation stenting with the TRYTON Side-Branch Stent™.. Dedicated bifurcation stents have been proposed as a potential alternative for treatment of true coronary bifurcation lesions.. We treated 20 consecutive patients with coronary bifurcation lesions and significant involvement of the side-branch (SB) with the TRYTON Stent and an additional XIENCE-V™ everolimus-eluting stent. At 9 months, we assessed the ratio of uncovered to total stent struts (RUTSS) with OCT, angiographic late luminal loss (LLL), and in-stent and in-segment restenosis. Clinical endpoints at 1 year included major adverse cardiac events (MACE) and their components [target lesion revascularization (TLR), myocardial infarction (MI), and cardiac death].. LLL (N = 16) was 0.34 (0.17-0.46), 0.29 (0.24-0.48) and 0.57 (0.29-0.73) mm in the proximal main vessel (MV), distal MV and SB, respectively. In-bifurcation binary in-stent restenosis occurred in four patients (25%), in-segment restenosis in five (31.25%). The RUTSS (N = 13) was 4.0 ± 5.8, 0.7 ± 1.3, 0, and 2.5 ± 3.6% in the proximal MV, distal MV, SB, and polygon of confluence, respectively. At 1 year, MACE occurred in 5 (25%) [4 TLR (20%), 3 MI (15%)].. The homogeneous stent strut coverage and the low LLL in the MV reflect proper healing characteristics of the TRYTON Stent in combination with the XIENCE-V™ stent. However, proximal MV edge and ostial SB restenoses together with overall clinical outcomes do not fulfill expectations of a dedicated bifurcation stent. © 2012 Wiley Periodicals, Inc.

Topics: Aged; Antineoplastic Agents; Coronary Angiography; Coronary Circulation; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Myocardial Revascularization; Prospective Studies; Prosthesis Design; Regional Blood Flow; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Despite the wide use of everolimus as an antineoplastic coating agent for coronary stents to reduce the rate of restenosis, little is known about the health hazards of everolimus-eluting stents (EES). We describe a case of pneumonitis that developed 2 months after EES implantation for angina. Lung pathology demonstrated an organizing pneumonia pattern that responded to corticosteroid therapy. Although the efficacy of EES for ischemic heart disease is well established, EES carries a risk of pneumonitis.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Male; Paclitaxel; Pneumonia; Prednisolone; Radiography, Thoracic; Retreatment; Risk Assessment; Sirolimus; Tomography, X-Ray Computed; Treatment Outcome

The purpose of this study was to examine the angiographic and clinical results of stent full metal jacket in treating long lesions using everolimus-eluting stents (EES).. Data are lacking regarding the use of EES for this lesion subgroup.. From 2007 to 2011, 77 symptomatic patients who had severe coronary stenoses necessitating implantation of stents with total length longer than 60 mm were treated with overlapping EES.. The mean age of patient was 61 ± 11 years with male predominance (66%). Diabetes mellitus was seen in 35 (45.5%) patients. Majority of patients had class III angina with normal heart function. On average, 3.1 stents were implanted per lesion; the mean stent size and length were 2.70 ± 0.28 mm and 82 ± 16 mm. Restudy angiography was performed on 71 patients (72 lesions) at 8.9 ± 2.5 months. Angiographic restenosis was seen in 9 (12.5%) lesions; the lesion length and late loss were 67 ± 15 mm and 0.4 ± 0.6 mm, respectively. The use of intravascular ultrasound has been found to be a predictor of less restenosis (P = 0.02; HR: 0.02; CI: 0.01-0.59). The in-hospital and 1 year major adverse cardiac event rates were 7.8% and 13%. The annual cardiac death rates were 2.6%, 3.4%, and 5.3% in the first 3 years.. The use of EES full metal jacket for long lesions is only associated with good short-term clinical and angiographic outcomes. Long-term follow-up has revealed a high cardiac death rate which may necessitate prolongation of dual antiplatelet therapy.

Topics: Cardiotonic Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Sirolimus

We hypothesized that the tissue components of in-stent restenosis (ISR) might differ between drug-eluting stents (DES) and bare-metal stents (BMS) and that these differences could be distinguished by qualitative and quantitative optical coherence tomography (OCT) analyses.. One-hundred and twenty-two initial ISR lesions (sirolimus-eluting stents: n=28; paclitaxel-eluting stents: n=51; BMS: n=43) were evaluated with OCT. Based on their OCT appearance, the lesions were classified as homogeneous, layered or heterogeneous. The optical properties of backscatter, attenuation and signal intensity of the neointimal tissue (NIT) were quantified. To evaluate the vascular response after balloon angioplasty (BA), the rate of reduction of the NIT area (NITA) was calculated (NITA before - after BA/NITA before BA at the minimum lumen cross-sectional area). Among the morphologic OCT patterns, the layered type was predominant with DES, whereas lesions were homogeneous with BMS (P<0.001). Backscatter and signal intensity were significantly higher with BMS (P<0.05 and P<0.001 respectively). The NITA reduction rate was significantly greater in the layered and heterogeneous groups than in the homogeneous group (P<0.01).. The morphologic OCT patterns of the NIT in ISR differed significantly between DES and BMS, probably reflecting pathologic differences. Layered and heterogeneous tissues might respond better than homogeneous tissue to simple balloon dilatation, suggesting a possible direction for OCT-based ISR treatment strategies. 

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Metals; Middle Aged; Neointima; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Humans; Male; Middle Aged; Prosthesis Failure; Retreatment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence

Topics: Carbon; Carbon Compounds, Inorganic; Chromium Alloys; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Radiography; Silicon Compounds; Sirolimus; Stents

To report the four-month and nine-month angiographic results as well as one-year clinical follow-up from the first-in-man study with the silicon carbide and sirolimus-eluting bioabsorbable polymer (poly-L-lactic acid (PLLA) polymer) -coated cobalt-chromium Orsiro stent.. A group of 30 patients with documented myocardial ischaemia related to a single de novo coronary stenosis up to 22 mm in length, in vessels with a 2.5 to 3.5 mm reference diameter, and between >50% and <90% diameter stenosis were enrolled at two sites. The primary endpoint of the study was in-stent late lumen loss at nine months. The secondary endpoints included major adverse cardiac events (MACE) at one year defined as the composite of cardiac death, ischaemia-driven target lesion revascularisation (TLR) and target vessel myocardial infarction (MI). Procedural success was 100%. Angiographic late lumen loss was 0.12±0.19 mm and 0.05±0.22 mm at four and nine months respectively. At one-year clinical follow-up, the composite MACE was 10% with one patient who died from cardiac death and two patients who had ischaemia-driven target lesion revascularisation. There was no report of MI or stent thrombosis.. The Orsiro drug-eluting stent demonstrated potency with low rates of in-stent neointimal hyperplasia and cardiovascular events but warrants further evaluation in a larger population cohort with longer follow-up time points.

Topics: Aged; Carbon Compounds, Inorganic; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hyperplasia; Incidence; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Silicon Compounds; Sirolimus; Treatment Outcome

The pathogenesis of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains unclear. The purpose of this study is to analyse tissue characterizations of neointima in restenosis lesions after sirolimus-eluting stent (SES), comparing with those after bare metal stent (BMS) using integrated backscatter intravascular ultrasound (IB-IVUS).. A total of 54 consecutive patients who had ISR lesions after SES (n = 20) or BMS (n = 34) implantation were enrolled. For tissue characterization of neointima, IB-IVUS was performed by cross-sectional (at the minimum lumen area) and volumetric (within the stented segment) analyses. In addition, angiographic patterns of restenosis were evaluated with division into focal and diffuse. The focal angiographic pattern of restenosis was predominantly observed in the SES group (SES vs. BMS; 80.0 vs. 26.5%; P = 0.0001), whereas the diffuse pattern was more common in the BMS group (SES vs. BMS; 20.0 vs. 73.5%; P = 0.0001). On both cross-sectional and volumetric IB-IVUS analyses, the neointimal tissue in restenosis lesions after SES implantation had a significantly larger percentage of lipid tissue (cross-sectional: 23.3 ± 12.7 vs. 15.7 ± 11.9%; P = 0.033; volumetric: 22.8 ± 10.4 vs. 16.3 ± 7.0%; P = 0.008) and a significantly smaller percentage of fibrous tissue compared with that after BMS implantation (cross-sectional: 73.6 ± 11.6 vs. 82.0 ± 11.2%; P = 0.011, volumetric: 73.8 ± 9.5 vs. 80.5 ± 6.7%; P = 0.004).. This IB-IVUS study indicates that larger amounts of lipid tissue are present in neointima of SES when compared with BMS, suggesting that neoatherosclerosis may in part be responsible for ISR after SES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Neointima; Prospective Studies; Prosthesis Design; Prosthesis Failure; Retreatment; Sirolimus; Stents; Ultrasonography, Interventional

In order to confirm the relation between stent struts and the jailed side branch (SB), the actual wire re-crossing position and the optimal wire re-crossing position during a bifurcation stenting, we developed the instant stent-accentuated three-dimensional optical coherence tomography (iSA 3D-OCT) system based on a novel algorithm. Stent struts in two-dimensional optical coherence tomography (2D-OCT) are represented as high-intensity line segments or spots in low-intensity background. Stent struts disappear and a vessel image is created by the mean filter followed by the minimum filter. A strut image is created by subtracting a vessel image from an original image, and accentuated. By adding a vessel image to a strut image, iSA 2D-OCT is created. It took only 3 s to accentuate stent struts of 100 frames by ImageJ with its macro program. By the iSA 3D-OCT system which consists of the console of OCT, the USB selector, USB cables, the USB flash drive, the computer, and three freeware programs, it took about 65 s from an export of the image data to an observation of iSA 3D-OCT semi-automatically. During a bifurcation stenting procedure, we could confirm the relation between stent struts and the jailed SB, the actual wire re-crossing position and the optimal wire re-crossing position. Using the iSA 3D-OCT system, a detailed process during a bifurcation PCI can be observed in very short waiting time, about 65 s. It is expected to improve the outcome of a complicated bifurcation PCI by the iSA 3D-OCT system.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Humans; Imaging, Three-Dimensional; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Design; Sirolimus; Tomography, Optical Coherence

Topics: Angina, Unstable; Angioplasty, Balloon, Coronary; Automation; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Imaging, Three-Dimensional; Male; Middle Aged; Retreatment; Risk Assessment; Severity of Illness Index; Sirolimus; Tomography, Optical Coherence; Treatment Failure; Treatment Outcome; Vascular Patency

The bioresorbable vascular stent (BVS) is totally translucent and radiolucent, leading to challenges when using conventional invasive imaging modalities. Agreement between quantitative coronary angiography (QCA), intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in the BVS is unknown. Forty five patients enrolled in the ABSORB cohort B1 study underwent coronary angiography, IVUS and OCT immediately post BVS implantation, and at 6 months. OCT estimated stent length accurately compared to nominal length (95% CI of the difference: -0.19; 0.37 and -0.15; 0.47 mm(2) for baseline and 6 months, respectively), whereas QCA incurred consistent underestimation of the same magnitude at both time points (Pearson correlation = 0.806). IVUS yielded low accuracy (95% CI of the difference: 0.77; 3.74 and -1.15; 3.27 mm(2) for baseline and 6 months, respectively), with several outliers and random variability test-retest. Minimal lumen area (MLA) decreased substantially between baseline and 6 months on QCA and OCT and only minimally on IVUS (95% CI: 0.11; 0.42). Agreement between the different imaging modalities is poor: worst agreement Videodensitometry-IVUS post-implantation (ICCa 0.289); best agreement IVUS-OCT at baseline (ICCa 0.767). All pairs deviated significantly from linearity (P < 0.01). Passing-Bablok non-parametric orthogonal regression showed constant and proportional bias between IVUS and OCT. OCT is the most accurate technique for measuring stent length, whilst QCA incurs systematic underestimation (foreshortening) and solid state IVUS incurs random error. Volumetric calculations using solid state IVUS are therefore not reliable. There is poor agreement for MLA estimation between all the imaging modalities studied, including IVUS-OCT, hence their values are not interchangeable.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Densitometry; Everolimus; Humans; Linear Models; Observer Variation; Predictive Value of Tests; Prosthesis Design; Registries; Reproducibility of Results; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

A 58-year-old man underwent an elective coronary bypass graft for severe four-vessel stenosis. Cardiogenic shock developed just after coronary bypass grafting with a left internal mammary artery (LIMA) to left anterior descending (LAD) artery and superficial venous graft to 1st and 2nd obtuse marginal (OM1/OM2) arteries the posterior descending artery (PDA) was too small to graft. Despite significant inotropes and an intra-aortic balloon pump, the patient deteriorated in intensive care unit with cardiogenic shock and ventricular arrhythmia. Urgent coronary angiography revealed a rupture or torn LIMA graft with extravasation of contrast into the left pleural cavity. There was no distal LIMA to LAD flow probably due to graft thrombosis. Revascularisation was performed on the severe ostial native LAD stenosis with a drug eluting stent. The rupture graft was then stented with a polytetrafluoroethylene-covered stent, which stopped the bleeding, and latter, led to total graft thrombosis. The patient improved significantly and supportive inotropes could be weaned down. At 11 month follow-up, the patient had mild left ventricular dysfunction, widely patent ostial LAD stent and thrombosed LIMA graft.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Male; Mammary Arteries; Middle Aged; Polytetrafluoroethylene; Prosthesis Design; Rupture; Severity of Illness Index; Shock, Cardiogenic; Sirolimus; Treatment Outcome; Vascular System Injuries

To compare the outcomes between paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) for the treatment of drug-eluting stent (DES) fracture.. DES fracture is considered as an important predictor of in-stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting.. From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points.. Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024).. This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture-associated DES ISR with PES as compared with SES, and better long-term outcomes, is in need of confirmation by larger prospective registries and randomized trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Ontario; Paclitaxel; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Stent fracture has emerged as a complication of drug-eluting stent and is now recognized as contributing to in-stent restenosis and possibly stent thrombosis. Although optical coherence tomography (OCT) can detect stent fractures in the absence of circumference struts, it is challenging to visualize stent fractures with only cross-sectional OCT images. We describe two cases of restenosis with stent fracture detected by a novel three-dimensional OCT image reconstruction technique. This technique allows identification of a single stent fracture even in the absence of angiographic signs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Imaging, Three-Dimensional; Male; Prosthesis Design; Prosthesis Failure; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Sirolimus

We determined the effect of two-time inflation of the stent balloon on stent expansion and its responsible factor.. Subjects included 61 patients with de novo coronary artery lesions, in whom 12 sirolimus-eluting, 27 paclitaxel-eluting, and 22 other stents were deployed twice at identical inflation pressures (11.3±2.3 atm) and inflation times (5, 10, 20, and 40 s). After the first and second deployments, minimum lumen diameter (MLD), minimum lumen area (MLA), and distensibility index (DI) were determined using intravascular ultrasound.. After the second inflation, MLA was significantly increased (5 s: 12.9%, 10 s: 14.5%, 20 s: 9.4%, 40 s: 9.5%). MLD and DI were also significantly increased. In the single and double inflation groups, DI in each group was significantly correlated with inflation time (single: r=0.409, double: r=0.351). DI was not significantly different between double 5-s and single 10-s inflations, between double 10-s and single 20-s inflations, or between double 20-s and single 40-s inflations. Additional stent balloon inflation by higher pressure in 30% and another balloon in 18% of the patients were required.. Two-time stent balloon inflation may allow better stent expansion regardless of inflation time and two-time inflation may be equivalent to longer inflation.

Topics: Aged; Angioplasty, Balloon, Coronary; Catheterization; Coronary Stenosis; Drug-Eluting Stents; Endosonography; Equipment Design; Female; Humans; Insufflation; Male; Paclitaxel; Sirolimus; Stents

We report the case of an acutely ill 3-year-old female, with a previous medical history of Kawasaki disease, who presented to care with an acute myocardial infarction. We describe the coordinated therapies employed by pediatric and adult cardiologists aimed to establish coronary revascularization.

Topics: Angioplasty, Balloon; Anticoagulants; Biomarkers; Cardiac Catheterization; Coronary Aneurysm; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Electrocardiography; Everolimus; Female; Humans; Immunosuppressive Agents; Infant; Mucocutaneous Lymph Node Syndrome; Myocardial Infarction; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Prosthesis Failure; Sirolimus

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Humans; Male; Microscopy, Electron, Scanning; Polymers; Prosthesis Design; Severity of Illness Index; Sirolimus; Treatment Outcome; Vascular Calcification

In this study we compared the outcomes of the everolimus-eluting stent (EES) versus the zotarolimus-eluting stent (ZES) in patients treated at a tertiary medical center, with up to one year of follow-up.. Unselected consecutive patients were retrospectively recruited following stenting with the ZES (n = 197) or EES (n = 190). The first 100 consecutive patients in each cohort underwent syntax scoring. The primary endpoint of the study was target vessel failure, defined as the combined endpoint of cardiac death, non-fatal myocardial infarction, or target vessel revascularization. Secondary endpoints included target lesion revascularization, target lesion failure, acute stent thrombosis, total death, cardiac death, and non-fatal myocardial infarction.. The two groups were similar, including for Syntax scores (19.6 ± 12.8 versus 20.6 ± 13.6), number of stents per patient (2.9 ± 1.9 versus 2.9 ± 2.1), and cardiovascular risk factors. By one year, the primary outcome occurred in 20.8% EES versus 26.7% ZES (P = 0.19) patients. The secondary endpoints were as follows: target lesion revascularization (8.9% versus 20.6%, P = 0.003), target vessel revascularization (18.9% versus 25.6%, P = 0.142), definite and probable stent thrombosis (0% versus 2.5%), non-fatal myocardial infarction (2.7% versus 3.6%), and mortality (3.2% versus 5.1%) for the EES versus the ZES, respectively.. EES had similar target vessel failure to ZES, but superior target lesion revascularization and target lesion failure at one year of follow-up in an unselected cohort of patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Iowa; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Gender-related differences in long-term outcomes of patients receiving the Endeavor zotarolimus-eluting stent (ZES) (Medtronic) have not been well defined. In this study, we evaluate the differences between men (M) and women (W) for 2-year target vessel failure (TVF) in an unselected consecutive series of patients treated with the ZES at our institution.. Data on 197 consecutive patients (133 M, 64 W) stented with the ZES were retrospectively analyzed. The primary endpoint of the study was to compare gender-related outcomes in TVF, defined as the combined endpoint of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (TVR). Secondary endpoints included TLR, TVR, acute stent thrombosis (ST) as defined by the academic research consortium (ARC), and cardiac death. The cine angiograms of the first consecutive 122 patients (79 M, 43 W) were independently reviewed by a cardiologist blinded to clinical outcome and SYNTAX scoring was performed. Follow-up was achieved using medical records and/or phone calls and was censored at 730 days. Descriptive analysis was performed on all variables. Univariate analysis compared the M and W cohorts. Logistic regression analysis modeling for predictors of TVF was performed and survival analysis between the 2 groups was plotted.. The 2 groups were well matched for demographic, clinical, angiographic, and procedural variables. Angiographic complexity was also statistically similar between the 2 groups as judged by SYNTAX scoring (15.8 ± 10.9 M vs 13.5 ± 8.3 W; P=.197). At 2-year follow-up, TVF was 22.6% and 32.8% (P=.684) with no statistical difference between TLR (18.1% M vs 12.8% W), TVR (21.8% M vs 32.8% W), cardiac death (2.3% M vs 6.3% W), and definite and probable stent thrombosis (2.26% M vs 3.13% W). Logistic regression analyses modeling for age, gender, New York Heart Association (NYHA) class, non-left main (LM) bifurcation lesions, ostial lesions, trifurcating LM, and pre-percutaneous coronary intervention (PCI) lesion severity showed that a higher NYHA class (odds ratio [OR], 2.68; P=.005), ostial lesions (OR, 5.68; P<.001), bifurcating non-LM lesions (OR, 2.74; P=.015), and trifurcating LM lesions (OR, 28.24; P<.001) predicted a higher TVF. Female gender (P=.086) and age (P=.09) were not independent predictors of TVF.. In this cohort of patients receiving ZES, men and women had similar outcomes at 2-year follow-up consistent with recent reports in the current era of PCI. Complex coronary anatomy (ostial, non-LM bifurcations, and LM trifurcations) and advanced heart failure were stronger predictors of higher TVF than gender and age.

Topics: Academic Medical Centers; Aged; Aged, 80 and over; Analysis of Variance; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Electrocardiography; Female; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Prosthesis Failure; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sex Factors; Sirolimus; Survival Rate; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Aspirin; Clopidogrel; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Medication Adherence; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Sirolimus; Ticlopidine; Withholding Treatment

Topics: Cardiovascular Agents; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus

A 73-year-old woman suffering from anterior thoracic pain on exertion presented to our hospital. We performed coronary angiography and noted three stenotic legions in each coronary artery. For each angiographic finding, we implanted a bare metal stent (BMS), sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) into the right coronary artery, left anterior descending and left circumflex coronary arteries, respectively. Nine months later, she died of lung disease, and we could compare the histopathological findings among the three coronary stents. In the drug-eluting stents, very thin intima, infiltration of inflammatory cells, and fibrin deposition were observed, while thick intima and no inflammatory findings were observed in the BMS. Fibrin deposition was more marked in the PES than in the SES. This report shows marked differences in the subsequent pathological course among three stents in the same patient.

Topics: Aged; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Paclitaxel; Radiography; Sirolimus; Stents

The administration of drugs using biodegradable polymer nanoparticles as carriers has generated immense interest due to their excellent biocompatibility and the prolonged drug release. The scope of this work was to determine the applicability of sirolimus-loaded biodegradable poly(D,L-lactide) (PDLLA) nanoparticles as drug carriers to prevent restenotic processes after stent implantation. The average 250 nm sized 20%(w/w) sirolimus-loaded nanoparticles were extensively characterized with regard to in vitro degradation, biocompatibility and in vitro drug release. The particles show biphasic release kinetics consisting of a short burst release of 50%(w/w) sirolimus payload, followed by a longer, slower release phase, which are desirable for the application as a drug delivery carrier. All presented results exhibit the potential of sirolimus-loaded PDLLA nanoparticles as promising local and sustained drug delivery systems administered intraluminally to reduce in-stent restenosis after stent implantation.

Topics: Absorbable Implants; Cell Line; Cell Proliferation; Cell Survival; Coronary Restenosis; Coronary Stenosis; Drug Carriers; Drug Delivery Systems; Endothelial Cells; Humans; Myocytes, Smooth Muscle; Nanoparticles; Particle Size; Polyesters; Sirolimus; Stents

We aimed at comparing the long term clinical outcome of SES and PES in routine clinical practice.. Although sirolimus-eluting stents (SES) more effectively reduce neointimal hyperplasia than paclitaxel-eluting stents (PES), uncertainty prevails whether this difference translates into differences in clinical outcomes outside randomized controlled trials with selected patient populations and protocol-mandated angiographic follow-up.. Nine hundred and four consecutive patients who underwent implantation of a drug-eluting stent between May 2004 and February 2005: 467 patients with 646 lesions received SES, 437 patients with 600 lesions received PES. Clinical follow-up was obtained at 2 years without intervening routine angiographic follow-up. The primary endpoint was a composite of death, myocardial infarction (MI), or target vessel revascularization (TVR).. At 2 years, the primary endpoint was less frequent with SES (12.9%) than PES (17.6%, HR = 0.70, 95% CI 0.50-0.98, P = 0.04). The difference in favor of SES was largely driven by a lower rate of target lesion revascularisation (TLR; 4.1% vs. 6.9%, P = 0.05), whereas rates of death (6.4% vs. 7.6%, P = 0.49), MI (1.9% vs. 3.2%, P = 0.21), or definite stent thrombosis (0.6% vs. 1.4%, P = 0.27) were similar for both stent types. The benefit regarding reduced rates of TLR was significant in nondiabetic (3.6% vs. 7.1%, P = 0.04) but not in diabetic patients (5.6% vs. 6.1%, P = 0.80).. SES more effectively reduced the need for repeat revascularization procedures than PES when used in routine clinical practice. The beneficial effect is maintained up to 2 years and may be less pronounced in diabetic patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Switzerland; Thrombosis; Time Factors; Treatment Outcome

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; TOR Serine-Threonine Kinases; Treatment Outcome

The feasibility of percutaneous coronary intervention (PCI) using drug-eluting stents and its comparability with bypass surgery in treatment of unprotected left main coronary artery (LMCA) stenosis has been shown previously. We compared the mid-to long-term outcome between sirolimus-(SES) vs. paclitaxel-eluting stents (PES) in an all-comer analysis that included all patients with unprotected LMCA stenosis who underwent PCI with SES or PES.. From March 2003 and June 2007, 196 patients underwent PCI with SES or PES for unprotected LMCA stenosis at Seoul National University Main or Bundang Hospital; SES was implanted in 141 patients and PES in 55 patients. The baseline clinical and procedural characteristics were mostly similar between the SES and PES group.. After 2 years of follow-up, there were no differences in the rate of cardiac death (9.1% vs. 8.5%) and nonfatal MI (5.5% vs. 2.8%) between the two groups. However, the risk of repeat revascularization tended to be lower in the SES group compared with the PES group [TLR, 9.9% vs. 20.0% (P=0.06); TVR, 17.7% vs. 30.9% (P=0.05)], which did not reach statistical significance. The rate of stent thrombosis (ST) was also similar between the two groups (3.6% vs. 2.1% for definite ST, 3.6% vs. 2.8% for definite+probable ST).. In all-comers undergoing first generation DES implantation for unprotected LMCA stenosis, PES and SES showed comparable 2-year clinical results regarding hard endpoints and major adverse cardiac events.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Stenosis; Coronary Thrombosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Predictive Value of Tests; Registries; Risk Factors; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Foreign-Body Migration; Humans; Male; Middle Aged; Prosthesis Design; Prosthesis Failure; Severity of Illness Index; Sirolimus; Stress, Mechanical; Tomography, X-Ray Computed

Drug-eluting stents (DES) have markedly reduced the incidence of coronary in-stent restenosis. However, DES may be still vulnerable to coronary thrombus, and the long-term outcome remains unknown, especially in infancy. Here, we present a 9-month-old infant, who developed severe stenosis of the left main coronary artery after surgery for Brand-White-Garland syndrome, and was successfully treated with DES. He was healthy and his cardiac function had improved to the normal level at 6 years old. An angiographic examination and computed tomography showed the complete persistence of DES and no evidence of intimal thickening.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Electrocardiography; Humans; Immunosuppressive Agents; Infant; Male; Sirolimus; Time Factors; Treatment Outcome

Though restenosis after drug-eluting stent implantation is still observed, the factors affecting post-sirolimus-eluting stent restenosis (re-restenosis) have not been fully determined. We evaluated the long-term angiographic outcomes and examined background factors affecting re-restenosis. We enrolled 51 patients with 68 sirolimus-eluting stent (SES) restenosis lesions who underwent target lesion revascularization (TLR) and angiographic follow-up studies. Re-restenosis was observed in 29 of 68 restenosis lesions, and the rate was 42.6%. Study subjects were divided into two groups: a re-restenosis (Re-R) group (20 patients) with 29 lesions and a restenosis (R) group (31 patients) with 39 lesions with no re-restenosis. There were no differences in age, sex, coronary risk factors, past history, or medications between the two groups. Re-restenosis was observed more frequently in the right coronary artery (Re-R group vs. R group; 65.5 vs. 33.3%, P = 0.009). The incidence of stent fracture was higher in the Re-R group (Re-R group vs. R group; 48.3 vs. 12.8%, P = 0.003). QCA results showed that the initial lesion length at the time of first coronary intervention was significantly longer in the Re-R group (Re-R group vs. R group; 21.6 ± 3.37 vs. 12.6 ± 4.98 mm, P = 0.049). The rate of re-restenosis was 47.1% when treated with POBA alone, while it was 36.7% with SES treatment. In multivariate analysis, the initial lesion length at the time of first coronary intervention (odds ratio = 1.64, 95% CI 1.29-2.06, P < 0.001) and stent fracture (odds ratio = 12.42, 95% CI 1.89-81.4, P = 0.009) were independent predictors of re-restenosis. This study demonstrates that recurrent restenosis with SES treatment is associated with lesion length and stent fracture, a finding that is beneficial in the management of restenosis after SES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Asian People; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Japan; Logistic Models; Male; Middle Aged; Odds Ratio; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate the predictors of coronary stent fracture in patients treated with closed-cell design stents including the sirolimus-eluting stent (SES) and its bare-metal platform, Bx velocity stent (BVS).. Various mechanical factors have been considered to be the predictors of stent fracture, especially in patients treated with SES. However, it is unknown whether SES is more prone to fracture compared with BVS.. We retrospectively analyzed 391 lesions treated with SES or BVS in 339 patients who underwent follow-up coronary angiography.. A total of 30 stent fractures (7.7%) in 28 patients treated with 29 SES (96.7%) and one BVS (3.3%) was found. On univariate analyses, stent fracture was related to angulated lesions (>45°) during diastole, longer stent, larger number of stents per lesion (P<0.001), right coronary artery (RCA) placement (P=0.008), and SES (P=0.016). On multivariate analyses, however, angulated lesion (odds ratio: 6.73; 95% confidence interval: 2.71-16.71; P<0.001) and RCA placement (odds ratio: 2.82; 95% confidence interval: 1.03-7.72; P=0.044) served as independent predictors of stent fracture while SES (P=0.080) and total stent length (P=0.069) showed only trends that did not reach statistical significance.. This study showed that fracture of SES or BVS with the same closed-cell design platform was related to angulated lesion and RCA placement, but SES itself was not an independent predictor of stent fracture.

Topics: Aged; Angioplasty, Balloon, Coronary; Comparative Effectiveness Research; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Plaque, Atherosclerotic; Risk Factors; Sirolimus; Treatment Outcome

Long-term outcomes of patients with bifurcated lesions and the restenotic response of the side branches after sirolimus-eluting stent (SES) implantation, comparing 1-stent with 2-stent treatment, are still under discussion.. Japan Post-Marketing Surveillance Registry (J-PMS) is a prospective registry designed to evaluate the safety and efficacy of the SES in routine clinical practice. Angiograms of 1,063 patients with 1,250 lesions were analyzed at the independent core lab. Of these, 324 patients with bifurcation lesions were enrolled. Clinical endpoints were assessed at 3 years. Both main and side branches were evaluated by quantitative coronary angiography at post-procedure (n=349) and 8-month follow up (n=293). Two-stent treatment was performed in 12% of the cases. In-segment restenosis rates at 8 months were 25.6% in the side branch, but newly developed restenosis was seen in only 6.8%. Late loss at the carina of the side branch was -0.11mm in the 1-stent group. Major adverse cardiovascular events rate was 18.3% at 3 years. Target-lesion revascularization rate up to 3 years was 21.6% in the 2-stent group and 8.7% in the 1-stent group (P=0.037). Stent thrombosis occurred in 6 cases (2.0%) until 3 years. Of these, 4 cases were treated with 2-stent (10.81% vs. 0.76% in 1-stent, P=0.003, respectively).. In a real-world setting, treatment of coronary bifurcation lesions using SES demonstrated favorable long-term outcomes as long as the side branch was not stented.

Topics: Angioplasty; Aspirin; Calcinosis; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Japan; Myocardial Infarction; Platelet Aggregation Inhibitors; Product Surveillance, Postmarketing; Sirolimus; Survival Analysis; Thrombophilia; Ticlopidine; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Stent fracture (SF) has been implicated as a risk factor for in-stent restenosis, but its incidence and clinical characteristics are not well established. Therefore we investigated the conditions associated with stent fracture and its clinical presentation and outcome. Between 2004 and 2007, consecutive cases of SF were collected from the Seoul National University Hospital. Clinical characteristics and outcome of patients with fractured stents were compared with a ten-fold cohort of age and gender matched controls (n = 236). A total of 4,845 patients received percutaneous coronary intervention and 3,315 patients (68.4%) underwent angiographic follow-up. Twenty-eight fractured stents were observed in 24 patients. The incidence of SF was 0.89% for sirolimus-eluting stents (SES) and 0.09% for paclitaxel-eluting stents. Chronic kidney disease, stent implantation in the right coronary artery (RCA), and SES use were independent predictors of drug-eluting stent fracture by multivariate analysis. SF was significantly associated with binary restenosis (11.4% vs 41.7%, P < 0.001) and increased risk of target lesion revascularization (8.1% vs 33.3%, P = 0.001). Patients with SF but without significant restenosis showed excellent outcome despite only medical treatment. In conclusion, SF is associated with increased rates of restenosis and repeat revascularization. Significant risk factors include chronic kidney disease, RCA intervention, and SES use.

Topics: Age Factors; Aged; Cardiovascular Agents; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Failure; Registries; Risk Factors; Sex Factors; Sirolimus

Drug-eluting stents reduce restenosis due to neointimal growth suppression. Considering long-term outcomes, it is both difficult and important to predict drug-eluting stent restenosis. Thus, this study was designed to examine the utility of myocardial fractional flow reserve (FFR) as a predictor of sirolimus-eluting stent (SES) restenosis. Thirty-three patients (35 lesions) were enrolled. Upon completion of SES implantation, FFR was obtained under hyperemia. At 8 months of follow-up, coronary angiography revealed that five lesions had restenosis. Percent diameter stenosis (restenosis 68.7 ± 12.8% vs. non-restenosis 68.7 ± 12.4%, p = 0.78) and lesion length (restenosis 15.8 ± 9.4 mm vs. non-restenosis 14.4 ± 9.2 mm, p = 0.60) were similar. At post-intervention, percent diameter stenosis (restenosis 16.4 ± 6.1% vs. non-restenosis 14.0 ± 7.4%, p = 0.48) and minimum stent area (restenosis 6.01 ± 1.08 mm2 vs. non-restenosis 6.27 ± 1.85 mm2, p = 0.92) were also equivalent. However, proximal edge lumen area was smaller (restenosis 4.24 ± 1.40 mm2 vs. non-restenosis 7.73 ± 2.64 mm2, p = 0.004) and FFR was lower in the restenosis group (restenosis 0.81 ± 0.12 vs. non-restenosis 0.92 ± 0.06, p = 0.029). SES patients with restenosis had a lower FFR post stent deployment, suggesting the decreased FFR may be a useful predictor for SES restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Fractional Flow Reserve, Myocardial; Humans; Japan; Logistic Models; Male; Middle Aged; Odds Ratio; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The purpose of this study was to assess the mechanism(s) of late stent thrombosis (LST) and vascular healing responses in first-generation polymeric drug-eluting stents (DES).. Recent clinical trials have reported variations in late lumen loss between first-generation sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Little is known, however, about the vascular responses, time course of healing, and underlying mechanism(s) of complications of LST between platforms in human coronary implants.. The overall analysis included 174 cases (230 DES lesions) from the CVPath Institute's stent registry. Histomorphometry was performed on coronary stents from 127 patients (171 lesions) who died ≥ 30 days after receiving stent implants in which fibrin deposition, endothelial strut coverage, inflammatory response, and mechanism(s) of in-stent thrombosis were assessed.. Both platforms demonstrated increased neointimal thickness over time where values were greater in PES (mean 0.13 mm; range 0.03 to 0.20 mm) than SES (mean 0.10 mm; range 0.04 to 0.15 mm; p = 0.04). The percentage of uncovered struts was similar between SES and PES including stents with LST (SES = 21% vs. PES = 27%; p = 0.47). The underlying mechanism(s) of LST, however, was strikingly different between platforms; localized strut hypersensitivity was exclusive to SES, whereas malapposition secondary to excessive fibrin deposition was the underlying cause in PES. Moreover, although both PES and SES showed nearly complete strut coverage after 12 months for on-label use, the majority of stents placed for off-label indications remained unhealed after 12 months in both types of DES.. Differential mechanisms of LST involving either hypersensitivity or excessive fibrin were identified between first-generation DES in which overall stent healing was further delayed in DES placed for off-label indications.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Failure; Radiography; Registries; Risk Assessment; Sirolimus; Survival Analysis; Time Factors

This serial angiographic study evaluated the incidence and predictors of late restenosis after sirolimus-eluting stent (SES) implantation.. Previous studies showed late restenosis (i.e., late catch-up phenomenon) after implantation of 7-hexanoyltaxol-eluting stents and nonpolymeric, paclitaxel-eluting stents.. Between August 2004 and December 2006, SES implantation was performed in 1,393 patients with 2,008 lesions, in whom 8-month and 2-year follow-up coronary angiography were planned.. Of 2,008 lesions, 1,659 (83%) underwent 8-month follow-up angiography (8.3 ± 2.2 months). Restenosis was observed in 122 lesions (7.4%). Coronary angiography 2 years (1.9 ± 0.4 years) after SES deployment was performed in 1,168 lesions (74% of lesions without restenosis at 8-month follow-up angiography). Late restenosis was observed in 83 lesions (7.1%). There was significant decrease in minimum luminal diameter (MLD) between 8-month and 2-year follow-up (2.56 ± 0.56 mm vs. 2.35 ± 0.71 mm, p < 0.001). Multivariate analysis showed in-stent restenosis before SES implantation and MLD at 8-month follow-up as independent predictors of late restenosis.. Between 8-month and 2-year follow-up after SES implantation, MLD decreases, which results in late restenosis in some lesions. In-stent restenosis before SES implantation and MLD at 8-month follow-up are independent predictors of late restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Coronary stent infection is exceedingly rare, with only 23 reported cases. We present a patient with an everolimus-coated stent infection that led to an infected pseudoaneurysm in the left anterior descending artery. Medical therapy failed and the patient underwent emergent surgical intervention; however, he died of multiorgan failure after the operation.

Topics: Aged; Aneurysm, False; Angioplasty, Balloon, Coronary; Bacteremia; Cardiac Output, Low; Coronary Stenosis; Everolimus; Fatal Outcome; Humans; Male; Prosthesis-Related Infections; Reoperation; Sirolimus; Staphylococcal Infections; Stents

As data on the use of the latest-generation drugeluting stents (DES) in bifurcation interventions are lacking, we realized a multicenter registry to assess the procedural and clinical results obtained in patients with unselected bifurcated lesions treated with the novel zotarolimus-eluting Resolute stent (ZRS).. Three Italian centers participated in the study. Consecutive patients with significant stenosis of bifurcated lesions undergoing DES implantation were treated with ZRS. The recommended technique was the "provisional TAP approach" [main-vessel (MV) stent implantation eventually followed by kissing balloon and sidebranch (SB) stenting according to TAP technique]. Clinical characteristics, procedural details and clinical follow-up data were prospectively recorded. Procedural success was defined as post-percutaneous coronary intervention visual stenosis > 20% on MV and TIMI 3 flow on both MV and SB. Primary endpoint was major adverse coronary events (cardiac death, myocardial infarction and target vessel revascularization) at 9-month follow up. A total of 180 patients were enrolled. The target lesion was located in the distal left main in 16% and in the left anterior descending artery in 52%. All but 3 cases were treated according to the provisional TAP approach (kissing balloon rate, 69%; overall SB stenting rate, 10.6%). Procedural success was obtained in 98.3% (3 failures due to final SB TIMI flow < 3). At 9-month follow up, the survival free from MACE was 97.8% (1 cardiac death and 3 repeat revascularizations).. The use of the latest-generation ZRS in unselected bifurcated lesions treated by a provisional approach is associated with excellent procedural results and with promising clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Italy; Male; Middle Aged; Myocardial Infarction; Registries; Retrospective Studies; Risk Factors; Sirolimus; Survival Rate; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Myocardial Infarction; Paclitaxel; Patient Selection; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Patients suffering from acute myocardial infarction with involvement of unprotected left main (LM) coronary artery disease represent a very high-risk subgroup. A 37-year-old male patient was admitted with posterolateral acute myocardial infarction and in borderline hemodynamic condition. His left ventricular ejection fraction was 30% with posterior, lateral wall, and apical akinesis along with mild mitral regurgitation. Emergency coronary angiography demonstrated ostial occlusion of the left circumflex artery (without stump, flow Thrombolysis in Myocardial Infarction 0/Rentrop 0) and severe distal LM disease with superimposed thrombus. The primary percutaneous coronary intervention procedure combined intracoronary reteplase plus thrombus aspiration to restore flow in the left circumflex and deployment of two everolimus-eluting stents with mini-crush technique to successfully reconstruct the LM bifurcation. The patient recovered without complications and had a favorable outcome at mid-term.

Topics: Adult; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Fibrinolytic Agents; Humans; Infusions, Intra-Arterial; Male; Myocardial Infarction; Prosthesis Design; Recombinant Proteins; Sirolimus; Stroke Volume; Suction; Thrombolytic Therapy; Tissue Plasminogen Activator; Treatment Outcome; Ultrasonography, Interventional; Ventricular Function, Left

A 57-year-old man was admitted for exertional angina pectoris. Coronary angiography showed a 99% stenosis in the left circumflex artery. A sirolimus-eluting stent was deployed in the culprit lesion and excellent angiographic results were obtained. Six-month routine follow-up coronary angiography showed a 90% focal restenosis at the proximal edge of the stent. At this site, optical coherence tomography imaging revealed restenotic tissue with a ruptured-plaque-like appearance overlying the stent struts. Also, a low intensity area suggestive of the presence of a lipid core was evident within the neointimal tissue in another cross section.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Humans; Male; Middle Aged; Plaque, Atherosclerotic; Sirolimus; Tomography, Optical Coherence

The aim of the present study was the comparison of the everolimus-eluting stent (EES) with the paclitaxel-eluting stent (PES) in patients treated for long chronic total occlusions (CTOs). Previous randomized trials have shown the superiority of EESs over PESs. No data exist about the efficacy and safety of EESs in patients treated for complex CTOs requiring multiple stent implantation. We identified 258 patients treated for CTOs who received multiple EESs (n = 112) or PESs (n = 146), with a total stent length of ≥40 mm. The primary end point was in-segment restenosis, defined as >50% luminal narrowing at the segment site, including the stent and 5 mm proximal and distal to the stent edges of the target vessel, on the follow-up angiogram. The secondary end point was the 9-month composite of major adverse cardiovascular events. The 2 patient groups were similar in all baseline characteristics. The median lesion length was 48 mm in the EES group and 46 mm in the PES group (p = 0.793). The incidence of the primary end point of the study was 11.8% in the EES group and 31.4% in the PES group (p = 0.001). The major adverse cardiovascular event rate was lower in the EES group than in the PES group (8.9% and 22.6%, respectively, p = 0.003). Definite or probable stent thrombosis occurred in 5 patients in the PES group (3.4%), with no stent thrombosis occurring in the EES group (p = 0.048). On multivariate analysis, EES was the only variable independently related to the risk of binary angiographic restenosis with an odds ratio of 0.29 (95% confidence interval 0.14 to 0.62; p = 0.002). In conclusion, in patients treated for long CTOs and requiring multiple stent implantation, EESs performed better than PESs, with a >50% reduction in the risk of restenosis and major adverse cardiovascular events.

Topics: Aged; Chronic Disease; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Paclitaxel; Sirolimus; Treatment Outcome

Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES).. Patients (N=100) with one de novo target lesion ≤ 34 mm long and reference vessel diameter (RVD) ≥ 2.25-≤ 4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9 month in-stent late loss in workhorse lesions (defined as RVD ≥ 2.5-≤ 4.25 mm, lesion ≤ 24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8 ± 9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72 ± 0.53 mm; lesion length was 15.4 ± 7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17 ± 0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001).. Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.

Topics: Aged; Angioplasty, Balloon, Coronary; Chromium; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Platinum; Prospective Studies; Sirolimus; Ultrasonography, Interventional

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Microscopy, Electron, Scanning; Polymers; Prosthesis Design; Prosthesis Failure; Sirolimus; Surface Properties; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Biocompatible Materials; Cardiovascular Agents; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Stenosis; Data Interpretation, Statistical; Drug-Eluting Stents; Humans; Sirolimus

Topics: Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Sirolimus; Tomography, Optical Coherence

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Sirolimus

Topics: Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Sirolimus

We sought to assess the efficacy and safety of everolimus-eluting stents for unprotected left main disease.. A total of 173 consecutive patients with de novo significant unprotected left main stenosis received an everolimus-eluting stent in four French centres. Among them, 140 (81 %) had involvement of the distal portion of left main, and 129/140 (92%) were treated with provisional side branch T-stenting, with a side branch stenting rate of 20%. Angiographic success was achieved in all cases. At 12 months, the cumulative rate of major adverse cardiac or cerebrovascular events (MACCE) was 26/173 (15%) including death from any cause (N=5, 2.9%), stroke (N=4, 2.3%), Q-wave myocardial infarction (MI) (N=2, 1.2%), non-Q-wave MI (N=6, 3.5%) and any repeat revascularisation (N=16, 9.3%). At one year, the rate of target-lesion revascularisation (TLR) was 5/173 (2.9%), target-vessel revascularisation was 12/173 (7 %) and the rate of definite or probable left main stent thrombosis 1/173 (0.6 %).. Unprotected left main stenting using everolimus-eluting stents and a strategy of provisional side branch T-stenting for distal lesions, is safe and effective in the midterm, with a relatively low rate of events and reintervention at one year.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Pilot Projects; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stroke; Thrombosis; Time Factors; Treatment Outcome

Biolimus-eluting stents (BESs) with a biodegradable polymer in abluminal coating achieve more complete coverage at 9 months compared with sirolimus-eluting stents (SESs) with a durable polymer, as assessed by optical coherence tomography (OCT). Whether this advantage persists or augments after complete resorption of the polymer (>12 months) is unknown.. The LEADERS trial compared the performance of BES with that of SES. Patients were randomly allocated to a sequential angiographic follow-up, including OCT in selected sites, at 9 and 24 months. Struts coverage was compared using Bayesian hierarchical models as the primary outcome for the OCT substudy.. Fifty-six patients (26 BES, 30 SES) were enrolled in the OCT substudy. Twenty-one patients (10 BES, 11 SES) agreed to perform a second OCT follow-up at 24 months. Eleven lesions and 12 stents were analyzed sequentially in the BES group (2,455 struts at 9 months, 2,131 struts at 24 months) and 11 lesions and 18 stents in the SES group (3,421 struts at 9 months, 4,170 struts at 24 months). The previously reported advantage of BES over SES in terms of better strut coverage at 9 months was followed by improvement in coverage of the SES, resulting in identical coverage in both BES and SES at 24 months: 1.5% versus 1.8% uncovered struts, difference -0.2%, 95% credibility interval, -3.2% to 2.6%, P = .84.. More complete strut coverage of BES as compared with SES at 9 months was followed by improvement of coverage in SES between 9 and 24 months and a similar long-term coverage in both stent types at 24 months.

Topics: Adult; Angioplasty, Balloon, Coronary; Case-Control Studies; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Polymers; Randomized Controlled Trials as Topic; Serum Albumin; Serum Albumin, Human; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Paclitaxel; Sirolimus

Simultaneous drug-eluting stent thrombosis in multivessel disease is a low incidence, but could cause lethal clinical event. We report a case with death caused by simultaneous subacute stent thrombosis of sirolimus-eluting stents in the proximal left anterior descending artery and in the proximal left circumflex artery.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cilostazol; Clopidogrel; Coronary Angiography; Coronary Occlusion; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Electrocardiography; Fatal Outcome; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Sirolimus; Tetrazoles; Ticlopidine; Ventricular Fibrillation

Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice.. We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 +/- 0.41 SES were implanted with a mean length of 21.1 +/- 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery.. These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Germany; Humans; Immunosuppressive Agents; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Prospective Studies; Registries; Renal Insufficiency; Risk Factors; ROC Curve; Severity of Illness Index; Shock, Cardiogenic; Sirolimus; Stroke; Treatment Outcome; Ventricular Function, Left

We describe a 66-year-old woman with aortitis syndrome, successfully treated with percutaneous coronary intervention using sirolimus-eluting stent (SES) for ostial stenosis of left main coronary artery after Bentall operation. At one-year follow-up, she had no evidence of restenosis and no clinical events. Stent implantation with SES may be useful for ostial left main coronary stenosis after Bentall operation in selected patients with aortitis syndrome.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Postoperative Complications; Prosthesis Implantation; Sirolimus; Takayasu Arteritis

We sought to report the results of both bench-testing and our first clinical experience with this novel technique.. The optimal stenting technique for bifurcation lesions has yet to be defined.. This technique works by flaring the proximal side of the stent in side branch out like a flower petal. We tested it in vitro and the resultant stent structure and stent polymer damage was observed in both main branch and side branch with an optical microscopy, multislice computer tomography, intravascular ultrasound, endoscopy, and by electron microscopy. We also applied this technique in 33 patients and assessed patient outcomes up to 9 months prospectively. Drug-eluting stents were used for the bench tests and for all patients.. Bench-testing showed complete coverage of the bifurcation with minimal stent-layer overlapping. There was little polymer damage by electron microscopy. Procedural success was achieved in all cases and restenosis occurred in 2 cases. In both restenosis cases, "petal" stenting technique was done reluctantly after another stent had already been deployed in the main branch before any stenting of the side branch. There were no incidences of restenosis when this technique was used electively.. In terms of damage to the polymer and ostial strut coverage, this new "flower petal stenting" technique is effective for treatment of bifurcation lesion and it may well be superior to other available techniques.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endoscopy; Female; Humans; Male; Materials Testing; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Paclitaxel; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

This paper studies in-stent restenosis (ISR) after percutaneous coronary intervention (PCI) following bare-metal stent (BMS) and drug-eluting stent (DES) in all consecutive patients between 2004 and 2007 undergoing PCI for ISR lesions at our centre.. We compared the clinical presentation, pattern and angiographic outcomes in 838 patients with BMS ISR (487) and SES ISR (351). About 18% of the patients presented with acute coronary syndrome with 2% presenting as ST elevation myocardial infarction, similar in both groups. Angiographic pattern was predominantly focal with SES ISR (47%SES ISR vs. 19% BMS ISR; p<0.001) and diffuse with BMS ISR (SES ISR 16% vs. BMS ISR 36%; p=0.003). In our series the use of balloon angioplasty was higher for the treatment of SES ISR patients as compared to BMS ISR (41.6% vs. 18.3%; p<0.001) and the usage of stent was higher in BMS ISR patients (38.6% vs. 23.4%; p<0.001). Angiographic recurrent restenosis with conventional treatment in a consecutive series of patients was 38.6% and target lesion revascularisation was seen in 33.6%. These outcomes were seen slightly higher in SES ISR group (41.1% vs. 36.9%, p=ns). We have identified unstable angina at presentation (OR 3.02; 95%CI: 1.58-5.77, p=0.001), focal pattern of ISR (OR 0.50; 95% CI: .25-.99, p=0.04), stent usage (OR .25; 95% CI .13-.47, p<0.001), and baseline% diameter stenosis (OR1.03; 95%CI: 1.03-1.06, p=0.01) as independent predictors of BMS ISR recurrent restenosis. Unstable angina, focal pattern of ISR, reference vessel diameter, and% diameter stenosis were shown to be independent predictors of SES ISR.. ISR is not a benign condition, and one fifth of the patients presented with acute coronary syndrome. The pattern of restenosis is predominantly non-focal with BMS ISR and focal with SES ISR. Recurrent restenosis rates are high following conventional treatment and further optimal therapies mainly with SES ISR needs to defined.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Japan; Logistic Models; Male; Metals; Middle Aged; Odds Ratio; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Stents; Time Factors; Treatment Outcome

Two months after left anterior descending (LAD) artery and left circumflex (LCx) artery bare metal stent implantation, a proliferative subocclusive in-stent restenosis in LCx coronary with severe LM coronary (LM) involvement developed. The present clinical case describes a simplified strategy for unprotected LM percutaneous coronary intervention using two bioabsorbable biolimus-eluting stents without involvement of the LAD coronary using an "L" technique.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Male; Metals; Middle Aged; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

We report on two patients with sirolimus-eluting stent (SES) restenosis lesions who showed highly echolucent regions by optical coherence tomography (OCT) and who could be assessed histologically after removal by directional coronary atherectomy (DCA). One restenosis lesion had a bilayer structure of hyperechoic outer layers and highly echolucent inner layers on OCT images and histologically exhibited myxomatous neointima tissue in the highly echolucent regions; another restenosis case showed patchy and highly echolucent regions throughout the layers and its histology revealed fibrin thrombosis. We should be aware that patterns of echolucent on OCT images may have various histology. OCT allows the visualization of fine lesions that conventional intravascular ultrasound (IVUS) cannot provide. The OCT images of drug-eluting stent restenosis lesions often show echolucent regions [Shuzoh et al., EuroInterv 2006;1:484]. However, no histological study of the lesions has been reported to date. Here we report on two patients with SES restenosis lesions that showed highly echolucent regions by OCT and that could be assessed histologically after removal by DCA.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Tomography, Optical Coherence; Ultrasonography, Interventional

Percutaneous coronary intervention (PCI) has been widely used to treat obstructive coronary artery disease. With the advent of drug-eluting stent (DES) in real world registry was proved as promising therapy. The limitation of the use of DES is the limited health care expenditure. We propose the use of Chinese made DES among Thai patients and that this will solve the cost issue. The clinical result of this DES has not been well known.. Prospective study from November 2005 to March 2007 using the structured registry form to evaluate the safety and efficacy of new Chinese made Firebird sirolimus eluting stent (Firebird SES) on clinical parameters from in-hospital, 30 days and 12 months or longer term follow-up. End point is major adverse cardiac event (MACE) including death, MI, TLR and CABG at 30 day and cumulative MACE at 12 month follow-up.. Ninety consecutive patients who were treated with Firebird stent implantation (107 target lesions) were analyzed. Angiographic success (defined as < 30% diameter stenosis) was 85%. Procedure success was 77.8%. MACE at 30 day was 16.6%, cumulative MACE at 12 months was 18.8%. There were total 9 deaths during the study period, two deaths occurred at before 30 days, 3 deaths occurred before 12 months and other 4 deaths occurred after 12 months to 1305 days. Eighty patients (88.9%) had either office visit or telephone call follow-up after 12 months, 38 patients (42.2%) underwent clinical driven coronary arteriography, binary restenosis was 26.3%. Shock and smoking history was the analyzed predictor of MACE at follow-up.. The implantation of Firebird DES in unselected patients (all comers) is safe, effective and could be an alternative choice of stent for Thai patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Registries; Sirolimus; Survival; Thailand; Treatment Outcome

There is little information about long-term (> 1 year) outcomes after sirolimus-eluting stent (SES) implantation in dialysis patients. Percutaneous coronary intervention (PCI) using SES was performed in 63 dialysis patients with 77 lesions. A control group for comparison was composed of 45 consecutive dialysis patients with 62 lesions who received PCI using bare metal stents (BMS). Clinical follow-up duration was 21.7 +/- 8.4 months in the SES group and 32.1 +/- 9.2 months in the BMS group (P < 0.01). There was no significant difference in the in-segment restenosis rate (30% versus 40%, P = 0.20) between the 2 groups. The 3-year mortality (22.5% versus 22.2%, P = 0.75), myocardial infarction (3.8% versus 4.9%, P = 0.93), target lesion revascularization (24.7% versus 31.0%, P = 0.61), and stent thrombosis rates (3.8% versus 2.4%, P = 0.73) were not significantly different between the SES and BMS groups. Compared to BMS, SES do not improve long-term clinical outcomes in dialysis patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to compare outcomes after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in the treatment of cardiac allograft vasculopathy (CAV).. PCI in patients with CAV is associated with increased rates of restenosis compared with PCI in patients without CAV. There are no dedicated studies on the influence of different drug-eluting stents (DES) on the outcomes of patients with CAV.. This is a retrospective observational study of 108 consecutive patients with CAV who underwent PCI with SES and PES at UCLA Medical Center and University of Padova Medical Center between 2002 and 2008.. Baseline characteristics were similar among SES (n = 68) and PES (n = 40) patients with the exception of older patients, larger minimal lumen diameter, and smaller diameter stenosis in the SES-treated patients. Angiographic follow-up at 1 year was high in the SES and PES groups (74% vs. 76%, p = 0.8). The SES and PES groups had similar binary restenosis rates (10% vs. 9%, p = 0.7), percent diameter stenosis (24 +/- 24% vs. 24 +/- 18%, p = 0.94), and late lumen loss (0.67 +/- 1.03 mm vs. 0.68 +/- 1.11 mm, p > 0.9). One-year clinical outcomes were not significantly different among CAV patients treated with either SES or PES (major adverse cardiac events: 10% vs. 15%, p = 0.5; death: 3% vs. 5%, p = 0.4; myocardial infarction: 3% vs. 5%, p = 0.4; target vessel revascularization: 4% vs. 8%, p = 0.3).. In patients who underwent PCI for CAV, both SES and PES were safe and effective with no significant differences in clinical and angiographic outcomes. Randomized clinical trials comparing different DES with longer follow-up are necessary to identify the optimal treatment strategy for patients with CAV.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Heart Transplantation; Humans; Italy; Los Angeles; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Retrospective Studies; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Transplantation, Homologous; Treatment Outcome

Topics: Angina, Unstable; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Imaging, Three-Dimensional; Lipids; Male; Middle Aged; Sirolimus; Tomography, Optical Coherence; Treatment Failure

Using serial volumetric intravascular ultrasonography, we evaluated the predictors of late intimal hyperplasia (IH) increases after drug-eluting stent implantation. All eligible patients who underwent 6-month angiography without visual restenosis were requested to undergo a 2-year follow-up examination. Complete serial (after stenting and early [6-month], and late [2-year] follow-up) angiographic and intravascular ultrasound data were available for 135 patients with 143 lesions: 99 sirolimus-eluting stents and 44 paclitaxel-eluting stents. The external elastic membrane, stent, lumen, and peri-stent plaque volumes (external elastic membrane minus stent) were normalized by stent length. The percentage of IH volume was calculated as IH volume/stent volume x 100. The early reduction in the minimum lumen area was greater than the late reduction in the minimum lumen area (-0.8 +/- 0.8 vs -0.2 +/- 0.5 mm(2), p <0.001). A progressive increase occurred in the percentage of IH volume: 8.1 +/- 7.1% from baseline to 6 months and 2.4 +/- 3.9% from 6 months to 2 years (p <0.001, between the early and late increases in the percentage of IH). The use of paclitaxel-eluting stents was the only independent predictor for the percentage of IH volume at 6 months (beta = 0.419, p <0.001). The use of paclitaxel-eluting stents (beta = 0.365, p <0.001, 95% confidence interval 3.7 to 9.7) and the post-stenting normalized plaque and media volume (beta = 0.195, p = 0.020, 95% confidence interval 0.1 to 1.6) were the only independent predictors for the percentage of IH volume at 2 years. However, when the percentage of IH at 6 months was forced into the model, the percentage of IH at 6 months and the post-stenting normalized plaque and media volume, not paclitaxel-eluting stent use, predicted the 2-year percentage of IH. In conclusion, although IH continued to increase beyond 6 months, the growth rate of intima and luminal loss attenuated with time.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Chi-Square Distribution; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Incidence; Male; Middle Aged; Paclitaxel; Probability; Registries; Risk Assessment; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Chronic renal failure (CRF) is an emergent pathology in industrialized countries and is associated with high prevalence of coronary artery disease. Our aim is to determine the influence of CRF in the appearance of adverse cardiovascular events after sirolimus-eluting stent implantation in a non selected cohort.. Observational retrospective study with a cohort of 461 patients who received one or more sirolimus-eluting stent between September 2002 and December 2005 at our institution. We evaluated the incidence of adverse cardiovascular events during the follow-up period and their relation with chronic kidney disease. We used the abbreviated Modification of Diet in Renal Disease (MDRD) equation to calculate the GFR.. The mean follow-up was 42 months (SD ± 13) and the mean age was 61 ± 11 years and 85 percent of the group were men. Chronic renal failure was present in 50 patients, 11 percent of the cohort. In a multivariate model, after adjustment for age, sex, left ventricle election fraction, anemia, diabetes, hypertension, Killip class and stent thrombosis, chronic renal failure was an independent predictive factor of death from any cause (hazard ratio, 3.82; 95 percent confidence interval, 1.41-10.33, p = 0.008), and an significant risk factor for restenosis (hazard ratio 3.47; 95 percent confidence interval, 1.01-11.97, p = 0.045). Significant differences were not found in thrombosis between patients with or without CRF (8% vs 3.4%, p = 0,109), although a trend was observed in the CRF group. There no were statistical association with need for a new target vessel revascularization (TVR) after coronary intervention either (18.8% versus 10.5%, p = 0.094).. The presence of chronic renal failure in patients with coronary disease is associated with higher risk of restenosis and is a potent predictor of mortality after sirolimus-eluting stent implantation.

Topics: Aged; Angioplasty; Anticoagulants; Cause of Death; Cohort Studies; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Implants; Drug-Eluting Stents; Female; Follow-Up Studies; Glomerular Filtration Rate; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prognosis; Retrospective Studies; Risk Factors; Sirolimus; Thrombophilia; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Metals; Myocardial Infarction; Patient Selection; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Metals; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

We investigated the long-term clinical outcomes and independent predictors of major cardiac events in unprotected left main coronary artery disease (ULMCA) patients treated by percutaneous coronary intervention with drug-eluting stent (DES).. There is limited information on long-term (>3 years) outcomes after DES implantation for ULMCA. Furthermore, bifurcation angle and SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score are emerging as parameters for patient risk stratification, and their prognostic implications have still to be elucidated.. One hundred forty-eight patients with ULMCA treated with DES were analyzed and compared with a historical cohort of 79 patients who received bare-metal stents for the treatment of ULMCA. Patient-oriented composite end point was defined as the occurrence of all-cause death, any myocardial infarction, or any revascularization.. The 4-year cumulative incidence of all-cause death, any myocardial infarction, any revascularization, and patient-oriented composite were 35.6%, 3.8%, 25.2%, and 54.4%, respectively. These end points had relatively increased from 1 year to 4 years by Delta70%, Delta5%, Delta50%, and Delta68%, respectively. When compared with a historical cohort who received bare-metal stents for ULMCA treatment, landmark analysis performed after the first 2 years of follow-up demonstrated that the DES cohort had significantly higher patient-oriented composite end point over the last 2 years of follow-up (26% vs. 8%, p = 0.02). EuroSCORE (European System for Cardiac Operative Risk Evaluation), cardiogenic shock, and SYNTAX score were identified as independent predictors for the 4-year patient-oriented composite, whereas bifurcation angle was not.. Late increase in patient-oriented composite end points after DES implantation for ULMCA warrants careful and long-term follow-up. SYNTAX score and EuroSCORE appear to have a significant prognostic value in long-term patient risk.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cohort Studies; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Patient Selection; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

We studied the effect of oral sirolimus, administered to prevent and treat in-stent restenosis (ISR), on the variation of serum levels of inflammatory markers following coronary stenting with bare metal stents. The mean age of the patients was 56 +/- 13 years, 65% were males and all had clinically manifested ischemia. Serum levels of high sensitivity C-reactive protein (hs-CRP) concentration were determined by chemiluminescence and serum levels of all other biomarkers by ELISA. One group of patients at high risk for ISR received a loading oral dose of 15 mg sirolimus and 5 mg daily thereafter for 28 days after stenting (SIR-G). A control group (CONT-G) was submitted to stenting without sirolimus therapy. The increase in hs-CRP concentration was highest at 24 h after stenting in both groups. A significant difference between SIR-G and CONT-G was observed at 4 weeks (-1.50 +/- 5.0 vs -0.19 +/- 0.4, P = 0.008) and lost significance 1 month after sirolimus discontinuation (-1.73 +/- 4.3 vs -0.01 +/- 0.7, P = 0.0975). A continuous fall in MMP-9 concentration was observed in SIR-G, with the greatest reduction at 4 weeks (-352.9 +/- 455 vs +395.2 +/- 377, P = 0.0004), while a positive variation was noted 4 weeks after sirolimus discontinuation (227 +/- 708 vs 406.2 +/- 472.1, P = 0.0958). SIR-G exhibited a higher increase in P-selectin after sirolimus discontinuation at week 8 (46.1 +/- 67.9 vs 5.8 +/- 23.7, P = 0.0025). These findings suggest that the anti-restenotic actions of systemic sirolimus include anti-proliferative effects and modulation of the inflammatory response with inhibition of adhesion molecule expression.

Topics: Biomarkers; Case-Control Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Enzyme-Linked Immunospot Assay; Female; Humans; Immunosuppressive Agents; Luminescence; Male; Middle Aged; Sirolimus; Stents

We examined angiographic and late-term clinical outcomes according to sex in recent percutaneous coronary intervention (PCI) trials involving zotarolimus-eluting stents (ZES).. Differences in outcome between men and women undergoing PCI have been inconsistently described with bare metal and first-generation drug-eluting stents.. Clinical and angiographic outcomes among ZES-treated patients were evaluated by sex using propensity score modeling in a patient-level systematic overview of six trials and were also compared to patients receiving bare metal stents (BMS).. Among 2,132 patients, 608 were female (28.5%). Compared to men, women were older and more frequently had diabetes, hypertension, and a smaller reference vessel diameter (P < 0.05 for all). For both sexes, the relative reductions in 8-month angiographic binary restenosis and late lumen loss were statistically significant and of similar extent with ZES compared to BMS. By 2 years, treatment with ZES resulted in significantly lower target vessel revascularization (TVR) and target vessel failure (TVF; 10.0% vs. 21.5%, P = 0.0003) among women that paralleled risk reductions for men. However, among ZES-treated patients, 2-year rates of TVR (8.2% vs. 10.4%, P = 0.005) and TVF (9.9% vs. 12.8%, P = 0.004) were significantly lower among women, although rates of death and myocardial infarction were similar.. Despite greater baseline clinical and angiographic risk than men, women undergoing PCI with ZES compared to BMS experienced significant reductions in angiographic restenosis and repeat revascularization yet similar safety. Among all patients treated with ZES, late-term safety and efficacy outcomes are similar, if not lower, among women compared to men.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Predictive Value of Tests; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

Neointimal formation can protect against thrombosis after sirolimus-eluting stent (SES) implantation; however, promoters of neointimal formation are unknown.. Six-month follow-up angioscopy was performed in 141 consecutive patients with SES implantation. All patients received aspirin (100 mg) and ticlopidine (200 mg) daily until angioscopy. We defined 2 grades of neointimal coverage as follows: insufficient coverage including no or partial neointimal coverage of stent struts, and sufficient coverage. The possible promoters of neointimal formation that were evaluated in this study were the condition of coronary artery disease (stable angina or acute coronary syndrome); angioscopic markers, including visible thrombus and plaque color (white or yellow); serum markers, including low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting blood glucose, hemoglobin A(1c), high-sensitive C-reactive protein, and fibrinogen; blood pressure and smoking; intervention markers, including stent size and length and intravascular ultrasound measurements; and medication, including statins, anticoagulants, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, calcium antagonists, and β-blockers.. Univariate analysis revealed that high-sensitive C-reactive protein, plaque color, and the condition of coronary artery disease were significantly correlated with the grade of neointimal coverage. Multivariate analysis using these 3 parameters revealed that only acute coronary syndrome (vulnerable disease) significantly promoted neointimal coverage.. Vulnerable disease may promote neointimal coverage after SES implantation.

Topics: Acute Coronary Syndrome; Aged; Angioscopy; C-Reactive Protein; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Image Processing, Computer-Assisted; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Tunica Intima

Data on the relevance of the location of coronary bifurcation lesions treated by crush stenting with outcomes were limited.. We hypothesized that the location of the bifurcation lesion correlated with clinical outcome.. A total of 212 patients with 230 true bifurcation lesions treated by crush stenting with drug-eluting stents (DES) were assessed prospectively. Surveillance quantitative angiographies were indexed at 8 months after procedure. Primary endpoint was major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).. Patients in the distal right coronary artery (RCAd) group were characterized by higher proportions of prior myocardial infarction and very tortuous lesions. However, lesions in the RCAd group, compared to those of other groups, had the lowest late lumen loss, with resultant lowest incidence of MACE at a mean follow-up of 268±35 days. Independent predictors of MACE included unsatisfied kissing (KUS; hazard ratio [HR]: 12.14, 95% confidence interval [CI]: 4.01-12.10, P = .001) and non-RCA lesion (HR: 20.69, 95% CI: 5.05-22.38, P = .001), while those of TLR were KUS (HR: 10.21, 95% CI: 0.01-0.34, P = .002), bifurcation angle (HR: 4.728, 95% CI: 2.541-4.109, P = .001), and non-RCA lesion (HR: 16.05, 95%CI: 1.01-4.83, P = .001).. Classical crush stenting with drug-eluting stents is associated with significantly better outcomes in RCAd. Quality of kissing inflation is mandatory to improve outcome.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The optimal duration of dual antiplatelet therapy remains controversial.. Between December 2006 and March 2008, 823 patients were enrolled in a prospective multicenter registry for 3-month dual antiplatelet therapy (aspirin 100-200mg+clopidogrel 75 mg daily) followed by aspirin mono-therapy after zotarolimus-eluting stents (ZES). Major exclusion criteria were: cardiogenic shock, stent thrombosis (ST)-segment elevation myocardial infarction (MI) within 48h, previous drug-eluting stent implantation, severe left ventricular dysfunction, bifurcation lesions requiring 2-stenting, left main and graft lesions. The primary outcome was a composite of cardiac death, MI, or ST at 1 year. The median duration of dual antiplatelet therapy was 95 days (interquartile range 90-101). At 1 year, 3 patients (0.4%) had cardiac deaths, 3 patients (0.4%) had MI, and 4 patients (0.5%) had definite or probable ST, leading to the primary outcome in 5 patients (0.6%). Death, MI, or any revascularization occurred in 68 patients (8.3%). Among patients who were event-free at 3 months (n=812), clopidogrel was discontinued at 3 months in 661 patients and was continued for longer than 3 months in 151 patients. Discontinuation of clopidogrel at 3 months did not increase the primary outcome (HR 0.90; 95%CI, 0.09-9.02), death, MI, or any revascularization (HR 0.89; 95%CI, 0.48-1.67) after adjustment for the propensity score.. Three-month dual antiplatelet therapy seems to be feasible after ZES implantation in relatively low-risk patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Chi-Square Distribution; Clopidogrel; Coronary Angiography; Coronary Stenosis; Disease-Free Survival; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

The absolute benefit of drug-eluting stents (DES) in low-risk patients and lesions is not well established.. The long term clinical outcomes after percutaneous coronary intervention in a single coronary artery disease may not be affected by the type of stent.. This study assessed and compared 2-year clinical outcomes of 304 consecutive patients (147 BMS patients and 157 DES patients) treated with a single coronary stent (4.0 mm) for single de novo large coronary artery disease in 3 referral cardiac centers. The primary outcome was a composite of major adverse cardiac events at 2 years after the index procedure.. The reference vessel diameter was similar in both groups (3.92 ± 0.29 mm in BMS vs 3.95 ± 0.24 mm in DES, P = 0.50). Late loss was larger in the BMS group (1.04 ± 0.83 mm vs 0.73 ± 0.91 mm in DES, P = 0.03). The incidence of major adverse cardiac events at the 2-year clinical follow-up was very low, 24 of 304 patients (7.9%), regardless of stent type deployed (7.5% in BMS vs 8.3% in DES, P = 0.83). The rate of target vessel revascularization was also similar in both groups (4.8% in BMS vs 5.7% in DES, P = 0.80).. Two-year clinical outcomes after PCI with a single large coronary stent (4.0 mm) were excellent. The clinical outcomes were not affected by the type of stent used.

Topics: Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Postoperative Period; Prosthesis Design; Retrospective Studies; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Tubulin Modulators

The first generation of the bioresorbable everolimus drug-eluting vascular scaffold showed signs of shrinkage at 6 months, which largely contributed to late luminal loss. Nevertheless, late luminal loss was less than that observed with bare metal stents. To maintain the mechanical integrity of the device up to 6 months, the scaffold design and manufacturing process of its polymer were modified.. Quantitative coronary angiography, intravascular ultrasound with analysis of radiofrequency backscattering, and as an optional assessment, optical coherence tomography (OCT) were performed at baseline and at a 6-month follow-up. Forty-five patients successfully received a single bioresorbable everolimus drug-eluting vascular scaffold. One patient had postprocedural release of myocardial enzyme without Q-wave occurrence; 1 patient with OCT-diagnosed disruption of the scaffold caused by excessive postdilatation was treated 1 month later with a metallic drug-eluting stent. At follow-up, 3 patients declined recatheterization, 42 patients had quantitative coronary angiography, 37 had quantitative intravascular ultrasound, and 25 had OCT. Quantitative coronary angiography disclosed 1 edge restenosis (1 of 42; in-segment binary restenosis, 2.4%). At variance with the ultrasonic changes seen with the first generation of bioresorbable everolimus drug-eluting vascular scaffold at 6 months, the backscattering of the polymeric struts did not decrease over time, the scaffold area was reduced by only 2.0% with intravascular ultrasound, and no change was noted with OCT. On an intention-to-treat basis, the late lumen loss amounted to 0.19±0.18 mm with a limited relative decrease in minimal luminal area of 5.4% on intravascular ultrasound. OCT showed at follow-up that 96.8% of the struts were covered and that malapposition of at least 1 strut, initially observed in 12 scaffolds, was detected at follow-up in only 3 scaffolds. Mean neointimal growth measured by OCT between and on top of the polymeric struts equaled 1.25 mm(2), or 16.6% of the scaffold area.. Modified manufacturing process of the polymer and geometric changes in the polymeric platform have substantially improved the medium-term performance of this new generation of drug-eluting scaffold to become comparable to those of current drug eluting stents.. URL: http://clinicaltrials.gov. Unique identifier: NCT00856856.

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polymers; Retrospective Studies; Sirolimus; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Humans; Hypoglycemic Agents; Insulin; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Several reports have suggested that stent fractures in sirolimus-eluting stents (SESs) might be related to in-stent restenosis (ISR). However, the role of stent strut fracture in ISR has not been clearly elucidated. Therefore, we investigated the association of the SES fracture and ISR.. From 2003 to 2006, SES implantations with follow-up coronary angiography (CAG) for 628 lesions in 557 patients were analyzed. We reviewed clinical and procedural factors that might affect SES fracture and ISR. The median time interval from stent implantation to follow-up CAG was 9 months (range: 2-30 months).. ISR occurred in 38 patients (5.7%), and 21 stent fractures (3.3%) were identified by follow-up CAG. Fourteen cases occurred in the left anterior descending artery, and seven occurred in the right coronary artery. The binary ISR rate in the stent fracture group was higher compared with that of the nonfracture group (38.1% vs. 4.6%, P<0.001). Predictors of ISR as estimated by multivariate analysis were a stent diameter less than 2.75 mm [odds ratio (OR)=2.76, P=0.012], a stent length over 28 mm (OR=3.30, P=0.024), and stent fracture (OR=11.03, P<0.001) after controlling for the angiographic and clinical risk factors of ISR.. Stent fracture was an independent predictor of ISR and may be one of the crucial mechanisms of ISR after implantation of an SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Prosthesis Failure; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Drug eluting stents have led to a substantial reduction of in-stent restenosis. Stent fracture (SF) is an important cause for the cases of restenosis which still occur. Sites of increased vessel movement, long stents, and overlapping stents have been observed to be more prone to fracture. We report the case of a patient with multiple drug eluting SFs at the site of coronary artery bypass insertion. The decision to implant stents at the site of bypass insertion should be made carefully. SF should be considered when gaps between previously implanted stents are observed.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Thrombosis; Treatment Outcome

A 56 year-old woman underwent percutaneous coronary intervention for a lesion in a small mid-left anterior descending coronary artery (reference vessel diameter by quantitative coronary angiography: 2.11 mm) with a novel drug-eluting stent specifically designed for small vessels, the CardioMind Sparrow stent delivery system. This is a self-expandable sirolimus-eluting nitinol stent directly mounted into a 0.014-inch coronary guidewire. The stent has a very thin strut thickness (67 micron), limiting its radiopacity. A specific X-ray stent-enhancing visualization technique, "StentBoost", allowed clear visualization and understanding of the steps needed for an appropriate release and deployment of the aforementioned stent.

Topics: Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Middle Aged; Prosthesis Design; Radiographic Image Enhancement; Radiography, Interventional; Sirolimus; Treatment Outcome

Stent thrombosis is defined as thrombotic occlusion of a stent resulting in acute coronary syndrome (ACS). However, all thrombotic occlusions of stents might not result in ACS. The present case report describes silent, very late thrombotic occlusion of a drug-eluting stent that was confirmed from specimens removed by directional coronary atherectomy.

Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Electrocardiography; Humans; Male; Middle Aged; Sirolimus; Time Factors; Ultrasonography, Interventional

In percutaneous coronary intervention for chronic total occlusion (CTO), the retrograde approach is an advanced technique. To improve the long-term patency rate, stent implantation is necessary for CTO, however, antegrade stent delivery to the lesion is contraindicated in cases where there is an anomalous origin or deviation of the coronary artery, or the edge of a previously implanted stent extends into the aorta. We report a successful case of retrograde stent implantation via a septal perforator in a patient with marked deviation of the RCA origin. In this case, antegrade stent implantation was difficult because antegrade catheter insertion carried a risk of crush deformation of an ostial stent.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Stenosis; Coronary Vessel Anomalies; Drug-Eluting Stents; Equipment Design; Humans; Male; Metals; Middle Aged; Prosthesis Design; Prosthesis Failure; Radiography, Interventional; Sirolimus; Stents; Treatment Outcome

To evaluate the long-term follow-up of drug-eluting stents (DES) in the treatment of unprotected left main coronary artery (ULMCA).. One hundred and forty-eight patients (mean age 71 +/- 10 years) with ULMCA stenoses underwent percutaneous coronary intervention (PCI) with DES. Mean ejection fraction (EF) was 63 +/- 13% and distal ULMCA was involved in 63.5% of cases. In-hospital outcome showed one intra-procedural death, no stent thrombosis and 2% non Q-wave myocardial infarction (MI). Clinical follow-up was available in all patients (874 +/- 382 days): 10.1% of them had died, 8.8% had target lesion revascularisation (TLR) and 4.1% experienced MI. Major adverse cardiac events (MACE) occurred in 20.3%. Mortality predictors were EF < or = 55% (OR 3.6, 95%-C.I. 1.3-10.1, p = 0.016) and EuroSCORE > or = 6 (OR 3.9, 95%-CI 1.1-14.1, p = 0.037). TLR predictors were distal lesion (OR 8.5, 95%-CI 1.1-15, p = 0.041) and age < 64 years (OR 3.1, 95%-CI 1-9, p = 0.042). MACE predictor was EF < or = 55% (OR 2.4, 95%-CI 1.1-5.2, p = 0.027).. ULMCA stenting with DES is safe, with favourable in-hospital outcome. Long-term results are acceptable with a mortality rate of 10%, a TLR rate of 9%, and a MACE rate of 20%. Low EF and high EuroSCORE predict mortality, while younger age and distal lesions predict TLR. Low EF also predicts MACE.

Topics: Age Factors; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Hospital Mortality; Humans; Kaplan-Meier Estimate; Middle Aged; Odds Ratio; Paclitaxel; Proportional Hazards Models; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stroke Volume; Time Factors; Treatment Outcome

Repetitive mechanical forces within the coronary artery may result in stent fracture after stent implantation, particularly in patients with complex coronary disease. This study sought to estimate the incidence of Cypher stent fracture in patients with moderately severe coronary disease and to identify the angiographic predictors of fractures in patients identified in a global Cypher fracture registry. Stent fracture analysis was performed in 305 patients treated with the Cypher stent in SIRIUS and in 39 patients with stent fractures reported in the Cypher fracture registry. Fractures were classified as isolated strut fractures (type 1, single-strut fracture; type 2, incomplete transverse fracture) and stent fracture (type 3, complete transverse fracture without displacement; type 4, transverse fracture with displacement). Isolated strut fractures were identified in 4 patients (1.3%) enrolled in SIRIUS (type 1 1.0%, type 2 0.3%); no stent fractures were identified. In 39 patients with 44 clinically reported Cypher fractures, isolated strut fractures were present in 15.4% (all type 2) and stent fractures were found in 84.6% (type 3 38.4%, type 4 46.2%). Compared with patients in SIRIUS, patients with clinically reported fractures had much greater lesion complexity, including extensive calcification, angulation > or =45 degrees , lesion length > or =20 mm, proximal vessel tortuosity, total occlusions, and an ostial location. Clinically reported fractures were associated with a high rate of repeat target lesion revascularization (52.6%). In conclusion, stent fracture after Cypher stent placement occurs more often in patients with "ultra"-complex coronary anatomy, but is an uncommon event in patients treated with mild to moderate lesion complexity.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Incidence; Prosthesis Failure; Retrospective Studies; Sirolimus; Time Factors

There is limited information about optimal management of drug-eluting stent (DES) restenosis. This study evaluated the incidences of re-restenosis and re-target lesion revascularization (TLR) after the treatment of sirolimus-eluting stent (SES) restenosis.. A total of 102 lesions in 101 patients who underwent TLR for SES restenosis were classified according to: (1) focal (lesion length < or = 10 mm) or non-focal restenosis (>10 mm); and (2) use of DES for TLR: (1) focal restenosis treated with DES (focal-DES, n=40); (2) focal restenosis treated by balloon angioplasty (focal-balloon, n=31); (3) non-focal restenosis with DES (non-focal-DES, n=17); and (4) non-focal restenosis by balloon angioplasty (non-focal-balloon, n=14). Re-restenosis and re-TLR were observed in 6 (19.4%) and 5 lesions (12.5%) of the focal-DES group, in 13 (65.0%) and 11 (35.5%) of the focal-balloon group, in 7 (50.0%) and 6 (35.3%) of the non-focal-DES group, and in 8 (61.5%) and 7 (50.0%) of the non-focal-balloon group, respectively (P<0.05 for restenosis and TLR between the focal-DES group and other groups).. Re-DES implantation for focal DES restenosis results in lower re-restenosis and re-TLR rates compared to re-DES implantation for non-focal DES restenosis or conventional balloon angioplasty either for focal or non-focal DES restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Hospitals; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Risk Assessment; Sirolimus; Treatment Outcome

We describe two cases of severe, multivessel coronary vasospasm that occurred a few months after placement of sirolimus-eluting stents in patients with severe coronary disease, and involved segments not significantly atheromatous and not previously treated. The literature suggests that biocellular interference with the endothelial equilibrium on the part of drugs eluted from a stent poses a serious risk of tardive and widespread postangioplasty coronary spasm in comparison with the use of a bare-metal stent.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vasospasm; Drug-Eluting Stents; Humans; Intra-Aortic Balloon Pumping; Male; Middle Aged; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Vasodilator Agents

Bifurcation lesions are technically challenging and plagued by a high incidence of restenosis, especially at the side branch orifice, which results in a more frequent need for revascularization during the follow-up period. This report discusses two clinical experiences with a novel side branch ostial stent, the BIGUARD stent, designed for the treatment of bifurcation lesions; procedural success with no in-hospital complications was observed in types IVb and Ia lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Sirolimus; Treatment Outcome

Treatment of lesions associated with coronary artery aneurysms (CAA) remains a challenge. This is especially true in patients presenting with multiple CAA. We, therefore, describe a case of a 48-year-old male with severe multivessel disease related to CAA who was treated using drug-eluting stents to address the stenoses located at the CAA edges. The value of intravascular ultrasound to guide and optimize the results of this complex intervention is emphasized.

Topics: Angioplasty, Balloon, Coronary; Coronary Aneurysm; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure; Everolimus; Humans; Immunosuppressive Agents; Male; Middle Aged; Retreatment; Sirolimus; Ultrasonography, Interventional

A 74-year-old male underwent cardiac catheterization that revealed a chronic total occlusion of the proximal left anterior descending coronary artery (LAD). The right coronary artery provided only faint collateral circulation to the LAD. Multislice computed tomography (MDCT) disclosed that a conus artery took off directly from the aorta and provided good collateral circulation to the LAD. Percutaneous coronary intervention of the LAD was successfully performed using contralateral injection via the isolated conus artery. Whenever sufficient collateral filling is not visualized in a chronically occluded LAD, an isolated conus artery should be considered. MDCT is a helpful tool in this setting.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Collateral Circulation; Contrast Media; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Humans; Image Enhancement; Image Processing, Computer-Assisted; Immunosuppressive Agents; Male; Sirolimus; Tomography, Spiral Computed

The data of long-term outcomes of sirolimus-eluting stent (SES) according to lesion location of unprotected left main coronary artery (LMCA) is scarce.. The purpose of this study was to evaluate the long-term outcomes after implantation of the SES in LMCA.. A total of 84 patients (51 males) who had undergone SES implantation for the treatment of native LMCA stenosis were enrolled. The patients were divided into 2 groups based on angiographic lesion location: those with significant stenosis in the ostium and/or body (group 1; n = 39) and those involving bifurcation (group 2; n = 45).. All of the group 1 patients were treated with simple lesion coverage while different stenting techniques were used in group 2 (cross-over: 44.8%, T: 6.7%, kissing: 37.8%, and crush techniques: 11.1%). The 8-month quantitative angiographic findings and in-hospital and 2 year rates of major adverse cardiac events (MACE) were compared between the 2 groups. Although angiographic success and in-hospital MACE rates were similar in both groups with 1 cardiac death due to acute stent thrombosis in group 2, at 2-year follow-up, the MACE rate was significantly higher in group 2 than in group 1 at 2 years (22.2% vs 2.6%, respectively, P = 0.008). Coronary angiography revealed a significantly higher binary restenosis rate in group 2 compared with group 1 (20% vs 0%, respectively, P = 0.003).. Interventional treatment using SES in left main lesions showed favorable short-term and long-term outcomes in selected patients with lesion location being an important determinant of clinical and angiographic outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

(1) Angioplasty is one method of unblocking a stenosed coronary artery. A metal stent is sometimes placed in the vessel lumen. Drug-eluting stents coated with an immunosuppressant or cytotoxic drug have been developed with the objective of reducing the risk of recurrent stenosis; (2) We examined the available literature on the efficacy and adverse effects of drug-eluting stents, based on the standard Prescrire methodology; (3) We found a plethora of clinical trials of drug-eluting stents, and numerous meta-analyses, reflecting the broad economic implications of the market for these devices. Yet drug-eluting stents appear to be no more effective than bare metal stents in reducing overall morality, cardiac mortality, the risk of myocardial infarction, or stent thrombosis. Few follow-up data are available beyond 4 years; (4) Revascularisation of the treated coronary artery was about half as frequent with drug-eluting stents as with bare metal stents. However, the apparent advantage is difficult to quantify because in some trials the decision to re-operate was based solely on angiographic criteria, leading to more frequent revascularization. Sirolimus-eluting stents appear to be slightly more effective than paclitaxel-eluting stents in terms of the revascularisation rate; (5) In contrast, late thrombosis (more than a year after stent placement) seems to be more frequent with drug-eluting stents than with bare metal stents. This risk can be reduced by long-term antiplatelet treatment (with clopidogrel plus aspirin), but the benefit is offset by the accompanying increased risk of severe haemorrhagic events. Serious allergic reactions have also been reported; (6) In most cases, especially when the risk of restenosis is low or moderate, it is better to use a bare metal stent. Coronary artery bypass grafting should be considered when there is a high risk of restenosis. Drug-eluting stents are just one alternative to surgery.

Topics: Angina, Unstable; Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Hypersensitivity; Meta-Analysis as Topic; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Ticlopidine; Treatment Outcome

There is a hypothesis that advanced neointimal stent coverage may protect against stent thrombosis. In the present study, differences in neointimal growth and prevalence of in-stent thrombus between paclitaxel- and sirolimus-eluting stent (PES and SES) were evaluated by optical coherence tomography (OCT).. Follow-up angiographic and OCT examinations at approximately 6 months were performed for 40 patients (20 PES, 20 SES). Late loss was measured by quantitative coronary angiography. Neointimal hyperplasia (NIH) thickness on stent struts was measured by cross-sectional OCT images at 1 mm intervals. After measuring the NIH area in each cross-section, NIH volume was calculated as integral of NIH area within the stent. Late loss, NIH thickness, and NIH volume were greater for PES than for SES (0.42 +/-0.44 vs 0.13 +/-0.12 mm, 118 +/-141 vs 31 +/-39 mum, 53.2 +/-30.5 vs 24.3 +/-14.0 mm(3); P<0.05, respectively). In-stent thrombus was found more frequently in PES than in SES (50 vs 15%; P=0.02).. Although the degree of neointimal growth in PES was generally greater, in-stent thrombus was more common compared with SES. Presence of thrombus in first-generation drug-eluting stents was not related to advanced neointimal growth.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to compare outcomes among unselected patients undergoing percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES).. Although the benefits of both SES and PES are well-established, studies comparing these stents directly have yielded conflicting results.. We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing nonemergent PCI with either SES or PES implantation.. Between July 2004 and June 2006, 6,035 patients underwent PCI with either SES (n = 3,443) or PES (n = 2,592) at 47 U.S. centers. Baseline clinical and angiographic characteristics were generally similar for the 2 stent types. At 1-year, there were no differences in the primary end point of cardiac death or myocardial infarction (MI) between the SES and PES groups (9.1% vs. 10.0%, p = 0.11) or in any individual end points including cardiac death, nonfatal MI, or stent thrombosis. In unadjusted analyses, target lesion revascularization (TLR) was slightly more common with SES than with PES (4.4% vs. 3.3%, p = 0.048), but this difference was no longer apparent after adjusting for baseline characteristics as well as site-related factors (adjusted hazard ratio: 1.09, 95% confidence interval: 0.78 to 1.50).. Among unselected patients undergoing PCI, adjusted rates of both ischemic complications as well as clinically important restenosis were similar for SES and PES. The unexpected finding that TLR was influenced by site characteristics suggests that the correlation between TLR and angiographic restenosis might be weaker than previously described and warrants further study.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The aim of the present study was to compare the effects of drug-eluting stents (DES) and coronary artery bypass grafting (CABG) in patients suffering from chronic stable angina with multivessel disease, involving significant proximal stenosis in the left anterior descending artery (LAD).. All consecutive patients suffering from chronic stable angina with multivessel disease involving significant proximal LAD stenosis underwent DES implantation (n=600) or CABG (n=709) at our institution. At 2 years, the unadjusted mortality was significantly lower in the DES group than in the CABG group (2.2% vs 5.2%, P=0.004), but the adjusted risk of death was similar (odds ratio (OR) 0.74, 95%CI 0.28-1.97, P=0.555). Furthermore, both the adjusted rate of nonfatal myocardial infarction and cerebrovascular events was also comparable. However, the unadjusted and adjusted risk of major adverse cardiac cerebrovascular events in the DES was significantly higher than in the CABG (13.3% vs 9.6%, OR 2.71, 95%CI 1.56-4.74, P<0.001), which is probably attributed to the higher subsequent revascularization rate after DES implantation.. DES showed comparable long-term mortality for the treatment of multivessel disease involving significant proximal stenosis in LAD in comparison with CABG.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cerebrovascular Disorders; Chronic Disease; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Registries; Reoperation; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Hyperplasia; Myocardial Infarction; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to explore the determinants of neointimal coverage after sirolimus-eluting stent (SES).. Although SES has significantly reduced in-stent restenosis by inhibiting neointimal hyperplasia, insufficient neointimal coverage after stenting might result in adverse outcomes.. We evaluated 28 SES lesions with both angioscopy and intravascular ultrasound (IVUS). Quantitative assessments of the lesions and stent expansion were performed by IVUS at the time of stent implantation, and degree of neointimal coverage was judged by angioscopy at follow-up (11 +/- 6 months) whether the stent struts were embedded by the neointima ("complete/incomplete" neointimal coverage).. "Complete" coverage was identified in 10 (36%), and "incomplete" coverage was identified in 18 (64%). Time from the stenting to angioscopy as well as the lesion and procedural characteristics were similar between the complete and incomplete coverage groups. The IVUS parameters were also similar, except for the final minimum stent cross-sectional area (CSA) (7.0 +/- 1.8 mm(2) in complete vs. 5.3 +/- 1.9 mm(2) in incomplete, p = 0.02) and lumen CSA at the distal reference site (6.1 +/- 1.4 mm(2) in complete vs. 4.9 +/- 1.2 mm(2) in incomplete, p = 0.02). The ratio of the stent area to the vessel area was significantly larger in the complete coverage than in the incomplete coverage group (0.52 +/- 0.11 vs. 0.39 +/- 0.09, p = 0.002).. Adequate stent sizing relative to the vessel size might contribute to the angioscopically complete neointimal coverage after SES implantation.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Angioscopy; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Angioscopy; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Hyperplasia; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Stenosis; Drug-Eluting Stents; Humans; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Although the efficacy and safety of Cypher and Taxus stents for particular patients and lesions had been proven by random clinical trials, their long-term comparative effect for unselected Chinese patients in daily practice is still unknown.. From April 2004 to April 2005, 682 consecutive patients who were implanted with a Cypher stent (C group: n = 456, 57.3 +/- 10.8 years old) or a Taxus stent (T group: n = 226, 57.2 +/- 10.2 years old) in our center were analyzed. A mean 3 year clinical and 7 month angiographic follow-up was performed.. There was no difference in major adverse cardiac events (MACE) rates in the C and T groups (16.4% vs 21.7%; P = .113), and there was also no difference in cardiac death or myocardial infarction (MI) rates in both groups (2.6% vs 1.8%; P = .598, 3.3% vs 3.5%; P = .826 respectively), but target vessel revascularization (TVR) was higher in the T group (10.5% vs 16.4%; P = .036). There was no difference in total stent thrombosis or its components in both groups (total: 3.9% vs 3.5%; P = 1.000, early: 0.2% vs 0.9%; P = .256, late: 0.7% vs 1.3%; P = .404, and very late: 3.1% vs 1.3%; P = .201 respectively). A 7 month angiographic follow-up indicated that both in-stent and in-segment restenosis rate were significantly lower in the C group (11.1% vs 21.0%; P = .034 and 12.2% vs 24.0%; P = .018), and in-stent and in-segment late loss were significantly smaller in the C group (0.18 +/- 0.08 mm vs 0.53 +/- 0.38 mm; P = .000 and 0.17 +/- 0.09 mm vs 0.38 +/- 0.19 mm; P = .000).. Results from this 3 year follow-up, single-center study showed almost the same effective and safe profile for both Cypher and Taxus stents, except for a better reducing restenosis effect in the Cypher stent.

Topics: Angioplasty, Balloon, Coronary; Cardiotonic Agents; China; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Sirolimus

Treatment of bifurcation lesion with a drug-eluting stent (DES) remains problematic. The purpose of this study was to investigate an appropriate treatment strategy for bifurcation lesion with a Sirolimus-eluting stent (SES).. One-hundred-forty-one patients with 169 bifurcation lesions were treated at three centers in Japan using a Sirolimus-eluting stent. Forty-six lesions (39 patients) were treated on side branches, and provisional stenting was performed in these cases. We evaluated the angiographic results and clinical outcomes with this strategy. Patients with acute myocardial infarction were excluded.. After a follow-up period of 184 +/- 65 days, there were no deaths or myocardial infarction (MI), and only one (2.0%) target lesion revascularization (TLR). The strategies used for side-branch treatment were balloon only (83.7%) and T or Modified T stent (16.3%). The final kissing balloon technique was performed on 53.4% overall. In patients with a 6-month follow-up angiogram who had 25 bifurcation lesions (including 5 LMT bifurcation Lesions, 6 LCX-OM Lesions, 13 LAD-Dx lesions, and 1 RCA lesion) that were treated with balloon only, the percent diameter stenosis (%DS) of the side branch at follow-up was similar to that after the procedure (47.2 +/- 34.4% vs. 46.4 +/- 24.1%).. In the treatment of bifurcation lesions using a SES, the results of provisional stenting for the side branch are acceptable. Percent DS of the side branch remained unchanged over time after PCI.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Sirolimus; Treatment Outcome

Topics: Aged; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Follow-Up Studies; Humans; Male; Prosthesis Failure; Sirolimus; Stents; Time Factors

A potential cause of drug-eluting stent restenosis is strut fracture. To date, few cases have been reported in the available literature and a best treatment method has not been established. We describe two cases of sirolimus-eluting stent fracture combined with focal restenosis and also review those previously reported.

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure; Female; Humans; Male; Middle Aged; Recurrence; Sirolimus

Topics: Absorbable Implants; Biocompatible Materials; Coronary Stenosis; Drug-Eluting Stents; Humans; Metals; Polymers; Sirolimus; Thrombosis

Topics: Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Outcome Assessment, Health Care; Prognosis; Registries; Sirolimus; Troponin I; Troponin T

Treatment of ostial coronary lesions represents a challenge for interventional cardiologists. The efficacy of drug-eluting stents (DES) has been demonstrated as improving the outcomes of patients in a few studies. It is not known, however, which DES, sirolimus-eluting stent (SES) versus paclitaxel-eluting stent (PES), is superior for the treatment of ostial lesions.. In this retrospective study, 95 consecutive patients with de-novo ostial lesions underwent coronary SES (n=47, lesions=48) or PES implantation (n=45, lesions=47), and quantitative coronary analysis was performed at the time of stent implantation and subsequently at 8 months post stenting. Ostial lesion was defined as > or =50% diameter stenosis rising within 3 mm of either left anterior descending coronary artery or left circumflex artery or right coronary artery measured by quantitative coronary analysis. Major adverse cardiac events including death, thrombosis, nonfatal myocardial infarction, and target lesion revascularization were compared between the two groups.. Baseline clinical and angiographic characteristics were well balanced between the two groups. At 8 months clinical and angiographic follow-up, overall major adverse cardiac events and target lesion revascularization rates were similar in both groups (6.4 vs. 11.2%, P=0.184; 4.3 vs. 8.9%, P=0.170, respectively). The in-stent and in-segment restenosis were, however, significantly higher in PES group compared with SES group (15.5 vs. 0%, P=0.001; 22.2 vs. 4.3%, P=0.003). Similarly, the late loss in both in-stent and in-segment was significantly higher in the PES group than in SES group (0.65+ or -0.67 vs. 0.16+ or -0.18 mm; 0.68+ or -0.65 vs. 0.15+ or -0.12 mm; P<0.001, respectively).. In this small sample-size, nonrandomized, and nonprospective study, the data indicated that implantation of DES appears safe and effective for the treatment of patients with de-novo ostial coronary lesions, but SES implantation showed more favorable results in respect of restenosis compared with PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Odds Ratio; Paclitaxel; Retrospective Studies; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome

There is some controversy on long-term cardiac outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in diabetes mellitus (DM). We compared cardiac adverse events after SES and PES implantation in patients with DM over a period of 3 year.. A total of 634 patients with DM treated with SES (n = 428) or PES (n = 206) were consecutively enrolled in the KOMATE registry from 2003 to 2004. We assessed major adverse cardiac events (MACEs, cardiovascular death, nonfatal myocardial infarction, ischemia driven target vessel revascularization) and stent thrombosis (ST) according to the definitions set by the Academic Research Consortium.. Propensity score (PS) analysis was performed to adjust different baseline characteristics. The mean follow-up duration was 38 +/- 8 month (at least 36 month and up to 53 month). The 3-year MACE rate did not show a significant difference between the two groups [52 (12.1%) in SES vs. 29 (14.1%) in PES, P = 0.496]. The definite and probable ST at 3 year were similar in both SES and PES [12 (2.8%) in SES vs. 7 (3.4%) in PES, P = 0.681]. There were no differences in hazard ratio for MACE and ST between two stents [MACE, crude: 0.844 (0.536-1.330) and adjusted for PS: 0.858 (0.530-1.389); ST, crude: 0.820 (0.323-2.083) and adjusted for PS: 0.960 (0.357-2.587)].. The present study demonstrated that long-tem cardiac outcomes including ST were not significantly different between SES and PES in patients with DM.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Stenosis; Diabetes Complications; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Korea; Male; Middle Aged; Paclitaxel; Registries; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Patient Selection; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stent (DES) therapy reduces restenosis in patients with diabetes when compared with bare metal stent implantation. There are significant differences between commercially available DES platforms both in terms of design characteristics and clinical outcomes. Randomized active-comparator inter-DES trials powered for clinical endpoints are unlikely to be performed in patients with diabetes, however, direct comparison randomized trials utilizing surrogate endpoints support a superior anti-restenotic efficacy with sirolimus- versus paclitaxel-eluting stents. Thrombotic stent occlusion may be higher in patients with diabetes compared with nondiabetic patients, though there is no clear signal of a safety differential between the two platforms. Insufficient data on comparative performance in diabetics exist in relation to the approved zotarolimus-eluting and everolimus-eluting stent platforms. If all other factors are equal, then there seems to be no reason why the diabetic patient should not receive treatment with the sirolimus-eluting stent, which appears to have superior antirestenotic efficacy in this patient group.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Hypoglycemic Agents; Insulin; Meta-Analysis as Topic; Metals; Paclitaxel; Patient Selection; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Sirolimus; Thrombosis; Treatment Outcome

This study was designed to investigate whether endothelial dysfunction is related to drug-eluting stent (DES) implantation at 6 months after stenting.. Current available DES could delay vessel healing and subsequently impair endothelial function.. Endothelial function was estimated at 6-month follow-up in 75 patients (31 men, mean age 62.1 years) with a DES (39 sirolimus-eluting stents [SES], 36 paclitaxel-eluting stents [PES]), and 10 patients with a bare-metal stent (BMS) to the left anterior descending artery, by incremental acetylcholine (Ach) infusion (20 microg/min, 50 microg/min, 100 microg/min) and nitrate (200 microg/min) into the left coronary ostium. Vascular responses were quantitatively measured in arterial segments 5 mm proximal and distal to DES and compared with corresponding segments in the BMS group and midsegments in the left circumflex artery as a reference nonstented artery. All antianginal agents were withheld for at least 72 h before coronary angiography.. Greater vasoconstriction to Ach was observed in both the SES and PES groups than in the BMS group or control segments of left circumflex artery. Vasoconstriction to Ach was more prominent in arterial segments distal to stents in both SES and PES groups compared with those in the BMS group (p < 0.001). The degree of vasoconstriction to Ach was similar between the SES and PES groups. Endothelium-independent vasodilatation to nitrate did not differ significantly between the study groups.. Abnormal vasoconstriction to Ach was found in the SES and PES groups, especially in arterial segments distal to DES at 6 months after stenting, which suggests that DES has a potential long-term adverse effect on local coronary endothelial dysfunction.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Electrocardiography; Endothelium, Vascular; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Ultrasonography, Interventional; Vasoconstriction

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug-Eluting Stents; Humans; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Automation; Cardiopulmonary Resuscitation; Chest Wall Oscillation; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Risk Assessment; Severity of Illness Index; Sirolimus; Treatment Outcome; Ultrasonography, Doppler

Late Angiographic Stent Thrombosis (LAST) following drug-eluting stent is quite a well recognised entity today with most reported cases having occurred following antiplatelet therapy withdrawal late after stent implantation. Angioplasty of these late thrombotic stent occlusions poses a new technical challenge quite different from usual native vessel thrombotic occlusions, an issue that has not been addressed at length primarily due to the limited numbers and stray nature of the reports. We herein report our experience with percutaneous intervention in five such cases of late stent thrombosis >2 years following drug-eluting stent implantation from a single centre.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Device Removal; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Prosthesis Failure; Retrospective Studies; Risk Assessment; Sampling Studies; Sirolimus; Thrombosis; Time Factors

Cases of stent strut fractures (SSFs) after DES implantation have been reported, but the clinical significance is uncertain. Then we sought to define the incidence and clinical implications of SSFs developed after drug-eluting stent (DES) implantation.. We gathered SSF cases from 13 centers in Korea retrospectively. SSF was defined as angiographically visible interrupted connection of stent struts or fewer visible stent struts at the suspected site than normally looking stented area on intravascular ultrasound (IVUS). Furthermore, we classified the SSFs cases into three patterns (disruption, avulsion, and displacement) according to the interruption site and absence or presence of displacement.. Thirty-seven SSFs (2 disruption, 7 avulsion, 28 displacement) were detected in 35 lesions in 35 patients. All fractured stents were sirolimus-eluting stents (SESs). The incidence of SSFs was 0.84% and the proportion of restenosis related with SSF was 6.3% after SES implantation driven from the data of 8 centers. The average length of stent used was 49 mm, overlapping stenting was performed in 19 lesions (54%), and the average maximal angulation in the initial coronary angiography was 67 degrees . Twenty-four fractures (65%) were associated with focal in stent restenosis and 11 fractures (30%) with target lesion revascularization. No acute coronary syndrome developed.. SSF after DES implantation might be a considerable complication after DES implantation especially after SES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Failure; Retrospective Studies; Sirolimus

This post-marketing surveillance registry is aimed at determining the safety and reliability of the CYPHER Select Sirolimus-eluting stent (SES) in routine clinical practice.. Little information and angiographic follow-up data in large-scale "real world" registry is available for the CYPHER Select SES, an advanced-generation SES.. This was a prospective multicenter (20 centers) registry. 1189 consecutive patients who received at least 1 CYPHER Select SES during daily clinical practice were enrolled. Patients who underwent emergency stenting for acute myocardial infarction were excluded.. The procedure's success rate was 98.3% for CYPHER Select SES implantation, and follow-up rates were 98% with 100% data auditing. Target lesion revascularization (TLR) at 12 months occurred in 60 (5.14%) cases, cardiac death in 13 cases (1.11%), Q wave myocardial infarction (MI) in 5 cases (0.43%), non-Q-MI in 9 cases (0.77%), target vessel revascularization (TVR) in 67 cases (5.74%), and MACE defined as cardiac death, nonfatal MI and TLR in 76 cases (6.51%). MACE-free survival rate at 12 months was 93.7%. Angiographic follow-up at 9 months was performed in 418 (68.3%) lesions treated by CYPHER Select SES. The binary restenosis rate was 4.8% in-stent and 9.6% in-segment. Subgroup analysis showed diabetes, bifurcation lesion and combined use of different stents were independent risk factors of cumulative MACE. In-segment MLD

Topics: Adult; Aged; Aged, 80 and over; China; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Product Surveillance, Postmarketing; Prospective Studies; Registries; Risk Factors; Sirolimus

Reduced coronary endothelium-dependent vasodilation may play a role in the pathophysiology of in-stent restenosis. Moreover, endothelial dysfunction may cause to progression of athetrosclerosis in coronary arteries in patients undergoing percutaneous coronary intervention, especially stent deployment. We believe that the agents improving endothelial dysfunction and healing-enhanced stents, namely vascular endothelial growth factor (VEGF)-eluting stents, estradiol-eluting stents and stents attracting endothelial cells, might take an important role in the prevention of stent restenosis strategies in the near future.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endothelium, Vascular; Estradiol; Female; Humans; Male; Risk Assessment; Sensitivity and Specificity; Severity of Illness Index; Sirolimus; Vascular Endothelial Growth Factors

Topics: Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus

Simultaneous multivessel stent thrombosis is a rare, but can cause catastrophic clinical results. We report a case occurred ST simultaneously in DES and BMS. Our case demonstrated that the use of multiple stents, irrespective of stent type, in multiple coronary artery lesions should be undertaken with great attention in the patient who has multiple adverse clinical predictors such as AMI.

Topics: Adult; Catheterization; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Electrocardiography; Female; Graft Occlusion, Vascular; Humans; Platelet Aggregation Inhibitors; Sirolimus; Stents

Despite excellent clinical results for sirolimus (rapamycin)-eluting stents, the exact mechanisms of antirestenotic activity and affected cellular targets are incompletely understood. Therefore, we determined the presence and tem- porospatial expression pattern of FKBP12, the primary intracellular receptor of rapamycin, in rat carotid arteries after balloon injury, as well as in human in-stent restenosis and primary stable coronary atheroma. FKBP12 expression was assessed by immunohistochemistry. Rat carotid arteries revealed maximal expression in 57.7 +/- 4.0% of neointimal cells at day 7. A large proportion of these FKBP12+ cells showed luminally confined co-expression with dendritic cell markers. Despite a considerably thicker neointima at day 28, presence of FKBP12 decreased (8.5 +/- 1.9%, p = 0.02) with a scattered pattern in luminal and deep neointima. Likewise, human in-stent restenosis atherectomy specimens (time after stent implantation 2-12 months) revealed a comparable extent of cellular rapamycin receptor expression (9.3 +/- 1.0%) that significantly differed from that found in primary stable atheroma (1.3 +/- 0.4%, p < 0.001). In conclusion, the rapamycin receptor is predominantly present during early neointima formation, while mature neointimal atheromas show a relatively low expression without confinement to luminal areas. Co-expression of FKBP12 and dendritic cell markers suggests that dendritic cells may be another important target for early and long-term rapamycin effects.

Topics: Aged; Animals; Atherectomy, Coronary; Cardiovascular Agents; Carotid Artery Injuries; Catheterization; Coronary Restenosis; Coronary Stenosis; Disease Models, Animal; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Rats; Rats, Sprague-Dawley; Sirolimus; Tacrolimus Binding Protein 1A; Time Factors; Tunica Intima

We evaluated the incidence, clinical presentation, and angiographic in-stent restenosis (ISR) pattern of late target lesion revascularization (TLR) after sirolimus-eluting stent (SES) implantation.. Late TLR is an unusual finding beyond 6-9 months after bare-metal stent implantation. However, late TLR after SES implantation has not been sufficiently evaluated.. The study population consisted of 804 patients with 1,020 native lesions that were patent at 6-month follow-up angiogram after SES implantation.. Late TLR was performed in 18 patients with 18 lesions (1.8%) at 24.1 +/- 2.6 months (range; 18-30 months) after SES implantation. Clinical presentation of late TLR patients was silent ischemia in eight patients and recurrent angina in 10 patients, but none had an acute coronary syndrome. Angiographic ISR pattern of late TLR lesions were focal ISR in 12 lesions (67%) and diffuse ISR in six lesions (33%). Serial quantitative coronary angiographic analysis of these lesions showed a minimal lumen diameter of 2.6 +/- 0.5 mm immediately after SES implantation, 2.4 +/- 0.4 mm at 6-month follow-up and 0.7 +/- 0.6 mm at 24-month follow-up (ANOVA P < 0.001). By stepwise multiple logistic regression analysis, the only independent predictor of late TLR was stent length (P < 0.001, OR = 1.040, 95% CI = 1.019-1.061).. Late TLR was performed in 1.8% of 1,020 native lesions that were patent at 6-month follow-up angiogram. Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Two-thirds of late TLR lesions had a focal angiographic ISR pattern.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Probability; Prosthesis Failure; Retreatment; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Statistics, Nonparametric; Survival Rate; Time Factors

Treatment of coronary bifurcation lesions (CBL) remains challenging. This study sought to evaluate a novel dedicated stent system (Frontier stent) by angiographic and clinical comparison with the provisional T-stenting technique using drug-eluting (DES) and bare metal stents (BMS). The study group comprised 105 CBL in 105 patients. 35 consecutive CBL were treated with the Frontier system. The control group of 70 CBL (35 DES, 35 BMS) was pair matched with the former group stratified by the type of CBL (Medina classification) and the reference diameter of the main branch (MB). Clinical, procedural, and quantitative angiographic data (QCA) were obtained in all patients. A follow-up angiography 6 +/- 2-month post-index intervention was performed in 84/105 (80%) patients, clinical 6-month follow-up was available in all patients (100%). All Frontier stent procedures were clinically and angiographically successful. Post-procedural QCA analysis of the MB and the side branches revealed comparable minimal lumen diameters (MLDs) between groups. Moreover, contrast use and radiation exposure were not different between groups. DES use, however, was associated with a significantly lower late lumen (LL) loss in the main and the side branch as compared to the Frontier stent and BMS group. Likewise, MACE rates were lowest in the DES group (6%, P < 0.05 vs. BMS) as compared to the Frontier stent (9%) and the BMS group (16%). The Frontier stent accomplishes treatment of CBL with excellent acute clinical, procedural, and angiographic results. Provisional T-stenting using DES provides superior clinical and angiographic long-term results as compared to BMS and Frontier stents. The results of next generation CBL systems combining a dedicated specific CBL design with DES surfaces are to be awaited.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Female; Humans; Male; Matched-Pair Analysis; Metals; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Treatment Outcome

Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary.. 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS).. The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.

Topics: Aged; Angioplasty, Balloon, Coronary; Case-Control Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Diabetes Mellitus; Diabetic Angiopathies; Drug-Eluting Stents; Equipment Safety; Female; Follow-Up Studies; Hospital Mortality; Humans; Middle Aged; Probability; Prospective Studies; Registries; Risk Assessment; Severity of Illness Index; Sirolimus; Statistics, Nonparametric; Survival Rate; Treatment Outcome

It is now emerging that, in patients who are at high risk for cardiovascular complications and, in particular, those with diabetes, the occurrence of late restenosis and thrombosis after treatment of coronary artery disease with drug-eluting stents is higher than earlier reports have suggested. Therefore, the aim of this study was to assess the prevalence of in-stent restenosis in a cohort of consecutive patients with diabetes treated for coronary disease in 2005 with drug-eluting stents [either sirolimus (58%) or paclitaxel (42%)]. The duration of follow-up was 9.0+/-3.4 months [mean+/-1 standard deviation (S.D.)]. A total of 154 patients (type 2 diabetes: 91%) were included in the study (age: 66+/-10 years), and the total number of implanted stents was 184. Two subjects died from cardiac causes, while myocardial infarction and (un)stable angina were observed in 3 (2%) and 39 (25%) patients, respectively. In-stent restenosis, appraised by angiography, was observed in 17 individuals (11%) after a mean follow-up of five months. Mean HbA(1c) in patients with restenosis was 7.6+/-1.8%. There was no difference in the rate of restenosis with sirolimus-(n=8) compared with paclitaxel-(n=9) eluting stents. Male gender, oral therapy for diabetes and stent diameter were predictors of in-stent restenosis. In conclusion, even over a medium-term period, in-stent restenosis remains a potential risk for coronary diabetic patients treated with drug-eluting devices.

Topics: Aged; Cohort Studies; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Sirolimus; Survival Analysis; Treatment Outcome

When it is difficult to deliver multiple drug-eluting stents (DES) or when size constraints limit DES implantation, bare-metal stents (BMS) may be implanted contiguous to DES. However, the clinical outcomes after overlapping DES and BMS implantation are not known. From September 2004 to June 2006, 4,872 consecutive patients who underwent percutaneous coronary intervention consented to be enrolled in a prospective registry. Of these patients, 44 (0.9%) with de novo lesions were treated with DES and BMS overlap stenting. All patients were followed to 12 months for the assessment of clinical outcomes. The average implanted stent diameter was 2.68 +/- 0.30 mm for DES and 2.35 +/- 0.38 mm for BMS. Overlapping BMS were implanted distal to DES in all but 1 case. One patient (2.3%) experienced acute stent thrombosis and died 2 days after the procedure. No other patient died or had a myocardial infarction during 12 months. The target vessel revascularization rate at 12 months, however, was 31.8%, mainly driven by diffuse in-stent restenosis in the BMS segments. In conclusion, the incidence of DES and BMS overlap stenting is rare in daily practice, but this procedure is associated with a high rate of target vessel revascularization.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Female; Follow-Up Studies; Humans; Male; Myocardial Infarction; Paclitaxel; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome

The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear.. To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell'Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P=0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P=0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients (P=0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction <35%, Charlson comorbidity index, insulin-dependent diabetes, and total lesion length.. In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non-insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Combined Modality Therapy; Comorbidity; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus; Diabetic Angiopathies; Female; Humans; Insulin; Italy; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Risk Factors; Sirolimus; Stents; Tacrolimus; Treatment Outcome

The sirolimus-eluting stent (SES) has dramatically reduced the rate of restenosis in comparison to that with the bare-metal stent (BMS). In previous studies, the minimal luminal diameter (MLD) of lesions treated with a BMS was shown to improve from 6 months to 1 year.. To evaluate 6-month and 1-year outcomes, angiographic follow-up data were analyzed for 285 patients (451 lesions) who underwent successful SES implantation compared to follow-up data for 2,561 patients (3,367 lesions) who underwent BMS implantation.. Angiographic follow-up was performed at 6 months for 396 SES-treated lesions and 2,628 BMS-treated lesions and at 1 year for 322 SES-treated lesions and 1,540 BMS-treated lesions. The 6-month angiographic restenosis rate was significantly lower for SES-treated lesions than for BMS-treated lesions (4.8% vs. 23.4%, p<0.01). From immediately after stent implantation to 6 months, quantitative coronary angiography revealed a significantly larger decrease in MLD of BMS-treated lesions than in MLD of SES-treated lesions (p<0.01). In BMS-treated lesions in which repeat revascularization was not performed at 6 months, MLD increased significantly from 2.08+/-0.63 mm at 6 months to 2.11+/-0.61 mm at 1 year (p<0.01). In SES-treated lesions, however, MLD decreased significantly from 2.55+/-0.56 mm at 6 months to 2.44+/-0.61 mm at 1 year (p<0.05).. From 6 months to 1 year, stenosis of BMS-treated lesions regressed, but stenosis of SES-treated lesions progressed.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Humans; Prosthesis Design; Sirolimus; Time Factors

In selected patient cohorts the polymer-free rapamycin-eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer-based paclitaxel-eluting TAXUS stent (B). To test for equivalency in unselected real-world patients with coronary lesions of various complexities, we retrospectively compared both stent designs.. A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA-analysis at baseline. Clinical follow-up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months.. Nominal stent diameter was 2.96 +/- 0.38 mm in Group A vs. 3.05 +/- 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 +/-13.0 mm vs. 23.63 +/- 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05).. Up to 6 months after PCI of real-world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer-free rapamycin-eluting YUKON stent and the polymer-based paclitaxel-eluting TAXUS stent.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Polymers; Probability; Prognosis; Reference Values; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Analysis; Treatment Outcome; Vascular Patency; Vasodilator Agents

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Prognosis; Prosthesis Failure; Retreatment; Sensitivity and Specificity; Sirolimus; Survival Rate; Treatment Outcome; Vascular Patency

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Polymers; Prognosis; Radiography; Risk Assessment; Sensitivity and Specificity; Sirolimus; Survival Analysis; Treatment Outcome

To assess the safety and efficacy of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in orthotopic heart transplantation (OHT) patients with unprotected left main coronary artery (ULMCA) disease.. Accelerated transplant coronary artery disease occurs in 50% of patients at 5 years and is the major cause of death following OHT. The optimal treatment for ULMCA disease in OHT patients is unknown.. From April 2003 to December 2006, five OHT patients with ULMCA disease underwent PCI with DES at the University of California, Los Angeles, Medical Center.. Technical success was achieved in all five patients. At a median follow-up of 518 days (range 124-990 days), all five patients were alive and free from death, myocardial infarction, and target vessel revascularization. No binary restenosis was present in four patients who underwent surveillance angiography. One patient underwent repeat OHT for progressive left ventricular dysfunction.. In OHT patients, ULMCA PCI with DES is feasible with an excellent technical success rate and is a reasonably palliative treatment option for this difficult patient population.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Graft Rejection; Graft Survival; Heart Failure; Heart Transplantation; Humans; Male; Middle Aged; Palliative Care; Registries; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Rate; Treatment Outcome

This study evaluated the inflammatory reaction at the site of overlapping drug-eluting stents (DES) in a porcine model of in-stent restenosis.. Twenty bare metal stents (BMS) (group I; n=10), 20 sirolimus-eluting stents (SES) (group II: n=10), 20 paclitaxel-eluting stent (PES) (group III: n=10), and 10 PES and 10 SES (group IV: n=10) were overlapped in the left anterior descending coronary arteries of 40 pigs. Follow-up coronary angiography and histopathology were performed at 4 weeks after stenting. For the overlapped segments, the minimal luminal diameter at 4 weeks was smaller in group I than in the other groups (1.78+/-0.13 mm, 2.79+/-0.09 mm, 2.90+/-0.04 mm, 2.80+/-0.07 mm, respectively; p<0.001), and the neointimal area (5.51+/-0.58 mm2, 2.38+/-0.53 mm2, 2.07+/-0.37 mm2, 2.39+/-0.58 mm2, respectively; p<0.001) and area stenosis (68.74+/-4.02%, 27.79+/-4.73%, 23.66+/-3.24%, 27.63+/-4.07%, respectively; p<0.001) were higher in group I than in the other groups; however, the inflammatory score was higher in group III than in the other groups (1.80+/-0.42, 2.10+/-0.32, 2.90+/-0.31, 2.50+/-0.52, respectively; p<0.001) and the endothelization score was lower in group III than in the other groups (2.80+/-0.42, 2.30+/-0.67, 1.30+/-0.48, 2.10+/-0.74, respectively; p<0.001).. Compared with BMS, DES inhibit neointimal hyperplasia, but inflammation and poor endothelization occur at the site of overlapping stents.

Topics: Animals; Cell Proliferation; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Disease Models, Animal; Drug-Eluting Stents; Endothelium, Vascular; Female; Hyperplasia; Inflammation; Paclitaxel; Sirolimus; Stents; Swine; Tunica Intima

Randomized controlled trials indicate that sirolimus-eluting stents (SES) reduce the rates of restenosis and need for subsequent revascularization procedures, but patients enrolled in randomized trials represent a highly selected population. This study examined the performance of SES in a 'real world' setting by comparing the outcomes of trial-eligible versus ineligible patients undergoing percutaneous coronary intervention.. From the US commercial introduction of SES in April 2003 until December 2003, all patients that received an SES at our institution were followed in a prospective registry (n=838). For the purpose of this analysis, the registry population was divided into two groups based on the inclusion and exclusion criteria of the stenosis in a native coronary artery (SIRIUS) trial. The primary endpoint of the study was the rate of target lesion revascularization (TLR) at follow-up. Secondary endpoints included major adverse cardiac events (MACE) such as cardiac death, myocardial infarction, and target vessel revascularization. Clinical follow-up was complete for 92% of patients with a median duration of 14.2 months.. Overall, 296 patients (35.3%) met entry criteria for the SIRIUS trial and thus comprised the SIRIUS eligible group. Patients in the SIRIUS ineligible group (n=542) were more likely to have chronic kidney disease and earlier bypass surgery and had longer mean stent length. At 1 year, TLR occurred in 3.0% of the SIRIUS eligible population and in 9.2% of the SIRIUS ineligible group (P=0.001). The secondary endpoint of cumulative MACE occurred in 6.6% of the SIRIUS eligible versus in 17.7% of the SIRIUS ineligible population (P<0.001). Two patients (0.4%) in the SIRIUS ineligible group had a late stent thrombosis on days 39 and 99, respectively, versus none in the SIRIUS eligible group.. Among 'real world' patients treated with SES, the incidence of TLR and MACE at 1 year was substantially greater among SIRIUS ineligible patients compared with SIRIUS eligible patients. These findings confirm that pivotal clinical trials of drug-eluting stents tend to enroll low-risk patients and that the estimated rates of TLR and MACE derived from such trials may not reflect subsequent outcomes with unrestricted clinical use.

Topics: Aged; Anti-Inflammatory Agents; Coronary Restenosis; Coronary Stenosis; Death; Drug-Eluting Stents; Eligibility Determination; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Revascularization; Patient Selection; Randomized Controlled Trials as Topic; Registries; Reproducibility of Results; Sirolimus

The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology classification scheme has prognostic impact for early and late outcomes when bare-metal stents are used. Its value after drug-eluting stent placement is unknown. The predictive value of this lesion morphology classification system in patients treated using sirolimus-eluting stents included in the German Cypher Registry was prospectively examined. The study population included 6,755 patients treated for 7,960 lesions using sirolimus-eluting stents. Lesions were classified as type A, B1, B2, or C. Lesion type A or B1 was considered simple (35.1%), and type B2 or C, complex (64.9%). The combined end point of all deaths, myocardial infarction, or target vessel revascularization was seen in 2.6% versus 2.4% in the complex and simple groups, respectively (p = 0.62) at initial hospital discharge, with a trend for higher rates of myocardial infarction in the complex group. At the 6-month clinical follow-up and after adjusting for other independent factors, the composite of cumulative death, myocardial infarction, and target vessel revascularization was nonsignificantly different between groups (11.4% vs 11.2% in the complex and simple groups, respectively; odds ratio 1.08, 95% confidence interval 0.8 to 1.46). This was also true for target vessel revascularization alone (8.3% of the complex group, 9.0% of the simple group; odds ratio 0.87, 95% confidence interval 0.72 to 1.05). In conclusion, the modified ACC/AHA lesion morphology classification system has some value in determining early complications after sirolimus-eluting stent implantation. Clinical follow-up results at 6 months were generally favorable and cannot be adequately differentiated on the basis of this lesion morphology classification scheme.

Topics: Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Outcome Assessment, Health Care; Prognosis; Prospective Studies; Registries; Sirolimus; Troponin I; Troponin T

Damage to the polymer coating on sirolimus-eluting stents (SES) may occur when it is delivered through complex lesions such as calcified lesions. The present study evaluated damage to the polymer of SES that could not be delivered into lesions.. SES that could not be delivered into lesions were prospectively collected and examined using a scanning electron microscope.. There were 5 undelivered SES. In all cases, moderate or severe calcification with and without vessel tortuosity were reasons for unsuccessful delivery. Scanning electron microscopy demonstrated damage to the polymer of 4 out of the 5 undelivered SES.. Damage to the polymer coating of SES may occur when delivered through a calcified coronary artery.

Topics: Aged; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure; Female; Humans; Male; Microscopy, Electron, Scanning; Polymers; Prospective Studies; Sirolimus

We present the case of an 86-year-old female with stenosis of the anomalous left main trunk originating from a stenosed ostial right coronary artery. She underwent successful percutaneous coronary intervention using simultaneous sirolimus-eluting kissing stents (SKS) for anomalous bifurcating lesions.

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessel Anomalies; Drug-Eluting Stents; Female; Humans; Sirolimus

This study was aimed to evaluate outcomes of patients with unprotected left main coronary artery (LMCA) stenosis who were treated with drug-eluting stents. Sixty-three consecutive patients with unprotected LMCA stenosis were treated with sirolimus-eluting stents in 52 (83%) patients and paclitaxel-eluting stents in 11 (17%) patients, in whom percutaneous intervention was considered the sole alternative because of high surgical risk and/or patient preference. Urgent percutaneous coronary intervention within 24 hours after angiography was performed in 6 (10%) patients. The patients were predominantly at high surgical risk with 35 (56%) having EuroSCORE >6 and 39 (62%) having Parsonnet score >15. Involvement of the distal LMCA was observed in 46 (73%) patients. Procedural success was achieved in all patients. Intravascular ultrasound was used in 51 (81%) patients. Single-stenting strategy was adopted in 36 (78%) patients with bifurcation stenosis. There were no death, Q-wave myocardial infarction, stent thrombosis, or urgent repeat revascularization events during hospitalization. Over a mean follow-up of 11.7 +/- 7.7 months, 18 (29%) patients experienced major adverse cardiac events, including 3 (5%) deaths, 7 (11%) myocardial infarctions, and 10 (16%) target lesion revascularizations. Stent thrombosis developed in 1 (0.6%) patient at 35 days after the procedure. Bifurcation involvement was an independent predictor of major adverse cardiac events by multivariate analysis (hazard ratio 12.90, 95% confidence interval 1.36 to 122.45, p = 0.0259). In conclusion, drug-eluting stent placement for unprotected LMCA stenosis may be a feasible therapeutic alternative in patients at high surgical risk. However, bifurcation stenosis remains a significant predictor of unfavorable clinical outcome.

Topics: Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Electrocardiography; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Myocardial Revascularization; Paclitaxel; Prospective Studies; Sirolimus; Stents; Treatment Outcome; Tubulin Modulators; Ultrasonography, Interventional

The predictors and clinical significance for stent fracture (SF) in drug-eluting stents (DES) remain unknown. We identified procedural factors leading to SF and its clinical consequences in DES.. Percutaneous coronary interventions were performed on 3,920 patients with DES over 12 months. In-stent restenosis (ISR) of DES was observed in 188 cases with 121 cases (64.4%) receiving a sirolimus-eluting stent (SES) and 67 (35.6%) a paclitaxol-eluting stent (PES).. SF was identified in 35 (18.6%) of the 188 cases. The 35 cases were then compared with 153 cases of ISR without angiographic evidence of SF. SF was identified in 29 (23.9%) SES compared with 6 (9.0%) in PES (P < 0.05). With univariate analysis, additional factors associated with SF included longer mean stented segment length, male gender, overlapping stents, vessel segment angulation >75 degrees , and more stents (all P < 0.05). With multivariate adjustment, three factors, i.e., stenting on a bend >75 degrees (OR = 13.8, 95%CI 3.7 to 51; P < 0.001), SES (OR = 4.1, 95%CI 1.3 to 13.4; P < 0.018) and overlapping stented segments (OR = 3.9, 95%CI 1.1 to 14.1; P < 0.041) were statistically significant independent predictors of SF while larger stent diameter was protective (OR = 0.14, 95%CI 0.04 to 0.70; P < 0.017).. SF proved to be associated with angiographically-documented clinical ISR. Although the exact mechanism is unknown, factors that appear to play a negative role in SF include vessel tortuosity, use of SES and overlapping stents. Larger stent diameter was protective. Further studies are needed to better define the factors important in the mechanism of SF.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cineangiography; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Incidental Findings; Male; Middle Aged; Odds Ratio; Paclitaxel; Prosthesis Design; Prosthesis Failure; Research Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Wisconsin

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cineangiography; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Incidental Findings; Paclitaxel; Prosthesis Design; Prosthesis Failure; Risk Assessment; Risk Factors; Sirolimus; Stress, Mechanical; Time Factors; Treatment Outcome

Flow dynamics and shear stress may influence downstream vessel segments. The aim of this study was to investigate the potential impact of lumen narrowing within sirolimus-eluting stents (SES) on vessel response at adjacent reference sites.. In 135 patients after SES implantation, minimal lumen area (MLA) within the stent and average lumen area at distal or proximal adjacent reference segments (5 mm) were obtained at baseline and follow up. In the smaller in-stent MLA group (MLA <3 mm(2)), lumen area decreased significantly at the distal reference compared with the larger in-stent MLA group (MLA >or=3 mm(2)), although no significant difference was seen at the proximal reference.. In-stent lumen patency may influence vascular responses at adjacent reference segments after SES implantation.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Safety; Sirolimus; Ultrasonography

This is a report of a case in which stent delivery to the lesion location proved difficult because of severely calcified and tortuous proximal vasculature. Efforts to deliver a stent using a buddy wire, anchoring technique and five-in-seven guiding system were unsuccessful, whereas an aspiration catheter enabled stent delivery to the target lesion. This technique offers a potential alternative for cases in which some stent delivery methods are problematic. In addition, this technique may also prevent potential injury to drug-eluting polymer during stent delivery.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Equipment Design; Humans; Male; Middle Aged; Sirolimus; Suction; Treatment Outcome

Although the safety of drug-eluting stents has been under considerable scrutiny, limited real-world follow-up data extending up to 4 years are available. The randomized clinical trials carefully selected patients and are not reflective of everyday practice. From April to October 2002, 508 consecutive patients treated with sirolimus-eluting stents (SES) were enrolled. The control group consisted of 450 patients treated with bare-metal stents during the preceding 6 months. After 4 years of follow-up, the incidence of composite major adverse clinical events (all-cause death, myocardial infarction, or target vessel revascularization) was found to be significantly lower in the SES group (23.0% vs 28.7%, adjusted hazard ratio 0.66, 95% confidence interval 0.51 to 0.86), as were rates of target vessel revascularization (12.2% vs 17.8%, adjusted hazard ratio 0.57, 95% confidence interval 0.39 to 0.83). There were no differences in all-cause mortality (10.5% for SES vs 10.6% for bare-metal stents, p = 0.9) or in the rates of cardiac death (4.5% vs 6.9%, p = 0.1). Although there was no difference in overall stent thrombosis (2.3% vs 2.2%, p = 1.0), SES had a higher rate of very late stent thrombosis (1.4% vs 0%, p = 0.02), balanced by a lower rate of early stent thrombosis (0.4% vs 1.8%, p = 0.05). In conclusion, after 4 years, SES were found to remain safe and effective compared with bare-metal stents. Nevertheless, the higher rate of very late stent thrombosis remains a concern. Longer term follow-up will be required to determine the extent of this problem.

Topics: Age Factors; Case-Control Studies; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus, Type 1; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Netherlands; Registries; Shock, Cardiogenic; Sirolimus; Time Factors

Aorto-ostial lesions (AOL) are technically challenging, given their greater propensity to be calcific and associated with elastic recoil compared to non-ostial lesions. This study set out to assess angiographic and clinical outcomes in patients with AOL treated using either paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES) compared to bare-metal stent (BMS) implantation.. We retrospectively identified 175 consecutive patients with 175 AOL involving the left main, right coronary artery or bypass graft. PES, SES and BMS were implanted in 69, 50 and 56 patients, respectively.. Angiographic and procedural success was 100 and 97.1% for PES, 100 and 94% for SES, and 100 and 94.6% for BMS, respectively (p not significant). At 12 months, the rates of target lesion (8.7% for PES, 4.0% for SES) and target vessel revascularization (3.0% for PES, 8.0% for SES) were significantly lower in the drug-eluting stent group compared to BMS (32.1 and 35.7%, respectively). There was no difference in the rate of death/MI in the BMS versus drug-eluting stent groups (5.4 vs. 2.4%, p = 0.32).. In the treatment of AOL, drug-eluting stents reduce the need for repeat revascularization at 12 month follow-up compared to BMS, with no difference in mortality or MI rate.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Advertising; Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug-Eluting Stents; Government Regulation; Health Education; Humans; Risk; Sirolimus; Television; United States; United States Food and Drug Administration

To evaluate long-term outcomes after drug-eluting stents (DES) implantation in small coronary vessels.. Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been reported to improve both the angiographic and clinical outcomes compared with bare metal stents even in 'real world' settings. Currently, no data is available on long-term outcomes after DES implantation in small vessels.. Since April 2002, our institution has implanted DES, either SES or PES, as a default strategy in all patients irrespective of their clinical presentation. Between October 2002 and September 2003, 197 consecutive patients were enrolled: 107 consecutive patients received at least one 2.25-mm SES (SES group) and 90 consecutive patients received at least one 2.25-mm PES (PES group).. The two cohorts presented with high-risk characteristics. At 2 years, the cumulative incidence of major adverse cardiac events (MACE) in the SES group was significantly lower than that in the PES group (10.3% vs. 23.3%, P=0.02). There were two subacute angiographic stent thromboses in the PES group and none in the SES group. By multivariate analysis, PES utilization (HR 2.37, 95% CI 1.07-5.26), presentation with acute coronary syndromes (ACS) (HR 3.34, 95% CI 1.44-7.70) and multi-vessel disease (MVD) (HR 3.91, 95% CI 1.27-12.0) were identified as independent predictors of MACE.. In an unselected population treated for small vessel disease, SES were associated with significantly better 2-year clinical outcomes than PES. The use of PES and the presentation with ACS and MVD were identified as independent predictors of MACE.

Topics: Aged; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Proportional Hazards Models; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome

The sirolimus-eluting stent (SES) is currently the sole drug-coated stent approved for use in Japan, but there are few reports on its safety and outcomes in Japan.. From May 2004 to February 2005, a total of 297 patients with 402 lesions were treated with SES at 6 hospitals in the Kansai district. Follow-up angiography was performed in 82% of the patients and 80% of the lesions at 182+/-35 days after stenting. Coronary stenosis was evaluated using quantitative coronary angiography. Clinical and angiographic data were analyzed. Minimum lesion diameter was 0.75+/-0.52 mm and the reference diameter was 2.81+/-0.47 mm before stenting. The SES successfully dilated 99.5% of the lesions with few major adverse cardiac events. Restenosis occurred in 4.0% and the target lesion revascularization rate was 3.7%. Restenosis correlated with chronic hemodialysis, calcification, occlusion, ostial lesions, lesions kinked>45 degrees, right coronary artery (RCA) lesions and lesions at the ostium of the RCA.. SES demonstrated a high rate of successful implantation with few complications, and mid-term outcomes were excellent. Patients with lesions at the ostium of the RCA or under chronic hemodialysis developed restenosis.

Topics: Adult; Aged; Aged, 80 and over; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Japan; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

We report 13 cases of coronary stent patients, undergoing a non cardiac surgery. Despite an heterogenous perioperative management of antiplatelet agents, none of these patients developed any significant complications. Recently, several case reports of postoperative drug eluting stent thrombosis have been reported. However, the actual incidence of this dramatic event is not known. This confirms the need to perform prospective studies or registries of patients with coronary stents undergoing non cardiac surgery, in order to propose evidence-based recommendations on perioperative antiplatelet management in such patients.

Topics: Aged; Aged, 80 and over; Anesthesia, General; Coronary Restenosis; Coronary Stenosis; Drug Implants; Female; France; Hematoma; Humans; Incidence; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Postoperative Complications; Prospective Studies; Registries; Sirolimus; Stents; Surgical Procedures, Operative; Thrombophilia; Thrombosis

Stent fracture is uncommon but may have consequences including restenosis. To date, stent fractures reported have been related to aggressive post dilation. We describe a case that involves fracture of a stent deployed to nominal pressure. Unlike most stent fractures reported that involve stent struts only our case demonstrated circumferential disruption with complete separation of the stent segments.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Humans; Middle Aged; Prosthesis Design; Prosthesis Failure; Radiography, Interventional; Sirolimus; Stents; Time Factors; Treatment Outcome

Predictors of cardiac events and restenosis after sirolimus-eluting stent (SES) implantation in small coronary arteries were evaluated.. Although SES implantation has markedly reduced the risk of restenosis, small vessel disease remains a major cause of SES failure.. We prospectively investigated the factors predictive of cardiac events and restenosis in 1,092 consecutive patients who received SES implantation for 1,269 lesions in small coronary arteries (< or = 2.8 mm). Follow-up angiography at 6 months was performed in 751 patients with 889 lesions (follow-up rate 70.3%).. Restenosis (diameter stenosis > or = 50%) was angiographically documented in 65 patients with 77 lesions (8.7%): 55 focal (71.4%), 8 diffuse (10.4%), 2 diffuse proliferative (2.6%), and 12 total (15.6%). Lesion length, stent length, reference artery size, and in-stent restenotic lesions were univariate predictors of restenosis. By multivariate analysis, lesion length (OR 1.04; 95% CI 1.02-1.05; P < 0.001) and in-stent restenotic lesions (OR 3.38; 95% CI 1.80-6.35; P < 0.001) were significant independent predictors of restenosis. During follow-up (23.2 +/- 7.9 months), there were 17 deaths (5 cardiac and 12 noncardiac), 5 nonfatal Q-wave myocardial infarctions, and 42 target lesion revascularizations. The cumulative probability of survival without major adverse cardiac events (MACE) was (96.6 +/- 0.6)% at 1 year and (95.1 +/- 0.7)% at 2 years. In multivariate analysis, lesion length (HR 1.04; 95% CI 1.01-1.07; P = 0.004) and in-stent restenotic lesions (HR 3.29; 95% CI 1.58-6.86; P = 0.001) were independently related to MACE.. SES implantation in small coronary arteries is safe and effective, with lesion length having a major impact on restenosis and MACE.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Male; Middle Aged; Odds Ratio; Predictive Value of Tests; Prospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

The goal of this study was to determine whether three-dimensional (3D) reconstruction of traditional coronary angiography could optimize the choice of drug-eluting stent (DES) length and number during percutaneous coronary intervention (PCI).. Coronary angiography is subject to significant foreshortening artifact that limits the ability of the operator to accurately determine lesion length.. The angiographic images of the target vessels of consecutive PCI procedures were postprocessed using a 3D reconstruction algorithm. The appropriate length and optimal number of DES to span each target lesion were calculated and compared with the number and length of DES actually chosen by the operator.. A total of 42 target vessels were analyzed, and 3D reconstruction was successful in 38/42 (90.5%) of cases. The results of 3D analysis would have changed operator decision making in six cases (16%): in four cases, the stent chosen by the operator was too short requiring an additional DES; in two cases, the chosen DES was too long and exchanged for a shorter one. In each of these six cases, 3D analysis would have determined the correct stent length prior to stent selection. The optimal stent number derived by 3D reconstruction was significantly less than the actual number of stents per lesion used by the operator (1.31 +/- 0.47 versus 1.54 +/- 0.68, P = 0.01), and the optimal stent length trended less than the actual stented length (27.5 +/- 12.8 mm versus 28.7 +/- 14.7 mm, P = 0.23).. 3D reconstruction algorithm of standard coronary angiography is a promising technique to improve DES utilization during PCI.

Topics: Algorithms; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Humans; Image Processing, Computer-Assisted; Immunosuppressive Agents; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Research Design; Sirolimus; Stents; Treatment Outcome

To identify risk factors for clinical-driven target lesion revascularisation (TLR) in patients treated with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in a real-world scenario.. From 1 January 2003 to 18 May 2005, all patients treated with a Cypher or Taxus stent were consecutively registered and followed for 9 months. Re-intervention was driven by clinical symptoms.. Western Denmark Heart Registry.. 4432 patients with 6102 lesions treated with a Cypher (n = 3791 lesions) or Taxus (n = 2311 lesions) stent.. Percutaneous coronary intervention.. TLR, defined as either new percutaneous coronary intervention or coronary artery bypass graft operation of the target lesion, within 9 months from the index procedure.. TLR within 9 months was performed in 2.5% of lesions treated with the Cypher stent and in 3.3% of lesions treated with the Taxus stent (OR 1.36, 95% CI 1.00 to 1.84). After adjustment by multivariate logistic regression, Taxus stent implantation was an independent predictor of TLR (OR 1.43, 95% CI 1.05 to 1.95). Implantation of >1 stent per lesion (OR 1.62, 95% CI 1.13 to 2.33) and reference diameter <2.8 mm (OR 1.42, 95% CI 1.00 to 2.02) were also identified as independent predictors of TLR.. These data from the registry reflect a real-world clinical scenario with operator-driven use of drug-eluting stents and symptom-driven re-intervention. In this setting, use of the Taxus stent, implantation of multiple stents per lesion and stent implantation in small vessels were independent predictors of TLR.

Topics: Analysis of Variance; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Denmark; Drug Delivery Systems; Equipment Design; Humans; Logistic Models; Paclitaxel; Registries; Risk Factors; Sirolimus; Stents; Treatment Outcome

This study was designed to compare coronary collateral function in patients after bare-metal stent (BMS) or drug-eluting stent (DES) implantation.. Drug-eluting stents have an inhibitory effect on the production of cytokines, chemotactic proteins, and growth factors, and may therefore negatively affect coronary collateral growth.. A total of 120 patients with long-term stable coronary artery disease (CAD) after stent implantation were included. Both the BMS group and the DES group comprised 60 patients matched for in-stent stenosis severity of the vessel undergoing collateral flow index (CFI) measurement at follow-up and for the duration of follow-up. The primary end point of the investigation was invasively determined coronary collateral function 6 months after stent implantation. Collateral function was assessed by simultaneous aortic, coronary wedge, and central venous pressure measurements (yielding CFI) and by intracoronary electrocardiogram during balloon occlusion.. There were no differences between the groups regarding age, gender, body mass index, frequency of cardiovascular risk factors, use of cardiovascular drugs, severity of CAD, or site of coronary artery stenoses. Despite equal in-stent stenosis severity (46 +/- 34% and 45 +/- 36%) and equal follow-up duration (6.2 +/- 10 months and 6.5 +/- 5.4 months), CFI was diminished in the DES versus BMS group (0.154 +/- 0.097 vs. 0.224 +/- 0.142; p = 0.0049), and the rate of collaterals insufficient to prevent ischemia during occlusion (intracoronary electrocardiographic ST-segment elevation > or =0.1 mV) was higher with 50 of 60 patients in the DES group and 33 of 60 patients in the BMS group (p = 0.001).. Collateral function long after coronary stenting is impaired with DES (sirolimus and paclitaxel) when compared with BMS. Considering the protective nature of collateral vessels, this could lead to more serious cardiac events in the presence of an abrupt coronary occlusion.

Topics: Aged; Chemotactic Factors; Collateral Circulation; Coronary Stenosis; Coronary Vessels; Cytokines; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Intercellular Signaling Peptides and Proteins; Male; Middle Aged; Paclitaxel; Sirolimus; Stents

The purpose of this study was to examine the outcomes of patients who developed coronary in-stent restenosis (ISR) or stent thrombosis (STH) inside drug-eluting stents (DES).. Drug-eluting stents have markedly reduced the incidence of restenosis. However, when restenosis occurs within a DES, its optimal management remains unclear.. We retrospectively analyzed clinical and angiographic data from 92 patients who underwent revascularization for ISR (n = 84) or STH (n = 8) within a DES at our institution. Regular follow-ups were available up to 2 years. We recorded the occurrence of major adverse cardiac events (MACE), defined as deaths from all causes, myocardial infarction (MI), or target lesion revascularization (TLR), among patients treated by the "DES sandwich" technique or by other treatment methods.. In-hospital MACE included 1 periprocedural MI and 2 deaths. Over a mean follow-up of 15 +/- 6 months, the overall rates of death, MI, and TLR were 8.7%, 2.2%, and 30.6%, respectively. By actuarial analysis, the 12-month TLR and MACE rates were 28.2% and 42.9%, respectively.. Current treatments of ISR or STH in DES are associated with a high long-term rate of MACE.

Topics: Aged; Angioplasty, Balloon, Coronary; Cause of Death; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Equipment Failure; Female; Humans; Male; Middle Aged; Probability; Prognosis; Retreatment; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Survival Rate

Topics: Animals; Antineoplastic Agents; Cell Proliferation; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug Delivery Systems; Endothelium, Vascular; Humans; Mice; Mice, Transgenic; Paclitaxel; Plasminogen Activator Inhibitor 1; Risk Factors; RNA, Messenger; Sirolimus; Stents; Tissue Plasminogen Activator; Up-Regulation

Angiographic pattern of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation was known to be different to that after bare metal stent (BMS) implantation. But the different angiographic patterns of ISR and its prognosis between sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) has not been properly addressed in large scale studies.. We evaluated the angiographic pattern of ISR and their subsequent clinical outcomes in 177 ISR lesions of 163 consecutive patients previously treated with SES (n=97) or PES (n=80) from February 2003 to April 2005.. In angiographic ISR pattern, diffuse ISR was more common in PES implantation (SES vs PES; 23.7% vs 48.7%, p=0.001) mainly because of higher incidence of diffuse intrastent ISR (8.2% vs 33.8%, p<0.001, respectively) whereas focal ISR was more common in SES implantation (76.3% vs 51.3%, p=0.001, respectively) mainly because of higher incidence of focal margin ISR (27.8% vs 2.5%, p<0.001, respectively). Among 177 ISR lesions, clinically driven target lesion revascularization (TLR) was performed in 53.6% in SES implantation and 56.3% in PES implantation (p=0.725).. Angiographic pattern of ISR differed after SES and PES implantation, but their subsequent TLR rate was similar to both types of DES.

Topics: Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Prospective Studies; Sirolimus; Stents

Bifurcated lesions are associated with higher complexity and restenosis. Sometimes implantation of two stents is necessary, requiring larger guiding catheters. We describe the implantation of two drug-eluting stents (DES) utilizing the balloon-crushing technique and 6 Fr catheters.. This was a prospective and observational study of a cohort of 15 consecutive patients with 1 bifurcated lesion treated with 2 DES through a 6 Fr catheter and the balloon-crushing technique between April and November 2005. The baseline characteristics of the patients, lesions and procedures were registered. Clinical follow up was obtained by telephone contact.. Patient age ranged from 71.6+/- 9.4 years; 6 patients (40%) had diabetes; ejection fraction was 56 +/- 12%; radial access was used in 4 patients (26.6%). In 9 patients (60%) the target lesion was the left main artery; in 3 patients (20%) the target lesion was the LAD/diagonal and in the remaining 3 patients (20%), the target lesion was the circumflex/obtuse marginal. The median follow-up period was 316 days. There were 2 sudden deaths: 1 patient whose target lesion was the left main artery died 10 days following the procedure, and the other patient whose lesion was in the in LAD/diagonal died at day-187, 10 days following stent thrombosis. Both of them presented with severe ventricular dysfunction prior to the intervention. One patient required new percutaneous intervention due to in-segment restenosis in the left main artery. The composite major adverse cardiac events at follow up was 5 (33.3%, 2 deaths, 2 non-Q-wave myocardial infarctions and 1 revascularization).. This technique permits the treatment of bifurcated lesions with 2 stents using 6 Fr guiding catheters, which could be very useful in radial access procedures. However, though the angiographic results were very satisfactory, the events observed in the follow-up period require a word of caution about its mid-term safety.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Catheterization; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Probability; Prospective Studies; Risk Assessment; Sirolimus; Stents; Survival Rate; Treatment Outcome

We describe a diabetic patient with a very long lesion in a small and diffusely diseased left anterior descending artery that had 2 sizable and diseased diagonal branches (double-bifurcation lesion). The authors successfully used sirolimus-eluting stents and the sleeve technique to reconstruct the vessel and its 2 bifurcations. The sleeve technique is a modified version of the crush technique. It involves stent placement in the side branch ostium, balloon-crush of the proximal protruding stent segment against the main vessel wall, and reconstruction of the side branch ostium by kissing balloon inflation, followed by stenting of the main vessel and reconstruction of the bifurcation again by a second kissing balloon inflation.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Circulation; Coronary Stenosis; Female; Follow-Up Studies; Humans; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Treatment Outcome; Vascular Patency

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; France; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Device Removal; Female; Follow-Up Studies; Humans; Male; Radiography; Retreatment; Risk Assessment; Sirolimus; Stents; Treatment Outcome

Late loss is becoming an important end point to compare drug-eluting stents; however, little is known about its pattern of distribution. We analyzed the pattern of late loss distribution in sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) in a consecutive cohort of patients. From a cohort of 529 patients treated with drug-eluting stents in 1 year, we selected all patients who underwent angiographic follow-up. Three hundred fifty-nine patients with 592 de novo lesions received SESs (286 lesions) or PESs (306 lesions). Late loss and binary angiographic restenosis were analyzed. Binary restenosis occurred in 56 lesions (19.6%) treated with SESs compared with 53 (17.3%) treated with PESs (p = 0.48). The 2 late loss distributions were skewed to the right and were not normally distributed (p <0.001 for SES, p = 0.003 for PES). Late loss was significantly lower in the SES group (p = 0.03), with a median value of 0.29 mm (interquartile range -0.09 to 0.66) versus 0.41 mm (-0.02 to 0.85) in the PES group. When analyzing only restenotic lesions, late loss had a normal distribution in the SES and PES groups (p = 0.96 and 0.44, respectively) and was similar in the 2 groups (1.75 +/- 0.51 vs 1.82 +/- 0.62, p = 0.48). When evaluating nonrestenotic lesions, late loss was also normally distributed in the 2 groups (p = 0.75 for SES, p = 0.73 for PES) but was significantly lower (p = 0.002) after SES implantation (0.14 +/- 0.39) than after PES implantation (0.27 +/- 0.44). In conclusion, SESs and PESs have a bimodal pattern of late loss distribution. The observed difference in late loss between SES and PES seems to be partly explained by the decrease in late loss after SES implantation in nonrestenotic lesions (where SES approaches "zero late loss"). Thus, late loss may not be a reliable marker of the true efficacy of these devices due to its complex and nongaussian distribution.

Topics: Aged; Cohort Studies; Coronary Angiography; Coronary Stenosis; Endothelium, Vascular; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Time Factors; Tubulin Modulators

Involvement of the proximal LAD is considered an indication for coronary artery bypass graft (CABG) surgery due to the high restenosis rates associated with this location after percutaneous coronary interventions (PCI). This seems to be different, however, when using sirolimus-eluting stents, a finding if proven to be true could have a major impact on clinical decision making regarding the optimal revascularization strategy for these patients.. We analyzed 2274 patients treated for proximal LAD stenoses using SES from the German Cypher Stent Registry. The incidence of TVR and other major clinical adverse events were determined and independent predictors of TVR were specified using a multiple logistic regression model.. Event-free survival was achieved in 89.5% of patients. TVR was performed in 179 patients (7.9%) and the combined incidence of all cause death, myocardial infarction and TVR was 10.5% (231 patients). Independent predictors of TVR were multivessel disease (OR 1.74, 95% CI 1.16-2.62, p = 0.008), stent diameter < or = 2.75 mm (OR 1.61, 95% CI 1.10-2.40, p = 0.02) and the administration of GP IIb/ IIIa antagonists (OR 1.60, 95% CI 1.05-2.60, p = 0.03). TVR rate was as high as 11.2% for 2.5 mm SES and as low as 4.0% for 3.5 mm SES (p < 0.001 for trend test).. TVR among patients treated with SES for proximal LAD stenoses is low and is related in part to operator dependent factors. Treatment with SES should be considered as an effective treatment for these patients.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Female; Humans; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

Drug eluting stents have demonstrated their superiority versus bare metal stents in the reduction of restenosis and major adverse cardiac events. Most studies do not identificate differences between rapamycin and paclitaxel eluting stent.. Retrospective study. We identified all patients treated with rapamycin eluting stents or paclitaxel eluting stents during 2003 and 2004 in our center. We analized major adverse cardiac events incidence in the whole group and we investigated for differences between paclitaxel and rapamicin groups.. 170 patients were included. 98 treated with rapamycin eluting stents and 72 with paclitaxel eluting stents. Medium follow up was 365 days. There were no differences between groups in demographic or periprocedural variables. The incidence of major adverse cardiac events was 3.5% in the entire group (2.0% in rapamycin group and 5.6% in paclitaxel group; p = 0.43).. Drug eluting stents show a low incidence of major adverse cardiac events when they are utilized in usual clinical practice. With regard to this, we have not found differences between most used devices in our environment, rapamycin eluting stents and paclitaxel eluting stents.

Topics: Combined Modality Therapy; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Male; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Time Factors

This observational and clinical follow-up study involved the first 50 patients who were treated with the Janus tacrolimus-eluting carbostent (Sorin Group) at our hospital. The patients' mean age was 66 (10) years, 38% were diabetic, and 56% were admitted with acute coronary syndrome. In total, 56 lesions were treated (52% were type B2/C), of which 12% involved in-stent restenosis, 5% were chronic occlusions, 23% were long lesions (>20 mm), 25% were in small vessels (< or = 2.5 mm), 7% were aorto-ostial lesions, 5% were in vein grafts, and 14% involved angiographically visible thrombus. Some 63 Janus carbostents were implanted (i.e., 1.26 [0.49] stents/patient). A successful outcome was achieved for all lesions. One patient (2%) required reintervention at the target lesion because of acute thrombosis. During a follow-up period of 10 (3) months, eight (16%) major adverse cardiac events occurred: there was one (2%) death due to heart failure and seven patients (14%) required revascularization, in five (10%) cases because of restenosis of the Janus carbostent.

Topics: Adult; Aged; Aged, 80 and over; Coronary Restenosis; Coronary Stenosis; Drug Implants; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Retreatment; Sirolimus; Stents

Concerns have been raised about the long-term safety of drug-eluting stent (DES) implantation due to late angiographic stent thrombosis (LAST). We investigated the incidence and 6-month clinical and angiographic outcomes of LAST after DES versus bare metal stent (BMS) implantation. This study comprised 6,551 patients treated with BMSs (n = 4,104) or DESs (n = 2,447). LAST was defined as angiographically proved stent thrombotic occlusion with acute ischemic symptoms >30 days after stenting. Major adverse cardiac events were defined as death, Q-wave myocardial infarction, and target lesion revascularization. Patients treated with DESs had a significantly higher risk profile than did patients treated with BMSs. There were 8 cases (0.33%) of LAST in the DES group and 7 (0.17%) in the BMS group, showing similar event rates after risk adjustment (adjusted hazard ratio 1.2, 95% confidence interval 0.1 to 18.4, p = 0.9). Four patients with LAST treated with DESs (50%) and 1 treated with BMSs (14%) were associated with discontinuation of antiplatelet therapy. Two cases (25%) of LAST with DESs occurred in patients on aspirin monotherapy and another 2 cases (25%) occurred in patients on dual antiplatelet therapy. There was no case of in-hospital death associated with LAST events. At 6-month follow-up after LAST events, major adverse cardiac events occurred in only 3 patients (43%) in the BMS group. In conclusion, the incidence of LAST was similar after DES and BMS implantations. LAST treated with DESs was associated with antiplatelet therapy discontinuation in a significant number of patients, and LAST events also developed on dual antiplatelet therapy. Patients with LAST and DESs showed favorable outcomes during follow-up.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Incidence; Korea; Male; Middle Aged; Paclitaxel; Postoperative Period; Risk Factors; Sirolimus; Stents; Treatment Outcome

Randomized follow-up studies revealed that sirolimus-eluting stent (SES) has an effect on reducing in-stent restenosis resulting from inhibition of neointimal proliferation comparing with bare metal stent (BMS). These data were obtained from separate patients. However, the response against different kinds of these two stents in the same patient had not yet been described. The present case was planned overlapping hybrid stenting with a SES and a BMS in tandem lesions. Not only intravascular ultrasound but also coronary angioscopy at three months follow-up studies showed that neointimal proliferation had been inhibited both in the SES alone segment and in the overlapping segment comparing with BMS alone segment. Our images clearly demonstrated the different degree of neointimal proliferation between the SES and the BMS in the same patient.

Topics: Angina Pectoris; Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Humans; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Treatment Outcome

Deployment of drug-eluting stents has been associated with late thrombosis and restenosis on withdrawal of antiplatelet agents. We report a complication of inflammation and localized coronary artery aneurysms immediately adjacent to the stent after 4 years of implantation. Late chronic inflammatory responses may evolve for up to 4 years after sirolimus-eluting stent implantation and can cause weakening, erosion, and aneurysms of the coronary arteries.

Topics: Angioplasty, Balloon, Coronary; Coronary Aneurysm; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Follow-Up Studies; Humans; Male; Middle Aged; Pericardium; Prosthesis Failure; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Surgical Flaps; Treatment Outcome; Vascular Surgical Procedures

To assess the clinical prognosis of patients with coronary artery diseases undergoing percutaneous revascularization with drug-eluting stent implantation in the proximal left anterior descending coronary artery.. One hundred and seventy consecutive patients with mean age of 65 years, 49 of them females (29%), undergoing implantation of at least one drug-eluting stent in our medical center. The total number of drug-eluting stents implanted was 189, of which 115 (61%) were sirolimus-eluting (CYPHER) and 74 (39%) were paclitaxel-eluting stents (TAXUS). In 100 (60%) of the cases, multivessel coronary artery disease was present. In 61 (36%) patients another coronary artery segment was treated in addition to the proximal left anterior descending coronary artery. The mean clinical follow-up period was 11 +/- 5 months, and angiographic controls were performed between 6 and 9 months. The final endpoint was a composite of death, acute myocardial infarction and need for reintervention on the anterior descending. The secondary endpoint included the occurrence of restenosis, need for reintervention on the proximal segment of the left anterior descending and stent thrombosis.. The procedure achieved immediate angiographic success in all patients. Two deaths, two acute myocardial infarctions, and two percutaneous coronary reinterventions due to stent thrombosis were recorded during in-hospital stay. At the sixth month of follow-up, an additional cardiac death and three myocardial infarctions were observed; three repeat revascularization procedures were required. Up to the end of the follow-up, three additional deaths, three myocardial infarctions and eight revascularization procedures of the anterior descending, two of them surgical, were verified. Survival free from major adverse cardiac events was 91%. Cardiac mortality was 3%. Binary restenosis in the proximal segment of the left anterior descending coronary artery was 4.1%. Target vessel revascularization-free survival was 94%. No cases of late stent thrombosis were observed.. Percutaneous revascularization of the proximal left anterior descending coronary artery with implantation of drug-eluting stents is a safe and very efficient therapeutic strategy in the short and long terms.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Implants; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Prognosis; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Myocardial bridging is the most common congenital coronary abnormality, and is frequently found on post-mortem cardiac examination. Although often asymptomatic, clinical presentation can vary from unstable angina to sudden cardiac death. Only isolated cases of using drug eluting stents (DES) for bridging segments have been described. Our objective was to retrospectively analyze a series of patients undergoing percutaneous coronary intervention (PCI) with DES for symptomatic myocardial bridging and follow post-procedure outcomes. Results revealed favorable peri-procedural angiographic and short-term clinical results with DES implantation. Although initial data regarding DES implantation for symptomatic myocardial bridging are promising, long-term follow up, particularly related to in-stent restenosis will be important.

Topics: Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Stenosis; Coronary Vessel Anomalies; Drug Delivery Systems; Female; Heart Defects, Congenital; Humans; Male; Myocardial Infarction; Paclitaxel; Prognosis; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Survival Analysis; Time Factors; Treatment Outcome; Vascular Patency

Vascular response at edges of drug-eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative effects.. To compare the vascular responses at edges of sirolimus analogous-eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS).. 306 edges were analyzed in 153 patients treated with drug-eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6-month follow-up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow-up minus basal) was also calculated. Edge restenosis was defined as obstruction >50%.. Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 +/- 22 mm(3) to 72.2 +/- 25 mm(3): P = 0.02) and distal (from 54.4 +/- 22 mm(3) to 59.8 +/- 22 mm(3): P = 0.001) edges.. Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous-eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6-month follow-up.

Topics: Aged; Cardiovascular Agents; Case-Control Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Humans; Prosthesis Design; Prosthesis Failure; Sirolimus; Stents; Treatment Outcome

Drugeluting coronary stents (DES) are increasingly used during percutaneous coronary interventions (PCI). Due to limited budgets in Germany, no special reimbursement has been given for their use and therefore they were mainly used in selected patients.. In order to determine the change in indications in patients treated with a Sirolimus-eluting stent (SES) in daily clinical practice between 2002 and 2005, we analysed data from a prospective multi-centre DES registry, the German Cypher Stent Registry.. From April 2002 until September 2005, 11 507 patients at 132 hospitals, who received at least one SES during their PCI, were included. Between 2002 and 2005, the median age of patients increased from 63 years to 66 years (p for trend <0.0001), whereas the prevalence of prior coronary bypass surgery (p<0.0001) and prior PCI (p<0.001) significantly decreased. Initial presentation of patients was stable over time, with a small increase of patients treated for non-ST elevation myocardial infarction (p=0.05). We found a significant increase in the treatment of complex stenoses (p<0.0001) as well as an increase in the proportion of chronic total occlusions (p<0.01). There was a steady increase in the proportion of patients treated for de novo lesions (p<0.0001), which was accompanied by a relative decrease in the proportion of patients treated for in-stent restenosis (p<0.0001). Concerning interventional characteristics a significant increase in the length of SES implanted per lesion, the numbers of SES implanted per lesion as well as an increase of the proportion of patients treated for more than one stenosis during one intervention could be observed (all p<0.0001). There was a significant decrease in the use of glycoprotein II b/IIIa antagonists during the PCI (2002: 26.5 to 14.2% in 2005, p<0.0001). MACE rates until hospital discharge did not change significantly over time.. Between 2002 and 2005 there were two trends in the use of SES: a) a significant increase in the use of SES for de novo lesions and b) a significant trend to use SES for longer lesions, smaller arteries, more complex lesions and more SES per lesion. In summary these findings indicate that still SES are mainly used in patients with lesions that are at high risk for restenosis.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Germany; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Practice Patterns, Physicians'; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome

Percutaneous intervention for coronary bifurcation lesions has been associated with increased clinical complication rates compared with nonbifurcation lesions, primarily as a result of restenosis. Therefore, there is a need for new techniques. The purpose of this study was to evaluate a new drug-eluting stent and implantation technique for the treatment of de novo coronary bifurcation lesions. The Axxess Plus trial was a prospective multicenter single-arm study that enrolled 139 patients. Each patient received a self-expanding, conically shaped nickel-titanium Axxess Plus biolimus A9-eluting stent at the level of the carina. Depending on the lesion anatomy, additional nonstudy stents were placed distally if necessary. Clinical and angiographic follow-up were scheduled at 6 months after the procedure. The overall rate of target lesion revascularization was 7.5% at 6 months. A mean of 2.4 stents were implanted per patient; 51.2% of patients received a stent to the side branch, 29.4% received balloon angioplasty only, and 20.6% of side branches were not treated. In-stent late loss in the Axxess stents was 0.09 mm. Incidences of angiographic in-stent restenosis were 7.1% in the parent vessel stents and 9.2% in the group receiving stents in the side branch (7.9% excluding bare metal stents placed distal to the Axxess stent), compared with 25% for balloon angioplasty treatment and 12% for no treatment. Late stent thrombosis was observed in 3 cases, 2 of which were associated with confirmed premature cessation of antiplatelet therapy. In conclusion, the Axxess Plus conical stent effectively treats bifurcation lesions alone or in conjunction with other drug-eluting stents.

Topics: Aged; Antibiotics, Antineoplastic; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Female; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Stents

The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently.. Between July 2002 and June 2005, 10,629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group (P=0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group (P=0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group (P=0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction (P=0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization (P<0.00001), and 16.9% in DES and 21.8% in BMS for major adverse cardiac events (P<0.0001). Independent predictors of target-vessel revascularization in the DES group were diabetes mellitus (hazard ratio 1.36, 95% confidence interval 1.06 to 1.76), renal failure (hazard ratio 1.69, 95% confidence interval 1.06 to 2.69), and reference vessel diameter (hazard ratio 0.64, 95% confidence interval 0.45 to 0.93).. In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Clopidogrel; Combined Modality Therapy; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Diabetes Mellitus; Drug Implants; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Registries; Renal Insufficiency; Risk Factors; Sirolimus; Stents; Ticlopidine; Treatment Outcome

Topics: Abciximab; Aged; Angioplasty, Balloon; Antibodies, Monoclonal; Anticoagulants; Clopidogrel; Coronary Artery Disease; Coronary Stenosis; Coronary Thrombosis; Heparin; Humans; Immunoglobulin Fab Fragments; Immunosuppressive Agents; Male; Platelet Aggregation Inhibitors; Sirolimus; Stents; Ticlopidine

Conflicting opinion exists regarding the optimal dose of acetyl salicylic acid (ASA) to be given after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). We sought to evaluate the influence of ASA dose on the incidence of unexplained subacute and late stent thrombosis in the era of DES.. We performed a retrospective analysis of the incidence of subacute and late stent thrombosis in our patient population over a 2-year period. The analysis was limited to patients being discharged and maintained on a daily ASA dose of either 81 mg or 325 mg and having received at least 1 sirolimus-eluting stent.. During the study period, 1,093 patients (1,807 separate PCI procedures) met the inclusion criteria. The incidence of unexplained subacute and late stent thrombosis was 1.1% in the study population (12 out of 1,093 patients). When considering the total number of individual procedures performed on the study population during the study period (1,807 procedures), the incidence of unexplained subacute or late stent thrombosis was 0.7%. Six were subacute and 6 were late thrombosis. No significant difference was observed in the incidence of stent thrombosis between the 2 ASA dose groups. Seven patients had stent thrombosis in the 81 mg group (1.2% of 583 patients), while 5 had thrombosis in the 325 mg group (1% of 510 patients); p = 0.727.. In conclusion, we found no significant difference in the incidence of unexplained subacute or late stent thrombosis with the use of an 81 mg versus 325 mg dose of aspirin post-PCI with sirolimus-eluting stents.

Topics: Administration, Oral; Aged; Angioplasty, Balloon, Coronary; Aspirin; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Dose-Response Relationship, Drug; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Platelet Aggregation Inhibitors; Postoperative Care; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cell Proliferation; Coronary Restenosis; Coronary Stenosis; Drug Implants; Humans; Muscle, Smooth, Vascular; Paclitaxel; Sirolimus; Stents; Tunica Intima

Topics: Acetylcholine; Coronary Angiography; Coronary Stenosis; Dilatation, Pathologic; Drug Implants; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Ultrasonography, Interventional; Vasoconstrictor Agents

Stenting the main vessel with provisional stenting of the side branch (SB) is the method of choice for most bifurcation lesions. There is limited data on which of the two techniques of bifurcation stenting compatible with a provisional approach, culotte or T-stenting, offers the best outcome.. Between February 2004 and October 2005, 80 consecutive patients with bifurcation lesions requiring a second stent on the SB were treated with either culotte (n = 45) or T-stenting (n = 35). Coronary angiograms were analyzed using a quantitative angiography system dedicated to bifurcations. Propensity scores were used to adjust for baseline differences between groups.. Acute procedural success was 100% for both groups. Residual diameter stenosis of the SB ostium was 3.44% +/- 7.39% in the culotte group versus 12.55% +/- 11.47% in the T-stenting group (P < .0001). One patient (2.2%) in the culotte group had subacute thrombosis 2 days after the procedure. The culotte group had a lower target lesion revascularization rate compared with the T-stenting group (8.9% vs 27.3% propensity score adjusted; P = .014) and a trend toward lower major cardiac adverse events at 9 months (13.3% vs 27.3%; P = .051).. Both techniques of provisional SB stenting in bifurcation lesions achieve high procedural success with low complication rates. The culotte technique yields a better immediate angiographic result at the SB ostium, and, using drug-eluting stents, a better clinical outcome at 9 months.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents

Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established.. We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels.. This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of > or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded.. Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07).. Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Coronary Vessels; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Ischemia; Paclitaxel; Sirolimus; Stents

Drug-eluting stents have been developed to reduce the rates of restenosis after coronary angioplasty. Several studies have demonstrated that rapamycin eluting stents are reliable and effective.. To report the experience in our Health Centre with rapamycin-eluting stents.. Forty two stents with rapamicine were implanted to 32 diabetic patients, between June 2002 and December 2004. After the procedure, subjects were clinically followed-up for an average period of 19.9+/-9.9 months, evaluating functional capacity, angina pectoris, dyspnea, need for hospital admission, acute coronary events and cardiac death. In those subjects clinically suspected to have restenosis, a coronary angiography was performed.. Twenty-nine subjects (90.6%) remained asymptomatic, two subjects (6.3%) developed angina pectoris but restenosis was ruled out, and one subject (3.1%) died.. The use of rapamycin-eluting stents in these patients was safe and successful with no evidence of clinic restenosis. These positive results are similar to those reported in the Diabetes Study.

Topics: Angioplasty; Chi-Square Distribution; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Reproducibility of Results; Sirolimus; Treatment Outcome

Favorable early results of percutaneous drug-eluting stents in unprotected left main (LM) disease are available, but outcome data beyond 6 to 10 months are lacking. We evaluated the long-term results of sirolimus-eluting stents (SESs) in patients with LM disease. From November 2002 to December 2004, consecutive patients with LM disease, without contraindications to double antiplatelet therapy and undergoing SES implantation, were enrolled prospectively. The primary end point of the study was occurrence of major adverse cardiovascular events. In total 85 patients were treated with 118 SES and followed for 595 +/- 230 days. Event-free survival rates at 1 year and 2 years were 85.5% and 78.6%, respectively. Only 2 deaths occurred overall (2.4%), the first in-hospital in a very high-risk patient according to the European System for Cardiac Operative Risk Evaluation and the second in a patient with severe systolic dysfunction already at the index procedure). Myocardial infarction was adjudicated in 3 patients (3.6%), 2 occurring periprocedurally and 1 during follow-up for a de novo nontarget lesion. There were 7 (10.8%) target lesion revascularizations at 24 months, with all but 1 percutaneous and in a subject with bifurcation LM disease at baseline. At 9-month angiography, late loss was 0.15 +/- 0.81 mm and restenosis rate was 8.2%. An increased incidence of adverse events was noted in patients undergoing SES after dilation with extremely oversized balloons. No case of stent thrombosis was reported. In conclusion, this single-center experience suggests that percutaneous use of SESs to treat LM disease in unselected high-risk patients is safe and effective even 1 year after implantation.

Topics: Aged; Coronary Angiography; Coronary Stenosis; Disease-Free Survival; Female; Humans; Male; Sirolimus; Stents

Randomised trials in a highly selected patient population have demonstrated a dramatic reduction in the incidence of in-stent restenosis (ISR) following implantation of sirolimus-eluting (S-E) Cypher coronary stents compared with bare metal stents (BMS). The clinical outcome following implantation of S-E stents for treatment of complex, unselected BMS ISR is less well defined. The aim of this study was to assess the safety and efficacy of S-E coronary stents in the treatment of an unselected population of BMS ISR. All patients who received S-E stents for treatment of BMS ISR from May 1 2002-November 30 2003 at a single institution were entered into a prospectively collected database. In-hospital and long-term outcomes were collected. Sixty patients were identified who received S-E stents for the treatment of ISR. Four patients (6%) had undergone previous brachytherapy and 22% were diabetic. The most common target vessel was the left anterior descending coronary artery (40%), and 6% of lesions were in saphenous vein grafts (SVGs). The mean reference diameter was 2.67+/-0.52 (range 1.75-4.0) mm and the mean lesion length was 16.22+/-11.46 (range 3-68) mm. There were no procedural or in-hospital major adverse cardiac events (MACE). Long-term follow-up was available in 59 patients (98%). The 12-month MACE rate (cardiac death, myocardial infarction or target lesion revascularisation) was 12% with a 7% percutaneous coronary intervention rate and a 7% coronary artery bypass graft rate. There were no cardiac deaths and two non-cardiac deaths. Of the seven patients who had clinical restenosis at 12 months, four had previously failed brachytherapy and three involved SVGs. In conclusion, the use of S-E stents appears safe and efficacious in the treatment of an unselected population of BMS ISR with results comparing favourably with historical controls. Further randomised studies are needed to delineate the optimal management of this high risk group of patients.

Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Postoperative Complications; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stent (DES) thrombosis (ST) can be devastating. The study aim was to evaluate intravascular ultrasound (IVUS) predictors for DES thrombosis by comparing IVUS studies after implantation in 13 patients with 14 DES thrombosis lesions with a group of controls (30 lesions in 27 patients) matched for history of chronic renal failure and type of DES. Five patients (38%) discontinued dual antiplatelet therapy at the time of ST. There were 3 in-stent restenosis lesions (21%) treated using DESs in the ST group compared with 0 in the control group (p <0.05). Compared with the control group, IVUS studies in the ST group showed a smaller minimum stent area (4.6 +/- 1.1 vs 5.6 +/- 1.7 mm(2), p = 0.0489). In the ST group, 11 of 14 stents had a minimum stent area < or =5.0 mm(2) compared with 12 of 30 in the control group (p = 0.0392). Minimum stent area in patients who stopped clopidogrel therapy and developed ST (5.30 +/- 1.15 mm(2)) tended to be larger compared with that in patients who developed ST while using clopidogrel (4.24 +/- 0.96 mm(2), p = 0.091). Within the 5-mm-long proximal and distal reference segments analyzed, the ST group had larger proximal reference maximum plaque burdens and smaller minimum lumen areas, along with a tendency toward similar findings in the distal reference segments. In conclusion, IVUS findings at the time of DES implantation in patients who subsequently developed ST showed a smaller minimum stent area (especially in patients who developed ST while using clopidogrel) and more residual disease at the stent edges.

Topics: Aged; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Endosonography; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Predictive Value of Tests; Prognosis; Prosthesis Failure; Retrospective Studies; Sirolimus; Stents

Percutaneous coronary intervention (PCI) of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually resulted in sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents, reviving therefore this indication for PCI despite the absence of direct comparative studies with coronary artery bypass graft surgery.. To assess the acute, mid- and long-term outcomes of patients treated with sirolimus-eluting stents for unprotected LMCA stenoses and to compare them with those treated for protected LMCA disease in the same time period from the German Cypher Registry.. The German Cypher Registry included 6755 patients. Eighty-two patients treated for unprotected LMCA disease were compared with 118 patients treated for protected LMCA stenoses. All patients were treated by sirolimus-eluting stents. The primary end point was death, myocardial infarction (MI) and target vessel revascularisation at 6 months' follow-up. Survival free of MI at the long term was considered as the safety end point.. One-third of the patients in both groups were treated for the distal left main bifurcation. Angiographic success was 98.5% for both groups. The cumulative combined incidence of all-cause death, non-fatal MI and target vessel revascularisation at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (hazard ratio = 0.81 (95% CI 0.37 to 1.74), p = 0.8). At long-term, death/MI were reported among 20.2% (95% CI 13.5% to 29.6%) of the protected group versus 11.8% (95% CI 6.3% to 21.4%) of the unprotected group (p = 0.2).. Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns about treatment of unprotected LMCA disease.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Disease-Free Survival; Drug Implants; Female; Follow-Up Studies; Humans; Male; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome; Tubulin Modulators

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Cardiac allograft vasculopathy is the most common cause of long-term graft failure in adult and pediatric heart transplant recipients. In the absence of a specific treatment for this condition, percutaneous revascularization has been the main palliative treatment in the adult population. Revascularization of pediatric patients, however, is more problematic secondary to the lack of a large pool of outcome data and the encounter of special technical challenges. We present the case of a 5-year-old girl who presented with severe cardiac allograft vasculopathy of her left main coronary artery and was treated with sirolimus stent placement.

Topics: Child, Preschool; Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Female; Heart Transplantation; Humans; Sirolimus; Stents; Treatment Outcome

The effect of insulin therapy on adverse cardiovascular outcomes in diabetic patients has been debated and a reduced benefit in clinical restenosis outcomes after sirolimus stenting has been reported among diabetic patients requiring insulin therapy. We analyzed 297 diabetic patients receiving sirolimus-eluting stents, including 115 (39%) on insulin therapy, and compared outcomes with 541 nondiabetic patients treated consecutively during the same interval. The rates of target lesion revascularization (9.5% vs 3.5%, p = 0.003) and cardiac death or myocardial infarction (MI, 7.1% vs 3.1%, p = 0.012) were significantly higher for diabetic patients. Insulin treatment was independently associated with increased risk for target lesion revascularization (odds ratio [OR] 2.48, 95% confidence interval [CI] 1.22 to 5.00) and cardiac death or MI (hazard ratio [HR] 2.85, 95% CI 1.41 to 5.77), whereas the adjusted risk for diabetic patients not treated with insulin was not significantly different from patients without diabetes for target lesion revascularization (OR 1.32, 95% CI 0.66 to 2.62) or cardiac death or MI (HR 1.04, 95% CI 0.50 to 2.17). In conclusion, diabetes mellitus is associated with increased risk for target lesion revascularization and cardiac death or MI after receiving sirolimus-eluting stenting, and is significantly exaggerated by the requirement for insulin therapy.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Stenosis; Diabetes Mellitus; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Hypoglycemic Agents; Immunosuppressive Agents; Insulin; Israel; Male; Middle Aged; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome

Progression of neointimal stent coverage (NSC) and changes in thrombus were evaluated serially by coronary angioscopy for up to 2 years after sirolimus-eluting stent (SES) implantation.. Serial angioscopic observations were performed in 20 segments of 20 patients at baseline, at 6 months and at 2 years after SES implantation. NSC was classified as follows: 0, uncovered struts; 1, visible struts through thin neointima; or 2, no visible struts. In each patient, maximum and minimum NSC was evaluated. Existence of thrombus was also examined.. The maximum NSC increased from 6 months to 2 years (mean (SD) 1.2 (0.4) vs 1.8 (0.4), respectively, p = 0.005), while the minimum NSC did not change (0.7 (0.5) vs 0.8 (0.4), respectively, p = 0.25). The prevalence of patients with uncovered struts did not decrease from 6 months to 2 years (35% vs 20%, respectively, p = 0.29). Although there were no thrombus-related adverse events, new thrombus formation was found in 5% of 6-month, and in 20% of 2-year follow-up evaluations. The prevalence of thrombus inside the SES at baseline, 6 months and 2 years was similar (40%, 40% and 30%, respectively; p = NS).. Neointimal growth inside the SES progressed heterogeneously. Uncovered struts persisted in 20% of the patients for up to 2 years and subclinical thrombus formation was not uncommon.

Topics: Aged; Angioscopy; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Risk Factors; Sirolimus; Tunica Intima

We previously reported that the 1-year survival-free from target lesion revascularization was 97.4% in patients with chronic total occlusion (CTO) treated with sirolimus-eluting stents (SES). There are currently no long-term results of the efficacy of SES in this subset of lesions. We assessed the 3-year clinical outcomes of 147 patients with CTO treated with either SES or bare metal stents (BMS).. A total of 147 (BMS = 71, SES = 76) patients were included. Four patients died in the BMS group while five patients died in the SES group, P = 0.8; two myocardial infarctions occurred in both groups, P = 0.9; and target vessel revascularization was performed in nine patients in the BMS and seven in the SES group, P = 0.5. The cumulative event-free survival of MACE was 81.7% in BMS group and 84.2% in SES group, P = 0.7. Two patients of the SES group had a coronary aneurism at 3-year angiographic follow-up.. The use of SES was no longer associated with significantly lower rates of target vessel revascularization and major adverse cardiac events in patients with CTOs after 3 years of follow-up compared with BMSs.

Topics: Angioplasty, Balloon, Coronary; Chronic Disease; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Equipment Design; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Netherlands; Proportional Hazards Models; Registries; Retreatment; Sirolimus; Stents; Survival Rate; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Chronic Disease; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Equipment Design; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Netherlands; Registries; Retreatment; Sirolimus; Stents; Survival Rate; Treatment Outcome

Drug-eluting stent (DES) implantation may be associated with endothelial dysfunction. However, changes in long-term endothelial function based on the type of DES remain largely unknown. We assessed coronary endothelial function after DES implantation compared to bare-metal stents (BMS) and determined the differences according to DES type. Patients who had single BMS or DES implantation in the left anterior descending artery and showed no restenosis in follow-up angiography at 6 to 9 months were assigned to the BMS group (5 patients) or DES group (9 sirolimus-eluting stents, SES, and 8 paclitaxel-eluting stents, PES). Endothelium-dependent vasomotion, after intracoronary infusion of acetylcholine, was determined by quantitative coronary angiography. Also, endothelium-independent vasomotion was assessed after nitrate infusion. In the distal and far distal segments, the SES (SES versus BMS, distal: -27.6 +/- 16.3% versus -0.6 +/- 1.6%; P = 0.01, far distal: -24.8 +/- 13.2% versus -0.9 +/- 1.3%; P = 0.02) and PES groups (PES versus BMS, distal: -25.4 +/- 17.1% versus -0.6 +/- 1.6%; P = 0.01, far distal: -26.6 +/- 15.9% versus -0.9 +/- 1.3%; P = 0.01) had similar patterns showing significant vasoconstriction compared with the BMS group. In addition, the DES group showed a significant reduction of diameter in distal (SES: P = 0.001, PES: P = 0.04) and far distal segments (SES: P = 0.002, PES: P = 0.001) compared with proximal and near proximal segments. However, the BMS group did not demonstrate significantly different vasomotion between proximal and distal segments. Vasodilatation by nitrate infusion was preserved in all subjects. SES or PES implantation could be associated with the similar pattern of endothelial dysfunction identified predominantly in the long distal portion of the treated vessel.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Stenosis; Endothelium, Vascular; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Radiography; Sirolimus; Stents; Treatment Outcome; Tubulin Modulators; Vasoconstriction; Vasodilation

We report a case of late multiple stent fractures following the deployment of sirolimus-eluting stents (SESs) for diffuse right coronary artery (RCA) stenosis. A 44-year-old male with hyperlipidemia was referred to our hospital for acute myocardial infarction (AMI). Percutaneous coronary intervention (PCI) was performed for total occlusion of the proximal segment of the RCA, and 5 SESs were consecutively implanted for long, diffuse stenotic lesions. A follow-up coronary angiography (CAG) performed 8 months later revealed strut fractures in the middle of all the stents, except the most proximal one. Multislice computed tomography confirmed the locations of the fractured struts inside of the stents.

Topics: Adult; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Male; Prosthesis Failure; Sirolimus

Treatment of long and diffuse lesions of coronary arteries remains one of most complicated sections of endovascular treatment. From 2003 to 2005 treatment with the use of stents with drug coating was conducted in 198 patients with long and diffuse coronary artery lesions. This made up 26% of total number of patients subjected to percutaneous coronary intervention during this time. Mean age of patients was 58 +/- 11 years, 164 (83%) of them were men, 37 (19%) had chronic occlusions of coronary arteries, in 91 (46%) side branches went out from the damaged segment. Patients were divided in two groups: 1st (n=136) comprised patients with lesion length from 22 to 33 mm, 2nd consisted of patients in whom lesion length exceeded 33 mm. Control group comprised 54 patients with lesion length less than 23 mm subjected to endovascular treatment with the use of stents with drug coating during same period of time. Average length of stented segment was 27.3 +/- 3.6 mm in the first group, 44.5 +/- 9.8 mm in the second group and 14 +/- 3.6 in the control group. Immediate success of the procedure was somewhat lower in group II compared with group I (87 and 91%, respectively). Hemopericardium and cardiac tamponade requiring urgent surgery developed in 2 group II patients (3.2%) during first 2 hours after attempt of recanalization of long chronic occlusions of the anterior descending artery. One patient (1.6%) had small-focal myocardial infarction after procedure, in another patient (1.6%) subacute occlusion developed after stenting of venous graft to the right coronary artery which we failed to eliminate. In the first group in 2 patients (1.4%) small-focal myocardial infarction developed. There were no complications in the control group. In 8 months after procedure angiographic restenosis developed in 6 patients (5%) in the 1st group, in 4 (8%) in the second and in 1 (2%) in the control group, however differences were not significant. Rates of repeat revascularizations of the target stenosis were 3, 5 and 0%, respectively. Of 10 cases of restenosis in patients with long stenoses in 5 cases restenosis was located inside stent and was focal (length less than 10 mm), in 3 cases it was located proximal or distal to stent, and in 2 patients manifested as complete occlusion of the stented segment. Treatment of long and diffuse lesions with the use of stents with drug coating appears safe and effective. Overall rate of development of perioperative complications is higher in treatm

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Prosthesis Failure; Sirolimus; Stents; Tomography, Optical Coherence

In-stent restenosis after implantation of sirolimus-eluting stents (SES) still occur in some cases and stent fracture was recently suggested as a new potential mechanism of restenosis. We report a case of delayed stent strut fracture after percutaneous coronary intervention with SES. Until now, three cases regarding Cypher stent fracture have been reported in the literature. Further investigation should be performed to elucidate the clinical significance of stent fractures of SES.

Topics: Angioplasty, Balloon, Laser-Assisted; Blood Vessel Prosthesis Implantation; Coronary Restenosis; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Middle Aged; Prosthesis Failure; Sirolimus; Stents

Topics: Catheterization; Coronary Stenosis; Humans; Immunosuppressive Agents; Prosthesis Design; Radiography, Interventional; Sirolimus; Stents; Tomography, Optical Coherence

There are fundamental differences between the CYPHER and TAXUS stents, including the drug coatings, polymers and stent platforms. In this registry study, we sought to investigate the procedural success and 30-day outcomes of the patients who were treated with either the CYPHER or TAXUS stents for de novo bifurcation lesions.. A total of 83 patients with 85 de novo bifurcation lesions treated with either the CYPHER or TAXUS stents from June 2002 to May 2004 were recruited for analysis.. True bifurcation lesion, stenosis in both the main vessel and side branch, constituted 39% of the treated lesions. The procedural success was 96% and 93% in CYPHER and TAXUS groups, respectively. Bifurcation stenting was performed in 13% of the overall study population. Two patients each in the CYPHER (8%) and TAXUS (3%) groups had a slight elevation of cardiac enzymes after the procedure. At 30-day follow up, 2 patients in the TAXUS and none in the CYPHER group had subacute stent thrombosis (SAT), leading to myocardial infarction (MI). Urgent target vessel revascularization (TVR) was attempted in these 2 patients, but failed in 1 of them. A total of 6 adverse events (1 stroke, 2 MIs and 3 TVRs) from 4 patients (2 patients with 2 adverse events) in the TAXUS group, and 1 adverse event (TVR) in the CYPHER group were reported. The adverse event rate was slightly, but not significantly, higher in the TAXUS group (7% vs. 4%; p = 1.000).. Our results suggest that the procedural success and 30-day outcomes were similar in patients who had been treated with either the CYPHER or TAXUS stent for de novo bifurcation lesions. The occurrence of SAT in the TAXUS but not in the CYPHER group warrants further evaluation.

Topics: Acute Disease; Aged; Coronary Stenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Registries; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

There is a clear need for a large multicentre trial comparing the efficacy of the two available drug eluting stents, sirolimus and paclitaxel, in diabetic patients with multivessel disease.

Topics: Catheterization; Coronary Stenosis; Diabetic Angiopathies; Drug Implants; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

We present a case of restenosis of a sirolimus drug-eluting stent in the ostium of the right coronary artery due to severe crimping and underexpansion of the stent in an area of heavy calcification, detected by intracoronary ultrasound but not by angiography. We discuss issues relevant to management of the restenotic drug-eluting stent in the aorto-ostial location.

Topics: Aged; Angioplasty, Balloon; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Recurrence; Sirolimus; Stents

This study was performed to evaluate the clinical and serial angiographic outcomes of patients undergoing sirolimus-eluting stent (SES) implantation for unprotected left main coronary artery (LMCA) stenosis.. The efficacy of SES has led to their expanded use for off-label indications, including LMCA disease.. Unprotected LMCA intervention with SES was attempted in 50 patients. Surveillance angiography was performed at three and nine months' follow-up.. The target lesion involved the distal LMCA in 47 patients (94%). In-lesion restenosis occurred in 21 patients (42%), was focal in 85% of cases, and in 82% involved the branch ostia, sparing the LMCA itself. Target lesion revascularization (TLR) occurred in 19 patients (38%) over a mean follow-up of 276 +/- 57 days; TLR was ischemia-driven in 7 patients (14%). Late loss was significantly greater within the left circumflex (LCX) ostium compared to the parent vessel (PV) of the LMCA bifurcation (0.83 +/- 0.89 mm vs. 0.49 +/- 0.72 mm, p = 0.04). Late loss continued to increase between three- and nine-month follow-up. Final minimal luminal diameter and maximal balloon pressure were independent predictors of restenosis of the PV.. Restenosis is a frequent finding when serial angiographic follow-up is performed after SES implantation for unprotected distal LMCA lesions. Restenosis is usually focal, most often involves the LCX ostium, and often occurs without symptoms.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Humans; Male; Sirolimus; Stents

This study sought to determine the clinical and angiographic outcomes after drug-eluting stent (DES)-supported percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO).. There are few data about the efficacy of DES-supported PCI for CTO.. All consecutive patients who had a sirolimus-eluting stent or a paclitaxel-eluting stent implanted for CTO from December 2003 to December 2004 were analyzed. Clinical and angiographic outcomes of patients treated with DES were compared with a case-matched control group of patients treated with bare metal stents (BMS) in the 12 months before the routine use of DES.. Successful DES-supported PCI was performed in 92 patients and 104 CTO. The case-matched control group consisted of 26 patients and 27 CTO successfully treated with BMS. There were no differences between groups in baseline clinical and angiographic characteristics. Stent length in the DES group was higher as compared with that of BMS group (51+/-28 mm vs. 40+/-19 mm, P=0.073). The 6-month major adverse cardiac event (MACE) rate was lower in the DES group as compared with that of BMS group (9.8% vs. 23%, P=0.072). The angiographic follow-rate was 80% in the DES group and 81% in the BMS group. The 6-month restenosis rate was 19% in the DES group and 45% in the BMS group (P<0.001). By multivariate analysis, it was found that in the DES group, the only predictors of restenosis were stented segment length (OR 1.031, 95% CI 1.01-1.06, P=0.009) and a target vessel reference diameter<2.5 mm (OR 6.48, 95% CI 1.51-27.83, P=0.012), while the only predictor of MACE was stent length (OR 1.04, 95% CI 1.01-1.08, P=0.006).. DES implantation for CTO decreases the risk of mid-term restenosis and MACE. Small vessels and diffuse disease requiring the implantation of multiple stents and very long stents for full coverage of the target lesion are still associated with a relatively high risk of restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Case-Control Studies; Chi-Square Distribution; Chronic Disease; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Logistic Models; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Sirolimus; Stents; Treatment Outcome

Late luminal loss after percutaneous coronary intervention, although not normally distributed, has been shown to be monotonically correlated with the probability of binary angiographic restenosis after drug-eluting stent implantation. A recently proposed method has been shown to predict the restenosis rate after sirolimus-eluting stent and paclitaxel-eluting stent implantation using a power transformation of the value of late loss obtained after implantation of the 2 stent types. We used the same method to compute and compare restenosis rates from late loss values observed in the "head-to-head" randomized sirolimus-eluting stent versus paclitaxel-eluting stent comparisons available thus far. Our results showed that the model proposed has a poor overall ability to predict the real incidence and relative risk of restenosis because the use of late loss as an end point tended to overestimate the difference in restenosis, and the derived effect estimate of 1 stent compared with that of the other seemed to be overemphasized with respect to the real risk. We thus believe that further investigations are needed to appraise the real clinical effect of late loss and its reliability as an end point in direct comparative drug-eluting stent trials before its use can be recommended as a clinical surrogate.

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Humans; Immunosuppressive Agents; Paclitaxel; Predictive Value of Tests; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Failure; Treatment Outcome

Topics: Adult; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents; Takayasu Arteritis; Treatment Outcome

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Stenosis; Humans; Image Processing, Computer-Assisted; Male; Sirolimus; Stents; Tomography, Spiral Computed; Tomography, X-Ray Computed

Sirolimus-eluting stent (SES) implantation for the treatment of single coronary lesions is proven to be effective and durable. However, the safety and efficacy of overlapping SES for the treatment of long lesions have not been well established.. We conducted a retrospective analysis to compare the clinical outcomes of overlapping versus nonoverlapping SES.. Fifty-five patients who received overlapping SES were compared with 39 patients who received nonoverlapping SES.. The baseline clinical and angiographic characteristics were balanced between the two study groups. The in-hospital complications were similar between groups, except that non-Q-wave myocardial infarction was significantly higher in the Overlapping SES group when compared with the Nonoverlapping SES group (23.6% vs. 7.7%, P = 0.04). This higher rate of myonecrosis is due to periprocedural side branch compromises, including side branch narrowing, occlusion, and flow reduction. At 30 days and 6 months follow-up, all clinical outcomes were similar between the study groups. In addition, the event-free survival rate was similar between groups (P = 0.87).. The implantation of overlapping SES for the treatment of long, native coronary lesions is feasible and effective but is associated with an increased rate of periprocedural myonecrosis. This phenomenon is caused primarily by side branch compromises, but does not have any adverse impact on late clinical events.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Radiography; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice.. Between April 2002 and September 2005, data were collected on 15,157 patients who underwent implantation of > or =1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7+/-11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18,295 lesions were treated (20,503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade <3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months.. This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Cause of Death; Clopidogrel; Comorbidity; Coronary Disease; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Drug Implants; Female; Fibrinolytic Agents; Follow-Up Studies; Humans; Internet; Male; Middle Aged; Myocardial Infarction; Product Surveillance, Postmarketing; Registries; Risk Factors; Sirolimus; Stents; Thrombosis; Ticlopidine; United States

Diabetics are at an increased risk of restenosis and adverse events after coronary stenting. Drug-eluting stents may, therefore, be useful in these patients. Our objective was to evaluate the use of sirolimus-eluting stents in diabetics with complex coronary lesions.. Between May 2002 and August 2003, we treated 231 patients with 260 complex coronary lesions using sirolimus-eluting stents. Of these patients, 56% did not have diabetes (ND), 22% had non-insulin-dependent diabetes (NIRD), and 20% had insulin-dependent diabetes (IRD). The primary clinical endpoint was target vessel failure at 1 year. The primary angiographic endpoints in the stent were late loss and binary restenosis at 6 months.. At 6 months, late loss was greater in the IRD group (0.35 [0.71] mm) than in the ND group (0,096 [0.54] mm; P =.016) or the NIRD group (0.058 [0.52] mm; P=.017), and restenosis was more frequent (IRD, 16.3%; ND, 6.3%; and NIRD 7.8%; P=.05 for linear trend). At one year, target vessel failure occurred more frequently in the IRD group (IRD, 17.4%; NIRD, 7.7%; ND, 7.7%; P=.07 for linear trend) and the rate of survival free of target vessel failure was lower in the IRD group (82.1%) compared with the ND group (92.3%, P=.06) or the NIRD group (92.3%, P=NS). The only independent predictor of restenosis and target vessel failure was female sex.. Despite IRD patients having greater late lumen loss and more frequent restenosis at six months and a trend towards a poorer clinical outcome at 1 year, no independent relationship was found between type of diabetes and clinical outcome.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Data Interpretation, Statistical; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Prognosis; Sirolimus; Stents; Time Factors; Treatment Outcome

The sirolimus-eluting stent (SES) and the paclitaxel-eluting stent (PES) reduce restenosis in small coronary artery lesions. However, it is not clear which of these stents is superior in terms of clinical outcomes.. The authors retrospectively examined 197 patients with 245 de novo small coronary artery lesions (

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Radiography; Reoperation; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

Late morbidity and death as a result of progressive coronary vascular obliteration remains a major unsolved problem after orthotopic heart transplantation. Various percutaneous catheter intervention (PCI) methods have been used to treat transplant coronary artery disease (CAD), but few reports have assessed the longitudinal results of these procedures. Of 1,440 cardiac transplant patients at University of California, Los Angeles, Medical Center, treated between 1984 and 2004, 65 patients who had undergone orthotopic heart transplantation underwent PCI on a total of 156 coronary artery lesions because of transplant CAD between July 1993 and August 2004. The procedural success rate was 93%. Angiographic follow-up was available for 42 patients and 101 lesions 9.5 +/- 5.8 months after PCI. The global restenosis rate was 36%. Multivariate analysis was used to assess 49 clinical, angiographic, and immunologic variables per lesion. The use of a cutting balloon increased the risk of restenosis (odds ratio 11.5, p <0.01) and the use of stents decreased the risk of restenosis (odds ratio 0.34, p <0.05) compared with other PCI methods. The restenosis rate with drug-eluting stents was 19%, lower than that with bare metal stents (31%). Of the 65 patients, 20 (31%) died within 1.9 +/- 1.8 years after PCI. The actuarial survival rate was 56% at 5 years after the first PCI. In conclusion, although the restenosis rate after PCI was higher than that in nontransplant patients with CAD, the immediate and long-term results were acceptable in this high-risk population. Despite the intense inflammation associated with transplant CAD, drug-eluting stents appeared to reduce the occurrence of restenosis. Compared with historical controls, PCI may also improve the actuarial survival rate of patients undergoing orthotopic heart transplantation.

Topics: Adult; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Reoperation; Sirolimus; Stents; Survival Analysis; Treatment Outcome

The "crush technique" has been proposed as an alternative approach to treat bifurcation lesions because of its predictability and high procedural success rate. However, few data are available regarding its safety and long-term efficacy. We report the long-term clinical outcomes of patients with coronary bifurcation lesions treated with sirolimus-eluting stents using the crush technique. From April 2003 to May 2004, 120 patients with coronary bifurcation lesions were treated with sirolimus-eluting stents using the crush technique. Six months of clinical follow-up was completed in 95.8% of patients. Mean patient age was 64 years; 36% had diabetes mellitus, and the left anterior descending artery/diagonal was the most frequent bifurcation location (69%). Final kissing balloon inflation was performed in 87.5% of patients. Compared with the main vessel, side branch lesions were shorter, with a smaller reference diameter and final in-stent minimum lumen diameter. Procedural success was achieved in 97.5%. At 30 days of follow-up, 1 patient had died of noncardiac causes and 2 patients (1.7%) had subacute stent thrombosis. At 6 months of follow-up, target lesion revascularization was required in 13 patients (11.3%), all of whom had focal restenosis predominantly at the side branch ostium. In conclusion, the crush technique with final kissing balloon inflation can be safely used by experienced operators to treat highly complex bifurcation lesions with sirolimus-eluting stents. The safety profile of this technique is similar to that of other bifurcation stenting techniques reported thus far. Nonetheless, despite the excellent patency rates of the main vessel, the need for revascularization at the ostium of the side branch was not fully eliminated.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Registries; Retreatment; Sirolimus; Stents; Treatment Outcome

A number of percutaneous stenting techniques have been proposed for optimal treatment of bifurcation lesions. However, to date the most favorable interventional approach still remains controversial, since bifurcation lesions are associated with high procedural complication and restenosis rates. In the era of drug-eluting stents, crush stenting technique simplified the procedure, concurrently allowing full lesion coverage. The purpose of the present report is to review three cases treated with crush stenting and to describe in detail the technique and its variations.

Topics: Aged; Aged, 80 and over; Angina Pectoris; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Middle Aged; Paclitaxel; Sirolimus; Stents; Treatment Outcome

We sought to demonstrate the safety and feasibility of an integrated coronary revascularization strategy that combines minimally invasive left internal thoracic artery to left anterior descending coronary artery anastomosis with drug-eluting stent implantation to non-left anterior descending coronary artery lesions.. Over 18 months, 47 consecutive patients with multivessel coronary artery disease underwent thoracoscopic harvesting of the left internal thoracic artery to graft the left anterior descending coronary artery. Anastomoses were constructed by hand, off-pump, and under direct vision through a 4-cm non-rib-spreading, muscle-sparing chest incision. Non-left anterior descending coronary artery lesions were then treated percutaneously using sirolimus- or paclitaxel-eluting stents. Angiographic follow-up was performed in all patients.. Within the first 90 days of hospitalizations, there were no deaths, myocardial infarctions, neurologic events, or wound complications. Forty patients underwent left internal thoracic artery to left anterior descending coronary artery grafting, and 7 patients underwent left internal thoracic artery to left anterior descending coronary artery/diagonal sequential grafting for a total of 54 anastomoses. Angiographic patency scores were FitzGibbon A 96.2% (52/54) and FitzGibbon A + B 100% (54/54). A total of 65 drug-eluting stents were implanted in 61 non-left anterior descending coronary artery coronary lesions of which 49.1% (30/61) were type B2 or C lesions, including 5 left main lesions. Diabetes was present in 53.2% of patients (25/47). At a mean follow-up time of 7.0 +/- 4.8 months, the target lesion or vessel repeat revascularization rate was 6.6% (4/61) for drug-eluting stents and 1.9% (1/54) for left internal thoracic artery to left anterior descending coronary artery grafting. One anastomosis required balloon dilation, but no patients have required repeat coronary artery bypass grafting.. Integrated coronary revascularization using drug-eluting stents is feasible and safe. There are sufficient data to justify a randomized comparison of integrated coronary revascularization with standard coronary artery bypass grafting.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Stenosis; Drug Implants; Endoscopy; Feasibility Studies; Female; Humans; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coronary Stenosis; Humans; Sirolimus; Stents

This study aimed at evaluating reduction in intimal hyperplasia volume following angioplasty using sirolimus-eluting stents (Cypher) compared with thin-strut bare-metal stents (Pixel) in patients with small vessels.. Eighty patients with coronary artery disease were prospectively included in two consecutive series, the first using sirolimus-eluting stents (50) and the second using bare-metal stents (30).. The use of sirolimus-eluting stents reduced: in-stent net volume obstruction [5.0% (SE = 0.77) x 39.0% (SE = 4.72), p < 0.001], in-stent late loss [0.25 mm (SE = 0.03) x 1,11 mm (SE = 0.13), p < 0.001], in-segment late loss [0.30 mm (SE = 0.04) x 0.83 mm (SE = 0.11), p < 0.001], in-stent restenosis (0% x 33.3%, p < 0.001) and in-segment restenosis (4% x 36.7%, p < 0.001). The event-free survival rate was 96% in the sirolimus-eluting stent group versus 86.7% in the bare-metal stent group (BMS) (p = 0.190).. Sirolimus-eluting stents are superior to thin-strut bare-metal stents in reducing intimal hyperplasia (less in-stent obstruction and less late lumen loss) in patients with small vessels. The use of these stents significantly reduced angiographic restenosis at eight months.

Topics: Adolescent; Adult; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coronary Restenosis; Coronary Stenosis; Drug Implants; Female; Follow-Up Studies; Humans; Hyperplasia; Male; Metals; Middle Aged; Prospective Studies; Sirolimus; Stents; Tunica Intima

The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting.. The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes.. We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%.. The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001).. The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Delayed-Action Preparations; Female; Humans; Male; Middle Aged; Paclitaxel; Postoperative Complications; Prognosis; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Acetylcholine; Adult; Coronary Angiography; Coronary Stenosis; Coronary Vasospasm; Coronary Vessels; Drug Implants; Endothelium, Vascular; Humans; Injections, Intra-Arterial; Male; Myocardial Infarction; Nitroglycerin; Sirolimus; Stents; Vasoconstriction; Vasoconstrictor Agents

The cost effectiveness of drug-eluting stents in Canada is debated and deserves further evaluation in high-risk patients.. We performed an economic analysis from the third-party payer perspective based on the clinical results and resource-utilization data of the C-SIRIUS (The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients with Long De Novo Lesions in Small Native Coronary Arteries) trial, which examined the safety and efficacy of sirolimus-eluting stents (SES) versus bare metal stents (BMS) in high-risk patients with single long de novo lesions in small coronary arteries. Only inpatient costs were considered, including physician fees. We postulated that the incremental cost required to avoid a repeat revascularization (RR) procedure with BMS versus simple balloon angioplasty (BA) could be considered the willingness to pay (WTP) to avoid restenosis in Canada. We assessed the incremental cost-effectiveness ratio (ICER) of SES compared with BMS in these high-risk patients compared with WTP. Results are expressed in 2003 Canadian dollars.. With a 7% absolute reduction in the need for RR compared with BA, BMS are associated on average with an ICER of US dollars 12,551/RR avoided (RRA) in Canada. In C-SIRIUS, SES further reduced the need for RR at 1 year from 22% to 4% (p = 0.015) compared with BMS. With a 1.5 stent-to-lesion (STL) ratio and an SES retail price of US dollars 2,700 compared with US dollars 700 for BMS, the ICER of SES versus BMS was US dollars 11,275/RRA -- borderline cost effective compared with the implicit WTP of US dollars 12,551 for such health benefit in Canada. Using a lower STL ratio (1.2) would improve the ICER to US dollars 7941/RRA.. Treatment of long lesions in small vessels with SES increases net healthcare costs. However, the ICER for SES compares favorably with the currently accepted comparator, i.e. BMS, to reduce coronary restenosis -- at least for higher risk patients undergoing single-vessel revascularization.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Canada; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Female; Follow-Up Studies; Health Resources; Humans; Immunosuppressive Agents; Male; Middle Aged; Randomized Controlled Trials as Topic; Reoperation; Risk Factors; Sensitivity and Specificity; Sirolimus; Stents; Treatment Outcome

We evaluated the time-behavior of changes in collateral circulation after successful percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in chronic (>1 month) total occlusions (CTO), and assessed their relationship with myocardial ischemia.. It has been hypothesized that the immediate reduction of collateral flow after PCI of CTO could expose the patients to a higher risk of future ischemic events in the case of vessel reocclusion.. In 42 patients with CTO, two consecutive balloon inflations and final DES deployment were performed after positioning of a pressure guidewire. Minimal lumen diameter (MLD), diameter stenosis (DS), angiographic collateral grading (Rentrop score), myocardial (FFRmyo), coronary (FFRcor), and collateral fractional flow reserve (FFRcoll) were evaluated. Chest pain and the sum of ST-segment elevation (SigmaST) were analyzed to document the occurrence and extent of myocardial ischemia.. Percutaneous coronary intervention induced a progressive improvement of indexes of stenosis severity (MLD, DS, Thrombolysis in Myocardial Infarction flow, FFRmyo, and FFRcor) and a rapid reduction in collateral circulation (FFRcoll and Rentrop score). A progressive worsening of ischemia at each balloon inflation occurred, concomitant with the reduction of collateral circulation. At linear regression analysis, an inverse relationship of FFRcoll with SigmaST (R2 = 0.352, p < 0.001) and angina pain score (R(2) = 0.247, p < 0.001) was observed.. In CTO, collateral circulation, which provides most coronary flow at baseline, rapidly declines after successful stent implantation and the restoration of an antegrade flow. This rapid de-recruitment of collaterals is likely to put such patients at risk of future ischemic events.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Collateral Circulation; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Electrocardiography; Exercise Test; Female; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Stents

In-stent neointimal hyperplasia typically has a homogenous echoreflective appearance during intravascular ultrasound (IVUS) imaging. However, the neointimal hyperplasia of some brachytherapy failure lesions contains a very echolucent, dark zone that has been termed black hole. We sought to investigate the frequency and determinants of black holes (BH) after sirolimus-eluting stent (SES) implantation.. A prospective, consecutive series of 33 intrastent SES restenosis (> 50% neointimal hyperplasia with a minimal lumen area < 4.0 mm2) was studied with IVUS. Patients were divided into 2 groups: 8 patients with BH versus 25 patients without BH.. Fifty percent of the BH cases occurred in saphenous vein graft lesions. BH tissue was noticed in 8% of all patients with in-stent restenosis. Three patients in each group had previous vascular brachytherapy failure (p = 0.1). Compared to non-BH cases, a greater proportion of BH cases occurred after SES treatment of bare-metal stent restenosis (75% vs. 32%; p = 0.035). BH cases presented earlier (89.9 +/- 34.3 vs. 161.3 +/- 78.8 days; p = 0.001) with more severe in-stent restenosis, as indicated by greater absolute and relative amounts of neointimal hyperplasia (41.3 +/- 10.0 vs. 26.9 +/- 19.5 mm3; p = 0.012, and 19.6 +/- 6.8 vs. 10.4 +/- 7.9%; p = 0.0001, respectively).. Echolucent restenotic tissue (black hole) is more often observed in SES restenosis after treatment of saphenous vein graft lesions or treatment of bare-metal stent restenosis. It occurs earlier and is more severe than typical SES failures.

Topics: Aged; Coronary Restenosis; Coronary Stenosis; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Incidence; Male; Metals; Middle Aged; Prospective Studies; Saphenous Vein; Sirolimus; Stents; Ultrasonography, Interventional

Coronary stenting can significantly reduce the restenosis and reocclusion rates after successful balloon angioplasty for chronic total occlusions (CTO). Nevertheless, recanalization of CTO remains among the worst predictors for in-stent restenosis and reocclusion. This multicenter, nonrandomized study assessed the safety and effectiveness of the CYPHER sirolimus-eluting stent in reducing angiographic in-stent late loss in totally occluded native coronary arteries. A total of 25 eligible patients were treated with the CYPHER sirolimus-eluting stent. Baseline clinical and angiographic data were collected and 6-month follow-up angiography and intravascular ultrasound (IVUS) were performed. Clinical follow-up was required at 30 days, 6, 12, 18, and 24 months. Study stent implantation was successful in all patients, with a mean stent length of 28.4 +/- 11 mm. Six-month angiographic outcomes showed that mean lumen diameter stenosis did not change (2.22 +/- 0.56 mm postprocedure; 2.26 +/- 0.60 mm at 6 months follow-up; P = NS). Similarly, mean percent diameter stenosis did not change significantly (15.7 +/- 8.6% postprocedure, 19.3 +/- 11% at follow-up; P = NS). The absolute late lumen loss was -0.03 +/- 0.28 mm with a 6-month in-stent restenosis rate of 0%. IVUS follow-up revealed in-stent obstruction volume of only 4.9 +/- 6.8%. Long-term clinical follow-up showed target lesion revascularization at 12 months was only 4%, with target vessel revascularization of only 12%. The CYPHER sirolimus-eluting stent was safe and effective in the treatment of CTO compared to historical data with bare metal stents.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Chronic Disease; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

To investigate the influence of drug-eluting stent (DES) implantation on clinical and angiographic restenosis.. Registry study of data from the Swedish Coronary Angiography and Angioplasty Registry with a coronary angiographic substudy.. Multi-centre study.. During October 2002 to May 2004 a total of 23 590 percutaneous coronary intervention (PCI) procedures were performed at 25 hospitals. After selection, to achieve comparable groups, a total of 5068 patients of whom 4111 had a bare metal stent (BMS) implanted and 957 had a DES implanted, remained. End-point in the registry follow-up was >50% diameter restenosis at clinically driven reangiography within 12 months after index PCI. The primary end-point in the angiographic substudy was late loss in patients' DES at 6-month angiographic follow-up.. The rate of clinically driven restenosis, within 12 months, in patients receiving DES was less (3.9%) compared with those who received BMS (7.0%). In multivariate analysis the risk of clinical restenosis was one-third for DES compared with BMS (HR 0.36, 95% CI 0.25-0.52). In the angiographic substudy late loss was 0.07+/-0.53 mm (range -0.88 to 1.62). The amount of late loss was related to the presence of diabetes mellitus or not (0.19+/-0.45 mm vs. -0.12+/-0.58 mm), and lack of postdilatation of the stent or not (0.23+/-0.51 mm vs. -0.09+/-0.50 mm).. The use of DES in the Swedish 'real world' is effective in reducing the clinically driven restenosis rate, when compared with patients with BMS treatment. In the angiographic follow-up the average late loss was as low as observed in recent randomized multi-centre trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Delayed-Action Preparations; Disease-Free Survival; Drug Implants; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Multivariate Analysis; Radiographic Image Interpretation, Computer-Assisted; Registries; Sirolimus; Stents; Sweden

We investigated the fate of postprocedural incomplete stent apposition (ISA) after sirolimus-eluting stent (SES) implantation by evaluating long-term intravascular ultrasound findings in 168 consecutive patients (182 de novo lesions). Postprocedural ISA was defined as > or = 1 stent strut that was clearly separated from the vessel wall with evidence of blood speckle behind the strut without overlapping a side branch. After SES implantation, there were 61 ISA sites in 46 stents in 31 patients (23 at the proximal edge, 7 at the distal edge, and 31 within the stent body). There were no clinical, procedural, or intravascular ultrasound measurement differences between patients and lesions with versus without ISA. At follow-up, 15 acute ISA sites (25%) in 11 patients completely resolved and 40 sites (75%) in 20 patients persisted, although 32 of 46 persisting ISA sites (70%) decreased. There was a greater decrease in effective lumen area and a greater increase in peristent plaque area in the complete-resolution group than in the persistent-ISA group. No lesion developed stent thrombosis or in-stent restenosis (angiographic diameter stenosis > 50%). Six acute ISA sites were also associated with new, late acquired ISA, only 1 of which resulted in aneurysm formation. Although most ISAs after SES implantation do not resolve completely, the incidence of restenosis or thrombosis is not affected.

Topics: Acute Disease; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Postoperative Complications; Prosthesis Failure; Sirolimus; Stents; Ultrasonography, Interventional

The aim of this research was to evaluate the plaque prolapse (PP) phenomenon after bare-metal (BMS) and drug-eluting stent (DES) implantation in patients with diabetes mellitus using 3-dimensional volumetric intravascular ultrasound (IVUS).. Plaque prolapse has been observed in up to 22% of patients treated with BMS. Diabetic patients have a larger atherothrombotic burden and may be more prone to have PP. However, the incidence of PP and its clinical impact after DES implantation is unknown.. Three-dimensional IVUS was performed after intervention and at 9-month follow-up in 168 patients with diabetes (205 lesions) treated with bare BX Velocity stents ((BX Velocity/Sonic, Cordis, Johnson & Johnson) (BMS, n = 65), sirolimus-eluting stents (Cypher, Cordis) (SES, n = 69), and paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, Massachusetts) (PES, n = 71). Intravascular ultrasound data at the sites of PP were compared with stented segments without PP in each lesion. Outcomes were evaluated at 9- and 12-month follow-up.. There were 42 sites of PP (BMS = 11, SES = 11, PES = 20, p = NS) in 34 stented segments of 205 (16.6%) lesions. Plaque prolapse was more frequent in the right coronary artery and in chronic total occlusion lesions. Post-procedure PP volume was 1.95 mm3 in BMS, 2.96 mm3 in SES, and 4.53 mm3 in PES. At follow-up, tissue volume increased at PP sites in both BMS and PES, but not after SES. Neointimal proliferation was similar between PP and non-PP sites. Stent thrombosis and restenosis rates were similar between PP and non-PP lesions.. The incidence of PP after implantation of new generation tubular stents in patients with diabetes remains high. Drug-eluting stent implantation was not associated with increased risk of PP. Plaque prolapse was not associated with stent thrombosis or increased neointimal proliferation.

Topics: Aged; Chronic Disease; Coronary Disease; Coronary Stenosis; Diabetic Angiopathies; Drug Delivery Systems; Equipment Design; Female; Follow-Up Studies; Humans; Imaging, Three-Dimensional; Male; Metals; Middle Aged; Multicenter Studies as Topic; Paclitaxel; Prolapse; Randomized Controlled Trials as Topic; Risk Assessment; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Multiple overlapping drug-eluting stents have increasingly been used to treat diffuse coronary disease, but the safety and efficacy of this approach remains unclear. We assayed the clinical and angiographic outcomes after placement of "full metal jacket" stents (stented length >or=60 mm) in 347 consecutive patients (352 lesions) with very long de novo coronary lesions. Mean age was 61.0 +/- 10.1 years, and the mean stented length was 71.9 +/- 13.7 mm. The procedural success rate was 97.7%. Major in-hospital complications (1 death, 2 cases of acute stent thrombosis) occurred in 3 patients (0.7%). Angiographic follow-up data, obtained for 230 (234 lesions) of the 328 eligible patients (70.1%), showed that the restenosis rate was 13.7%. Multivariate analysis found that the reference artery diameter (odds ratio 0.05, 95% confidence interval [CI] 0.01 to 0.33, p = 0.002) and the use of Taxus stents (odds ratio 2.88, 95% CI 1.03 to 8.04, p = 0.043) were significant predictors of restenosis. During follow-up (16.6 +/- 6.9 months), 9 deaths (6 cardiac and 3 noncardiac), 1 nonfatal myocardial infarction, and 13 target lesion revascularizations occurred. The cumulative probability of survival without major adverse cardiac events (cardiac death, Q-wave myocardial infarction, and target lesion revascularization) was 95.4 +/- 1.1% and 91.4 +/- 2.1% at 1 and 2 years, respectively. Left ventricular dysfunction (ejection fraction <45%) was the only predictor of stent thrombosis (hazard ratio 18.24, 95% CI 1.65 to 201.19, p = 0.018) and cardiac death/Q-wave myocardial infarction (hazard ratio 5.37, 95% CI 1.28 to 22.49, p = 0.021). In conclusion, full metal jacket drug-eluting stents may be a safe and effective method to treat diffuse coronary disease and may be a useful treatment option for complex long lesions.

Topics: Adult; Aged; Aged, 80 and over; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Korea; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Myocardial Revascularization; Outcome Assessment, Health Care; Paclitaxel; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Ventricular Dysfunction, Left

We compared the clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a real-world scenario.. In selected patients, SES has been associated with lower late luminal loss than PES. Whether this emerging biological difference could translate into different clinical efficacy in daily practice is presently unknown.. This analysis included 1,676 consecutive patients with de novo coronary lesions treated solely with drug-eluting stents (SES = 992; PES = 684). All patients were enrolled in a dynamic prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR) during follow-up.. Overall, 29% of the patients had diabetes, 23% had prior MI, and 9% had poor left ventricular function. ST-segment elevation MI was diagnosed at admission in 12%. Multivessel intervention was performed in 16%. At 1-year follow-up, SES was associated with a reduced incidence of MACE (9.2% SES vs. 14.1% PES; p = 0.007) and TVR (5.0% SES vs. 10.0% PES; p = 0.0008) compared to PES. A propensity analysis with many clinical and angiographic variables was carried out to adjust for baseline differences. In this analysis, SES was associated with a 44% risk reduction of MACE (hazard ratio 0.56, 95% confidence interval 0.39 to 0.78) and a 55% reduction of TVR (hazard ratio 0.45, 95% confidence interval 0.29 to 0.70). This result was consistent across most subgroups tested. Similar rates of death and MI were observed in the 2 treatment groups.. In this large real-world population, SES improved 1-year clinical results as compared to PES.

Topics: Aged; Coronary Stenosis; Data Collection; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome

Four drug-eluting stents were deployed in the right coronary artery (RCA) of a symptomatic young woman who presented with a chronic total occlusion (CTO) of the RCA. The occlusion was successfully crossed using the recently described STAR technique. However, the patient died suddenly 15 hr later. Autopsy demonstrated a long segment of subintimal stenting in the proximal and mid RCA that was intraluminal in the distal vessel. Acute stent thrombosis in the subintimal stents was responsible for sudden death. This case highlights the potential risk of performing extensive subintimal stenting for CTO.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Chronic Disease; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Fatal Outcome; Female; Humans; Middle Aged; Sirolimus; Stents; Tunica Intima

Topics: Coronary Angiography; Coronary Stenosis; Drug Delivery Systems; Humans; Sirolimus; Stents

Available data indicate that stenting of the left main coronary artery (LMN) is safe and effective. Restenosis remains the main factor limiting the effectiveness of percutaneous coronary intervention (PCI).. To evaluate immediate and long-term results of treatment of patients with LMN disease and low preoperative risk of coronary artery bypass grafting.. Coronary stents were implanted into LMN in 64 patients. The following strategy was applied: drug eluting stent (DES) for LMN diameter < or =3.5 mm (28 subjects) and bare metal stent (BMS) for LMN diameter >3.5 mm (36 subjects). Patients enrolled in the study underwent clinical evaluation and coronary angiography. Immediate effect of the procedure and main adverse cardiac events were assessed: death, myocardial infarction and additional target lesion or non-target lesion revascularization.. Angiographic and clinical effectiveness of the interventions was 100%. Full revascularisation of ischaemic regions of the myocardium was performed. Mean clinical follow-up period was 9.4+/-4.0 months. Neither death nor myocardial infarction occurred. Additional PCIs were performed in 11 (17.2%) patients; however, target vessel revascularisation (TVR) rate within LMN was 9.4% (i.e. 6 subjects with BMS), and non-TVR rate was 7.8% (5 subjects).. LMN stenting is associated with high effectiveness of PCI in patients with low operative risk. Long-term follow-up revealed low incidence of major adverse cardiac events. Strategy of selective use of DESs in the study group produced good clinical outcome. Multivessel disease with LMN stenosis was associated with high rate of additional revascularisation of other vessels. Further improvement of treatment results may be obtained by more common use of DES for multivessel disease and LMN diameters larger than 4.0 mm.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Feasibility Studies; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Risk Factors; Sirolimus; Stents; Treatment Outcome

We examined the records of 38 patients who underwent 41 major and 18 minor noncardiac surgeries after successful drug-eluting stent (DES) implantation (57% sirolimus-eluting stents and 43% paclitaxel-eluting stents) at the Dallas Veterans Affairs Medical Center from April 2003 to January 2006. The mean patient age was 62 +/- 9 years, and all patients were men. A total of 41 major noncardiac surgeries (34% abdominal, 22% vascular, 17% genitourinary, and 27% other) were performed in 28 patients a median of 260 days after DES implantation. Also, 18 minor noncardiac surgeries (44% skin surgery, 44% injections, and 12% other) were performed in 10 patients a median of 297 days after DES implantation. No major adverse cardiac events or death occurred during or after the 41 major (0%, 95% confidence interval 0% to 9%) and 18 minor noncardiac (0%, 95% confidence interval 0% to 19%) surgeries. In conclusion, although our data were limited by the small sample size, they suggest a low risk of major cardiac complications in patients undergoing noncardiac surgery after coronary DES implantation.

Topics: Aged; Coronary Stenosis; Humans; Male; Middle Aged; Paclitaxel; Risk Factors; Sirolimus; Stents; Surgical Procedures, Operative; Texas; Treatment Outcome

A 76-year-old man presented with an anterior myocardial infarction. Coronary angiography showed 99% stenosis in the left anterior descending artery and total occlusion in the left circumflex artery (LCX). After successful percutaneus coronary intervention (PCI) for segment 7, a staged PCI to the LCX with a distal protection system was attempted, but the wire entered the subintima, creating a large dissection and intramural hematoma. Three sirolimus-eluting stents (SES) were implanted to cover the entire hematoma, but 2 weeks later intravascular ultrasound revealed stent malapposition, with healing of the residual hematoma, and vessel enlargement. Optical coherence tomography (OCT) showed the malapposition more clearly. Balloon dilatation successfully achieved apposition of the SES to the vessel wall, but 6 months later it revealed recurrence of malapposition, with the struts covered by thrombus-like tissue. This case suggests that SES implantation treatment of a long intramural hematoma can potentially cause late malapposition because of persistent vessel enlargement related to arterial wall injury and inhibition of neointimal hyperplasia by the SES. OCT is useful in showing the precise condition of the stent struts.

Topics: Aged; Catheterization; Coronary Stenosis; Coronary Vessels; Drug Delivery Systems; Hematoma; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Risk Factors; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima; Ultrasonography

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Humans; Immunosuppressive Agents; Paclitaxel; Risk; Sirolimus; Stents

A 62-year-old woman was admitted because of chest pain. Coronary angiography demonstrated stenosis of the left anterior descending coronary artery, where two bare metal stents had been implanted. Over 5 months in-stent restenosis occurred four times, and was treated at first with angioplasty but finally with two sirolimus-eluting stent insertions. Six months after the second insertion, angiography showed restenosis within one stent. The mechanism underlying this succession of rapid restenoses is unknown, but sirolimus-eluting stents appeared to show relative resistance.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Equipment Design; Female; Humans; Incidence; Metals; Middle Aged; Retreatment; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

This study examined the outcomes of patients who underwent sirolimus-eluting stent (SES) implantation for the treatment of heavily calcified coronary lesions (HCCL) with and without the use of rotational atherectomy (rotablator). We investigated 150 consecutive patients with angiographic evidence of HCCL who underwent SES implantation. Sixty-nine patients underwent SES implantation without the need of rotablator (SES), and 81 patients required rotational atherectomy to modify the plaque and facilitate the delivery of the stent (SES + rotational atherectomy). Clinical success was equivalent in both groups (>98%) and there were no in-hospital outcome differences. At 6 months, the target lesion revascularization rate was 4.9% in SES vs. 4.2% in SES + rotational atherectomy groups, respectively (P = NS). Mortality at 6 months was 7.9% in the SES group vs. 6.8% in the SES + rotational atherectomy group (P = NS). SES performs well in patients with complex HCCL, with a relative low event rate. Lesions requiring rotational atherectomy to facilitate dilation and stenting had similar outcomes after SES implantation to those that could be stented without the need for rotablator.

Topics: Aged; Anti-Inflammatory Agents; Atherectomy, Coronary; Calcinosis; Coronary Restenosis; Coronary Stenosis; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

Late angiographic stent thrombosis (LAST) in a drug-eluting stent has been reported in several studies. Most LAST occur just after discontinuation of antiplatelet therapy. We report the first case of LAST that occurred 21 months after implantation of a Cypher stent and 20 months after discontinuation of clopidogrel, results that suggest a mechanism other than the discontinuation of antiplatelet therapy might be responsible for LAST.

Topics: Adult; Clopidogrel; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Humans; Male; Platelet Aggregation Inhibitors; Sirolimus; Stents; Ticlopidine

Diabetic patients frequently have small-diameter vessels, which increases their risk of restenosis. The aim of this study was to determine the efficacy of sirolimus-eluting stent implantation in these high-risk patients following percutaneous coronary intervention.. Our study population comprised a subset of 85 diabetic patients from the DIABETES (DIABETes and sirolimus Eluting Stent) trial who had very small vessels, defined as those with a reference diameter < or =2.25 mm. In the 100 lesions treated, 49 sirolimus-eluting stents and 51 bare-metal stents were used. Glycoprotein IIb/IIIa inhibitors were used as recommended by the protocol and dual antiplatelet therapy was administered for 1 year.. Baseline clinical and angiographic characteristics were comparable in the two groups. The patients' mean age was 66 (9) years, 42% were women, and 37% were insulin-dependent. On average, the lesion length was 15.0 (9.0) mm and the reference diameter was 1.9 (0.2) mm. At 9-month follow-up, both late lumen loss and the restenosis rate were significantly lower in the sirolimus-eluting stent group than in the bare-metal stent group, at -0.03 (0.3) mm vs 0.44 (0.5) mm (P< .001), and 9.1% vs 39.1% (P=.001), respectively. These differences were also observed in the subgroup of insulin-dependent patients. At 1-year follow-up, the stent thrombosis rate was 0% in the sirolimus-eluting stent group, whereas two patients in the bare-metal stent group presented with stent thrombosis.. Sirolimus-eluting stent implantation in diabetics with very small vessels is safe and effective, even in insulin-dependent patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Clinical Trials as Topic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Data Interpretation, Statistical; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Patient Selection; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; Stents; Survival Analysis; Time Factors; Ultrasonography; Video Recording

The proximal left anterior descending artery (LAD) is a challenging area for percutaneous interventions; therefore, coronary artery bypass grafting is often considered and sometimes performed even in patients with single-vessel disease involving the proximal LAD. This study compares mid-term results of LAD revascularization using drug-eluting stents (Cypher) with minimally invasive direct coronary artery bypass grafting (MIDCAB).. From May 2002 to December 2003, 376 consecutive patients underwent myocardial revascularization of the LAD, 272 by Cypher and 104 by MIDCAB. After matching for age, sex, and extent of coronary artery disease, two groups of 83 patients each were used to compare the two revascularization modalities. The groups were similar; however, ejection fraction of less than 0.35 was more prevalent in the MIDCAB group and prior percutaneous coronary intervention in the Cypher group.. Thirty-day mortality was 1.1% in the MIDCAB and 0% in the Cypher group. Mean follow-up was 22.5 months. Two late cardiac deaths occurred in the MIDCAB group and one in the Cypher group (p = NS). Angina returned in 35% of the Cypher group and in 8.4% of the MIDCAB group (p < 0.001). There were 14 (16.8%) reinterventions in the Cypher compared with three (3.6%) in the surgical group (p = 0.005). Cox proportional hazard model showed that assignment to the Cypher group was the only independent predictor of reangina (hazard ratio [HR], 6.17, 95% confidence interval [CI], 2.46 to 15.4). Treatment with Cypher was also an independent predictor of reintervention (HR 8.26, 95% CI, 1.68 to 40).. Despite improved results of percutaneous interventions with Cypher to the LAD, mid-term clinical outcome of patients treated with MIDCAB was better.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Minimally Invasive Surgical Procedures; Sirolimus; Stents; Treatment Outcome

Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Female; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Treatment Outcome

A direct coronary stenting technique using drug-eluting stents may decrease drug-eluting stent efficacy due to possible damage to the surface coating of the stent. The DIRECT is a multicenter, prospective, nonrandomized trial designed to evaluate the direct stenting strategy for the sirolimus-eluting Bx-Velocity stent compared with the historical control (SIRIUS trial, stenting with predilation). Volumetric and cross-sectional intravascular ultrasound analyses at 8-month follow-up were performed in 115 patients (DIRECT n= 64, control n = 51). Patient and lesion characteristics were comparable between groups. The DIRECT group achieved an equivalent uniform expansion index, defined as minimum stent area/maximum stent area x 100, compared with the control group (65.9 +/- 11.7 vs 63.1 +/- 12.7, p = NS). At 8-month follow-up, vessel, stent, lumen, and neointimal volume index (volume in cubic millimeters/length in millimeters) and percent neointimal volume were similar between the DIRECT and control groups (vessel volume index 13.9 +/- 4.40 vs 15.0 +/- 3.83; stent volume index 6.83 +/- 2.02 vs 6.94 +/- 2.04; lumen volume index 6.71 +/- 2.04 vs 6.81 +/- 2.07; neointimal volume index 0.14 +/- 0.24 vs 0.16 +/- 0.23; percent neointimal volume 3.73 +/- 6.97 vs 3.14 +/- 5.32, p = NS for all). In addition, in-stent neointimal hyperplasia distribution was significantly smaller near the distal stent edge (0.22 vs 0.098 mm(3)/mm, p = 0.01 for an average neointimal volume index within 3 mm from the distal stent edge). In conclusion, direct coronary stenting with the sirolimus-eluting Bx-Velocity stent is equally effective in terms of uniform stent expansion and long-term quantitative intravascular ultrasound results compared with conventional stenting using predilation. This strategy appears to be associated with less neointimal hyperplasia near the distal stent edge.

Topics: Coronary Stenosis; Coronary Vessels; Dilatation; Female; Humans; Hyperplasia; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Ultrasonography, Interventional

Drug-eluting coronary stents are the most recent "breakthrough" technology in interventional cardiology. Whereas risk factors influencing restenosis and need for target vessel revascularization are well known, risk factors for dying or developing a myocardial infarction (MI) after drug-eluting coronary stent implantation need to be evaluated yet.. We evaluated data from the German Cypher Stent Registry.. From April 2002 to December 2004, 7445 patients at 122 hospitals, who received at least one sirolimus-eluting stent during percutaneous coronary intervention, were included. Complete follow-up at a median of 6.6 months (quartiles 6.1-8.1 months) was available in 6755 patients (91%). Death occurred in 1.8% (120/6755) of patients, nonfatal MI in 2.3% (156/6635), and death or MI in 4.1% (276/6755) of patients. Independent predictors of death or MI were initial presentation with ST-elevation MI or non-ST-elevation MI (OR [odds ratio] 2.21, 95% CI 1.66-2.95, P < .0001), cardiogenic shock (OR 3.05, 95% CI 1.67-5.55, P = .0003), renal insufficiency (OR 1.74, 95% CI 1.24-2.44, P = .0017), reduced left ventricular function (OR 1.74, 95% CI 1.21-2.50, P = .0027), age (per decade) (OR 1.19, 95% CI 1.05-1.36, P = .0058), diabetes mellitus (OR 1.39, 95% CI 1.05-1.84, P = .0183), 3-vessel disease (OR 1.32, 95% CI 0.99-1.77, P = .043), and prior MI (OR 1.35, 95% CI 1.01-1.80, P = .0468), whereas interventional and lesion characteristics showed no significant association.. These results demonstrate that the most powerful predictors of death or MI after sirolimus-eluting stent implantation during percutaneous coronary intervention are presentation with an acute coronary syndrome, impaired left ventricular ejection fraction, and conventional risk factors for coronary heart disease. Interventional and lesion characteristics do not play a major role.

Topics: Acute Disease; Aged; Coronary Disease; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Registries; Risk Factors; Sirolimus; Stents; Stroke Volume; Syndrome

Sirolimus-eluting stents (SES) have recently been shown to reduce restenosis in selected patients. The impact of this new stent on the use of coronary bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) in clinical practice is yet unknown. Therefore, we investigated the impact of SES on the clinical practice of CABG and PCI in a series of unselected consecutive patients.. Between April and October 2002, a policy of SES implantation for all procedures has been instituted in our hospital. In total, 798 patients were referred to PCI and 275 to CABG (SES group). A control group was composed of all interventions (806 PCI and 314 CABG) performed during the preceding 6 months (pre-SES). The main outcome was the occurrence of major adverse cardiac events (MACE) at 15 months. In the SES era, a significant shift was noted in the PCI group towards more multi-vessel stenting (28 vs. 24%; P<0.05), more bifurcation stenting (18 vs. 7%; P<0.0001), and the use of more stents (1.9 vs. 1.5; P<0.05). In the PCI elective patients, a shift was noted towards more three-vessel disease (pre-SES: 16% vs. SES: 23%; P=0.02). Furthermore, we observed a shift in the CABG group towards more impaired LV function (pre-SES: 34% vs. SES: 41%; P=0.02) and towards more three-vessel disease (pre-SES: 67% vs. SES: 75%; P=0.03). Overall, the cumulative MACE percentages at 1 year after coronary revascularization (PCI and CABG combined) decreased from 16.8 to 13.8% (P=0.03). The cumulative MACE percentages in the pure SES group and the pre-SES bare metal stent group at 12 months were 15.6 and 19.8%, respectively (P<0.01).. The introduction of the SES has certainly had an impact on the treatment strategy of coronary artery disease (CAD). Increased use of these stents allows more complex coronary anatomy to be treated by PCI, and results in lower repeat revascularization rates.

Topics: Case-Control Studies; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Drug Implants; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Several randomized trials have demonstrated that stent implantation after successful recanalization of long-term total occlusions decreases restenosis and reocclusion rates. The sirolimus-eluting stent (SES) has recently proved its efficacy to decrease restenosis in selected patients. However, the efficacy of SES implantation in patients who have chronic total occlusions is currently unknown. Therefore, we investigated procedural and 6- and 12-month angiographic outcomes (analyzed by quantitative coronary angiography) and left ventricular function in 60 patients who received SESs and 120 patients who received bare metal stents (BMSs). Minimum luminal diameter did not differ immediately after recanalization (SES group 3.04 +/- 0.50 mm vs BMS group 3.12 +/- 0.48 mm). After 6 months, the SES group still had significantly larger luminal diameters (3.04 +/- 0.44 mm vs 1.94 +/- 0.98 mm) and significantly lower restenosis and reocclusion rates (2% and 0%, respectively) than did the BMS group (32% and 6%, respectively). Late loss was significantly smaller in the SES group than in the BMS group. At follow-up, the SES group had fewer cardiac events, including target lesion revascularization (p <0.001), than did the BMS group. In conclusion, SES implantation after recanalization of chronic total occlusion provides a better clinical outcome with less restenosis and target lesion revascularization after 6 months than does BMSs.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Japan; Male; Prospective Studies; Severity of Illness Index; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Topics: Coronary Stenosis; Humans; Immunosuppressive Agents; Leg; Peripheral Vascular Diseases; Sirolimus; Stents

We evaluated the safety and effectiveness of postdilating a 3.0 mm sirolimus-eluting stents (SESs; six cells) with a 3.5-4.0 mm balloon. We identified 254 consecutive patients who underwent percutaneous coronary interventions using SESs with a nominal diameter of 3.0 mm (six cells). Patients were divided into two groups based on whether they were subsequently postdilated with a 3.0 mm (group 1: 168 patients, 251 lesions) or a 3.5-4 mm balloon (group 2: 86 patients, 102 lesions). There were no significant differences regarding the incidence of in-hospital and long-term follow-up. Angiographic follow-up was available in 72% and 74% of groups 1 and 2, respectively. The two groups had no significant differences regarding late lumen loss (0.51 +/- 0.36 vs. 0.52 +/- 0.33; P = 0.3) and binary restenosis rates (10.7% vs. 8.8%; P = 0.1). Six-month clinical follow-up was available in all patients. At long-term follow-up (mean: 10.6 +/- 3.7 for group 1 and 11.3 +/- 3.9 months for group 2), there were no significant differences between the two groups regarding major adverse cardiac events (8.9% vs. 9.2%; P = 0.9). Implantation of a 3.0 mm SES with postdilation with a 3.5-4 mm balloon did not result in any significant difference in complications, in-hospital non-Q-wave myocardial infarction, binary restenosis, or target lesion revascularization. These data should lessen concern that overdilation may dilute the beneficial effects of SESs.

Topics: Catheterization; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Sirolimus; Stents

Topics: Aged; Atherectomy, Coronary; Blood Vessel Prosthesis Implantation; Catheter Ablation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Humans; Immunosuppressive Agents; Sirolimus; Stents

Stenting of isolated proximal LAD stenoses is still a controversial issue since it is associated with higher target vessel revascularization (TVR) rate than both bypass surgery using the internal mammary artery, and stenting of other coronary artery territories. The sirolimus- eluting stent (SES) has been reported to significantly reduce restenosis rates in de novo coronary lesions. Therefore, we compared patients from the German Cypher Registry treated with SES for isolated proximal LAD lesions with those stented for isolated lesions in the proximal LCX or RCA.. A total of 349 patients treated with SES were analyzed. 249 patients were treated for proximal LAD stenosis, and 100 for proximal LCX/RCA stenoses. The combined clinical endpoint was MACCE (death of any cause, non-fatal MI and non-fatal stroke) and TVR at 6 months.. In-hospital events (death, MI and TVR) did not differ significantly between both groups (3.2% for the LAD group vs 2.0% for the LCX/RCA-group, p=0.73). The combined end point of death of any cause, non-fatal MI and non-fatal stroke at six months was 2.6% in the LAD group, and 2.2% in the LCX/RCA group (p=1.0). TVR occurred in 4.8% of the LAD group and in 6.5% of the LCX/RCA group at six months (p=0.58). The percentage of patients free from angina at daily activities was 80.6% in the LAD group, and 77.4% in the LCX/ RCA group (p=0.52).. SES once implanted into isolated proximal LAD stenoses appears as effective as reported in other vessel territories. Accordingly, stenting of the proximal LAD using SES might prove a suitable alternative to surgery.

Topics: Activities of Daily Living; Administration, Topical; Aged; Cause of Death; Coated Materials, Biocompatible; Coronary Stenosis; Female; Follow-Up Studies; Germany; Humans; Intracranial Embolism; Male; Middle Aged; Myocardial Infarction; Outcome Assessment, Health Care; Prospective Studies; Radiography; Registries; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Chronic total occlusion of the left main coronary artery (LMCA) is rare. Recently, percutaneous coronary intervention has been increasingly applied to unprotected LMCA lesions. We describe a patient with chronic total occlusion of the LMCA who was successfully treated with bifurcation stenting with sirolimus-eluting stents.

Topics: Adult; Coronary Stenosis; Humans; Male; Prosthesis Implantation; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Prognosis; Risk Assessment; Sirolimus; Stents; Treatment Outcome; Vascular Patency

The aim of this study was to assess the safety and effectiveness of > or =4 sirolimus-eluting stent (SES; Cypher, Cordis, Johnson and Johnson) implantation. The safety of implantation of > or =4 SESs in the same patient and setting has not been established. Furthermore, it has been hypothesized that sirolimus administration with the use of multiple stents may diminish the platelet inhibitory effects of clopidogrel and may trigger drug-drug interactions. We identified 96 consecutive patients (96 procedures) who underwent implantation of > or =4 SESs in 365 lesions (438 stents) during the same procedure. All patients received aspirin indefinitely and clopidogrel or ticlopidine for at least 1 year postprocedure; 57% and 47% of the patients were on calcium channel blocker and statin therapy, respectively. All stents were successfully deployed and glycoprotein IIb/IIIa inhibitors were used in 50% of the procedures. There were no in-hospital deaths, Q-wave myocardial infarction (MI), urgent bypass surgery, or repeat percutaneous coronary intervention; 18 patients (19%) suffered non-Q-wave MI (defined as CK-MB elevation >3 times the upper limit of normal). At 30-day follow-up, there was one (1%) subacute thrombosis resulting in target lesion revascularization. At mean follow-up time of 15.4 +/- 6.2 months, the frequency of target lesion revascularization, target vessel revascularization, and major adverse cardiac event rates were 12%, 16%, and 18%, respectively. No other notable clinical events that might have been attributed to the possible drug-drug interactions or discontinuation of concomitant antithrombotic, statin, or calcium channel blocker therapy were reported. Multiple (> or =4) SES implantation appears safe with no increase in major adverse cardiac events.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Survival Rate; Time Factors; Treatment Outcome; Vascular Patency

Treatment of bifurcation lesions is associated with high procedural complications and restenosis rate due to plaque shift, suboptimal angiographic results, difficulty in crossing the stent struts, and incomplete coverage of the side-branch ostium. The simultaneous kissing stent (SKS) technique involves two stents, one in main vessel (MV) and one in the side branch (SB) with overlapping stents in the MV proximally, extending proximally the carina of bifurcation. We analyzed our first 200 consecutive patients (202 lesions) who underwent SKS technique for true bifurcation lesions using sirolimus eluting stents, with a minimum follow-up of 6 months. Procedural success was 100% for MV and 99% for SB using SKS technique, with clinical success rate of 97%. In-hospital and 30-day major adverse cardiac events were 3% and 5%, respectively, with a procedure time of 36 +/- 14 min. At mean follow-up of 9 +/- 2 months, the incidence of target lesion revascularization was 4% in the entire group. Therefore, SKS technique using sirolimus-eluting stents may become an effective treatment strategy for large-size bifurcation lesions. However, in order to establish its superiority, SKS technique needs to be compared in a randomized manner with conventional stent techniques.

Topics: Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Prosthesis Design; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO).. We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up.. Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.

Topics: Case-Control Studies; Chronic Disease; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Drug Implants; Female; Follow-Up Studies; Hospitalization; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Drug Implants; Humans; Immunosuppressive Agents; Sirolimus; Stents

They reduce rates of restenosis but not mortality or infarction--so are they worth it?

Topics: Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Australia; Cell Proliferation; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Humans; Outcome Assessment, Health Care; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of CTO. A total of 200 patients will be followed up for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate.

Topics: Angioplasty, Balloon; Chronic Disease; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Delayed-Action Preparations; Follow-Up Studies; Humans; Multicenter Studies as Topic; Patient Selection; Randomized Controlled Trials as Topic; Research Design; Sirolimus; Stents

Stent thrombosis after sirolimus eluting stent implantation has been reported to occur at six hours to 375 days after the procedure and usually within the two weeks after discontinuation of antiplatelet medication. A case is reported of very late stent thrombosis after 17 months of sirolimus eluting stent implantation and eight months after clopidogrel discontinuation despite aspirin continuation. This case underlines the possible need for long term antiplatelet medication among patients receiving sirolimus eluting stents.

Topics: Adult; Aspirin; Blood Vessel Prosthesis; Catheterization; Clopidogrel; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug Implants; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Male; Platelet Aggregation Inhibitors; Prosthesis Failure; Retreatment; Sirolimus; Stents; Ticlopidine; Time Factors

We aimed to assess the incidence of underexpansion and the relationship between delivery pressure and expansion with sirolimus-eluting stents. Adequate stent expansion contributes to early and late improved outcomes. In 51 patients (53 lesions) with native coronary artery narrowing, balloon-expandable sirolimus-eluting stents (Cypher) were serially expanded with gradual balloon inflations [14 atm, 20 atm, and in case of minimal stent cross-sectional area (CSA)/reference lumen CSA < 50% at 20 atm, postdilatation with 0.5 mm larger balloon]. Intravascular ultrasound (IVUS) imaging was performed before intervention and after each gradual balloon inflation. Stent expansion (minimal stent CSA/reference lumen CSA) was measured. Stent expansion was 72% +/- 16% after 14 atm balloon inflation, 90% +/- 18% after 20 atm balloon inflation (P < 0.001 vs. 14 atm), and 90% +/- 18% at the end of the procedure (including optional postdilatations with 0.5 mm larger balloon; P = NS vs. 20 atm). Stent expansion addressed by MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen CSA > 80% of the reference or > 90% if minimal lumen CSA was < 9 mm2) was adequate in 15% of the cases after 14 atm balloon inflation, in 60% after 20 atm balloon inflation (P < 0.001 vs. 14 atm), and in 60% at the end of the procedure (P = NS vs. 20 atm). Sirolimus-eluting stent underexpansion is common when deployed at conventional pressures. Increasing balloon delivery pressure or assessing stent expansion with IVUS seems warranted in order to ensure adequate sirolimus-eluting stent deployment.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Stenosis; Equipment Failure; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Pressure; Prospective Studies; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

We describe two patients with in-stent thrombosis occurring 4 and 21 months after implantation of sirolimus-eluting stents. Both cases occurred following noncardiac surgery. In both cases, aspirin had been stopped prior to surgery. Both patient sustained a severe myocardial infarction; one died. The occurrence of late thrombosis of sirolimus-eluting stents is of concern.

Topics: Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Cardiac Surgical Procedures; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Coronary Thrombosis; Humans; Male; Myocardial Infarction; Platelet Aggregation Inhibitors; Postoperative Complications; Sirolimus; Stents; Time Factors

Sirolimus-eluting stents (SESs) are currently being used in patients undergoing percutaneous coronary intervention (PCI). SESs have not been evaluated in the treatment of acute myocardial infarction by primary angioplasty. We report our initial experience with SESs implanted during primary angioplasty. One hundred and three patients were treated within 12 hr after onset of acute myocardial infarction (AMI) with primary angioplasty and SES implantation. Those patients were compared to 504 patients treated with bare metal stents (BMSs). Angiographic success (TIMI flow grade 3 and residual stenosis < 50%) was completed in 98% of patients with SESs and no subacute stent thrombosis was reported. In-hospital outcomes were similar in the SES and BMS groups. At 6 months, major cardiac events were less frequent in the SES group than in the BMS group (9% vs. 24%, respectively; P < 0.001), driven by a lesser need for repeat revascularization with SESs (1% vs. 10.3% with BMSs; P = 0.014). Mortality at 6 months was 7% with SESs and 11% with BMSs (P = 0.14). SESs are safe and effective for the treatment of AMI by primary angioplasty. As compared to BMSs, SESs improve long-term outcome after AMI, mainly by reducing the need for repeat revascularization.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; District of Columbia; Female; Hospital Mortality; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Child; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Internal Mammary-Coronary Artery Anastomosis; Male; Mammary Arteries; Radiography; Sirolimus; Stents

The most effective strategy for bifurcation stenting is currently undefined. The Culotte technique was developed as a method that ensures complete bifurcation lesion coverage. However, it went out of favour due to a high rate of restenosis when utilizing bare metal stents. Drug-eluting stents reduce the rate of restenosis and need for repeat lesion revascularization compared with bare metal stents; we re-evaluated this technique with drug-eluting stent implantation.. Between April 2002 and October 2003, 207 patients were treated for at least one bifurcation lesion with drug-eluting stent implantation to both the main vessel and side branch. Of these, 23 were treated with the Culotte technique (11.1%) for 24 lesions. Sirolimus-eluting stents were used in 8.3%, and paclitaxel-eluting stents in the remaining 92.7%.. Clinical follow-up was obtained in 100%. One patient had a myocardial infarction at 14 days (maximum rise in creatine kinase 872 IU/L) related to thrombosis occurring in another lesion, and underwent repeat revascularization. There were no episodes of stent thrombosis in the Culotte lesions. At eight months follow-up, there were no deaths and no further myocardial infarction. One patient required target lesion revascularization (TLR), and a second underwent target vessel revascularization. The cumulative rates of survival-free of TLR and major adverse cardiac events were 94.7% and 84.6% respectively. Angiographic follow-up was obtained in 16 patients (69.6%) at a mean period of 8.3+/-4.3 months. The late lumen loss for the main vessel and side branch were 0.48+/-0.56 mm and 0.53+/-0.33 mm respectively, with binary restenosis rates of 18.8% and 12.5%.. In this small study of bifurcation stenting utilizing the Culotte technique with drug-eluting stent implantation, there was a low rate of major adverse events and need for target lesion revascularization at eight months, when compared with historical data of bifurcation stenting with bare metal stents. Further re-evaluation of this technique utilizing drug-eluting stents, is warranted in the setting of larger randomized studies.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Middle Aged; Probability; Prospective Studies; Radiography; Risk Assessment; Sirolimus; Stents; Survival Rate; Treatment Outcome

Graft disease remains a therapeutic challenge. Procedural complications and unsatisfactory patency rates are realized with both percutaneous intervention and repeat coronary artery bypass graft (CABG) surgery. The efficacy of sirolimus-eluting stents (SES) for the treatment of de novo coronary artery disease has been established, but the use of this technology to treat bypass graft disease remains undefined. The aim of this study was to evaluate the safety and feasibility of SES to treat patients with high-risk bypass graft disease.. The compassionate use of SES (SECURE) study included patients with recurrent coronary disease and no acceptable alternative available treatment, including brachytherapy or CABG. Outcomes from 76 patients (n = 94 lesions) with graft lesions treated with SES in the U.S. were compared with the outcomes of 176 patients (n = 311 lesions) with only native vessels. IVUS follow-up was performed at 8 months in 14 patients with graft SES treatment.. In-hospital outcomes were similar between both groups, with 99% of patients discharged without adverse events. The incidence of target vessel failure including death, MI, and TVR at 12 months in the bypass graft group (55.3%) was similar to that observed in the native vessel group (45.5%, p = 0.17). Intimal hyperplasia (IH) measured by IVUS was 11.8 +/- 16.5%; 50% of patients with graft SES had < 1% IH at 8 months.. Implantation of SES in high-risk patients with recurrent bypass graft disease is feasible. SES represents a future.

Topics: Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Registries; Sirolimus; Stents; Treatment Outcome; United States

Encouraging results with the use of the sirolimus-eluting stent (SES) have been recently presented in several multi-center trials. In the present study, the short- and mid-term clinical outcomes of the SES in everyday clinical practice of interventional cardiology were compared with a strategy using conventional bare metal stents.. In a total of 530 consecutive patients (males 86%, mean age 61 +/- 10 years) who had been treated with a SES were compared with a control group of 398 patients (males 87%, mean age 59 +/- 11 years) treated with a bare metal stent before the use of SES. In-hospital results and clinical outcomes during follow-up (11.22 +/- 3.4 versus 11.41 +/- 3.1 months) were obtained.. Patients treated with SES had more risk factors for coronary artery disease or multivessel disease compared to those with treated bare metal stent. The clinical success rate was 99.6% in the SES group and 98.5% in the bare metal stent group (p = ns), and non-Q-wave myocardial infarction (MI) occurred in 5.7% and 4.0% of patients, respectively. The incidence of death or MI during follow-up was not different (1.1% versus 1.3% and 0.8% versus 1.8%; p = ns). Percutaneous or surgical revascularization for target lesion restenosis was required in 2.1% of patients treated with SES and in 10.1% of those with bare metal stents (p < 0.001), and the event-free survival from death, cerebrovascular accident, MI or any percutaneous or surgical revascularization was 93.13% and 83.63%, respectively (p < 0.01).. The implantation of the SES is associated with excellent in-hospital and mid-term results, mainly because of dramatic reductions in the need for repeat revascularization, despite a higher risk factor profile and more complex lesion characteristics.

Topics: Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Prospective Studies; Registries; Sirolimus; Stents; Time Factors; Treatment Outcome; United States

We report intravascular ultrasound (IVUS) findings after crush-stenting of bifurcation lesions.. Preliminary results with the crush-stent technique are encouraging; however, isolated reports suggest that restenosis at the side branch (SB) ostium continues to be a problem.. Forty patients with bifurcation lesions underwent crush-stenting with the sirolimus-eluting stent. Postintervention IVUS was performed in both branches in 25 lesions and only the main vessel (MV) in 15 lesions; IVUS analysis included five distinct locations: MV proximal stent, crush area, distal stent, SB ostium, and SB distal stent.. Overall, the MV minimum stent area was larger than the SB (6.7 +/- 1.7 mm2 vs. 4.4 +/- 1.4 mm2, p < 0.0001, respectively). When only the MV was considered, the minimum stent area was found in the crush area (rather than the proximal or MV distal stent) in 56%. When both the MV and the SB were considered, the minimum stent area was found at the SB ostium in 68%. The MV minimum stent area measured <4 mm2 in 8% of lesions and <5 mm2 in 20%. For the SB, a minimum stent area <4 mm2 was found in 44%, and a minimum stent area <5 mm2 in 76%, typically at the ostium. "Incomplete crushing"--incomplete apposition of SB or MV stent struts against the MV wall proximal to the carina--was seen in >60% of non-left main lesions.. In the majority of bifurcation lesions treated with the crush technique, the smallest minimum stent area appeared at the SB ostium. This may contribute to a higher restenosis rate at this location.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Artery Disease; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Risk Factors; Sirolimus; Stents; Ultrasonography, Interventional

Hybrid coronary artery revascularization is a combination of minimally invasive coronary artery surgery and catheter-based coronary intervention. Hybrid procedures enable adequate revascularization of patients with multivessel coronary artery disease without complete opening of the chest and with the advantage of the most durable option, a left internal mammary artery (LIMA) graft is placed to the left anterior descending (LAD) artery. The hybrid concept is gaining renewed interest because totally endoscopic LIMA to LAD placement has become feasible and because drug-eluting stents in non-LAD targets may be competitive even for arterial bypass grafts. Simultaneous hybrid procedures would be desirable. We report on a case in which robotic totally endoscopic LIMA to LAD grafting using the da Vinci telemanipulation system was combined with placement of a rapamycin coated stent to the right coronary artery in one single procedure.

Topics: Aged; Catheterization; Coronary Stenosis; Endoscopy; Humans; Internal Mammary-Coronary Artery Anastomosis; Male; Sirolimus; Stents

Topics: Child; Coronary Aneurysm; Coronary Stenosis; Coronary Vessels; Female; Humans; Immunosuppressive Agents; Infusion Pumps, Implantable; Mucocutaneous Lymph Node Syndrome; Sirolimus; Stents

We performed this study in order to compare the immediate and mid-term outcomes of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in lesions of the unprotected left main coronary artery (LMCA). We assessed 54 patients from 5 centers who had undergone unprotected LMCA stenting (35 SES and 19 PES). The procedural success rates were 100 and 95%, respectively, in the SES and PES patients (p = 0.19). At the 6-month clinical follow-up, the event-free probability was 100% in the SES group, and 88% in the PES group (p = 0.07). At the 6-month angiographic follow-up (n = 24), the SES group exhibited a slightly lower late loss than did the PES group (0.24 +/- 0.44 vs. 0.65 +/- 0.60 mm, p = 0.09), and the restenosis rates were 8 and 9% (p = 0.94) in the SES and PES patients, respectively. In conclusion, both groups exhibited excellent in-hospital and 6-month outcomes with no significant differences between them.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Treatment Outcome; Ventricular Dysfunction, Left

Iatrogenic left main coronary artery ostial stenosis is a rare and late life-threatening complication of aortic valve replacement. The exact causes of this critical condition, despite being still nowadays elusive, are possibly related to the insertion of perfusion catheters into the left coronary system for cardioplegia delivery. We describe the case of a 69-year-old man, with normal coronary arteries documented by preoperative coronary angiography before surgery, who developed 1 year after aortic valve replacement worsening effort angina. A second coronary angiography revealed a severe left main ostial stem stenosis, which was successfully treated by sirolimus-eluting stent deployment. This case demonstrates a new percutaneous approach of this poorly understood, yet potentially fatal complication following aortic valve replacement.

Topics: Aged; Angioplasty, Balloon, Coronary; Aortic Valve Stenosis; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Stenosis; Echocardiography, Doppler; Heart Valve Prosthesis Implantation; Humans; Male; Reoperation; Sirolimus; Stents

To study the interaction of the sirolimus-eluting stent and vessel margins, we analyzed the intravascular ultrasound parameters in 317 edges of 167 stents having 18 edge stenoses at 8 months of follow-up from the SIRIUS trial. Of the baseline parameters, a larger reference percentage of plaque area and a larger edge stent area/reference minimum lumen area were associated with edge stenosis in the sirolimus-eluting stent cohort compared with the incidence of edge stenosis in the bare metal stent cohort. Thus, full lesion coverage and matching the stented segment properly to the adjacent segment using intravascular ultrasound guidance may improve sirolimus-eluting stent implantation efficacy further.

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Follow-Up Studies; Humans; Immunosuppressive Agents; Metals; Multicenter Studies as Topic; Odds Ratio; Predictive Value of Tests; Prognosis; Prosthesis Failure; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Stents; Ultrasonography, Interventional

High-grade involvement of the proximal left anterior descending artery (LAD), either in isolation or as part of multivessel coronary artery disease, remains a frequent indication for surgical revascularization. This is particularly true in complex proximal LAD lesions among high-risk patients, since stenting is usually ineffective in the long term as regards freedom from angina and target vessel revascularization (TVR) in such patient subsets. The sirolimus-eluting stent (SES) has been reported to significantly reduce clinical and angiographic restenosis rates. We therefore analyzed the clinical and angiographic long-term results of a group of complex patients treated with SES for proximal LAD stenoses.. A total of 80 consecutive patients treated with sirolimus-eluting stents (SES) for complex proximal LAD stenoses were analyzed. This high-risk cohort included diabetic patients, long, bifurcated, ostial and heavily calcified lesions, chronic total occlusions and in-stent restenoses. Late lumen loss and clinically-driven target lesion revascularization (TLR) were analyzed at 7 months.. Late lumen loss was 0.19 +/- 0.06 mm in the analysis segment (stent with 5 mm proximal and distal to it) at 7 months. TLR was performed in 6.3% of cases, and the combined rate of death from any cause, nonfatal MI and TLR was also 6.3% at 7 months.. SES, once successfully implanted into complex proximal LAD stenoses, appear effective, with rather acceptable rates of adverse events at 7-month follow-up. Accordingly, treating the proximal LAD using SES in complex patients may narrow the gap between PCI and surgery for this indication.

Topics: Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Stents

High levels of release of inflammatory markers after coronary angioplasty are predictors of late restenosis. Sirolimus-eluting stent reduces the risk of restenosis.. To compare the release of inflammatory markers after coronary angioplasty with sirolimus-eluting stent and bare metal stent.. Sixteen patients with a proximal left anterior descending coronery artery stenosis were randomly assigned to receive either bare metal stent (n = 8) or sirolimus-eluting stent (n = 8). We measured simultaneously aortic and coronary sinus concentrations of the von Willebrand factor antigen, tumor necrosis factor-alpha and interleukin-6 before, immediately and after 2 h after stenting. High-sensitivity C-reactive protein and troponin-I circulating levels were measured before and 6 and 24 h after coronary angioplasty.. Before stenting, all values were similar in both groups. The coronary sinus change of the von Willebrand factor antigen level between baseline and 2 h after stenting was + 20.1 +/- 26.9% in the bare metal stent group and -5.7 +/- 23.02% in the sirolimus-eluting stent group (P < 0.05). We observed a significant increase in the von Willebrand factor antigen (from 132.8+/-58.8 to 169 +/- 40.7%, P < 0.05) systemic concentrations 24 h after stenting in the bare metal stent group but not in the sirolimus-eluting stent group (from 140.6+/-84% to 136 +/- 39.5%), P = NS).. The present study shows that a difference in the release of inflammatory markers can be detected after coronary stenting with bare metal stent or sirolimus-eluting stent. The lower release of the von Willebrand factor antigen in the coronary sinus 2 h after the procedure and the lower systemic concentrations of the von Willebrand factor antigen 24 h after stenting in the sirolimus-eluting stent group are likely to reflect a reduced production of the von Willebrand factor antigen at the site of the vascular injury.

Topics: Antigens; Biomarkers; C-Reactive Protein; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Humans; Immunosuppressive Agents; Inflammation; Interleukin-6; Male; Metals; Middle Aged; Myocardial Revascularization; Prognosis; Sinus of Valsalva; Sirolimus; Stents; Troponin I; Tumor Necrosis Factor-alpha; von Willebrand Factor

We compared the clinical efficacy of paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs) in a contemporary cohort of patients who had complex lesions. We collected data on 9-month outcomes in 529 patients (281 in the PES group and 248 in the SES group) whose de novo lesions were treated with drug-eluting stents. The end point was per-patient in-hospital and follow-up major adverse cardiac events, which were defined as a composite of death, myocardial infarction, and target vessel revascularization, including target lesion revascularization. There were no in-hospital deaths or repeat revascularizations; however, 5.7% of the PES group and 2% of the SES group developed a myocardial infarction (p = 0.04). At a median follow-up of 10.6 months, the rate of major adverse cardiac events was similar between groups (18.1% vs 21%, adjusted hazard ratio 0.85, 95% confidence interval 0.57 to 1.25), without any difference in the occurrence of death or myocardial infarction. Diabetes and total stent length were independent predictors of major adverse cardiac events. Propensity analysis confirmed the similarity between devices (hazard ratio 0.87, 95% confidence interval 0.62 to 1.25). Most restenoses were focal and only 2 patients required surgical revascularization. In conclusion, implantation of drug-eluting stents in complex lesions was associated with favorable results and most patients remained free from surgical revascularization at follow-up. Overall, the 2 available stent platforms had similar performance characteristics.

Topics: Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Retrospective Studies; Severity of Illness Index; Sirolimus; Stents; Survival Rate; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Controlled Clinical Trials as Topic; Coronary Restenosis; Coronary Stenosis; Drug Implants; Humans; Immunosuppressive Agents; Myocardial Revascularization; Paclitaxel; Sirolimus; Stents

In the treatment of coronary stenosis, evolution after PTCA is not as good in diabetic patients compared to non diabetic ones, whatever the treatment used. We now have data of large clinical studies which show good results of drug loaded stents in diabetic patients, especially with either a cytostatic drug (sirolimus) or a cytotoxic one (paclitaxol). In the RAVEL study, among the 44 diabetic patients, 19 had sirolimus stenting with a restenosis rate of 0% vs a restenosis rate of 40% for the 25 patients with standard stents. In the 279 diabetic patient group of the SIRIUS study, the restenosis rate (50% or more stenosis rate) was 17.6% when sirolimus stenting was used vs 50.5% for the patients with standard stenting and at 9 months and target lesion revascularisation was from 22.3% with bare metal stents, compared to 6.9% with sirolimus eluting stents. In the TAXUS IV study, the advantage was evident in diabetic patients with a restenosis rate 80% lower in patients treated with oral anti diabetic therapy and 82% in patients treated with insulin. In the TAXUS VI study, the target lesion revascularisation rate of diabetic patients was 2.6% when taxus MR (modified release) was used, vs 22.6% with standard stents. The event which until now made PTCA different from surgery was restenosis, especially in diabetic patients. The analysis of use of recent active stenting registries has shown that diabetic patients have now much better long term results than previously reported.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Humans; Immunosuppressive Agents; Sirolimus; Stents

We describe an ST-elevation acute myocardial infarction involving the left main coronary artery in a middle-aged man who was treated by primary angioplasty with the use of sirolimus-eluting stents. To our knowledge, this is the 1st report of survival after sirolimus-eluting stent implantation in a patient with acute occlusion of the left main coronary artery. We discuss the case and review the literature.

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Electrocardiography; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Humans; Immunosuppressive Agents; Sirolimus; Stents; Treatment Failure

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Humans; Immunosuppressive Agents; Sirolimus; Stents

We present a case of kissing drug-eluting stent deployment in the left main coronary artery in a 43-year-old male with failed previous bypass grafting. We discuss the technique used for stent deployment and the rationale for using this technique in the drug-eluting stent era.

Topics: Adult; Coronary Angiography; Coronary Stenosis; Drug Implants; Humans; Immunosuppressive Agents; Male; Sirolimus; Stents; Ultrasonography, Interventional

Immediate and two month angiographic and intravascular ultrasound examination of sirolimus eluting stents deployed for complex coronary dissection is presented. The findings support the hypothesis that this novel treatment option is both effective and safe.

Topics: Aged; Aortic Dissection; Coronary Restenosis; Coronary Stenosis; Female; Humans; Sirolimus; Stents

Treating unprotected left main disease and degenerated saphenous vein grafts by percutaneous intervention remains one of the more challenging situations facing interventional cardiologists. We present two cases showing how the use of sirolimus-eluting stents in combination with other novel techniques might alter treatment paradigms in the future.

Topics: Aged; Balloon Occlusion; Coronary Stenosis; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Saphenous Vein; Sirolimus; Stents; Ultrasonography, Interventional

The factors associated with the occurrence of restenosis after sirolimus-eluting stent (SES) implantation in complex cases are currently unknown.. A cohort of consecutive complex patients treated with SES implantation was selected according to the following criteria: (1) treatment of acute myocardial infarction, (2) treatment of in-stent restenosis, (3) 2.25-mm diameter SES, (4) left main coronary stenting, (5) chronic total occlusion, (6) stented segment >36 mm, and (7) bifurcation stenting. The present study population was composed of 238 patients (441 lesions) for whom 6-month angiographic follow-up data were obtained (70% of eligible patients). Significant clinical, angiographic, and procedural predictors of post-SES restenosis were evaluated. Binary in-segment restenosis was diagnosed in 7.9% of lesions (6.3% in-stent, 0.9% at the proximal edge, 0.7% at the distal edge). The following characteristics were identified as independent multivariate predictors: treatment of in-stent restenosis (OR 4.16, 95% CI 1.63 to 11.01; P<0.01), ostial location (OR 4.84, 95% CI 1.81 to 12.07; P<0.01), diabetes (OR 2.63, 95% CI 1.14 to 6.31; P=0.02), total stented length (per 10-mm increase; OR 1.42, 95% CI 1.21 to 1.68; P<0.01), reference diameter (per 1.0-mm increase; OR 0.46, 95% CI 0.24 to 0.87; P=0.03), and left anterior descending artery (OR 0.30, 95% CI 0.10 to 0.69; P<0.01).. Angiographic restenosis after SES implantation in complex patients is an infrequent event, occurring mainly in association with lesion-based characteristics and diabetes mellitus.

Topics: Aged; Cohort Studies; Comorbidity; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus; Drug Implants; Female; Humans; Incidence; Male; Middle Aged; Netherlands; Risk Factors; Sirolimus; Stents

Although randomized, controlled clinical trials (RCTs) showed a reduced target vessel revascularization rate and a good safety profile for the sirolimus-eluting coronary Cypher stent, at least the safety data need to be confirmed by larger data in clinical practice. Under the circumstances of frozen medical budgets in Germany, there may also be a shift toward implantation of a drug-eluting stent (DES) for indications not yet evaluated by RCTs.. The authors analyzed the data of the German Cypher Registry a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher stent, in April 2002.. From April 2002 until December 2003, 3,579 interventions using a Cypher stent at 102 centers were included in the German Cypher Registry. This reflects a proportion of this DES compared to all stents implanted at the participating centers of < 10%. Patients' median age was 63.4 years (quartiles: 55-70 years) with 75% men. Renal insufficiency was seen in 10.1%, previous myocardial infarction in 37%, prior percutaneous coronary intervention (PCI) in 54.6%, and prior coronary artery bypass grafting (CABG) in 18.7%. In a large proportion of interventions, Cypher stents were implanted in lesions or in clinical situations not yet evaluated by RCTs: 10.1% ST elevation myocardial infarction, 1.8% cardiogenic shock, 2.1% left main stenoses, 5.5% CABG lesions, 23.2% in-stent stenosis, and 6% chronic total occlusions. PCI before DES implantation was performed in 65.5% of cases, a mean of 1.02 +/- 0.43 Cypher stents per lesion were implanted with a median sum length of all Cypher stents per lesion of 18 mm (quartiles: 13-21 mm). Maximum median balloon diameter during stent implantation was 3.00 mm (quartiles: 2.75-3.00 mm). Acute complication rate was low, with 0.2% deaths, 0.3% subacute stent thromboses, 1.3% myocardial infarctions, 2.1% urgent PCIs, and 0.2% CABGs.. In about one half of the patients included into the German Cypher Registry, the DES were implanted in lesions that were excluded from RCTs. The use of this sirolimus-eluting coronary stent in "real life" conditions was found to be safe concerning acute complications.

Topics: Administration, Topical; Aged; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coated Materials, Biocompatible; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Follow-Up Studies; Germany; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Outcome Assessment, Health Care; Prospective Studies; Randomized Controlled Trials as Topic; Registries; Shock, Cardiogenic; Sirolimus; Stents; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Citrates; Coronary Stenosis; Coronary Vessels; Drug Hypersensitivity; Drug Implants; Eosinophilia; Female; Gallium; Gallium Radioisotopes; Humans; Pericardial Effusion; Radionuclide Imaging; Radiopharmaceuticals; Sirolimus; Stents; T-Lymphocytes

Topics: Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Implants; Everolimus; Follow-Up Studies; Growth Inhibitors; Humans; Immunosuppressive Agents; Paclitaxel; Pilot Projects; Randomized Controlled Trials as Topic; Single-Blind Method; Sirolimus; Stents; Treatment Outcome

We evaluated the clinical and angiographic outcomes of patients presenting with restenosis after sirolimus-eluting stent (SES) implantation treated with repeated percutaneous intervention.. A total of 24 consecutive patients have undergone repeated percutaneous intervention to treat post-SES restenosis (27 lesions). The restenosis was located within the stent in 93% of lesions. From the 27 lesions, 1 (4%) was re-treated with a bare stent, 3 (11%) were treated with balloon dilatation, and the remaining 23 lesions (85%) were treated with repeated drug-eluting stent implantation (SES in 12 lesions [44%], paclitaxel-eluting stents in 11 lesions [41%]). The event-free survival rate was 70.8% after a median follow-up of 279 days from the post-SES treatment. The overall recurrent restenosis rate was 42.9%. The risk of recurrent restenosis was increased for patients with hypercholesterolemia, previous angioplasty, failed brachytherapy, post-SES restenosis needing early (<6 months) treatment, and post-SES restenosis treated with balloon dilatation. The recurrent restenosis rate of originally de novo lesions re-treated with drug-eluting stents was 18.2%.. Even though de novo lesions treated with SES at baseline and re-treated with drug-eluting stents had reasonably better outcomes than other lesion types and strategies, our study shows that the treatment of post-SES restenosis is currently suboptimal and warrants further investigation.

Topics: Aged; Angioplasty, Balloon, Coronary; Brachytherapy; Cohort Studies; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Drug Implants; Female; Follow-Up Studies; Humans; Hypercholesterolemia; Incidence; Male; Middle Aged; Paclitaxel; Radiography; Recurrence; Sirolimus; Stents; Treatment Outcome

We evaluated predictors of increased periprocedural creatine kinase-MB isoenzyme levels after implantation of sirolimus-eluting stents with an intent to fully cover the diseased segment. The total stent length per patient (predisposing factor) and elective use of glycoprotein IIb/IIIa (protective factor) were independent predictors of increased creatine kinase-MB isoenzyme levels.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Creatine Kinase; Creatine Kinase, MB Form; Databases, Factual; Equipment Design; Female; Humans; Immunosuppressive Agents; Isoenzymes; Linear Models; Male; Middle Aged; Myocardial Infarction; Platelet Glycoprotein GPIIb-IIIa Complex; Sirolimus; Stents; Time Factors

Everolimus, a novel proliferation signal inhibitor initially developed for the prevention of allograft rejection after organ transplantation, is a potent anti-proliferative and immunosuppressive agent. Compared to sirolimus, everolimus absorbs to local tissue more rapidly and possesses longer cellular residence time and activity. The stent-based intracoronary elution of everolimus was first investigated by BioSensors International using a bioabsorbable-PLA-polymer-coated S-Stent for drug delivery. Following preclinical animal studies that demonstrated excellent safety and efficacy of this device, the clinical FUTURE trial program was initiated. FUTURE I and II were designed to demonstrate safety and feasibility of the everolimus-eluting stent in a small patient population with focal de novo coronary lesions. At follow-up, an acceptable safety profile without evidence of stent thrombosis or late stent malapposition was observed. Moreover, these studies revealed a remarkable reduction of neointimal proliferation with everolimus-eluting stent implantation versus procedures utilizing bare-metal stents. Guidant Corporation licensed the exclusive rights to both the S-Stent and the bioabsorbable drug delivery platform. Guidant will conduct two pivotal trials (FUTURE III and IV) in order to demonstrate the efficacy of this stent design. FUTURE IV will make a non-inferiority comparison between everolimus and the already-approved drug eluting stent systems. Given the pooled results of FUTURE I and II, there is already some evidence suggesting that the everolimus-eluting stent is as potent a suppressor of reactive neointimal ingrowth as the sirolimus-eluting CYPHERTM stent. The everolimus-eluting coronary stent might shortly be established as a new and promising contender in the field of drug eluting stents for treatment of coronary heart disease.

Topics: Coronary Stenosis; Coronary Vessels; Everolimus; Feasibility Studies; Humans; Immunosuppressive Agents; Sirolimus; Stents

The long-term efficacy of percutaneous coronary intervention for mildly obstructive coronary narrowings is limited by the occurrence of restenosis, limiting the applicability of this therapy for these lesions. The present study reports on a consecutive series of 20 patients treated with sirolimus-eluting stent implantation for 23 angiographically mild de novo lesions (defined as a diameter stenosis <50% by quantitative coronary angiography). At a mean follow-up of 399 +/- 120 days, the survival-free of major adverse events was 95%, with no patient requiring target lesion revascularization.

Topics: Coronary Angiography; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Coronary Stenosis; Drug Delivery Systems; Humans; Male; Middle Aged; Radiography; Sirolimus; Stents; Wound Healing

The availability of the only drug eluting stent currently approved in the USA has been limited, so that operators often resort to the deployment of multiple undersized stents and post-stenting high pressure inflations with larger balloons to achieve optimal lesion coverage and stent expansion. A case of stent fracture following percutaneous coronary intervention in which this strategy was used is reported.

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug Implants; Equipment Failure; Female; Humans; Immunosuppressive Agents; Middle Aged; Retreatment; Sirolimus; Stents; Ultrasonography, Interventional

The impact of the use of sirolimus-eluting stents (SESs) in the treatment of in-stent restenosis in previously irradiated sites has not been adequately evaluated. Fifteen consecutive patients who underwent percutaneous coronary interventions using SESs in lesion sites previously intervened with intracoronary radiation therapy were identified. All stents were implanted successfully, and there were no major in-hospital complications. At 30-day follow-up, there was 1 case of subacute thrombosis that led to target lesion revascularization (TLR). At 6 months, 2 patients underwent TLR because of recurrent angina with angiographic restenosis, and 1 patient underwent target vessel revascularization distally to the SES site; no other major adverse cardiac events occurred at long-term follow-up (mean 17 +/- 8 months).

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Brachytherapy; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Equipment Design; Female; Follow-Up Studies; Humans; Magnetic Resonance Angiography; Male; Middle Aged; Prospective Studies; Risk Assessment; Sampling Studies; Sirolimus; Stents; Treatment Failure; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Coronary Vessels; Drug Delivery Systems; Humans; Paclitaxel; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Aneurysm; Coronary Angiography; Coronary Stenosis; Drug Hypersensitivity; Drug Implants; Equipment Failure; Female; Humans; Middle Aged; Sirolimus; Stents

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Middle Aged; Randomized Controlled Trials as Topic; Sirolimus; Stents

Topics: Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Randomized Controlled Trials as Topic; Sirolimus

Topics: Combined Modality Therapy; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Registries; Sirolimus; Stents

Topics: Combined Modality Therapy; Coronary Stenosis; Cost-Benefit Analysis; Diabetes Complications; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Registries; Sirolimus; Stents; Surveys and Questionnaires

Topics: Clinical Protocols; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Diabetes Mellitus, Type 2; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Stents

Topics: Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Netherlands; Randomized Controlled Trials as Topic; Registries; Sirolimus; Stents

Topics: Aged; Combined Modality Therapy; Coronary Stenosis; Drug Delivery Systems; Female; Germany; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Registries; Sirolimus; Stents

Topics: Combined Modality Therapy; Congresses as Topic; Coronary Stenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Registries; Sirolimus; Stents

Topics: Antineoplastic Agents; Combined Modality Therapy; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Everolimus; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Registries; Sirolimus; Stents

Topics: Animals; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Delayed-Action Preparations; Immunosuppressive Agents; Models, Animal; Sirolimus; Stents; Swine; Time Factors; Treatment Failure

Stent-based delivery of sirolimus (SRL) has shown reduction in neointimal hyperplasia and restenosis. The purpose of this study was to evaluate the chronic vascular response and the expression of cell cycle regulators after SRL-eluting stent implantation in a porcine coronary model.. Forty-nine pigs underwent placement of 109 oversized stents (control, n=54, SRL (140 microg/cm(2)), n=55) in the coronary arteries with histologic analysis and Western blot (PCNA, p27(kip1), CD45, MCP-1, IL-2, IL-6, TNF-beta) at 3, 30, 90 or 180 days.. At 3 days, the mean thrombus area was similar for control (0.38+/-0.19 mm(2)) and SRL (0.29+/-0.09 mm(2)) stents. After 30 days, the mean neointimal area was significantly less for the SRL (1.40+/-0.35 mm(2)) versus the control stents (2.94+/-1.28 mm(2), p<0.001). At 90 and 180 days, the mean neointimal area was similar for the SRL (3.03+/-0.92 and 3.34+/-0.99 mm(2)) as compared with control stents (3.45+/-1.09 and 3.65+/-1.23 mm(2)). Western blot analysis demonstrated an increased expression of p27(kip1) in the vessel wall at 90 days for the SRL versus control stents (p=0.05) but with increased levels of PCNA in the SRL as compared with control stents (p=0.003).. SRL-eluting stents favorably modulate neointimal formation for 30 days in the porcine coronary model. Long-term inhibition of neointimal hyperplasia is not sustained presumably due to delayed cellular proliferation despite increased levels of the cyclin-dependent kinase p27(kip1) in the vessel wall.

Topics: Animals; Biomarkers; Cell Cycle; Cell Cycle Proteins; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Cyclin-Dependent Kinase Inhibitor p27; Delayed-Action Preparations; Immunosuppressive Agents; Models, Animal; Polymers; Proliferating Cell Nuclear Antigen; Sirolimus; Stents; Swine; Swine, Miniature; Time Factors; Treatment Failure; Tumor Suppressor Proteins; Tunica Intima

Recent studies with eluting stents showed encouraging results in preventing in-stent restenosis. We report a case of a patient in whom the implantation of carbon-coated and eluting stents in two different vessels was associated with different angiographic results. A diabetic hypertensive 67-year-old woman with an acute inferior myocardial infarction underwent direct coronary angioplasty on the right coronary artery with the implantation of two carbon-coated stents. In view of the severity of an additional lesion of the left anterior descending coronary artery and diabetes, coronary angioplasty and stenting with an eluting stent was performed in this vessel. Five months later the patient presented with acute pulmonary edema and an increase in troponin I levels. A new coronary angiography showed a long subtotal in-stent restenosis of the right coronary artery, whereas the left anterior descending coronary artery was normal. Our case report suggests that eluting stents should be considered a precious and effective tool in preventing in-stent restenosis.

Topics: Aged; Angioplasty; Carbon; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus, Type 1; Female; Humans; Hypertension; Myocardial Infarction; Sirolimus; Stents

This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs).. The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated.. We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up.. All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group.. The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.

Topics: Aged; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents

The aim of this study was to evaluate the effectiveness of sirolimus-eluting stent (SES) implantation for patients with multivessel disease, which included left anterior descending artery (LAD) treatment. Since April 2002, SES has been utilized as the device of choice for all interventions in our institution as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Hospital (RESEARCH) registry. In the first 6 months of enrollment, 99 consecutive patients (17.6% of the total population) were treated for multivessel disease involving the LAD. The impact of SES implantation on major adverse cardiac events (MACE) was evaluated. All the patients received SES in the LAD. Additional stent implantation in the right coronary artery, the left circumflex, or in all three major vessels was attempted successfully in 32 (32%), 51 (52%), and 16 (16%) of the treated patients respectively. During a mean follow-up of 360 +/- 59 days (range, 297-472 days), we had one death, one non-Q-wave myocardial infarction, and eight patients required subsequent intervention. The event-free survival of MACE at 1 year was 85.6%. SES implantation for multivessel disease in a consecutive series of patients is associated with low incidence of adverse events. The reported results are related predominantly to the reduction in repeat revascularization.

Topics: Aged; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Combined Modality Therapy; Coronary Stenosis; Elective Surgical Procedures; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Combined Modality Therapy; Coronary Stenosis; Elective Surgical Procedures; Humans; Immunosuppressive Agents; Sirolimus; Stents

Topics: Coronary Angiography; Coronary Stenosis; Drug Implants; Humans; Hyperplasia; Immunosuppressive Agents; Male; Middle Aged; Proteoglycans; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

We investigated the pattern of late luminal loss after sirolimus-eluting or bare stent implantation.. The study population comprised 238 patients treated with sirolimus-eluting stents and 526 patients treated with conventional stents. The distribution of late loss of sirolimus stents was largely skewed to the right and differed from the distribution for bare stents. When divided according to the presence of binary restenosis (diameter stenosis >50%), restenotic lesions in the bare stent group (26.0%) had a late loss of 1.40+/-0.64 mm and in the sirolimus group (7.9%) of 1.16+/-0.76 mm. Nonrestenotic lesions in the bare stent group had a late loss of 0.58+/-0.44 mm, whereas the late loss of nonrestenotic lesions in the sirolimus group remained close to zero (-0.05+/-0.33 mm). Differences between poststenting and follow-up measurements in the sirolimus group (late loss) resembled variations observed in repeated angiographic measurements, as assessed from a random sample of 30 segments measured repeatedly. After multivariate adjustment, stent type did not influence the degree of late loss in restenotic lesions. However, nonrestenotic bare stents had a significantly larger estimated luminal loss (0.58 mm; 95% CI, 0.52 to 0.65) than sirolimus-eluting stents, for which the predicted late loss was almost 0 (-0.04 mm; 95% CI, -0.10 to 0.02).. The pattern of late loss after sirolimus-eluting stent implantation follows a peculiar behavior, different from lesions treated with conventional stents. Whether this is explained by an unusual statistical distribution or a biological all-or-none response of restenosis after sirolimus-eluting stenting remains to be investigated.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Implants; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Reproducibility of Results; Sirolimus; Stents

For recurrent in-stent restenosis (ISR), surgical revascularization or brachytherapy is still the principal therapeutic options. The present investigation explores the efficacy of a sirolimus-eluting stent to prevent restenosis in these lesions with a high risk of recurrence. In 22 consecutive patients with a recurrent and diffuse ISR, a sirolimus-eluting stent was implanted to cover the restenotic lesion. All patients were followed clinically for at least 1 year and underwent a repeat angiography after 7 months. A quantitative coronary angiographic analysis was done. The target vessel failure was 14% in the sirolimus-eluting stent group, with an angiographic late loss of only 0.39 +/- 0.54. No subacute stent thrombosis was observed, and the 1-year event-free survival was 86%. The three cases with restenosis were all focal and could be successfully treated by additional drug-eluting stent implantation. This study showed the efficacy of a sirolimus-eluting stent for the prevention of restenosis in a worst-case scenario of recurrent and diffuse ISR. The observed restenosis rate is lower than that reported after brachytherapy and suggests that sirolimus-eluting stents are a promising treatment option for ISR.

Topics: Aged; Angioplasty, Balloon, Coronary; Brachytherapy; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Recurrence; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Humans; Immunosuppressive Agents; Risk Factors; Sirolimus; Stents

Little is known about causes of intimal hyperplasia (IH) after sirolimus-eluting stent (SES) implantation.. Intravascular ultrasound was performed in 24 lesions with intra-SES restenosis and a comparison group of 25 nonrestenotic SESs. To assess stent strut distribution, the maximum interstrut angle was measured with a protractor centered on the stent, and the visible struts were counted and normalized for the number of stent cells. In SES restenosis patients, minimum lumen site was compared with image slices 2.5, 5.0, 7.5, and 10.0 mm proximal and distal to this site. The minimum lumen site had a smaller IVUS lumen area at follow-up (2.7+/-0.9 versus 6.2+/-1.9 mm2; P<0.01), larger maximum interstrut angle (135+/-39 degrees versus 72+/-23 degrees; P<0.01), larger IH area (3.4+/-1.5 versus 0.6+/-1.1 mm2; P<0.01) and thickness (0.7+/-0.3 versus 0.1+/-0.2 mm; P<0.01) at maximum interstrut angle, and fewer stent struts (4.9+/-1.0 versus 6.0+/-0.5; P<0.01) even when normalized for the number of stent cells (0.78+/-0.15 versus 0.97+/-0.07; P<0.01). Compared with nonrestenotic SES, the restenosis lesions also had a smaller minimal lumen area, larger IH area, thicker IH at maximum interstrut angle, fewer stent struts, and larger maximum interstrut angle. Multivariate analysis identified the number of visualized stent struts normalized for the number of stent cells and maximum interstrut angle as the only independent IVUS predictor of IH cross-sectional area (P<0.01 and P<0.01), minimum lumen area (P<0.01 and P<0.01), and IH thickness (P<0.01 and P<0.01).. The number and distribution of stent struts affect the amount of neointima after SES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Implants; Equipment Design; Equipment Failure; Female; Humans; Hyperplasia; Male; Middle Aged; Single-Blind Method; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

Topics: Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Female; Humans; Sirolimus; Stents; Time Factors

Topics: Angioplasty, Balloon, Coronary; Animals; Coated Materials, Biocompatible; Coronary Stenosis; Cost-Benefit Analysis; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Stenosis; Humans; Immunosuppressive Agents; Infusion Pumps, Implantable; Male; Middle Aged; Prosthesis Implantation; Sirolimus; Stents; Treatment Outcome

Topics: Antineoplastic Agents; Cell Division; Coronary Stenosis; Delayed-Action Preparations; Germany; Humans; Immunosuppressive Agents; Paclitaxel; Secondary Prevention; Sirolimus; Stents

A 71-year-old woman underwent right coronary artery (RCA) bare metal stenting during an acute myocardial infarction. Seven months later the patient received a sirolimus-eluting stent as treatment for an 80% left anterior descending coronary artery (LAD) stenosis. She remained asymptomatic until she presented with unstable angina 16 months later. Angiography demonstrated subtotal occlusion of the left obtuse marginal branch. The LAD sirolimus-eluting stent showed 0% stenosis. The RCA stent showed 30% restenosis. The left obtuse marginal branch lesion was successfully stented, but the patient suffered a fatal stroke 24 hours after the coronary intervention. At autopsy the 16-month-old LAD sirolimus-eluting stent was widely patent with a minute thrombus near the ostium of a small side branch. The stent surface appeared free of any other irregularities. Scanning light microscopy showed mild neointimal thickening. Scanning electron microscopy showed > 80% endothelialization of the stent. The 24-month-old RCA bare metal stent showed mild to moderate neointimal growth with > 90% endothelialization.

Topics: Aged; Angioplasty, Balloon, Coronary; Autopsy; Biopsy, Needle; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Equipment Design; Equipment Failure; Equipment Safety; Fatal Outcome; Female; Humans; Immunohistochemistry; Metals; Severity of Illness Index; Sirolimus; Stents; Stroke

Topics: Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Double-Blind Method; Humans; Immunosuppressive Agents; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Humans; Immunosuppressive Agents; Sirolimus; Stents

Topics: Anti-Bacterial Agents; Coronary Restenosis; Coronary Stenosis; Humans; Sirolimus; Stents; Ventricular Remodeling

Topics: Aged; Angina Pectoris; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Delayed-Action Preparations; Drug Implants; Female; Humans; Imaging, Three-Dimensional; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; Vascular Patency

Topics: Angioplasty, Balloon, Coronary; Animals; Antibiotics, Antineoplastic; Antineoplastic Agents; Coronary Restenosis; Coronary Stenosis; Docetaxel; Drug Implants; Humans; Injections, Intra-Arterial; Models, Animal; Paclitaxel; Rabbits; Rats; Sirolimus; Stents; Taxoids