sirolimus and Coronary-Occlusion

Chronic kidney disease (CKD) patients have worse adverse cardiovascular outcomes after percutaneous coronary intervention (PCI). Clinical outcomes comparing a limus-eluting stent (LES) to a paclitaxel-eluting stent (PES) in patients with CKD remain controversial.A systematic search was conducted using PubMed, EMBASE, and Cochrane Library. A pooled odds ratio (OR) and 95% confidence interval (CI) were used to calculate original data. We conducted heterogeneity, quality assessment, and publication bias analyses.A total of 17 trials involving 10,724 patients were included. No significant differences were found regarding target vessel revascularization, target lesion revascularization (TLR), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality, and major adverse cardiac events (MACE) between first-generation LES implantation and PES implantation. Second-generation LES implantation was associated with lower rates of all-cause mortality (OR, 0.56; 95% CI, 0.39-0.82; P = 0.003), MACE (OR, 0.61; 95% CI, 0.38-0.97; P = 0.04), and ST (OR, 0.45; 95% CI, 0.26-0.77; P = 0.004) compared with PES implantation. In all, the long-term all-cause mortality rate was significantly lower after LES implantation than after PES implantation in patients with CKD (OR, 0.78; 95% CI, 0.66-0.93; P = 0.004). However, second-generation LES implantation resulted in a higher rate of TLR (OR, 2.23; 95% CI, 1.53-3.25; P < 0.001) than PES implantation in dialysis patients.In patients with CKD, first-generation LES and PES implantation had comparable mortality and morbidity. Second-generation LES implantation was superior to PES in reducing long-term mortality, MACE, and ST. However, PES may be more effective than LES in dialysis patients.

Topics: Antineoplastic Agents; Coronary Occlusion; Drug-Eluting Stents; Humans; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Renal Insufficiency, Chronic; Sirolimus; Treatment Outcome

To evaluate clinical and angiographic outcomes after successful recanalization of chronic total coronary occlusion (CTO) with implantation of a long total stent length (SL).. Routine follow-up angiogram (RFUA) data after successful recanalization of CTO with a long SL are lacking.. RFUAs were performed at 6 months after successful recanalization of 106 CTOs using drug-eluting stents (DESs) with a long SL (≥ 20 mm) in 102 consecutive patients.. Mean number of stents was 3.9 ± 1.8 and mean total SL was 78 ± 32 mm (range, 23-174 mm). Sirolimus-eluting stents (SESs) were used in 100 lesions. In-stent total reocclusion occurred in 2 cases (1 SES and 1 non-SES DES). Restenosis rate was 18% in the 100 SES subgroup (total SL, 79 ± 33 mm; range, 23-174 mm; mean number of stents, 3.9 ± 1.8); younger age and longer total SL were found to be independent predictors of restenosis (longer age: hazard ratio, 0.939; 95% confidence interval, 0.885-0.996; P=.035; longer total SL: hazard ratio, 1.017; 95% confidence interval, 1.00-1.03; P=.045). Restenosis type was diffuse in only 11% and 89% were successfully treated by repeat percutaneous coronary intervention. During a median follow-up of 2 years (interquartile range, 1-4.3 years), major cardiac events other than those angiographically driven at RFUA occurred in 2 patients.. Angiographic restenosis rate remains acceptable in patients with complex CTO successfully treated by DES despite a long SL.

Topics: Aged; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Longitudinal Studies; Male; Middle Aged; Multivariate Analysis; Percutaneous Coronary Intervention; Retrospective Studies; Sirolimus; Treatment Outcome

To perform a systematic review and meta-analysis of studies reporting outcomes after drug-eluting stent (DES) implantation in chronic total occlusions (CTOs).. A review of publications and online databases in January 2010 retrieved 17 published studies that reported outcomes after DES implantation in CTOs: eight uncontrolled studies, seven nonrandomized comparative studies with bare-metal stents (BMS), one post-hoc analysis of a randomized trial, and one randomized trial. Data were pooled using random-effects meta-analysis models.. All published studies evaluated sirolimus- or paclitaxel-eluting stents. All studies reporting comparative angiographic outcomes revealed less binary angiographic restenosis with DES implantation compared to BMS (odds ratio: 0.15, 95% CI: 0.08, 0.26). Over a mean follow-up period of 18.9±16.5 months, the cumulative incidence of death, myocardial infarction, or stent thrombosis was similar between DES and BMS in all studies. Target lesion revascularization (odds ratio: 0.13, 95% CI: 0.06, 0.26) and target vessel revascularization (odds ratio 0.18, 95% CI: 0.11, 0.31) at 6-12 months were consistently lower among DES-treated patients. Similar patterns of safety and efficacy event rates were also observed in studies reporting>12 month outcomes.. Compared with BMS, treatment of chronic total coronary occlusions with DES is associated with significant reductions in angiographic and clinical restenosis with similar safety. The consistency and magnitude of treatment effect across both individual trials and the pooled analysis establish DES as the preferred therapy for percutaneous revascularization of CTOs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Patient Selection; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The PRISON-IV trial showed inferior outcome in patients with chronic total occlusions (CTOs) treated with the ultrathin-struts (60 μm for stent diameter ≤3 mm, 81μm >3 mm) hybrid-sirolimus eluting stents (SES) compared with everolimus eluting stents (EES, 81 μm). The aim of this study is to investigate if the use of smaller stents (≤3 mm) was responsible for the inferior outcome reported in the trial.. In the PRISON-IV trial 330 patients with CTO lesion were randomized 1:1 to receive either hybrid-SES or EES. The hybrid-SES failed to reach the non-inferiority primary endpoint of in-segment late lumen loss (LLL) at 9-month angiographic follow-up. In this sub-analysis, we divided the population according to the different size of stents implanted in those receiving only stents with diameter ≤3 mm (Group-A, 178 patients), only stents >3 mm (Group-B, 59 patients), and those receiving stents of both sizes (Group-C, 93 patients).. The present analysis suggests that the inferior performance of the ultra-thin hybrid-SES in CTO-PCI is particularly pronounced when smaller stent (≤3 mm diameter) are adopted, if compared with EES.

Topics: Aged; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome; Vascular Diseases

The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs).. The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs.. In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints.. Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; p. This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

Topics: Absorbable Implants; Aged; Belgium; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9™-eluting stent (BES) with a sirolimus-eluting stent (SES).. Among 1,707 patients enrolled in the prospective, multi-center, all-comers LEADERS trial, 81 with CTOs were treated with either a BES (n = 45) or a SES (n = 36). The primary endpoint was the occurrence of major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI) and clinically-indicated target vessel revascularization (TVR).. At 5 years, the rate of MACE was numerically higher in the CTO group than in the non-CTO group (29.6% vs. 23.3%; p = 0.173), with a significant increase in the incidence of target lesion revascularization (TLR) (21.0 vs. 12.6; p = 0.033), but no difference in stent thrombosis (ST). Patients with CTO receiving a BES demonstrated a lower incidence of MACE (22.2% vs. 38.9%; p = 0.147) with a significant reduction in TLR compared to patients receiving a SES (11.1% vs. 33.3%, p = 0.0214) with an incidence similar to that observed in the non-CTO group treated with BES (11.6%). Definite ST at 5 years nearly halved in the BES group (4.4% vs. 8.3%, p = 0.478) with no ST in the BES group after the first year (0% vs. 8.3%, p for interaction = 0.009).. The use of a BES showed a reduction in MACE, TVR, TLR, and ST over time in the CTO subset with similar outcome as for non-CTO lesions.

Topics: Absorbable Implants; Chronic Disease; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions.. Patients were divided into three groups: chronic TO (CTO; n=256), non-chronic TO (n=292), and no occlusion (n=2,941). Clinical and safety outcomes assessed through two years included target lesion failure (TLF: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation) and Academic Research Consortium definite or probable stent thrombosis. The rate of TLF at two years was not significantly different among patients in the CTO (9.1%), TO (9.8%), and no occlusion (10.4%) groups (log-rank p=0.800); neither were the components of TLF. Definite or probable stent thrombosis occurred more frequently in the TO group (2.8% vs. 1.2% in the CTO and 1.1% in the group with no occlusion, p=0.027). There were 10 late and six very late stent thrombosis events.. Apart from a higher rate of stent thrombosis in patients with TO, patients with totally occluded coronary arteries who receive revascularisation with an R-ZES have clinical outcomes comparable to those who receive a similar stent in non-occluded lesions.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Sirolimus-eluting stents (SES) have been shown to be superior to Endeavor zotarolimus-eluting stents (ZES) and comparable to Resolute ZES at eight-month angiography in patients treated for total coronary occlusions (TCO). This study investigated clinical outcome at three-year follow-up.. The PRISON III trial investigated the efficacy and safety of SES against ZES (Endeavor and Resolute) in two study phases. In the first phase, 51 patients were randomised to receive SES and 46 to Endeavor ZES. In the second phase, 103 and 104 patients were randomised to SES or Resolute ZES, respectively. Between one and three years there were only a few additional clinical events in all groups. As a result, the rates of target lesion revascularisation 12.2% vs. 19.6%, p=0.49, target vessel failure 14.3% vs. 19.6%, p=0.68, and definite or probable stent thrombosis 4.1% vs. 2.2% were comparable between SES and Endeavor ZES at three years. In the second study phase, the rates of target lesion revascularisation 10% vs. 5.9%, p=0.42, target vessel failure 10% vs. 7.9%, p=0.79 and definite or probable stent thrombosis 1.0% vs. 0% were similar between SES and Resolute ZES.. The present study demonstrated a low incidence of clinical events between one- and three-year follow-up with either SES compared to Endeavor ZES or SES versus Resolute ZES in patients treated for total coronary occlusions.

Topics: Aged; Antibiotics, Antineoplastic; Cardiovascular Diseases; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Reoperation; Sirolimus; Thrombosis

To compare long-term outcome of patients treated for chronic total occlusion (CTO) lesions versus patients treated for non-CTO lesions only.. Percutaneous coronary interventions (PCI) for CTO lesions generally have a higher adverse event risk than PCI for non-CTO lesions. However, long-term outcome data from prospective studies with second-generation drug-eluting stent (DES) use in CTO lesions is scarce.. We analyzed in this substudy of the TWENTE trial the data of 674 patients, who had stable angina and were electively treated with second-generation DES (Resolute zotarolimus-eluting or Xience V everolimus-eluting stents). Main outcome parameter was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR).. Patients with CTO lesions (n = 59, 8.8%) were more often treated for lesions in small vessels (94.9% vs. 63.1%, P < 0.001), long lesions (52.5% vs. 17.7%, P < 0.001) and multiple vessels (42.4% vs. 22.4%, P < 0.001), and were less often males (62.7% vs. 74.6%, P < 0.05) than patients with non-CTO lesions (n = 615, 91.2%). J-CTO scores ≥2 were present in 56% of CTO lesions. Despite significant differences in characteristics of patients, lesions, and interventional procedures, the TLF rate at 3-year follow-up was similar for both groups (13.6% vs. 12.9%, P = 0.89). In addition, a patient-oriented composite endpoint (any death, MI or revascularization) did not differ between groups (18.6% vs. 18.8%, P = 0.97).. Patients treated with second-generation DES for CTO lesions showed at 3-year follow-up an incidence of adverse clinical events that was low and similar to patients with non-CTO lesions only.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to analyze the incidence of drug-eluting stent thrombosis (sirolimus or everolimus) in patients with chronic total coronary occlusions (CTO) and to determine its clinical implications and related factors.. Data from the 12-month follow-up of the 207 patients included in the CIBELES trial with CTO were analyzed.. Stent thrombosis occurred in three patients, two definite and one probable (overall thrombosis rate: 1.4%). However, there were no cases of death or Q-wave myocardial infarction. In univariate analysis, patients with a higher incidence of stent thrombosis were those in whom the target vessel was the left anterior descending, who had single-vessel disease, were assigned to treatment with sirolimus-eluting stents, and those with smaller minimum luminal diameter immediately after the procedure. In multivariate analysis, the only independent predictor of stent thrombosis was minimal luminal diameter immediately after the procedure.. The rate of drug-eluting stent thrombosis in patients with CTO is relatively low (1.4%). The only independent predictor of stent thrombosis in this context was minimal luminal diameter after the procedure and the clinical presentation was in all cases relatively benign.

Topics: Aged; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Male; Middle Aged; Postoperative Complications; Sirolimus; Thrombosis

For the treatment of chronic total occlusion (CTO), the efficacy and safety of the everolimus-eluting stent (EES) remain less well defined. Also, there are limited data for the predictors of outcome after CTO intervention. The purpose of this study was to compare clinical outcomes of the EES with the first-generation drug-eluting stent (DES) in CTO intervention and to investigate the predictors of clinical outcome. The Korean National Registry of CTO Intervention is a retrospective cohort of 26 centers from the past 5 years. The primary end point was major adverse cardiovascular events (MACE) defined as a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Of the 1,754 all-comer patients, 1,509 patients (EES 311, sirolimus-eluting stent [SES] 642, paclitaxel-eluting stent 556) were finally analyzed after excluding 245 patients (mixed DESs in 46 and follow-up loss in 199). In the inverse probability weighting-adjusted population, the 1-year MACE rate of the EES was comparable with that of the SES (5.8% vs 3.4%, p = 0.796) and the paclitaxel-eluting stent (5.8% vs 6.9%, p = 0.740). Each component of MACE was also comparable among the 3 stents. Importantly, the independent predictors of MACE were diabetes mellitus, previous congestive heart failure, and left circumflex CTO. In conclusion, for the first time in the largest CTO cohort, the EES showed good 1-year clinical outcomes that were comparable with the SES. Independent predictors of MACE after CTO intervention were clinical factors (diabetes and congestive heart failure) and lesion location.

Topics: Antineoplastic Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Electrocardiography; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Registries; Republic of Korea; Retrospective Studies; Sirolimus; Survival Rate; Treatment Outcome

There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention.. After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUS-guided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45).. Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01563952.

Topics: Aged; Anti-Bacterial Agents; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Random Allocation; Sirolimus; Ultrasonography, Interventional

Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer patients of two third-generation stents that are often used clinically, but that have not yet been compared, and one of which has not previously been assessed in a randomised trial.. In this investigator-initiated, single-blind, multicentre, randomised, two-arm, non-inferiority trial, patients aged 18 years and older who required a percutaneous coronary intervention with implantation of a drug-eluting stent were recruited from four study sites in the Netherlands. We randomly assigned patients by independently managed computer-generated allocation sequences in a 1:1 ratio to receive either cobalt-chromium-based zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA, USA) or platinum-chromium-based everolimus-eluting stents (Promus Element, Boston Scientific, Natick, MA, USA). Patients and analysts were masked to the allocated stent, but treating clinicians were not. The primary endpoint of target-vessel failure was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularisation) at 12 months, analysed by intention to treat (with a non-inferiority margin of 3·6%). This trial is registered with ClinicalTrials.gov, number NCT01331707.. Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371 target lesions, were enrolled in the study. 370 (20%) patients presented with ST-elevation myocardial infarction and 447 (25%) with non-ST-elevation myocardial infarction. 906 patients were assigned to receive zotarolimus-eluting stents and 905 to receive everolimus-eluting stents. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned study treatment (six [1%] in the zotarolimus-eluting stent group vs five [1%] in the everolimus-eluting stent group; p=0·22). 12-month follow-up results were available for 1810 patients (one patient in the zotarolimus-eluting stent group withdrew consent). The primary endpoint was met by 55 (6%) of 905 patients in the zotarolimus-eluting stent group and 47 (5%) of 905 in the everolimus-eluting stent group. The zotarolimus-eluting stent was non-inferior to the everolimus-eluting stent (absolute risk difference 0·88%, 95% CI -1·24% to 3·01%; upper limit of one-sided 95% CI 2·69%; non-inferiority p=0·006). We noted no significant between-group differences in individual components of the primary endpoint. Definite stent thrombosis occurred in three (0·3%) patients in the zotarolimus-eluting stent group and six (0·7%) patients in the everolimus-eluting stent group (p=0·34). Longitudinal stent deformation was seen only in the everolimus-eluting stent group (nine [1·0%] of 905 vs 0 of 906, p=0·002; nine of 1591 [0·6%] everolimus-eluting stents implanted became deformed), but was not associated with any adverse events.. Both stents were similarly efficacious and safe, and provided excellent clinical outcomes, especially in view of the large number of patients who presented with acute myocardial infarctions.. Boston Scientific, Medtronic.

Topics: Adult; Aged; Aged, 80 and over; Coronary Occlusion; Death, Sudden, Cardiac; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Single-Blind Method; Sirolimus; Treatment Outcome; Young Adult

In the randomized PLATINUM trial, the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, Massachusetts) was noninferior to the XIENCE V cobalt-chromium everolimus-eluting stent (CoCr-EES; Boston Scientific and Abbott Vascular, Santa Clara, California) for the primary end point of 1-year target lesion failure. This study reports the 3-year outcomes. Patients (n=1,530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter≥2.50 mm to ≤4.25 mm and length≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. Three-year follow-up was available in 93.9% (703 of 749) of patients with CoCr-EES and 96.7% (733 of 758) of patients with PtCr-EES. Comparing CoCr-EES with PtCr-EES, 3-year rates of death (4.3% vs 3.7%, hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.52 to 1.48, p=0.62), cardiac death (1.9% vs 1.2%, HR 0.63, 95% CI 0.27 to 1.45, p=0.27), myocardial infarction (2.5% vs 2.3%, HR 0.92, 95% CI 0.48 to 1.79, p=0.81), ischemia-driven target lesion revascularization (4.9% vs 3.5%, HR 0.72, 95% CI 0.43 to 1.20, p=0.21), and Academic Research Consortium definite or probable stent thrombosis (0.5% vs 0.7%, HR 1.23, 95% CI 0.33 to 4.57, p=0.76) were not significantly different. In conclusion, 3-year results of the PLATINUM randomized, controlled, clinical trial demonstrate comparable safety and efficacy outcomes of the PROMUS Element PtCr-EES and the XIENCE V CoCr-EES.

Topics: Chromium Alloys; Coronary Angiography; Coronary Occlusion; Double-Blind Method; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Platinum Compounds; Prosthesis Design; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation.. The thicker strut of metallic stents potentially contributes to a higher incidence of SBO.. We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1.. Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p < 0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08).. Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Logistic Models; Male; Metals; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The present study was designed to examine the five-year angiographic follow-up of MACE-free patients enrolled in the PRISON II study.. In the PRISON II study a total of 200 patients were randomised to either bare metal stents (BMS) or sirolimus-eluting stents (SES) after successful recanalisation of total coronary occlusions (TCO). Patients free of MACE with available angiography at six months were approached for repeated angiography at five years. The primary endpoint was in-stent very late luminal loss (VLLL) at five years. The secondary endpoint was additional late luminal loss (ALLL) between six months and five years. At five years, repeated angiography was performed in 72 patients, 50/82 (61%) in the SES group and 22/58 (38%) in the BMS group. In-stent VLLL was lower in the SES group (0.19 mm ± 0.72 vs. 0.51 mm ± 0.71, p=0.09) compared to the BMS group and in-segment VLLL was comparable in both groups (0.01 mm±0.58 vs. 0.03 mm ± 0.73, p=0.89). Late catch-up in lumen diameter was observed in the SES group with a trend towards increased ALLL compared to the BMS group (in-stent, 0.35 mm ± 0.88 vs. 0.04 mm ± 0.81, p=0.16; in-segment, 0.20 mm ± 0.74 vs. -0.05 mm ± 0.73, p=0.19).. At five-year angiographic follow-up, late catch-up was observed after successful recanalisation of TCOs treated with SES. Despite a late catch-up, the angiographic results of SES were superior in-stent and similar in-segment compared to BMS.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this study was to examine the five-year clinical outcome in patients enrolled in the Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II) study.. Patients with totally occluded coronary arteries were randomised to either sirolimus-eluting stent (SES, n=100) or bare metal stent (BMS, n=100) implantation. At five years, patients in the SES group had significantly lower rates of target lesion revascularisation (12% vs. 30%, p=0.001), target vessel revascularisation (17% vs. 34%, p=0.009) and major adverse cardiac events (12% vs. 36%, p<0.001). There were no significant differences in death and myocardial infarction. Eight (8%) cases of stent thrombosis (seven definite and one probable; one early, one late, and six very late) were noticed in the SES group versus three cases (3%, one definite and two possible; all very late) in the BMS group (p=0.21).. The results of the present study show that the documented superior short-term angiographic and clinical results of SES in patients with total coronary occlusions are maintained during long-term 5-year follow-up as compared with BMS. On the other hand, there is a trend to a higher stent thrombosis rate in the SES group.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Longitudinal Studies; Male; Metals; Middle Aged; Myocardial Infarction; Sirolimus; Stents; Survival Rate; Thrombosis; Treatment Outcome

Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO).. A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up.. The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Percutaneous recanalization of total coronary occlusion (TCO) was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST) with drug-eluting stents (DES) for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO.. The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany) compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA) in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence tomography is performed in the first 60 randomized patients at 9 months to assess neointima thickness, percentage of neointima coverage, and stent strut malapposition and coverage. Personnel blinded to the allocated treatment will review all angiographic and optical coherence assessments. Secondary clinical endpoints include major adverse cardiac events, clinically driven target vessel revascularization, target vessel failure and stent thrombosis to 5-year clinical follow-up. An independent clinical event committee blinded to the allocated treatment will review all clinical events.. Clinical Trials.gov: NCT01516723. Patient recruitment started in February 2012.

Topics: Angioplasty, Balloon, Coronary; Belgium; Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Neointima; Netherlands; Polymers; Prospective Studies; Prosthesis Design; Research Design; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Chronic total coronary occlusions constitute a sub-group of lesions at very high risk of restenosis after successful percutaneous coronary intervention. The sirolimus-eluting coronary stent is the only drugeluting stent that has demonstrated to reduce angiographic restenosis and the need for new revascularisation procedures in comparison with bare-metal stents in randomised clinical trials focusing on these lesions. Everolimus-eluting stents have shown to offer optimal angiographic and clinical outcomes in comparison with bare-metal stents and paclitaxel-eluting stents, but no randomised trials have tested the device in chronic total occlusions. The CIBELES (non-acute Coronary occlusIon treated By EveroLimus- Eluting Stent) will randomise 208 patients with chronic total coronary occlusions in 13 centres from Portugal and Spain to receive everolimus- or sirolimus-eluting coronary stents. The primary endpoint will be angiographic in-stent late loss.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Portugal; Prosthesis Design; Research Design; Single-Blind Method; Sirolimus; Spain; Time Factors; Treatment Outcome

Percutaneous coronary intervention with bare metal stent (BMS) in chronic total coronary occlusions (CTOs) is associated with a higher rate of angiographic restenosis and reocclusion than that observed in subtotal stenoses. Preliminary reports have suggested a better performance of drug-eluting stents in CTO. In this multicentre, randomized trial, we compared the mid-term angiographic and clinical outcome of sirolimus-eluting stent (SES) or BMS implantation after successful recanalization of CTO.. Patients with CTO older than 1 month, after successful recanalization, were randomized to implantation of SES (78 patients) or BMS (74 patients) in 13 Italian centres. Clopidogrel therapy was prescribed for 6 months. The primary endpoint was in-segment minimal luminal diameter (MLD) at 8-month follow-up. Secondary clinical endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) at 24 months. Patients treated with SES showed, at in-segment analysis, a larger MLD (1.98 +/- 0.57 vs. 0.98 +/- 0.80 mm, P < 0.001), a lower late luminal loss (-0.06 +/- 0.49 vs. 1.11 +/- 0.79 mm, P < 0.001), and lower restenosis (9.8 vs. 67.7%, P < 0.001) and reocclusion (0 vs. 17%, P = 0.001) rates. At 24-month follow-up, patients in the SES group experienced fewer major adverse cardiac events (50.0 vs. 17.6%, P < 0.001) mainly due to a lower rate of both TLR (44.9 vs. 8.1%, P < 0.001) and TVR (44.9 vs. 14.9%, P < 0.001).. In CTO, SES is markedly superior to BMS in terms of restenosis and reocclusion rate, and incidence of repeat revascularization at 24 months. Clinicaltrials.gov identifier: NCT00220558.

Topics: Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Italy; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.. The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.. The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.. trialregister.nl NTR1108.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Clinical Protocols; Coronary Occlusion; Drug-Eluting Stents; Europe; Everolimus; Humans; Magnetic Resonance Imaging; Myocardial Contraction; Myocardial Infarction; Ontario; Prospective Studies; Prosthesis Design; Recovery of Function; Research Design; Sirolimus; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

We studied a novel sirolimus eluting stent with a bioabsorbable coating (SES) in >3 months old chronic total coronary occlusions (CTO).. Ninety-five patients were randomised to either BMS (n=47) or SES (n=48). The primary endpoints were late lumen loss (LLL) and in-segment restenosis (ISR) after six months. Secondary endpoints were target vessel revascularisation after six and 24 months. Occlusion length (37.6 mm), reference diameter (2.8 mm) as well as the stented segment (45.5 mm) were similar in both groups. Up until six months no death, myocardial infarction or stent thrombosis occurred in either group. Angiographic follow-up (45BMS/46SES): LLL 1.8 mm/0.77 mm (p<0.0001), ISR 60%/17.4% (p<0.0001). In-segment re-occlusion 15.5%/0% and TVR 53.3%/10.8% (p<0.0001). After 24 months: 1 BMS, 2 SES patients died; 0 BMS, 0 SES infarction; 0 BMS, 0 SES stent thrombosis and 3 BMS, 0 SES TVR between six and 24 months. Thus total TVR after 24 months was 60% for BMS and 10.8% for SES (p<0.0001).. The alternative sirolimus-coated stent was shown to reduce the relative risk of restenosis after six months by 71%, and of TVR after 24 months by 82%. Between six and 24 months, neither stent thrombosis occurred, nor repeat revascularisation was required in patients who received a SES.

Topics: Absorbable Implants; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The purpose of this study was to examine the 3-year clinical outcome in patients enrolled in the Primary Stenting of Totally Occluded Native Coronary Arteries II study.. Patients with totally occluded coronary arteries randomized to either sirolimus-eluting Cypher stents (SESs) (Cordis, a Johnson & Joshson Company, Miami Lakes, FL) (100 patients) or bare-metal BxVelocity stents (BMSs) (Cordis) (100 patients) were followed clinically for 3 years.. Between 1 and 3 years, there were infrequent additional clinical events that were equally distributed between the SES and the BMS group. After 3 years, target lesion revascularization was 7% in the SES group versus 27% in the BMS group (P < .001); and target vessel revascularization was seen in 11% in the SES group versus 30% in the BMS group (P = .002). Major adverse cardiac events were noted in 10% of the SES group versus 34% in the BMS group (P < .001). There were no statistically significant differences in death, myocardial infarction, and stent thrombosis according to the Academic Research Consortium criteria between the 2 groups.. Clinical outcome up to 3 years after implantation of SESs for total coronary occlusions continues to demonstrate a significant reduction in adverse clinical events compared with BMSs without the evidence for either disproportionate late restenosis or late stent thrombosis.

Topics: Combined Modality Therapy; Coronary Occlusion; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

We assessed the effectiveness and safety of the sirolimus-eluting stent (SES) in the treatment of chronic total coronary occlusions.. Chronic total occlusions (CTO) of coronary vessels have an unacceptable high restenosis rate of approximately 50% after stenting. Few data exist about the performance of drug eluting stents (DES) in the treatment of CTO.. All coronary interventions using the Cypher stent performed at 122 centers engaged in the German Cypher registry between April 2002 and December 2004 were analyzed; a total of 5,344 patients; 374 with and 4,970 without CTO were compared.. There was no significant difference between both groups regarding demographics, coronary status and left ventricular function. Patients in the CTO group had a higher level of angina symptoms, the coronary lesions were more complex and the stents used were smaller and longer than in the No-CTO group. The In-hospital outcome was similar in both groups, with importantly no difference regarding mortality and complications. Stenting was as successful in the CTO as in the No-CTO group; during a follow-up of 6.6 months we found no significant difference regarding the rate of mortality, complications, and revascularization between both groups.. Implantation of the Cypher stent reduces the restenosis rate and seems to be a safe and effective tool for the treatment of chronic total coronary occlusions.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis; Chronic Disease; Coronary Occlusion; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Female; Germany; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Registries; Sirolimus; Treatment Outcome

Topics: Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Humans; Lithotripsy; Sirolimus; Stents; Treatment Outcome

Reports of long-term outcomes of patients treated with drug-eluting stents in total coronary occlusions are limited. We analysed clinical outcomes of patients treated with the zotarolimus-eluting Resolute stent (R-ZES) implanted in coronary total occlusions versus non-occluded lesions.. Patients treated with R-ZES and included in four trials (RESOLUTE All Comers, RESOLUTE International, RESOLUTE China RCT, and RESOLUTE China Registry) were pooled and divided into three groups - patients with chronic total occlusions (CTO), patients with total occlusions that had occurred recently (rec-TO), and patients without total occlusions (non-TO). Clinical outcomes at five years were analysed. Of 5,487 patients treated with R-ZES in these trials, 8.0% had CTOs, 8.5% rec-TOs and 83.5% non-TOs. Patients had a mean age of 62.8 years, approximately 25% were female and 30% were diabetics. TLF was similar in the three groups at five years (TLF was 13.2%, 12.5% and 13.3% in the CTO, rec-TO and non-TO groups, respectively, p=0.96). Stent thrombosis tended to occur more frequently for rec-TO compared to CTO and non-TO patients (2.6% vs 1.2% and 1.3%, respectively, p=0.11).. In this large population of patients who had R-ZES implanted, five-year clinical outcomes were similar whether or not the stents were implanted in total occlusions.

Topics: Cardiovascular Agents; China; Coronary Artery Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Interventional therapies such as drug-eluting stents (DES) and drug-coated balloons (DCB) have significantly improved the clinical outcomes of patients with coronary occlusions in recent years. Despite this marked improvement, ischemic cardiovascular disease remains the most common cause of death worldwide. To address this, research efforts are focused on improving the safety and efficacy of the next generation of these devices. However, current experimental methods are unable to account for the influence of atherosclerotic lesions on drug uptake and retention. Therefore, in this study, we used an integrated approach utilizing both in vitro and in silico methods to assess the performance of DCB therapy. This approach was validated against existing in vivo results before being used to numerically estimate the effect of the atheroma. A bolus release of sirolimus was observed with our coating matrix. This, coupled with the rapid saturation of specific and non-specific binding sites observed in our study, indicated that increasing the therapeutic dose coated onto the balloons might not necessarily result in greater uptake and/or retention. Additionally, our findings alluded to an optimal exposure time, dependent on the coating matrix, for the DCBs to be expanded against the vessel. Moreover, our findings suggest that a biphasic drug release profile might be beneficial for establishing and maintaining the saturation of bindings sites within severely occluded vessels. Ultimately, we have demonstrated that computational methods may be capable of assessing the efficacy of DCB therapy as well as predict the influence of atherosclerotic lesions on said efficacy.

Topics: Angioplasty, Balloon, Coronary; Atherosclerosis; Cardiovascular Agents; Computer Simulation; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug Liberation; Drug-Eluting Stents; Humans; Models, Cardiovascular; Sirolimus; Treatment Outcome

Limited research has detailed the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with independent core laboratory and event adjudication. This study examined procedural, clinical, and patient-reported health status outcomes among patients undergoing CTO PCI with specific focus on outcomes for those treated with zotarolimus-eluting stents (ZES).. Among 500 consecutive patients undergoing attempted CTO PCI, procedural and in-hospital clinical outcomes were examined in addition to the 1-year composite endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events, MACE). In a pre-specified cohort of 250 patients, health status measures were ascertained at baseline and 1 year. A powered secondary endpoint was 1-year MACE among patients treated with ZES compared with a performance goal.. Demographic, lesion, and procedural characteristics for the overall population included prior bypass surgery, 29.8%; diabetes, 35.2%; occlusion length >20 mm, 71.3%; J-CTO score, 2.5 ± 1.1; and primary retrograde strategy, 30.8%. Overall guidewire crossing was 90.9%; clinical success following guidewire crossing, 94.3%; and 1-year MACE rate, 12.1%. One-year health status significantly improved from baseline with successful CTO-PCI (angina frequency, 72.7 ± 26.5 at baseline to 96.0 ± 10.8, p < .0001). Compared with a performance goal derived from prior CTO DES trials (1-year hierarchal MACE, 25.2%), treatment with ZES was associated with significantly lower MACE (18.2%, one-sided upper CI, 23.6%, p = .017).. Favorable procedural success, health status improvements and late-term clinical outcomes inform the relative risks and benefits of CTO PCI when performed in a clinically indicated, complex patient population representative of those treated in clinical practice.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Health Status; Humans; Male; Middle Aged; Patient Reported Outcome Measures; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Recovery of Function; Registries; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Aneurysm; Coronary Occlusion; Drug-Eluting Stents; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

We aimed to assess long-term safety and performance of the Orsiro sirolimus-eluting coronary stent with biodegradable polymer in a large unselected population and in pre-specified subgroups.. BIOFLOW-III is a prospective, multicenter, international, observational registry with follow-up visits scheduled at 6 and 12 months, and at 3 and 5 years (NCT01553526).. 1356 patients with 1738 lesions were enrolled. Of those, 392 (28.9%) declined to participate in the study extension from 18 months to 5 years, 37 (2.7%) withdrew consent, and 89 (6.6%) were lost to follow-up. At 5-years, Kaplan-Meier estimates of target lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, coronary artery bypass grafting and clinically driven target lesion revascularization was 10.0% [95% confidence interval (CI): 8.4; 12.0] in the overall population, and 14.0% [95% CI: 10.5; 18.6], 10.3% [95% CI: 7.8; 13.5], 1.8% [95% CI: 0.3; 12.0], and 11.3% [95% CI: 8.5; 15.1] in the pre-defined risk groups of patients with diabetes mellitus, small vessels ≤2.75 mm, chronic total occlusion, and acute myocardial infarction. Definite stent thrombosis was observed in 0.3% [95% CI: 0.1; 0.9] of patients.. These long-term outcomes provide further evidence on the safety and performance of a sirolimus-eluting biodegradable polymer stent within daily clinical practice. The very low definite stent thrombosis rate affirms biodegradable polymer safety and performance.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Artery Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Polyesters; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Although a number of drug-eluting stents have been developed with different design, composition, and polymers, the search for an ideal drug-eluting stent is ongoing. The Tetriflex (Sahajanand Medical Technology, Surat, India) is a newer-generation, ultrathin (60 µm) biodegradable polymer-coated sirolimus-eluting stent (SES) designed with a unique long dual Z-link on a cobalt-chromium alloy. The present registry aimed to evaluate the safety and clinical outcomes of the Tetriflex SES at 6-month post-implantation.. This was an investigator-initiated, retrospective, multicenter, single-arm, observational registry conducted at five tertiary-care centers in India. A total of 1,269 consecutive patients with coronary artery disease who underwent implantation of at least one Tetriflex SES between March 2017 and March 2018 were included. The primary outcome was considered a composite of cardiac death, myocardial infarction and target-lesion revascularization (TLR) at 6-month follow-up. Stent thrombosis was evaluated as a safety outcome at 6-month follow-up.. The mean age of patients was 54.99±10.80 years. Among 1,515 lesions treated with 1,682 Tetriflex SES, 58.3% were type C lesions. Six-month follow-up was done for 1,245 of 1,269 (98.1%) patients. At 6 months, composite events had occurred in 31 (2.5%) patients, consisting of ten (0.8%) cardiac deaths, 16 (1.3%) myocardial infarctions, and five (0.4%) TLRs. Stent thrombosis was observed in seven (0.56%) cases at 6 months. A subgroup analysis between diabetic and nondiabetic patients did not reveal any statistically significant difference for clinical outcomes at 6-month follow-up.. The results of the current registry outline the safety and effectiveness of the Tetriflex SES in real-world patients, as it displayed favorable clinical outcomes at 6-month follow-up, with low incidence of TLR and stent thrombosis.

Topics: Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; India; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Although bioresorbable polymer sirolimus-eluting Ultimaster stents (BP-SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real-world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP-SES implantation have not been fully investigated.. This study evaluated the 1-year clinical outcomes after BP-SES implantation in real-world PCI cases and identified the predictors of adverse outcomes.. In this single-center, all-comers study, we consecutively implanted BP-SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow-up assessment of these patients.. The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1-year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF.. The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP-SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1-year clinical outcomes after BP-SES implantation were found to be favorable among all-comer PCI cases, including patients receiving HD and those with in-stent restenosis.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Chronic Disease; Coronary Artery Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Japan; Kidney Diseases; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Renal Dialysis; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) usually involves multiple overlapping stents implantation to cover long coronary segments. A higher rate of restenosis has been described with stent overlapping. Recently, new long tapered stents emerged as a potential tool for treating long coronary lesions. Feasibility of using these new devices for the CTO PCI has not been described. The aim of this work was to describe our initial experience with 50 and 60 mm-long tapered sirolimus-eluting stents (SES) in CTO PCI.. We included 54 consecutive patients who underwent a CTO PCI and in whom an attempt to implant a 50 or 60 mm-long tapered SES was performed. Baseline clinical, angiographic, and procedural characteristics were recorded.. The median (IQR) age was 64 (58-73) years, and 45 (83.3%) patients were male. The tapered SES 50 and 60 mm-long was successfully implanted in 51 (94.4%) patients. In three patients, a 60 mm-long stent could not be implanted, and two or three overlapped shorter drug-eluting stents were deployed instead. An average of 1.4 ± 0.6 stents per patient was implanted. A single stent was deployed in 32 (59.3%) patients. During a median follow-up of 330 (149-551) days, repeat PCI in the target vessel was performed in two patients.. The use of the new BioMime Morph™ tapered SES for the treatment of CTO appears to be feasible in a high proportion of procedures. Further studies confirming the feasibility of this approach and its potential clinical advantages are needed.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the 9-month safety and efficacy of polymer-free sirolimus eluting drug eluting stents in septuagenarians and octogenarians.. An all-comer, worldwide single armed trial (ClinicalTrials.gov Identifier NCT02629575) was conducted to demonstrate the safety and efficacy of an ultra-thin strut, polymer-free sirolimus eluting stent (PF-SES). The primary endpoint was the 9-month target revascularization rate (TLR). Secondary endpoints included the rates of major adverse cardiac events (MACE), stent thrombosis (ST) and bleeding (BARC) in septuagenarians (≥70 years, <80 years), and in octogenarians (≥80 years) to be compared to the younger patient group (<70 years).. A total of 1607 patients were treated with PF-SES in the sub-70-year-old age group, 694 in septuagenarians, and 371 in the octogenarian patient group. At 9 months, the MACE rates were 7.2% in octogenarians, 5.3% in septuagenarians, and 3.0% in the younger patient group (P = 0.001). These were mostly driven by all-cause mortality (4.4% vs 1.9% vs 0.6%, P < 0.001) while the TLR rates were only numerically lower in the younger age group (P = 0.080). BARC 1-5 bleeding events were more frequent in the older age group (1.9% vs 2.7% vs 4.6%, P = 0.012) whereas the rates for ST were not different (0.7% vs 0.6% vs 0.6%, P = 0.970).. In octogenarians treated with PF-SES, the rates for MACE, overall mortality, and bleeding are higher as compared to the younger age groups. However, the rates for TLR and ST were not significantly different across the investigated age groups. PF-SES are safe and effective in octogenarians.

Topics: Age Factors; Aged; Aged, 80 and over; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Polymers; Sirolimus; Time Factors; Treatment Outcome

Coronary chronic total occlusions (CTO) usually coexist with diffusely diseased coronary segments proximal and/or distal to the CTO segment. During percutaneous treatment of CTO, multiple overlapping stents are often needed to treat these long lesions.. Aim of this study is to report the first use of long, tapered coronary sirolimus-eluting stents (SES) in this setting.. This is a retrospective analysis of 100 consecutive patients undergoing CTO recanalization following the hybrid algorithm. Procedural success rate was 89% (11 failures). Among the successful cases, "conventional" drug-eluting stents(DES) were used in 40(44.9%) patients, while in 49(55%) patients long-tapered SES were attempted with a success rate of 98% (1 cross-over to regular stents). Total stent length in the long-tapered DES group was higher compared to the "conventional" stenting group (76 ± 28 mm vs 46 ± 22 mm, P < .001), with a similar total number of stent (1.6 ± 0.8 vs 1.9 ± 0.8). At quantitative coronary analysis, proximal and distal segment involvement was more extended in patients undergoing long-tapered stenting, with longer overall lesion length. No differences in periprocedural complications and clinical outcomes at a mean follow-up of 303 ± 179 days were observed.. The use of long tapered coronary DES is technically feasible and safe for the percutaneous treatment of CTOs, especially for patients presenting with long lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome; Vascular Patency

We aimed to evaluate the mid-term outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), as compared with durable-polymer everolimus-eluting stents (EES).. We compiled a multicenter registry of patients undergoing CTO recanalization followed by BP-SES or EES implantation. The primary endpoint was the incidence of target-lesion failure (TLF, a composite of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization) at one year. Propensity score matching (PSM) was used to adjust for case mix.. Overall, 413 patients were included (BP-SES n = 242, EES n = 171). PSM resulted in 131 matched pairs, which represented the subject of the main analysis. Antegrade wire escalation was the most successful crossing technique (66% vs. 63%, p = 0.98) in both the BP-SES and EES groups, respectively. Procedural success rates were similar between groups (BP-SES 96% vs. EES 93%, p = 0.24). At one-year follow-up, there were no differences in the primary endpoint of TLF (5.7% vs. 8.3%, p = 0.44), and in cardiac death (0.9% vs. 2.8%, p = 0.32), target-vessel myocardial infarction (0.9% vs 1.9%, p = 0.57), target-lesion revascularization (3.7% vs 3.7%, p = 0.99), or stent thrombosis (0.9% vs. 1.9%, p = 0.57), in BP-SES vs. EES, respectively.. Patients undergoing CTO PCI with BP-SES suffer a low rate of TLF at one-year follow-up, which is similar to that of subjects treated with durable-polymer EES.

Topics: Absorbable Implants; Aged; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Registries; Sirolimus; Treatment Outcome

Late stent thrombosis and delayed vessel wall healing remain an important issue in coronary vessels treated with drug-eluting stents (DES), especially when long-vessel segments need to be covered, like in chronic total occlusions (CTO). Avoiding polymer use to avoid chronic inflammatory responses is a potential solution to reduce target vessel failure (TVF). We aimed to validate the clinical safety and efficacy at 1 year of the polymer-free Cre8 DES vs. nonpolymer-free DES for the percutaneous treatment of CTO.. Between September 2011 and August 2016, patients were prospectively enrolled in three CTO centres. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), including cardiac death, any myocardial infarction, stent thrombosis, TVF and target vessel revascularization.. A total of 102 Cre8 and 133 non-Cre8 patients were enrolled. At 1 year, a low cumulative MACCE was observed in the Cre8 group (6.9%, respectively). Moreover, a numerical trend towards better MACCE was observed in the Cre8 group vs. the non-Cre8 group (6.9 vs. 14.3%; P = 0.065). The clinically driven TVF rate was not statistically different between Cre8 and non-Cre8 patients (6.9 vs. 9.8%; P = 0.373). A borderline significant difference regarding mortality was observed in favour of Cre8 patients (0 vs. 3.8%; P = 0.049).. Low rates of MACCE and TVF up to 1 year were observed in the Cre8 group, supportive of the use of polymer-free DES for lesions with high complexity.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To compare vascular healing after drug-eluting stent (DES) implantation between plaque rupture (PR) and plaque erosion (PE).. Vascular response after stent implantation in patients with PR has been extensively studied. Little is known about vascular healing after stent implantation in PE.. Sixty-five ACS patients who received optical coherence tomography (OCT) imaging of the culprit lesions both before and after stent implantation at baseline as well as at 6 months were included in this study. Patients were divided into two groups: PR (n = 19) and PE (n = 24). Prestent thrombus burden and poststent intrastent structure (ISS) volume were analyzed during the index procedure. The ratio of uncovered to total stent struts per cross-section score (RUTTS) and neointimal thickness and area were measured at follow-up.. OCT imaging showed that compared with PR, PE showed a significantly lower prestent thrombus score (34.2 ± 19.2 vs. 68.6 ± 44.2, P = 0.009) at baseline and a smaller poststent ISS volume (0.7 ± 0.9 mm. PE was associated with less favorable healing following DES implantation when compared to PR at 6 months, indicating longer dual-antiplatelet therapy may be necessary for patients with PE. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Predictive Value of Tests; Prosthesis Design; Rupture, Spontaneous; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

The third generation drug eluting Orsiro stent had shown already promising results in non-complex lesions.. We evaluated angiographic and 24 month clinical results of the sirolimus eluting Orsiro stents (O-SES) after recanalization of coronary chronic total occlusions (CTO). Results were compared with the zotarolimus eluting Resolute Integrity (R-ZES).. In a prospective series 57 patients were treated with a R-ZES followed by 74 patients treated with a O-SES stent. Angiographic follow up after 9 months and clinical follow-up after 12 and 24 months was performed.. In-stent late lumen loss was 0.24±0.53 mm for the O-SES compared with 0.59±0.72 (P=0.01) for R-ZES. Rates for TLR were similar (O-SES 10.0% versus R-ZES 11.1%, P=0.84). There was no definite stent thrombosis.. The O-SES resulted in a significant lower late lumen loss but with similar clinical results up to 24 month compared to the R-ZES after treatment of CTO lesions.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Although studies have demonstrated comparable efficacy and safety profiles of everolimus- and zotarolimus-eluting stents (EES and ZES, respectively) for a broad spectrum of coronary artery diseases, there is paucity of data concerning their safety and efficacy for coronary chronic total occlusions (CTOs). This study compared the clinical performance of EES and ZES following successful percutaneous coronary intervention for CTOs.. The cohort included 539 consecutive CTO patients who underwent successful PCI using EES (n=313) and ZES (n=226) between September 2006 and August 2014. The primary outcome was defined as the composite of death, myocardial infarction, and target vessel revascularization.. During a median follow-up of 3.3years, in both groups, the primary outcome occurred in 12.2% of patients. After multivariable adjustment, no significant difference was observed between the two groups in the risk of primary outcome [hazard ratio (HR) 1.03, 95% confidence interval (CI) 0.59-1.79, P=0.930 for ZES compared with EES]. Similarly, there were no significant differences in the risk of death (adjusted HR 0.96, 95% CI 0.43-2.15, P=925), death or myocardial infarction (adjusted HR 0.93, 95% CI 0.46-1.88, P=0.829), and target vessel failure (adjusted HR 0.96, 95% CI 0.51-1.82, P=0.902). The incidence of definite/probable stent thrombosis was relatively low [0% (ZES) vs. 1.0% (EES), P=0.19].. No significant differences were observed between EES and ZES in terms of clinical outcomes for coronary CTOs at 3.3years.

Topics: Aged; Cohort Studies; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

Topics: Coronary Occlusion; Coronary Vasospasm; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Middle Aged; Recurrence; Sirolimus; ST Elevation Myocardial Infarction

To evaluate angiographic and clinical results of ZES compared with EES after recanalization of CTOs.. ZES and EES showed similar clinical results in non-CTO lesions. Whether ZES and EES are also comparable in true CTO lesions (TIMI 0 flow, duration of occlusion of more than 3 months) with a higher risk of restenosis has not been addressed so far.. 125 patients with successful CTO recanalization via antegrade or retrograde approach were included. EES were implanted in 68 patients and ZES in 57 patients. Dual antiplatelet therapy was prescribed for 12 months. Follow-up angiography was scheduled at 9 months and clinical follow-up at 12 months. The primary angiographic outcome measure was in-stent late lumen loss. Primary clinical outcome measures were target lesion revascularization rate (TLR) and major adverse cardiac events (MACE) as a composite of cardiac death, TLR and myocardial infarction not clearly attributable to a non-target vessel.. Baseline characteristics were similar in both groups. Mean stent length was 72.8 ± 33.0mm with EES and 70.8 ± 31.5 mm with ZES (P = 0.72). In-stent late lumen loss was 0.50 ± 0.71 mm for EES compared with 0.59 ± 0.72 (P = 0.52) for ZES. There were similar rates for TLR (EES 10.3% versus ZES 10.5%, P = 0.97) and MACE (EES 10.3% versus ZES 12.3%). No definite or probable stent thrombosis occurred. Stent length but not type of stent was predictive for in-stent late loss and TLR.. ZES and EES showed similar angiographic and clinical outcomes for treatment of CTOs. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Aged; Coronary Occlusion; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Sirolimus

The unique physical properties of optical coherence tomography (OCT) make it a useful technique in the study of restenosis mechanisms. In fact, OCT is able to differentiate between neointimal proliferation and neoatherosclerosis within the stent. We report a rare case of occlusive neoatherosclerosis presenting beyond one year after a successful drug-eluting stent implantation. The impact of OCT findings in the clinical decision making process is emphasized.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Hypolipidemic Agents; Male; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Retreatment; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

A 70-year-old man underwent percutaneous coronary intervention (PCI) using sirolimus-eluting stent (SES) at the just proximal site of left anterior descending coronary artery. Six months after SES implantation, he suffered from late stent thrombosis. Intravascular ultrasound (IVUS) images demonstrated positive remodeling of the vessel, indicating late-acquired incomplete stent apposition (ISA). An angioplasty with a bigger balloon was performed to obtain sufficient stent struts apposition. Twenty-six months after the second PCI, he developed ST-elevation myocardial infarction and his CAG showed re-occlusion of the SES. Optical coherence tomography showed ISA and IVUS revealed further enlargement of the coronary artery around the SES.

Topics: Aged; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Percutaneous Coronary Intervention; Postoperative Complications; Prosthesis Failure; Radiography; Sirolimus; Tomography, Optical Coherence; Ultrasonography, Interventional

This study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions.. Everolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited.. Patients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score.. A total of 23 patients were included. Mean age was 60.4 ± 9.0 years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7 ± 1.0. Median procedure time was 70 min (54-85), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1-30.0). A total of 64 BVSs were implanted with a mean number of 2.8 ± 1.0 BVSs per patient, a mean total BVS length of 64.8 ± 24.2 mm per lesion, and a mean BVS diameter of 3.1 ± 0.2 mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5-214.5) days one in-scaffold thrombosis was noted 4 days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred.. These results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases.

Topics: Absorbable Implants; Comorbidity; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Risk Factors; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Occlusion; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Male; Predictive Value of Tests; Prosthesis Design; Sirolimus; Tomography, Optical Coherence

There is limited experience regarding the feasibility of the bioresorbable vascular scaffold (BVS) in "all-comer" populations. We evaluated the impact of BVS use on procedural factors and clinical outcomes compared with the new-generation drug-eluting stent (DES).. We analyzed procedural feasibility and outcome data from 292 consecutive patients treated with either a new-generation DES or a BVS between May 2008 and May 2014 using propensity-score (PS) matching.. After PS matching, 96 patients treated with BVSs and 96 patients treated with DESs were selected. Lesion characteristics were similar between the 2 groups. Maximum balloon size after dilation was larger and maximum inflation pressure was higher in the BVS group, despite similar quantitative coronary angiography results. Procedure time (114.7 ± 39.2 minutes vs 90.4 ± 38.2 minutes; P < 0.001), amount of contrast medium used (268.3 ± 104.2 mL vs 229.2 ± 122.2 mL; P = 0.02), and fluoroscopy time (42.4 ± 17.9 minutes vs 34.5 ± 19.7 minutes; P < 0.001) were significantly increased in the BVS group compared with the DES group. In multivariable analysis, BVS use was identified as an independent predictor of long (> 120 minutes) procedure time (odds ratio, 7.83; 95% confidence interval, 2.81-25.78; P < 0.001). Procedural success (93.6% BVS vs 95.7% DES; P = 0.51) and 1-year major adverse cardiovascular events (10.2% BVS vs 10.5% DES; P = 0.82) were similar between the groups.. In real-world patients with predominantly complex lesions treated with BVSs, procedural success rates and short-term outcomes similar to those seen in patients treated with DESs are observed at the expense of longer procedure and fluoroscopy times.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Propensity Score; Prosthesis Design; Reproducibility of Results; Retrospective Studies; Sirolimus; Tissue Scaffolds; Treatment Outcome

Topics: Aged; Coronary Occlusion; Everolimus; Humans; Male; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence

This study aimed at evaluating the outcome of Biolimus eluting stent (BES) implantation in the treatment of chronic total coronary occlusions (CTO). We identified patients who underwent successful angioplasty for a CTO lesion with ≥1 BES between June 2008 and March 2012. All patients were followed up for major adverse cardiac events (MACE), which comprised death, non-fatal myocardial infarction (MI), cerebrovascular accident, target vessel revascularization (TVR), target lesion revascularization (TLR) and stent thrombosis. 125 patients underwent successful CTO angioplasty with ≥1 Biolimus-eluting stents. Mean age was 63.8 ± 12.0 years, and 82.4 % were males. Lesion location was right coronary artery (n = 80, 64 %), left anterior descending artery (n = 35, 28 %) and left circumflex artery (n = 10, 8 %). During follow-up of 579 ± 293 days, all cause mortality was n = 8 (6.4 %) patients, non-fatal MI was n = 3 (2.4 %), TVR was n = 3 (2.4 %) and TLR was n = 1 (0.8 %). Overall MACE was, therefore, n = 15 (12 %). BES is safe and effective in treatment of CTO lesions, with a low rate of major adverse cardiovascular events during follow-up.

Topics: Anti-Inflammatory Agents; Coronary Occlusion; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Retrospective Studies; Sirolimus; Survival Analysis; 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

To assess the incidence and impact on clinical outcomes of subintimal tracking in patients undergoing percutaneous coronary intervention for chronic total occlusion (CTO). Patients at 27 centres were consecutively enrolled when guidewire crossing of the CTO by either the antegrade or the retrograde approach was confirmed by intravascular ultrasound (IVUS). IVUS images were examined to identify the course of the wire. Clinical follow-up at one year and angiographic follow-up at nine months were performed after everolimus-eluting stent implantation. Among a total of 163 patients (59 antegrade and 104 retrograde), subintimal tracking was more frequent with the retrograde approach (24.2% vs. 12.3%, p=0.10). Although there was no difference in the one-year target vessel revascularisation rate between intimal and subintimal tracking with either the antegrade or the retrograde approach, angiographic follow-up revealed greater late loss in the subintimal group compared with the intimal group. Multivariate analysis identified the pre-procedural reference diameter as a predictor of subintimal tracking. Subintimal tracking was more frequent with the retrograde approach. After medium-term follow-up, no negative clinical impact of subintimal tracking was observed in this small study. However, further evaluation of the angiographic impact is needed.

Topics: Aged; Coronary Aneurysm; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Japan; Male; Percutaneous Coronary Intervention; Registries; Sirolimus; Ultrasonography, Interventional

The current case report demonstrates the interesting finding of incomplete bioresorbable vascular scaffold (BVS) strut coverage at 18 months after implantation for a chronic total occlusion of the left anterior descending coronary artery. In this case, local differences in shear stress could explain the simultaneous presence of well covered and uncovered BVS strut segments in the same optical coherence tomography frame. Even though current standard practice suggests dual antiplatelet therapy for 12 months after BVS implantation, further studies are required to establish optimal duration of dual antiplatelet therapy, particularly when tackling complex lesions.

Topics: Aged; Coronary Occlusion; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence

We investigated whether sirolimus-eluting stents (SES) are superior to next-generation zotarolimus-eluting stents (ZES) in treating patients with total coronary occlusions (TCO).. In a prospective, randomised trial we compared the SES with the zotarolimus-eluting stent (ZES; Endeavor or Resolute) after successful recanalisation of TCO. During the first phase of the trial, 51 patients were assigned to receive the SES and 46 patients to receive the Endeavor ZES. In the second phase we randomised 103 patients to the SES group and 104 patients to the Resolute ZES group. The primary endpoint was in-segment late lumen loss at eight-month follow-up. At eight months, patients in the SES group had less in-segment and in-stent late loss as compared to the Endeavor group: -0.13±0.3 mm vs. 0.27±0.6 mm (p=0.0002) and -0.13±0.5 mm vs. 0.54±0.5 mm (p<0.0001), respectively. In contrast, the SES and the Resolute ZES showed comparable amounts of in-segment (-0.03±0.7 mm vs. -0.10±0.7 mm, p=0.6) and in-stent (0.03±0.8 mm vs. 0.05±0.8 mm, p=0.9) late loss.. In the treatment of TCOs, the SES was associated with superior angiographic outcomes compared to the Endeavor ZES. On the other hand, the SES and the Resolute ZES showed comparable angiographic outcomes.

Topics: Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Prospective Studies; Sirolimus; Treatment Outcome

Transcatheter aortic valve-in-valve (VIV) implantation in high-risk patients with degenerative surgical bioprosthetic aortic valves is a novel application of transcatheter aortic valve replacement technology. Although transcatheter aortic VIV procedure is clinically effective in most patients, it is a more demanding procedure in terms of the technical aspects of procedural planning. VIV carries a higher risk of coronary occlusion which is associated with a higher rate of in-hospital mortality. We hereby report a technique of pre-emptive left main (LM) protection, by positioning a coronary stent in the proximal left anterior descending artery prior to VIV implantation. The patient treated was considered to be at an increased risk of LM occlusion as a result of the procedure. The technique was performed in anticipation of emergent bailout stenting of the LM. As predicted, the LM occluded during the procedure and LM protection facilitated the safe and effective treatment of an otherwise life-threatening procedure.

Topics: Aged; Aortic Valve Insufficiency; Bioprosthesis; Cardiac Catheterization; Cardiovascular Agents; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Interventional

We present an interesting case illustrating how coronary optical frequency domain imaging (OFDI) examination can be used to guide revascularization of a complex chronic total occlusion (CTO) in a patient presenting to our hospital with a 2-year history of angina, dyspnea, and a positive treadmill test. This case demonstrates the potential clinical role of high-resolution OFDI to optimize coronary stent implantation. OFDI may help to limit the coronary area covered by stents to the true coronary lesion.

Topics: Angioplasty, Balloon, Coronary; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Middle Aged; Regional Blood Flow; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Optical coherence tomography (OCT) allows a detailed assessment of intimal coverage and strut apposition which are well known substrates for late thrombosis. This study sought to assess and compare long-term coverage and apposition of PES and EES implanted in different lesions of the same coronary artery (and in the same patient).. A total of 30 patients were included. In these patients PES and EES were implanted in the same vessel in two similar lesions. The selection of the stent for each lesion was random. At 12 months, 30 PES were examined analysing 154±90 struts/stents and 30 EES analysing 158±72 struts/stents. The proportion of uncovered struts was 0.8±1.3% for EES and 1.5±2.9% for PES (p=0.3), and the proportion of malapposed struts was 1.25±2.1% and 0.98±2%, respectively (p=0.2). A pooled analysis was performed using the random effects model, given the significant heterogeneity found, which did not show significant differences between EES and PES for non-coverage (RR 0.73, 95% CI: 0.32-1.67) or malapposition (RR 1.60, 95% CI: 0.56-4.61). The presence of non-coverage in malapposed struts was 62% with PES and 15% with EES (p<0.0001), the maximal malapposition area being significantly larger with PES (0.6±0.3 vs. 0.25±0.2 mm², p=0.001).. In highly matched conditions, with PES and EES implanted in the same artery, both DES showed a comparable degree of intimal coverage and apposition at one-year follow-up. A smaller area of malapposition with non-covered struts was found with EES.

Topics: Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Coronary Occlusion; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

A conus artery is sometimes a good collateral source for the left anterior descending coronary artery and the right coronary artery (RCA). In some cases, the conus artery arises independently of the RCA from a separate orifice, which is called an isolated conus artery. The conus artery is often missed by angiography for RCA if a catheter is deeply engaged. This case report describes a percutaneous coronary intervention of chronic total occlusion of the proximal RCA with good collateral circulation from an isolated conus artery by super-selective ipsilateral injection via the artery.

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Collateral Circulation; Contrast Media; Coronary Angiography; Coronary Circulation; Coronary Occlusion; Drug-Eluting Stents; Humans; Injections, Intra-Arterial; Male; Predictive Value of Tests; Sirolimus; Treatment Outcome

After successful recanalization of a coronary chronic total occlusion (CTO) the risk for restenosis and subsequent need for repeat intervention is high. Everolimus-eluting stents (EESs) were associated with low rates of restenosis, reintervention and stent thrombosis in non-occluded lesions. We sought to determine the antiproliferative impact of the everolimus-eluting Xience V stent in CTOs.. Fifty-three patients with a CTO in a native coronary artery were included. CTO was defined as a duration of occlusion ≥3 months and thrombolysis in myocardial infarction 0 flow. EESs were exclusively implanted to completely cover the occluded and adjacent stenotic segments. Dual antiplatelet therapy was prescribed for 6 months. Follow-up angiography was scheduled at 6 months. Clinical follow-up was done at 12 months. The primary endpoint was late loss at the initial occlusion site. Secondary clinical endpoint was a composite of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and target lesion revascularization.. Mean occlusion length was 24 ± 17 mm, ranging from 4 to 74 mm. Mean stent length was 79 ± 36 mm, ranging from 18 to 158 mm. Reference diameter was 3.27 ± 0.58 mm. Late loss at the initial occlusion site was 0.22 ± 0.69 mm. There were six (11%) binary restenosis with a target lesion reintervention in three (6%) patients. There was no death, myocardial infarction or stent thrombosis within 12 months.. In patients with successful recanalization of complex CTOs the use of EESs results in a low angiographic late loss and restenosis rate without stent thrombosis throughout 12 months follow-up.

Topics: Adult; Aged; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Sirolimus; Treatment Outcome

Topics: Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Humans; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

Topics: Adult; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Janus Kinase 2; Male; Mutation; Myocardial Infarction; Platelet Aggregation Inhibitors; Platelet Count; Sirolimus; Thrombectomy; Thrombocytosis; Treatment Outcome

The aim of this study was to evaluate the 5-year clinical outcomes of patients who underwent sirolimus-eluting stent implantation for chronic total occlusion (CTO). Among 10,759 patients treated exclusively with sirolimus-eluting stent in the j-Cypher registry, clinical outcomes were compared between 1,210 patients with revascularization for CTO and 9,549 patients with revascularization for non-CTO only. The cumulative 5-year incidence of all-cause death (13.2% vs 14.3%, p = 0.56) and definite stent thrombosis (1.9% vs 1.6%, p = 0.76) was similar between the 2 groups. The adjusted risk for CTO relative to non-CTO for all-cause death and definite stent thrombosis was insignificant (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.81 to 1.16, and HR 0.99, 95% CI 0.6 to 1.65, respectively). The cumulative incidence of target lesion revascularization was significantly higher in the CTO group (20.7% vs 14.8%, p <0.001). The adjusted risk for target lesion revascularization was significant (HR 1.31, 95% CI 1.13 to 1.52, p <0.001). In the subgroup analysis, the risk for CTO for all-cause death tended to be lower in the subgroup of patients with left ventricular ejection fractions ≤40% (HR 0.68, 95% CI 0.45 to 1.01, p = 0.053), while the risk was significantly higher in the subgroup of patients with end-stage renal disease without hemodialysis (HR 1.66, 95% CI 1.02 to 2.70, p = 0.04). In conclusion, sirolimus-eluting stent implantation for CTO appears to be as safe as that for non-CTO for up to 5 years, except for the modestly elevated risk for target lesion revascularization and the higher risk for all-cause death in patients with end-stage renal disease without hemodialysis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cause of Death; Chronic Disease; Cohort Studies; Confidence Intervals; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Patient Safety; Prognosis; Registries; Retreatment; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Analysis; Time Factors; Treatment Outcome

We present a case of a 43-year-old woman who presented with a non-ST elevation myocardial infarction. During her first cardiac catheterisation, she was diagnosed with a chronic total occlusion of the right coronary artery and a flow limiting dissection of her middle left anterior descending artery. The dissection of the left anterior descending artery was stented with two overlapping everolimus-eluting stents. There were no complications from this percutaneous coronary intervention. On the following day, the patient continued to have persistent chest pain and returned to the catheterisation laboratory. It was then found that the patient had a total occlusion of the right coronary artery secondary to dissection. This was also stented with three everolimus-eluting stents with excellent clinical and angiographic results. It is important to consider spontaneous multivessel coronary dissections which can be treated successfully with percutaneous coronary intervention.

Topics: Adult; Chest Pain; Coronary Occlusion; Coronary Vessel Anomalies; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Myocardial Infarction; Sirolimus; Vascular Diseases

Topics: Angioscopy; Chronic Disease; Coronary Occlusion; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Middle Aged; Sirolimus

Chronic total occlusions remain a technical challenge for interventional cardiologists. This group of lesions carries a decreased rate of success and continues to be an important reason for surgical revascularization. Recently, retrograde percutaneous coronary intervention of total occlusions via epicardial and septal perforators was introduced as an alternative approach when a previous antegrade attempt has failed. We describe a unique case where retrograde approach was used as the initial recanalization technique in the absence of a right coronary ostium.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Everolimus; Female; Humans; Middle Aged; Prosthesis Design; Sirolimus; Treatment Outcome

We report a patient with fracture of a paclitaxol-eluting stent implanted for focal in-stent restenosis (ISR) with sirolimus-eluting stent fracture. This case report suggests that a drug-eluting stent (DES) implanted for ISR with DES fracture may develop recurrent stent fracture.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Paclitaxel; Prosthesis Failure; Recurrence; Retreatment; 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

There are few studies comparing the efficacy of different drug-eluting stents and their long-term clinical outcomes in percutaneous coronary intervention (PCI) of chronic total occlusive (CTO) lesions.. To compare the efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) for CTO, and to identify predictors of outcome after PCI, 200 patients with at least 1 successfully revascularized CTO were enrolled into either a SES (n=132) or PES (n=71) group. At 6-9-month angiographic follow-up, SES was superior to PES (late loss 0.27+/-0.60 vs 0.53+/-0.62 mm, P=0.04). During mean follow-up of 2 years, the SES group had a significantly lower cumulative target vessel failure (TVF) rate than the PES group (14.9% vs 28.4%, P=0.01), as a consequence of lower target vessel revascularization (9.7% vs 23.9%, P=0.01) and also a partially lower rate of myocardial infarction (MI: 3.1% vs 7.6%, P=0.04). SES was also superior to PES in both early (9 months) TVF (P=0.02 for log-rank test, respectively). Predictors for TVF were use of PES (hazard ratio (HR) 3.81, P<0.01), previous history of MI (HR 4.06, P<0.01), diabetes (HR 2.07, P=0.04) and chronic kidney disease (CKD; HR 3.56, P=0.05).. CTO lesions treated with SES showed better angiographic and long-term clinical outcomes than those treated with PES. Factors such as stent type, infarct-related CTO, diabetes and CKD affect the outcome of CTO intervention.

Topics: Aged; Angioplasty, Balloon, Coronary; Chronic Disease; Cohort Studies; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Recurrence; Registries; Sirolimus; Treatment Failure; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Microvessels; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Coronary Occlusion; Drug-Eluting Stents; Humans; Male; Middle Aged; Sirolimus; Thrombosis

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

The use of drug eluting stents (DES) in patients with a successfully recanalized chronic total occlusion (CTO) has been associated with a significant decrease in the need for repeat revascularization, and a favorable short-term clinical outcome when compared with the use of bare metal stents (BMS). Our group, however, has previously reported similar rates of target lesion revascularisation (TLR) and major adverse cardiovascular events (MACE) at 3 years follow-up in patients with a successfully opened CTO who were treated with either a sirolimus eluting stent (SES) or a BMS. The objective of this report was to evaluate the outcomes of these patients at 5-years clinical follow-up.. A total of 140 (BMS 64, SES 76) patients with successfully opened CTOs were included. Seven patients died in the BMS group whilst nine patients died in the SES group (P = 0.90). Noncardiac death was the major component of all-cause mortality (11 noncardiac deaths vs. 5 cardiac). There were two and three myocardial infarctions (MI) in the BMS and SES group, respectively (P = 1.0). The composite of death and MI occurred in seven (10.9%) and eleven (14.5%) patients in the BMS and SES group, respectively (P = 0.53). Clinically driven TLR was performed in eight patients (12.5%) in the BMS group, and five (6.6%) in the SES group (P = 0.26). Non-TLR target vessel revascularization was performed in one patient in the BMS group, and four in the SES group (P = 0.37). The 5-year device-oriented cumulative MACE rate was 15.6% and 11.8% in the BMS and SES group, respectively (P = 0.56).. In patients with a successfully treated CTO, clinical outcome after 5 years was similar between SES and BMS, however, clinically driven TLR was slightly higher in the BMS group.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

We have occasionally encountered restenosis due to the crushing of drug-eluting stents (DES) implanted in severely calcified lesions. We aimed to establish the role of rotational atherectomy (RA) in its treatment. At first, we conducted an experimental study and found that the size of the metallic particles generated during RA of stent struts was 5.6 +/- 3.6 mum. We performed RA on the restenosis of the sirolimus-eluting stents implanted in the severely calcified lesions of a 66-year-old male who had received hemodialysis for 13 years. He had restenosis in the proximal and mid-segments of the right coronary artery, and intravascular ultrasound images documented that these stents were crushed by calcified plaque behind them. RA ablated both crushed stent struts and the calcified lesions behind them, and there was no hemodynamic derangement during the procedure. Maximum dilatation of the lesions was achieved with balloon angioplasty, followed by stent implantation. RA is an effective strategy to treat restenotic lesions resulting from the crushing of DES in severely calcified lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Calcinosis; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Sirolimus; Treatment Outcome

The prospective multicenter German Drug-Eluting Stent (DES.DE) registry is an observational study to analyze and evaluate the therapeutic principle of the differential drug-eluting stents (sirolimus- and paclitaxel-eluting stents) and bare metal stents under real world conditions in the context of the German healthcare system. The baseline clinical and angiographic characteristics and follow-up events for 1 year were recorded for all enrolled patients. In addition, a health economics assessment was performed at 3, 6, 9, and 12 months after initial stent placement. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events, and target vessel revascularization were used as the primary objectives. From October 2005 to October 2006, 6,384 patients were enrolled (sirolimus-eluting stents, n = 2,137; paclitaxel-eluting stents, n = 2,740; bare metal stents, n = 485) at 98 Deutsches Drug-Eluting Stent Register sites. With similar baseline clinical and descriptive morphology of coronary artery disease between both drug-eluting stent groups, no differences were present at 1 year of follow-up in the rates of overall mortality (3.8% vs 4.1%), target vessel revascularization (10.4% vs 10.4%), overall stent thrombosis (3.6% vs 3.8%), and major adverse cardiac and cerebrovascular events (8.1% vs 8.0%). Compared with the bare metal stent group, patients treated with drug-eluting stents had significantly lower rates of myocardial infarction (3.2% vs 6.0%; p <0.01), stroke (1.2% vs 2.7%; p <0.05), and target vessel revascularization (10.4% vs 14.9%; p <0.01) without any difference in the stent thrombosis rate (3.7% vs 4.3%; p = 0.57) or mortality rate (4.0% vs 5.2%; p = 0.21). In conclusion, the data generated from the German Drug-Eluting Stent registry revealed no differences between patients receiving a paclitaxel-eluting stent and sirolimus-eluting stent in a "real-world" setting with regard to the clinical outcomes at 1 year.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Registries; Sirolimus; Stents; Stroke

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Patient Selection; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Myocardial infarction (MI) after drug-eluting stent placement has been associated with an unfavorable late prognosis. Although the etiology of periprocedural MI is multifactorial, sidebranch occlusion may be an important contributing factor. We sought to identify the incidence of sidebranch occlusion during zotarolimus-eluting stent (ZES) and paclitaxel-eluting stent (PES) placement and to relate sidebranch occlusion to the occurrence of periprocedural MI.. Angiograms were reviewed from patients randomly assigned to treatment with a ZES (597 patients; 943 sidebranches) or a PES (619 patients; 977 sidebranches). Sidebranch occlusion was defined as Thrombolysis in Myocardial Infarction flow grade 0 or 1. Sidebranch occlusion was correlated with frequency of MI, as assessed by the creatine phosphokinase MB isoenzyme. Sidebranch occlusion occurred less often after the first stent deployment in patients treated with ZES (2.2%) than in patients treated with PES (4.0%; P=0.032). A similar reduction in the frequency of sidebranch occlusion at any point during the procedure was found in patients treated with ZES (2.9% versus 4.8% in PES patients; P=0.042). Multivariable predictors of sidebranch occlusion included baseline sidebranch stenosis, complex lesion morphology, smaller baseline minimal lumen diameters, and the use of a PES. Of the 20 patients with MI within 30 days of the procedure, 30% had evidence of sidebranch occlusion during the stent procedure.. Patients treated with ZES were less likely to develop sidebranch occlusion during stent placement than patients treated with PES. Less frequent sidebranch occlusion with ZES may have contributed to the lower frequency rates of periprocedural MI in this study.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Occlusion; Creatine Kinase, MB Form; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Myocardium; Necrosis; Paclitaxel; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Collateral Circulation; Coronary Angiography; Coronary Circulation; Coronary Occlusion; Drug-Eluting Stents; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Thrombosis; Tomography, Optical Coherence; Treatment Outcome

There is limited evidence on the medium-term prognosis of patients with chronic total occlusion successfully treated with drug-eluting stent (DES) implantation.. We compared the medium-term outcome of 111 patients with chronic total occlusion (CTO) successfully treated with implantation of sirolimus-or paclitaxel-eluting stents versus 112 patients treated with bare metal stents.. During an overall follow-up period of 18 months, the composite endpoint of death, myocardial infarction or target lesion revascularization was significantly lower in the drug-eluting stent than in the bare metal stent group: 8.1% vs. 21.6%, respectively (p=0.005). The difference was due to the reduction of target lesion revascularization with DES compared to bare metal stents: 3.6% vs. 18.9%, respectively (p<0.001). The Cox proportional hazards model identified DES as an independent predictor of adverse cardiac events (adjusted hazard ratio, 0.16; 95% confidence interval 0.05 to 0.52, p=0.002).. During medium-term follow-up use of DES is associated with improved outcome compared to use of bare metal stents in patients with CTO.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Chronic Disease; Coronary Angiography; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Ischemia; Paclitaxel; Prognosis; Proportional Hazards Models; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Aged; Angina, Unstable; Coronary Occlusion; Drug Delivery Systems; Drug-Eluting Stents; Equipment Failure; Female; Humans; Immunosuppressive Agents; Sirolimus; Ultrasonography, Interventional

Late stent malapposition (LSM) has been demonstrated to be more common after drug-eluting stent (DES) implantation than after bare-metal stent (BMS) implantation. To date, this unusual intravascular ultrasonic finding after DES implantation, however, has not received enough attention, because previous studies suggested few adverse clinical sequelae from LSM. We present a case of angiographically-confirmed very late stent thrombosis (ST) in LSM after elective implantation of sirolimus-eluting stents. In this 32-year-old male patient, very late ST occurred at 29 months after DES implantation and at 20 months after the identification of LSM. Although this patient had received sufficient dual antiplatelet therapy with aspirin and clopidogrel for more than 1 year, he suffered from ST shortly after the discontinuation of clopidogrel. Thus, patients with LSM may pose a significant risk for very late ST after discontinuation of dual antiplatelet therapy. The findings suggest that dual antiplatelet therapy should be further prolonged in patients with LSM.

Topics: Adult; Angioplasty, Balloon, Coronary; Coronary Occlusion; Coronary Thrombosis; Equipment Design; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Radiography; Sirolimus; Stents; Time Factors