zotarolimus and Coronary-Stenosis

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Stenosis; Drug-Eluting Stents; Humans; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Aged; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Follow-Up Studies; Humans; Male; Prosthesis Failure; Sirolimus; Stents; Time Factors

Drug-eluting stent (DES) therapy reduces restenosis in patients with diabetes when compared with bare metal stent implantation. There are significant differences between commercially available DES platforms both in terms of design characteristics and clinical outcomes. Randomized active-comparator inter-DES trials powered for clinical endpoints are unlikely to be performed in patients with diabetes, however, direct comparison randomized trials utilizing surrogate endpoints support a superior anti-restenotic efficacy with sirolimus- versus paclitaxel-eluting stents. Thrombotic stent occlusion may be higher in patients with diabetes compared with nondiabetic patients, though there is no clear signal of a safety differential between the two platforms. Insufficient data on comparative performance in diabetics exist in relation to the approved zotarolimus-eluting and everolimus-eluting stent platforms. If all other factors are equal, then there seems to be no reason why the diabetic patient should not receive treatment with the sirolimus-eluting stent, which appears to have superior antirestenotic efficacy in this patient group.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Hypoglycemic Agents; Insulin; Meta-Analysis as Topic; Metals; Paclitaxel; Patient Selection; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Sirolimus; Thrombosis; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug-Eluting Stents; Humans; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Automation; Cardiopulmonary Resuscitation; Chest Wall Oscillation; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Risk Assessment; Severity of Illness Index; Sirolimus; Treatment Outcome; Ultrasonography, Doppler

Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; France; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Vascular response at edges of drug-eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative effects.. To compare the vascular responses at edges of sirolimus analogous-eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS).. 306 edges were analyzed in 153 patients treated with drug-eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6-month follow-up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow-up minus basal) was also calculated. Edge restenosis was defined as obstruction >50%.. Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 +/- 22 mm(3) to 72.2 +/- 25 mm(3): P = 0.02) and distal (from 54.4 +/- 22 mm(3) to 59.8 +/- 22 mm(3): P = 0.001) edges.. Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous-eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6-month follow-up.

Topics: Aged; Cardiovascular Agents; Case-Control Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional