Endeavor Zotarolimus-eluting Stent Research Articles

Ten-Year Outcomes of Sirolimus-Eluting Versus Zotarolimus-Eluting Coronary Stents in Patients With Versus Without Diabetes Mellitus (SORT OUT III)

We compared 10-year clinical outcomes in diabetes and nondiabetes patients treated with Endeavor zotarolimus-eluting (ZES) or Cypher sirolimus-eluting coronary stents (SES). A total of 1,162 patients were randomized to ZES (169 with diabetes) and 1,170 patients were randomized to SES (168 with diabetes). Patients were further stratified by diabetes status at the time of inclusion. A subgroup of patients with diabetes (n = 88) underwent angiographic re-evaluation 10 months after stent implantation. End points included a combined end point of death or myocardial infarction, and the individual end points of death, myocardial infarction, and revascularization. In patients with diabetes, we found no difference in the combined end point (odds ratio [OR] 0.81, 95% confidence interval [CI] 0.53 to 1.24), death (OR 0.80, 95% CI 0.51 to 1.25), or in MI (OR 1.07, 95% CI 0.60 to 1.91). However, diabetics with ZES more frequently underwent coronary revascularization compared with SES patients (OR 1.93, 95% CI 1.05 to 3.66). In patients without diabetes, ZES and SES had similar 10-year rates of all end points (death: OR 1.13, 95% CI 0.93 to 1.39; MI: OR 0.80, 95% CI 0.61 to 1.05; revascularization: OR 0.81, 95% CI 0.61 to 1.09). Landmark analysis from 5 to 10 years showed no difference in outcomes between SES and ZES in either subgroup. In conclusion, at 10 years, SES and ZES performed similarly in patients with and without diabetes. Although coronary revascularization was more prevalent in diabetes patients with ZES, this may, in part, have been related to the angiographic follow-up that was offered to a subgroup of diabetes patients.

Thirty days only double antiplatelet therapy after drug-eluting stenting: could a 'short-term' treatment be advantageous?

Thirty days only double antiplatelet therapy after drug-eluting stenting: could a 'short-term' treatment be advantageous?

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions.

PurposeTo evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI).Materials and MethodsFrom three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions.ResultsFor 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion–related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423–0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160–35.206, p=0.033).ConclusionSex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height.

DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial.

Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES). EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend towards reduction in myocardial infarction and repeat revascularisation in the NES group at five-year follow-up. At five-year follow-up, the incidence of device- and patient-oriented events was significantly lower in the NES group. Further studies, adequately powered for clinical outcomes, are warranted.

Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices.

Prognostic Significance of Polymer Coatings in Zotarolimus-Eluting Stents

Polymer coatings on drug-eluting stents (DES) serve as a vehicle for delivery of antirestenotic drugs. Whether they influence outcomes for contemporary DES is unknown. The evolution of polymer coatings for zotarolimus-eluting stents (ZES) provides a natural experiment that facilitates such analysis. The Resolute ZES (R-ZES) uses the same antirestenotic drug as the Endeavor ZES (E-ZES) but has a more biocompatible polymer with enhanced drug release kinetics. However, there are limited data on the real-world comparative efficacy of R-ZES and the preceding E-ZES. Thus, we analyzed 17,643 patients who received either E-ZES or R-ZES from 2008 to 2014 from the British Columbia Cardiac Registry. A total of 9,869 patients (56%) received E-ZES and 7,774 patients (44%) received R-ZES. Compared with E-ZES, R-ZES was associated with lower 2-year mortality (4.1% vs 6.4%, p <0.001) and 2-year target vessel revascularization (TVR; 6.8% vs 10.7%, p <0.001). R-ZES use was an independent predictor of lower mortality rate and TVR. This was confirmed in propensity-matched analyses for 2-year mortality (hazard ratio [HR] 0.59, 95% CI 0.49 to 0.71, p <0.001) and 2-year TVR (HR 0.86, 95% CI 0.75 to 0.98, p = 0.032). Instrumental variable analyses demonstrated R-ZES to be associated with lower 2-year mortality (Δ = -2.2%, 95% CI -4.3% to -0.2%, p = 0.032) and 2-year TVR (Δ = -3.3% to 95% CI -6.1% to -0.7%, p = 0.015). Acknowledging the limitations of observational analyses, this study has shown that R-ZES was associated with lower long-term TVR and mortality. These data are reassuring for the newer R-ZES and demonstrate how polymer coatings may influence the clinical performance of DES with wider implications for future DES development and design.

Clinical outcomes in low risk coronary artery disease patients treated with different limus-based drug-eluting stents--a nationwide retrospective cohort study using insurance claims database.

The clinical outcomes of different limus-based drug-eluting stents (DES) in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES), Endeavor zotarolimus-eluting stent (E-ZES) and everolimus-eluting stent (EES), using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES). After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group). Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

Comparison of Short- and Long-Term Cardiac Mortality in Early Versus Late Stent Thrombosis (from Pooled PROTECT Trials)

Studies have indicated varying mortality risks with timing of stent thrombosis (ST), but few have been adequately powered with prospective late follow-up. PROTECT randomized 8,709 subjects to either Endeavor zotarolimus-eluting or Cypher sirolimus-eluting stents. PROTECT Continued Access enrolled 1,018 patients treated with Endeavor zotarolimus-eluting stents. Subjects completed at least 4 and 3years of follow-up, respectively. ARC-defined definite and probable ST events were stratified by time from index procedure: early (≤30days), late (>30 and ≤360days), and very late (>360days). Rates of death and myocardial infarction were analyzed by ST timing. Median follow-up was 4.1years. There were 184 ST events (1.9%): 61 early, 27 late, and 96 very late. Patient and procedural characteristics were similar between timing groups. There was no difference in dual-antiplatelet therapy use at discharge (97%) or 1year (84%). Cardiac death in patients with ST at 4years occurred in 32.1% compared with 2.5% in patients without ST (p <0.001). Combined rates of cardiac death and myocardial infarction did not differ according to ST timing, yet early ST was more commonly associated with cardiac death at 4years than later ST (50.8% for early vs 18.5% for late vs 24.0% for very late; p <0.001). The relation between ST timing and outcomes did not differ between stent types. In conclusion, in prospective data, cardiac death was more common after early ST than later ST. Although ST remains infrequent, continued efforts to determine how to reduce ST, particularly within the first 30days, are warranted. (The PROTECT trial is registered with ClinicalTrials.gov, number NCT00476957.).

Thrombotic complications associated with early and late nonadherence to dual antiplatelet therapy.

This study sought to assess the frequency and clinical impact of dual antiplatelet therapy (DAPT) nonadherence. There are limited data on the impact of DAPT nonadherence during the first year after a second-generation drug-eluting stent placement. After successful Endeavor zotarolimus-eluting stent implantation, 2,265 patients were enrolled in a registry with limited exclusions and monitored during 12 months of prescribed DAPT. Predictors of any nonadherence (ANA) at 6 months were analyzed by multivariable analysis, and the association between ANA at 6 or 12 months with the endpoints of death, myocardial infarction, and stent thrombosis was assessed. The study population included 30% female patients, 34% with diabetes and 36% with acute coronary syndromes. ANA occurred in 208 patients (9.6%) before 6 months and 378 patients (18.5%) before 1 year. Major bleeding (odds ratio [OR]: 12.83, 95% confidence interval [CI]: 7.55 to 21.80, p < 0.001) was the only predictor of ANA at 6 months. In time-dependent analyses, ANA before 6 months was associated with an increased risk of death or myocardial infarction (7.6% vs. 3.0%, p < 0.001) and a numerical increase in stent thrombosis (2.0% vs. 0.9%, p = 0.12). After adjustment for baseline differences, ANA within 6 months remained associated with death or MI (OR: 1.95, 95% CI: 1.02 to 3.75). ANA occurring after 6 months did not increase the risk of subsequent ischemic events. DAPT ANA occurs frequently and is associated with increased risk for thrombotic complications if it occurs within the first 6 months. Major bleeding was a significant correlate of DAPT ANA within 6 months. (EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events; NCT01069003).

Late differences in outcomes of patients with stable angina and an isolated lesion in the proximal left anterior descending artery treated with new-generation drug-eluting stents

BackgroundNew-generation drug-eluting stents have demonstrated the mid-term efficacy and safety, but possible differences between stents may emerge in a long-term period. We compared long-term outcomes of patients with chronic stable angina and an isolated de-novo lesion in the proximal left anterior descending artery that underwent percutaneous coronary intervention with Endeavor-zotarolimus eluting stents (E-ZES) and everolimus eluting stents (EES). MethodsWe prospectively enrolled 600 patients. Of these, 180 underwent E-ZES and 420 underwent EES implantation. Clinical follow-up was performed up to 7years (median follow-up 61months). The evaluated clinical outcomes were Target Lesion Failure (TLF), a composite of cardiac death, myocardial infarction and Target Lesion Revascularization (TLR), the Patient-Related Outcome (PRO) and stent thrombosis. Differences between groups evaluated with the Kaplan–Meier method and possible independent predictors with Cox proportional hazard regression. ResultsAt 5years, the cumulative probability for outcomes was: TLF: 13.8% versus 7.5%, p=0.025, cardiac death: 3.1% versus 2.5%, p=0.937, myocardial infarction: 1.2% versus 1.8%, p=0.829, TLR: 10% versus 3.3%, p=0.003, PRO: 19.6% versus 13.8%, p=0.528, ST: 2.5% versus 2.7%, p=0.965, for E-ZES and EES respectively. Differences between stents increased after 30months. In multivariate analysis predictors of TLF adjusted for stent type were Diabetes mellitus and estimated Glomerular Filtration Rate (eGFR). ConclusionBoth stents provided a favorable safety profile, with EES demonstrating better effectiveness. There was a late emergence in difference of endpoints after 30months. Diabetes mellitus and eGFR predicted TLF.

Long-Term Outcome of Sirolimus-Eluting and Zotarolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus (A Danish Organization for Randomized Trials on Clinical Outcome III Substudy)

We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZES and SES had similar MACE rates at 5-year follow-up but SES was associated with a significantly higher risk of definite stent thrombosis (10 [1.0%] vs 23 [2.3%]; OR 0.43, 95% CI 0.20 to 0.91, p = 0.028). Moreover, during the last 4 years, ZES had fewer MACE, TVR, and stent thrombosis events among nondiabetic patients. In conclusion, SES remains superior to ZES in patients with diabetes throughout the 5-year follow-up, however, among nondiabetic patients, SES demonstrated a highly dynamic performance with favorable initial results followed by a late catch-up that included an overall higher risk of stent thrombosis.

First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients

BackgroundFirst-generation drug-eluting stents (DES) have become the most widely used devices worldwide for management of coronary artery disease. As remote follow-up data were becoming available, concerns emerged in regard to...

Usefulness of Postmarket Studies to Evaluate Long-Term Safety of Coronary Eluting Stents (from the ENDEAVOR and PROTECT Programs)

Differences in enrollment criteria and protocol requirements are believed to affect patient representation and outcomes from premarket and postmarket surveillance (PMS) trials. These differences have not been assessed in studies evaluating coronary stenting. We aimed to assess differences in clinical profile and long-term outcomes in patientsenrolled into premarket versus PMS trials assessing the Endeavorzotarolimus-eluting stent (E-ZES). We pooled patient-level data for 2,132 and 4,357 E-ZES-treatedsubjects enrolled into the ENDEAVOR program (premarket) and Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PMS), respectively. Follow-up data were available through 3years. Baseline characteristics and outcomes of patients enrolled in the 2 groups were compared. Propensity score-adjusted Cox proportional hazards models were used to assess the effect of differences in baseline characteristics. We also adjusted for protocol-mandated repeat angiography to account for differences in follow-up requirements. Despite significant differences in baseline characteristics, the unadjusted 3-year rates of major adverse cardiac events, major adverse cardiac and cerebrovascular events, and target vessel failure were similar (premarket vs PMS: 11.9% vs 12.7%, p= 0.369; 12.7% vs 13.9%, p= 0.191; and 13.8% vs 13.4%, p= 0.667, respectively). However, PMS trials had significantly higher rates of myocardial infarctions (p= 0.005) and definite or probable stent thrombosis (p= 0.016). After propensity score adjustment, myocardial infarction rates remained significantly different (hazard ratio 0.53, 95% confidence interval 0.30 to 0.91). To conclude, premarket and PMS trials assessing E-ZES implantation enrolled different patients. PMS trials were shown to be essential for the detection of safety signals.

Comparison of frequency and severity of longitudinal stent deformation among various drug-eluting stents: An intravascular ultrasound study

BackgroundLongitudinal stent deformation (LSD) in drug-eluting stents (DES) has been described as a disruption of stent structure. This study aimed to compare first- versus second-generation DES with respect to their actual stent length post deployment. MethodsA total of 617 DES for de novo coronary lesions in 552 patients were analyzed. Intravascular ultrasound (IVUS) was utilized to compare the degree and rate of LSD among six different DES types. IVUS-measured stent length was compared to the labeled length for calculation of absolute difference in stent length and relative absolute difference (absolute difference divided by the labeled length). ResultsThe baseline characteristics were comparable between groups, except for higher calcification in the sirolimus-eluting stent (SES) group (p=0.037). The absolute and relative difference in length showed the lowest degree in the SES group and the highest degree in the Endeavor zotarolimus-eluting stent group (p=0.085 and 0.078, respectively). The percentage of more than 5% relative absolute difference was the lowest in the SES group compared to the other groups (p=0.018). However, the percentage of significant (>15%) relative absolute difference was similar among groups (p=0.99). In multivariate linear regression analysis, labeled stent length and stent diameter, but not stent type, were identified as independent correlates to the absolute and relative difference in the actual stent length post-deployment. ConclusionThis IVUS analysis confirms that among second-generation DES, there is overall similar frequency and severity of LSD when deploying in common coronary lesions.

Abstract 458: Poor Progression of in-Stent Neoatherosclerosis in Patients With Everolimus-Eluting Stent Implantation: Coronary Angioscopic Observation

Very late stent thrombosis (VLST) is one of the most serious issues in the era of drug-eluting stents (DES). VLST has been attributed to delayed neointimal stent coverage (NSC) due to bio-suppressive drugs and vulnerability of in-stent neoatherosclerosis. The latter was recently proposed by pathologists as in-stent atherosclerotic lesions at chronic phase of coronary stenting. The aim of this study was angioscopic observation of in-stent vessel wall at 3 years after implantation of various generations of DES. Enrolled were 37 stented segments in 26 patients with stable angina (25 Cypher sirolimus-eluting stents, SES; 5 Endeavor zotarolimus-eluting stents, ZES; and 7 Xience V everolimus eluting stents, EES). Dual anti-platelet therapy, aspirin plus clopidogrel, had been continued since the stenting procedure. Coronary angiography showed no in-stent restenosis at chronic phase. Coronary angioscopy revealed the in-stent appearance; that is, grades of NSC [between score 0 (no coverage) and score 3 (full coverage)], presence of yellow plaque (YP), and subclinical stent thrombosis (ST). There was no significant difference in grades of NSC among SES, ZES, and EES (1.40±0.57, 1.71±0.77, and 1.80±0.75, respectively). YP and ST were not found in EES. YP was 24% and 20% in SES and ZES, respectively. ST was 20% both in SES and ZES. In conclusion, in-stent neoatherosclerosis appears not to progress at least for 3 years in EES-stented coronary segments, a representative of the second generation of DES.

STENT THROMBOSIS FOLLOWING IMPLANTATION OF ENDEAVOR ZOTAROLIMUS-ELUTING STENTS IN PATIENTS WITH COMPLEX CORONARY LESIONS – INSIGHTS FROM THE LARGE, PROSPECTIVE, RANDOMIZED, MULTICENTER OPTIMIZE TRIAL

Stent thrombosis (ST) is an infrequent event following 2nd generation drug-eluting stents (DES); however, its occurrence may be catastrophic. Our objective was to report the incidence of ST in a large population treated with Endeavor zotarolimus-eluting stents (E-ZES) and randomized to short- (3

Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type

To investigate the putative modifying effect of dual antiplatelet therapy (DAPT) use on the incidence of stent thrombosis at 3 years in patients randomized to Endeavor zotarolimus-eluting stent (E-ZES) or Cypher sirolimus-eluting stent (C-SES). Of 8709 patients in PROTECT, 4357 were randomized to E-ZES and 4352 to C-SES. Aspirin was to be given indefinitely, and clopidogrel/ticlopidine for ≥ 3 months or up to 12 months after implantation. Main outcome measures were definite or probable stent thrombosis at 3 years. Multivariable Cox regression analysis was applied, with stent type, DAPT, and their interaction as the main outcome determinants. Dual antiplatelet therapy adherence remained the same in the E-ZES and C-SES groups (79.6% at 1 year, 32.8% at 2 years, and 21.6% at 3 years). We observed a statistically significant (P = 0.0052) heterogeneity in treatment effect of stent type in relation to DAPT. In the absence of DAPT, stent thrombosis was lower with E-ZES vs. C-SES (adjusted hazard ratio 0.38, 95% confidence interval 0.19, 0.75; P = 0.0056). In the presence of DAPT, no difference was found (1.18; 0.79, 1.77; P = 0.43). A strong interaction was observed between drug-eluting stent type and DAPT use, most likely prompted by the vascular healing response induced by the implanted DES system. These results suggest that the incidence of stent thrombosis in DES trials should not be evaluated independently of DAPT use, and the optimal duration of DAPT will likely depend upon stent type (Clinicaltrials.gov number NCT00476957).

Prospective and Systematic Analysis of Unexpected Requests for Non-Cardiac Surgery or Other Invasive Procedures during the First Year after Drug-Eluting Stent Implantation

PurposeUnexpected requests for non-cardiac surgery requiring discontinuation of dual antiplatelet therapy (DAPT) frequently occur in daily clinical practice. The objectives of this study were to evaluate prevalence, timing and clinical outcomes of such unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stents (DESs) implantation.Materials and MethodsWe prospectively investigated the prevalence, timing and clinical outcomes of unexpected requests for non-cardiac surgery or other procedures during the first year after DESs implantation in 2117 patients.ResultsThe prevalence of requested non-cardiac surgery or invasive procedures was 14.6% in 310 requests and 12.3% in 261 patients. Among 310 requests, those were proposed in 11.3% <1 month, 30.0% between 1 and 3 months, 36.8% between 4 and 6 months and 21.9% between 7 and 12 months post-DES implantation. The rates of actual discontinuation of DAPT and non-cardiac surgery or procedure finally performed were 35.8% (111 of 310 requests) and 53.2% (165 of 310 requests), respectively. On multivariate regression analysis, the most significant determinants for actual discontinuation of DAPT were Endeavor zotarolimus-eluting stent implantation with 3-month DAPT (OR=5.54, 95% CI 2.95-10.44, p<0.001) and timing of request (OR=2.84, 95% CI 1.97-4.11, p<0.001). There were no patients with any death, myocardial infarction, or stent thrombosis related with actual discontinuation of DAPT.ConclusionThose unexpected requests with premature discontinuation of DAPT were relatively common and continuously proposed during the first year following DES implantation. No death, myocardial infarction or stent thrombosis occurred in patients with actual discontinuation of DAPT.

Atherosclerotic Change at One Year After Implantation of Endeavor Zotarolimus-Eluting Stent vs. Everolimus-Eluting Stent

Atherosclerosis progression is thought to be one of the mechanisms of late stent failure. Atherosclerosis progression is detected as yellow plaque formation on angioscopy. Cypher sirolimus-eluting stent has been reported to accelerate atherosclerosis progression, but the influence of Endeavor zotarolimus-eluting stent (Endeavor-ZES) or Xience everolimus-eluting stent (Xience-EES) on atherosclerosis has not been clarified. Therefore, we examined the serial changes in extent of atherosclerosis after the implantation of Endeavor-ZES or Xience-EES. Consecutive patients who received implantation of Endeavor-ZES (n=25) or Xience-EES (n=30) at de novo lesion of native coronary artery and who had successful angioscopy immediately after stent implantation (baseline) and at 1-year follow-up were included in the study. Change in the maximum yellow color grade (grade 0-3) of the stented segment from baseline to follow-up was examined and was compared between Endeavor-ZES and Xience-EES. The maximum yellow color grade decreased significantly from baseline to follow-up in Endeavor-ZES (1.6±1.1 vs. 0.4±0.8, P<0.001), but it did not change in Xience-EES (1.7±1.0 vs. 1.4±0.7, P=0.23). Although the maximum yellow color grade was not different between Endeavor-ZES and Xience-EES at baseline (P=0.72), it was significantly lower in Endeavor-ZES than in Xience-EES at follow-up (P<0.001). Atherosclerosis evaluated by yellow color of the plaque was significantly reduced at 1 year after Endeavor-ZES implantation, but was not changed after Xience-EES implantation.

Optimal duration of dual antiplatelet therapy following treatment with the endeavor zotarolimus‐eluting stent in real‐world Japanese patients with coronary artery disease (OPERA): Study design and rationale

In patients with coronary artery disease (CAD), there is an increasing therapeutic need among interventional cardiologists to conduct dual antiplatelet therapy (DAPT) whose duration is shorter than current guideline-recommended 6-12 months after the implantation of drug-eluting stents. However, no clinical grounds sufficient to rationalize the need are available. To define the optimal duration of DAPT and to examine the safety and efficacy of the Endeavor zotarolimus-eluting stent (E-ZES) in real-world Japanese patients with CAD. The present prospective, nonrandomized, multicenter, controlled study is uniquely designed to examine the analysis set to be formulated after integrating two different databases consisting of the following two study arms: the 3-month DAPT arm, in which 1,210 patients were consecutively enrolled at 106 medical institutions; and the 12-month DAPT arm, in which 1,210 patients will be consecutively extracted from the Endeavor Japan post-marketing surveillance at 60 medical institutions. The primary endpoint is "net adverse cardiac and cerebrovascular events-death, myocardial infarction, cerebrovascular accident, and major bleeding)" at 12 months after implantation. The secondary endpoints are as follows: major adverse cardiac events at 1, 3, 6, 9, and 12 months after implantation; target vessel revascularization and target lesion revascularization at 9 and 12 months after implantation; and stent thrombosis, DAPT compliance, and bleeding events at 12 months after implantation. Noninferiority in the E-ZES's profiles between the study arms will be investigated. The present study will provide insight into the optimal duration of DAPT after the E-ZES implantation in individual, real-world patients with CAD.