Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents
- 8 July 2010
- journal article
- research article
- Published by Massachusetts Medical Society in The New England Journal of Medicine
- Vol. 363 (2), 136-146
- https://doi.org/10.1056/nejmoa1004130
Abstract
New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (±SD) of in-stent stenosis (21.65±14.42% for zotarolimus vs. 19.76±14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27±0.43 mm in the zotarolimus-stent group versus 0.19±0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events. At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)Keywords
This publication has 18 references indexed in Scilit:
- Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificityEuroIntervention, 2010
- Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trialEuroIntervention, 2010
- Clinical and Angiographic Results With the Next-Generation Resolute Stent System: A Prospective, Multicenter, First-in-Human TrialJACC: Cardiovascular Interventions, 2009
- Correlation of Intravascular Ultrasound Findings With Histopathological Analysis of Thrombus Aspirates in Patients With Very Late Drug-Eluting Stent ThrombosisCirculation, 2009
- Novel high-throughput polymer biocompatibility screening designed for SAR (structure-activity relationship): application for evaluating polymer coatings for cardiovascular drug-eluting stents.Combinatorial Chemistry & High Throughput Screening, 2009
- Impact of polymer hydrophilicity on biocompatibility: Implication for DES polymer designJournal of Biomedical Materials Research Part A, 2008
- Development of a novel biocompatible polymer system for extended drug release in a next‐generation drug‐eluting stentJournal of Biomedical Materials Research Part A, 2007
- Clinical End Points in Coronary Stent TrialsCirculation, 2007
- Coronary-Artery StentsThe New England Journal of Medicine, 2006
- Quantitative Coronary Angiography in Clinical PracticePublished by Springer Science and Business Media LLC ,1994