Affiliation:
1. From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV,...
Abstract
Background—
Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial.
Methods and Results—
RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%,
P
=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%,
P
=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%,
P
=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%,
P
=0.12).
Conclusions—
At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria.
Clinical Trial Registration—
URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00617084.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Cardiology and Cardiovascular Medicine
Cited by
117 articles.
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