Comparison of Zotarolimus- and Everolimus-Eluting Coronary Stents Final 5-Year Report of the RESOLUTE All-Comers Trial
Author(s)
Type
Journal Article
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.
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.
Date Issued
2015-06-05
Date Acceptance
2015-05-07
Citation
Circulation-Cardiovascular Interventions, 2015, 8 (6)
ISSN
1941-7640
Publisher
American Heart Association
Journal / Book Title
Circulation-Cardiovascular Interventions
Volume
8
Issue
6
Copyright Statement
This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
drug-eluting stent
everolimus
percutaneous coronary interventions
zotarolimus
XIENCE V STENTS
REAL-WORLD PATIENTS
BARE-METAL STENTS
ARTERY-DISEASE
ANGIOGRAPHIC OUTCOMES
ANTIPLATELET THERAPY
BALLOON ANGIOPLASTY
CLINICAL-OUTCOMES
TWENTE TRIAL
FOLLOW-UP
Aged
Antineoplastic Agents
Drug-Eluting Stents
Everolimus
Female
Follow-Up Studies
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
Sirolimus
Treatment Outcome
Cardiovascular System & Hematology
Publication Status
Published
Article Number
e002230