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Randomized Controlled Trial
. 2015 Jun;8(6):e002230.
doi: 10.1161/CIRCINTERVENTIONS.114.002230.

Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial

Javaid Iqbal  1 , Patrick W Serruys  2 , Sigmund Silber  1 , Henning Kelbaek  1 , Gert Richardt  1 , Marie-Angele Morel  1 , Manuela Negoita  1 , Pawel E Buszman  1 , Stephan Windecker  1
Affiliations
Randomized Controlled Trial

Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial

Javaid Iqbal et al. Circ Cardiovasc Interv. 2015 Jun.

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.

Keywords: drug-eluting stent; everolimus; percutaneous coronary interventions; zotarolimus.

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Figures

Figure 1.
Figure 1.
Flow diagram of RESOLUTE all-comers trial. RESOLUTE indicates Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention.
Figure 2.
Figure 2.
Kaplan–Meier curves comparing zotarolimus- and everolimus-eluting stents for clinical end points. Zotarolimus- and everlomius-eluting stents had similar patient-oriented composite end point (PoCE; combination of all-cause mortality, myocardial infarction, and any revascularization; A), device-oriented composite end point (DoCE; combination of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target lesion revascularization; B), target vessel failure (TVF; combination of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target vessel revascularization; C), and major adverse cardiac events (MACE; combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization; D). Error bars indicate a point-wise 2-sided 95% confidence interval (1.96 SD). Standard error based on the Greenwood Formula.
Figure 3.
Figure 3.
Forest plot showing prespecified subgroups analysis comparing zotarolimus- and everolimus-eluting stents for target lesion failure at 5-year follow-up. Zotarolimus- and everolimus-eluting stents had similar device-oriented composite end point (DoCE) or target lesion failure (TLF), including combination of cardiac death, myocardial infarction (MI) not clearly attributable to a nontarget vessel, and clinically indicated target lesion revascularization. Error bars indicate a point-wise 2-sided 95% confidence interval (1.96 SD). Standard error based on the Greenwood Formula. EES indicates everolimus-eluting stents; and ZES, zotarolimus-eluting stents.
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