Five-Year Data Published From Medtronic's RESOLUTE Global Clinical Trial Program
February 9, 2017—Five-year safety and efficacy data from the RESOLUTE Global clinical trial program were published online by Robert W. Yeh, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. The investigators evaluated the 5-year cumulative incidence of cardiovascular events after implantation of the Resolute zotarolimus-eluting stent (ZES; Medtronic).
According to the investigators, the background of the study is that individual trials are often underpowered to show differences for low-frequency adverse events. The Resolute ZES was studied in 10 prospective clinical trials designed with identical adverse event definitions, ascertainment, and adjudication.
As summarized in JACC: Cardiovascular Interventions, the RESOLUTE Global clinical trial program includes 7,618 patients treated with the Resolute ZES in the RESOLUTE First-in-Human Study (N = 139), RESOLUTE All-Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated.
The investigators reported that the 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively.
The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe.
In the largest group of patients examined to date who received the Resolute ZES, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation, with much lower risks of these events out to 5 years, concluded the investigators in JACC: Cardiovascular Interventions.