One-Year Findings Published From the SORT OUT VIII Trial
April 2, 2019—One-year follow-up findings from the SORT OUT VIII trial were published by Michael Maeng, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2019;12:624–633).
The study compared the thin-strut Synergy biodegradable-polymer, platinum-chromium, everolimus-eluting stent (EES; Boston Scientific Corporation) to the NeoFlex biodegradable-polymer, stainless-steel, biolimus-eluting stent (BES; Biosensors International Group, Ltd.) in unselected patients undergoing percutaneous coronary intervention (PCI).
As summarized in JACC: Cardiovascular Interventions, SORT OUT VIII is a randomized, multicenter, all-comers, noninferiority trial. Investigators enrolled 2,754 patients with clinical indications for PCI at three sites in western Denmark. Patients were randomly assigned (1:1) to receive either the EES (n = 1,385) or the BES (n = 1,369).
The primary endpoint was target lesion failure, which was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, and was analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared to the BES with a predetermined noninferiority margin of 3%.
The investigators found that 55 patients (4%) who were assigned to the EES arm and 60 patients (4.4%) who were assigned to the BES arm met the primary endpoint (absolute risk difference 0.4%; upper limit of one-sided 95% confidence interval, 1.7%; P < .001). At 1-year follow-up, the EES was noninferior to the BES with respect to target lesion failure, concluded the investigators in JACC: Cardiovascular Interventions.