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.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.