BIOFLOW-III satellite-One-year clinical outcomes of diabetic patients treated with a biodegradable polymer sirolimus-eluting stent and comprehensive medical surveillance.
In percutaneous coronary interventions, drug-eluting stents (DESs) have reduced the risk of restenosis and repeat revascularization compared with bare-metal stents. The secondgeneration DESs with thinner stent struts have improved safety and efficacy compared with the first-generation DESs and has been associated with a reduced risk of late stent thrombosis. The persistence of polymer material on firstand second-generation DESs after completion of drug release has been Background—Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. Methods and Results—The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial—a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial—compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt–chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, −0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent–treated patients (rate ratio, 0.33; 95% confidence interval, 0.12–0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02–1.00; P=0.05). Conclusions—The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358. (Circ Cardiovasc Interv. 2016;9:e003610. DOI: 10.1161/CIRCINTERVENTIONS.115.003610.)