Journal Article

Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial

Heg, Dik, Roffi, Marco, Muller, Olivier, Windecker, Stephan, Siontis, George C M, Jüni, Peter, Cuculi, Florim, Piccolo, Raffaele, Tüller, David, Pilgrim, Thomas, Moarof, Igal, Hunziker, Lukas, Cook, Stéphane, Weilenmann, Daniel, Eberli, Franz R, Kaiser, Christoph

2018

Overview

Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104. 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88–1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06–1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51–2·05; p=0·950). 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. Clinical Trials Unit of the University of Bern and Biotronik.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Absorbable Implants / Acute Coronary Syndrome - complications / Acute Coronary Syndrome - mortality / Acute Coronary Syndrome - surgery / Adult / Aged / Aged, 80 and over / Anticoagulants / Aspirin / Biodegradability / Biodegradation / Cardiovascular disease / Cardiovascular diseases / Cause of Death / Chromium / Chromium plating / Clinical trials / Cobalt / Cobalt plating / Coronary artery / Coronary artery disease / Coronary Artery Disease - complications / Coronary Artery Disease - mortality / Coronary Artery Disease - surgery / Coronary vessels / Drug delivery / Drug-Eluting Stents - adverse effects / Everolimus - administration & dosage / Evidence-based medicine / Female / Follow-Up Studies / Heart attacks / Heart diseases / Humans / Immunosuppressive Agents - administration & dosage / Implantation / Implants / Incidence / Inhibitor drugs / Intention to Treat Analysis / Lesions / Male / Medical research / Middle Aged / Mortality / Motivation / Myocardial infarction / Myocardial Infarction - etiology / Myocardial Infarction - mortality / Patients / Percutaneous Coronary Intervention - instrumentation / Polymers / Prosthesis Design / Prosthesis Failure - etiology / Randomization / Rapamycin / Single-Blind Method / Sirolimus - administration & dosage / Stents / Surgical implants / Thromboembolism / Thrombosis / Thrombosis - etiology / Treatment Outcome