Thomas Pilgrim1, Raffaele Piccolo2, Dik Heg3, Marco Roffi4, David Tüller5, Olivier Muller6, Igal Moarof7, George C M Siontis8, Stéphane Cook9, Daniel Weilenmann10, Christoph Kaiser11, Florim Cuculi12, Lukas Hunziker8, Franz R Eberli5, Peter Jüni13, Stephan Windecker8. 1. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: thomas.pilgrim@insel.ch. 2. Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy. 3. Institute of Social and Preventive Medicine, Inselspital, University of Bern, Bern, Switzerland; Clinical Trials Unit, Inselspital, University of Bern, Bern, Switzerland. 4. Department of Cardiology, Geneva University Hospital, Geneva, Switzerland. 5. Department of Cardiology, Triemlispital, Zurich, Switzerland. 6. Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland. 7. Department of Cardiology, Kantonsspital Aarau, Aarau, Switzerland. 8. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. 9. Department of Cardiology, University and Hospital Fribourg, Fribourg, Switzerland. 10. Department of Cardiology, Kantonsspital St Gallen, St Gallen, Switzerland. 11. Department of Cardiology, University Hospital Basel, Basel, Switzerland. 12. Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland. 13. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Abstract
BACKGROUND: 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. METHODS: 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. FINDINGS: 2008 (95%) of 2119patients 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). INTERPRETATION: 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. FUNDING: Clinical Trials Unit of the University of Bern and Biotronik.
RCT Entities:
BACKGROUND: 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. METHODS: In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymersirolimus-eluting stents with durable-polymereverolimus-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. FINDINGS: 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-polymersirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymereverolimus-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-polymersirolimus-eluting stents than in those treated with durable-polymereverolimus-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). INTERPRETATION: 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. FUNDING: Clinical Trials Unit of the University of Bern and Biotronik.
Authors: Mahesh V Madhavan; James P Howard; Azim Naqvi; Ori Ben-Yehuda; Bjorn Redfors; Megha Prasad; Bahira Shahim; Martin B Leon; Sripal Bangalore; Gregg W Stone; Yousif Ahmad Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983
Authors: Juan F Iglesias; Dik Heg; Marco Roffi; David Tüller; Jonas Lanz; Fabio Rigamonti; Olivier Muller; Igal Moarof; Stéphane Cook; Daniel Weilenmann; Christoph Kaiser; Florim Cuculi; Marco Valgimigli; Peter Jüni; Stephan Windecker; Thomas Pilgrim Journal: J Am Heart Assoc Date: 2019-11-07 Impact factor: 5.501