Anna Franzone1, Thomas Pilgrim2, Dik Heg1, Marco Roffi1, David Tüller1, André Vuilliomenet1, Olivier Muller1, Stéphane Cook1, Daniel Weilenmann1, Christoph Kaiser1, Peiman Jamshidi1, Lorenz Räber1, Stefan Stortecky1, Peter Wenaweser1, Peter Jüni1, Stephan Windecker1. 1. From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi). 2. From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi). thomas.pilgrim@insel.ch.
Abstract
BACKGROUND:Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent forPercutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus. METHODS AND RESULTS: BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabetic patients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27-2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67-2.10; P=0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58-1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49-3.41; P=0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39-1.25; P=0.23, in nondiabetics). CONCLUSIONS: In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabetic patients treated withBP-SES or DP-EES were comparable at 1 year. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01443104.
RCT Entities:
BACKGROUND:Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus. METHODS AND RESULTS: BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabeticpatients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27-2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67-2.10; P=0.56) and nondiabeticpatients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58-1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49-3.41; P=0.60 for diabeticpatients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39-1.25; P=0.23, in nondiabetics). CONCLUSIONS: In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabeticpatients treated with BP-SES or DP-EES were comparable at 1 year. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01443104.
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
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