Konstantinos C Koskinas1, George C M Siontis1, Raffaele Piccolo1, Anna Franzone1, Alan Haynes1, Julie Rat-Wirtzler1, Sigmund Silber1, Patrick W Serruys1, Thomas Pilgrim1, Lorenz Räber1, Dik Heg1, Peter Jüni1, Stephan Windecker2. 1. From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.). 2. From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.). stephan.windecker@insel.ch.
Abstract
BACKGROUND:Diabetes mellitus and angiographic coronary artery disease complexity are intertwined and unfavorably affect prognosis after percutaneous coronary interventions, but their relative impact on long-term outcomes after percutaneous coronary intervention with drug-eluting stents remains controversial. This study determined drug-eluting stents outcomes in relation to diabetic status and coronary artery disease complexity as assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score. METHODS AND RESULTS: In a patient-level pooled analysis from 4 all-comers trials, 6081 patients were stratified according to diabetic status and according to the median SYNTAX score ≤11 or >11. The primary end point was major adverse cardiac events, a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization within 2 years. Diabetes mellitus was present in 1310 patients (22%), and new-generation drug-eluting stents were used in 4554 patients (75%). Major adverse cardiac events occurred in 173 diabetics (14.5%) and 436 nondiabetic patients (9.9%; P<0.001). In adjusted Cox regression analyses, SYNTAX score and diabetes mellitus were both associated with the primary end point (P<0.001 and P=0.028, respectively; P for interaction, 0.07). In multivariable analyses, diabetic versus nondiabetic patients had higher risks of major adverse cardiac events (hazard ratio, 1.25; 95% confidence interval, 1.03-1.53; P=0.026) and target lesion revascularization (hazard ratio, 1.54; 95% confidence interval, 1.18-2.01; P=0.002) but similar risks of cardiac death (hazard ratio, 1.41; 95% confidence interval, 0.96-2.07; P=0.08) and myocardial infarction (hazard ratio, 0.89; 95% confidence interval, 0.64-1.22; P=0.45), without significant interaction with SYNTAX score ≤11 or >11 for any of the end points. CONCLUSIONS: In this population treated with predominantly new-generation drug-eluting stents, diabetic patients were at increased risk for repeat target-lesion revascularization consistently across the spectrum of disease complexity. The SYNTAX score was an independent predictor of 2-year outcomes but did not modify the respective effect of diabetes mellitus. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00297661, NCT00389220, NCT00617084, and NCT01443104.
RCT Entities:
BACKGROUND:Diabetes mellitus and angiographic coronary artery disease complexity are intertwined and unfavorably affect prognosis after percutaneous coronary interventions, but their relative impact on long-term outcomes after percutaneous coronary intervention with drug-eluting stents remains controversial. This study determined drug-eluting stents outcomes in relation to diabetic status and coronary artery disease complexity as assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score. METHODS AND RESULTS: In a patient-level pooled analysis from 4 all-comers trials, 6081 patients were stratified according to diabetic status and according to the median SYNTAX score ≤11 or >11. The primary end point was major adverse cardiac events, a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization within 2 years. Diabetes mellitus was present in 1310 patients (22%), and new-generation drug-eluting stents were used in 4554 patients (75%). Major adverse cardiac events occurred in 173 diabetics (14.5%) and 436 nondiabeticpatients (9.9%; P<0.001). In adjusted Cox regression analyses, SYNTAX score and diabetes mellitus were both associated with the primary end point (P<0.001 and P=0.028, respectively; P for interaction, 0.07). In multivariable analyses, diabetic versus nondiabeticpatients had higher risks of major adverse cardiac events (hazard ratio, 1.25; 95% confidence interval, 1.03-1.53; P=0.026) and target lesion revascularization (hazard ratio, 1.54; 95% confidence interval, 1.18-2.01; P=0.002) but similar risks of cardiac death (hazard ratio, 1.41; 95% confidence interval, 0.96-2.07; P=0.08) and myocardial infarction (hazard ratio, 0.89; 95% confidence interval, 0.64-1.22; P=0.45), without significant interaction with SYNTAX score ≤11 or >11 for any of the end points. CONCLUSIONS: In this population treated with predominantly new-generation drug-eluting stents, diabeticpatients were at increased risk for repeat target-lesion revascularization consistently across the spectrum of disease complexity. The SYNTAX score was an independent predictor of 2-year outcomes but did not modify the respective effect of diabetes mellitus. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00297661, NCT00389220, NCT00617084, and NCT01443104.
Authors: Giuseppe Gargiulo; Stephan Windecker; Bruno R da Costa; Fausto Feres; Myeong-Ki Hong; Martine Gilard; Hyo-Soo Kim; Antonio Colombo; Deepak L Bhatt; Byeong-Keuk Kim; Marie-Claude Morice; Kyung Woo Park; Alaide Chieffo; Tullio Palmerini; Gregg W Stone; Marco Valgimigli Journal: BMJ Date: 2016-11-03
Authors: Yu Jin; Yi Xie; Allison C Ostriker; Xinbo Zhang; Renjing Liu; Monica Y Lee; Kristen L Leslie; Waiho Tang; Jing Du; Seung Hee Lee; Yingdi Wang; William C Sessa; John Hwa; Jun Yu; Kathleen A Martin Journal: Arterioscler Thromb Vasc Biol Date: 2017-10-12 Impact factor: 8.311