Gennaro Giustino1, Usman Baber1, Olga Salianski1, Samantha Sartori1, Gregg W Stone1, Martin B Leon1, Melissa Aquino1, Giulio G Stefanini1, P Gabriel Steg1, Stephan Windecker1, Monica O' Donoghue1, William Wijns1, Patrick W Serruys1, Marco Valgimigli1, Marie-Claude Morice1, Edoardo Camenzind1, Giora Weisz1, Pieter C Smits1, David Kandzari1, Clemens Von Birgelen1, George D Dangas1, Jin Y Cha1, Soren Galatius1, Raban V Jeger1, Takeshi Kimura1, Ghada W Mikhail1, Dipti Itchhaporia1, Laxmi Mehta1, Rebecca Ortega1, Hyo-Soo Kim1, Adnan Kastrati1, Philippe Genereux1, Alaide Chieffo1, Roxana Mehran1. 1. From the The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York City, NY (G.G., U.B., O.S., S.S., M.A., M.O., G.D.D., J.Y.C., R.M.); Division of Cardiology, Columbia University Medical Center, New York City, NY (G.W.S., M.B.L., P.G.); Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); Department of Cardiology, ErasmusMC, Rotterdam, The Netherlands (P.W.S.); Department of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, France (M.-C.M.); Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium (W.W.); Deparment of Cardiology, Institut Lorrain du Coeur et des Vaisseaux (ILCV) University Hospital Nancy-Brabois Vandoeuvre-lès-Nancy France (E.C.); Département Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U114, Paris, France (P.G.S.); Maasstad Hospital, Rotterdam, Netherlands (P.C.S.); Department of Cardiology, Piedmont Heart Institute, Atlanta, GA (D.K.); Department of Cardiology, Thoraxcentrum Twente, Enschede, Netherlands (C.V.B.); Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark (S.G.); Department of Cardiology, University Hospital Basel, Basel, Switzerland (R.V.J.); Department of Cardiology, Kyoto University Graduate School of Medicine, Kyoto, Japan (T.K.); Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK (G.W.M.); Department of Cardiology, Hoag Memorial Hospital Presbyterian, Newport Beach, CA (D.I.); Department of Cardiology, Ohio State University Medical Center, Columbus, OH (L.M.); Society of Cardiovascular Angiography and Interventions, Washington, DC (R.O.); Department of Cardiology, Seoul National University Main Hospital, Seoul, Korea (H.-S.K.); Department of Cardiology, University of Ferrara, Ferrara, Italy (M.V.); Departm
Abstract
BACKGROUND: The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. METHODS AND RESULTS: We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10,449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95% confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. CONCLUSIONS: Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.
RCT Entities:
BACKGROUND: The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. METHODS AND RESULTS: We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10,449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95% confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. CONCLUSIONS: Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.
Authors: Gennaro Giustino; Rafael Harari; Usman Baber; Samantha Sartori; Gregg W Stone; Martin B Leon; Stephan Windecker; Patrick W Serruys; Adnan Kastrati; Clemens Von Birgelen; Takeshi Kimura; Giulio G Stefanini; George D Dangas; William Wijns; P Gabriel Steg; Marie-Claude Morice; Edoardo Camenzind; Giora Weisz; Pieter C Smits; Sabato Sorrentino; Madhav Sharma; Serdar Farhan; Michela Faggioni; David Kandzari; Soren Galatius; Raban V Jeger; Marco Valgimigli; Dipti Itchhaporia; Laxmi Mehta; Hyo-Soo Kim; Alaide Chieffo; Roxana Mehran Journal: JAMA Cardiol Date: 2017-08-01 Impact factor: 14.676