机构：[a]Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands[b]State University of New York,Downstate School of Public Health, Brooklyn, New York[c]Clinical Trials Unit, Faculty of Medicine, University of Kelaniya,Kelaniya, Sri Lanka[d]Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston,Massachusetts[e]Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama[f]Latinoamerican Cardiological Studies, Cardiovascular Institute of Rosario, Rosario, Argentina[g]Sanofi, Bridgewater, New Jersey[h]CanadianVIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada[i]St. Michael’s Hospital, University of Toronto, Toronto,Ontario, Canada[j]Sanofi, Paris, France[k]Stanford Center for Clinical Research, Department of Medicine, Stanford University,Stanford, California[l]Russian Cardiological Scientific-Productive Complex, Moscow, Russian Federation[m]Regeneron Pharmaceuticals, Inc., Tarrytown, New York[n]University of Chile Clinical Hospital, Santiago, Chile[o]Duke Clinical Research Institute,Duke University Medical Center, Durham, North Carolina[p]Division of Cardiology, Department of Medicine, Duke UniversitySchool of Medicine, Durham, North Carolina[q]Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand[r]Department of Medicine III, Goethe University, Frankfurt am Main, Germany[s]Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado[t]Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris and Paris DiderotUniversity, Sorbonne Paris Cité, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France[u]NationalHeart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom.
BACKGROUND Patients with acute coronary syndrome (ACS) and concomitant noncoronary atherosclerosis have a high risk of major adverse cardiovascular events (MACEs) and death. The impact of lipid lowering by proprotein convertase subtilisin-kexin type 9 inhibition in such patients is undetermined. OBJECTIVES This pre-specified analysis from ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) determined whether polyvascular disease influenced risks of MACEs and death and their modification by alirocumab in patients with recent ACS and dyslipidemia despite intensive statin therapy. METHODS Patients were randomized to alirocumab or placebo 1 to 12 months after ACS. The primary MACEs endpoint was the composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint. RESULTS Median follow-up was 2.8 years. Of 18,924 patients, 17,370 had monovascular (coronary) disease, 1,405 had polyvascular disease in 2 beds (coronary and peripheral artery or cerebrovascular), and 149 had polyvascular disease in 3 beds (coronary, peripheral artery, cerebrovascular). With placebo, the incidence of MACEs by respective vascular categories was 10.0%, 22.2%, and 39.7%. With alirocumab, the corresponding absolute risk reduction was 1.4% (95% confidence interval [CI]: 0.6% to 2.3%), 1.9% (95% CI: -2.4% to 6.2%), and 13.0% (95% CI: -2.0% to 28.0%). With placebo, the incidence of death by respective vascular categories was 3.5%, 10.0%, and 21.8%; the absolute risk reduction with alirocumab was 0.4% (95% CI: -0.1% to 1.0%), 1.3% (95% CI: -1.8% to 4.3%), and 16.2% (95% CI: 5.5% to 26.8%). CONCLUSIONS In patients with recent ACS and dyslipidemia despite intensive statin therapy, polyvascular disease is associated with high risks of MACEs and death. The large absolute reductions in those risks with alirocumab are a potential benefit for these patients. (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab [ODYSSEY OUTCOMES]: NCT01663402) (C) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
基金：
Fondation Assistance Publique-Hopitaux de Paris, Paris, France
第一作者机构：[a]Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands
推荐引用方式(GB/T 7714)：
J. Wouter Jukema,Michael Szarek,Laurien E. Zijlstra,et al.Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome ODYSSEY OUTCOMES Trial[J].JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY.2019,74(9):1167-1176.doi:10.1016/j.jacc.2019.03.013.
APA：
J. Wouter Jukema,Michael Szarek,Laurien E. Zijlstra,H. Asita de Silva,Deepak L. Bhatt...&the ODYSSEY OUTCOMES Committees and Investigatorsz.(2019).Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome ODYSSEY OUTCOMES Trial.JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY,74,(9)
MLA：
J. Wouter Jukema,et al."Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome ODYSSEY OUTCOMES Trial".JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 74..9(2019):1167-1176
医学