机构：[1]State University of New York, Downstate School of Public Health, Brooklyn, NY[2]Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris and Paris University, Sorbonne Paris Cité, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France[3]National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom[4]Woodhull Medical Center, Brooklyn, NY[5]Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA[6]Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL[7]Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland[8]Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina[9]Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada and St Michael’s Hospital, University of Toronto, Ontario, Canada[10]MHAT “National Cardiology Hospital” EAD, Sofia, Bulgaria[11]Department of Cardiology, Leiden University Medical Center, the Netherlands[12]Regeneron Pharmaceuticals Inc, Tarrytown, NY[13]Duke Clinical Research Institute, Duke University Medical Center, Durham, NC[14]Sanofi, Bridgewater, NJ[15]Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand[16]St John’s Medical College, Bangalore, India[17]Department of Medicine III, Goethe University, Frankfurt am Main, Germany[18]Division of Cardiology, University of Colorado School of Medicine, Aurora, CO
Background: In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab was compared with placebo, added to high-intensity or maximum tolerated statin treatment after acute coronary syndrome in 18924 patients. Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths. The present analysis determined whether alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH in ODYSSEY OUTCOMES. Methods and Results: In prespecified analyses, hazard functions for total hospitalizations and death were jointly estimated by a semiparametric model, while in post hoc analyses, DAOH and percent DAOH were compared between treatment groups with Poisson regression and one-inflated beta regression, respectively. With 16629 total hospitalizations and 726 deaths, 331 fewer hospitalizations, and 58 fewer deaths were observed with alirocumab compared with placebo, translating to 15.6 total hospitalizations or deaths avoided with alirocumab per 1000 patient-years of assigned treatment. Alirocumab reduced total hospitalizations (hazard ratio, 0.96 [95% CI, 0.92-1.00]; P=0.04) and increased DAOH relative to placebo (rate ratio, 1.003 [95% CI, 1.000-1.007]; P=0.05), primarily through a reduction in days dead (rate ratio, 0.847 [95% CI, 0.728-0.986]; P=0.03). Patients randomized to alirocumab were also more likely to survive to the end of the study without hospitalization (odds ratio, 1.06 [95% CI, 1.00-1.13]; P=0.03). Conclusions: Alirocumab reduced total hospitalizations with corresponding small increases in DAOH and percent DAOH. These outcomes provide alternative patient-centered metrics to capture the totality of alirocumab clinical efficacy after acute coronary syndrome. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01663402.
基金：
Fondation Assistance Publique-Hopitaux de Paris, Paris, France
第一作者机构：[1]State University of New York, Downstate School of Public Health, Brooklyn, NY[*1]450 Clarkson Ave, MS 43, Brooklyn, NY 11203
通讯作者：
通讯机构：[1]State University of New York, Downstate School of Public Health, Brooklyn, NY[*1]450 Clarkson Ave, MS 43, Brooklyn, NY 11203
推荐引用方式(GB/T 7714)：
Michael Szarek,Ph. Gabriel Steg,Dina DiCenso,et al.Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial[J].CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES.2019,12(11):doi:10.1161/CIRCOUTCOMES.119.005858.
APA：
Michael Szarek,Ph. Gabriel Steg,Dina DiCenso,Deepak L. Bhatt,Vera A. Bittner...&ODYSSEY OUTCOMES Committees and Investigators.(2019).Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial.CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES,12,(11)
MLA：
Michael Szarek,et al."Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial".CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES 12..11(2019)
