한빛사논문
- 조회731
Seng Chan You, MD, MS1,2; Yeunsook Rho, PhD2,3; Behnood Bikdeli, MD, MS2,4,5,6; Jiwoo Kim, MS2,3; Anastasios Siapos, MSc2,7; James Weaver, MSc2,8; Ajit Londhe, MPH2,9,10; Jaehyeong Cho, BS2,11; Jimyung Park, BS2,11; Martijn Schuemie, PhD2,8,12; Marc A. Suchard, MD, PhD2,12,13; David Madigan, PhD2,14; George Hripcsak, MD, MS2,15,16; Aakriti Gupta, MD, MS2,4,5,6; Christian G. Reich, MD2,7; Patrick B. Ryan, PhD2,8,15; Rae Woong Park, MD, PhD1,2,11; Harlan M. Krumholz, MD, SM5,17,18
1Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Korea
2Observational Health Data Sciences and Informatics, New York, New York
3Health Insurance Review and Assessment Service, Wonju, Korea
4Division of Cardiology, Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York
5Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut
6Cardiovascular Research Foundation (CRF), New York, New York
7Real World Evidence Solutions, IQVIA, Durham, North Carolina
8Epidemiology Analytics, Janssen Research and Development, Titusville, New Jersey
9Janssen Research and Development, Titusville, New Jersey
10Now with Amgen, Thousand Oaks, California
11Department of Biomedical Sciences, Ajou University Graduate School of Medicine, Suwon, Korea
12Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles
13Department of Biomathematics, David Geffen School of Medicine at UCLA, University of California, Los Angeles
14Department of Statistics, Columbia University, New York, New York
15Department of Biomedical Informatics, Columbia University, New York, New York
16Medical Informatics Services, New York-Presbyterian Hospital, New York, New York
17Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
18Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
Corresponding Author: Harlan M. Krumholz, MD, SM, Center for Outcomes Research and Evaluation (CORE), Yale New Haven Hospital, One Church St, Ste 200, New Haven, CT 06510
Abstract
Importance
Current guidelines recommend ticagrelor as the preferred P2Y12 platelet inhibitor for patients with acute coronary syndrome (ACS), primarily based on a single large randomized clinical trial. The benefits and risks associated with ticagrelor vs clopidogrel in routine practice merits attention.
Objective
To determine the association of ticagrelor vs clopidogrel with ischemic and hemorrhagic events in patients undergoing percutaneous coronary intervention (PCI) for ACS in clinical practice.
Design, Setting, and Participants
A retrospective cohort study of patients with ACS who underwent PCI and received ticagrelor or clopidogrel was conducted using 2 United States electronic health record–based databases and 1 nationwide South Korean database from November 2011 to March 2019. Patients were matched using a large-scale propensity score algorithm, and the date of final follow-up was March 2019.
Exposures
Ticagrelor vs clopidogrel.
Main Outcomes and Measures
The primary end point was net adverse clinical events (NACE) at 12 months, composed of ischemic events (recurrent myocardial infarction, revascularization, or ischemic stroke) and hemorrhagic events (hemorrhagic stroke or gastrointestinal bleeding). Secondary outcomes included NACE or mortality, all-cause mortality, ischemic events, hemorrhagic events, individual components of the primary outcome, and dyspnea at 12 months. The database-level hazard ratios (HRs) were pooled to calculate summary HRs by random-effects meta-analysis.
Results
After propensity score matching among 31 290 propensity-matched pairs (median age group, 60-64 years; 29.3% women), 95.5% of patients took aspirin together with ticagrelor or clopidogrel. The 1-year risk of NACE was not significantly different between ticagrelor and clopidogrel (15.1% [3484/23 116 person-years] vs 14.6% [3290/22 587 person-years]; summary HR, 1.05 [95% CI, 1.00-1.10]; P = .06). There was also no significant difference in the risk of all-cause mortality (2.0% for ticagrelor vs 2.1% for clopidogrel; summary HR, 0.97 [95% CI, 0.81-1.16]; P = .74) or ischemic events (13.5% for ticagrelor vs 13.4% for clopidogrel; summary HR, 1.03 [95% CI, 0.98-1.08]; P = .32). The risks of hemorrhagic events (2.1% for ticagrelor vs 1.6% for clopidogrel; summary HR, 1.35 [95% CI, 1.13-1.61]; P = .001) and dyspnea (27.3% for ticagrelor vs 22.6% for clopidogrel; summary HR, 1.21 [95% CI, 1.17-1.26]; P < .001) were significantly higher in the ticagrelor group.
Conclusions and Relevance
Among patients with ACS who underwent PCI in routine clinical practice, ticagrelor, compared with clopidogrel, was not associated with significant difference in the risk of NACE at 12 months. Because the possibility of unmeasured confounders cannot be excluded, further research is needed to determine whether ticagrelor is more effective than clopidogrel in this setting.
논문정보
- Research article
- 2020년 10월 (BRIC 등록일 2021-10-19)
- 국내+국외 연구진
- 의약학 > 인체시스템의학
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