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Comparing Inverse Probability of Treatment Weighting and Instrumental Variable Methods for the Evaluation of Adenosine Diphosphate Receptor Inhibitors After Percutaneous Coronary Intervention.

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Date
2016-09
Authors
Federspiel, Jerome J
Anstrom, Kevin J
Xian, Ying
McCoy, Lisa A
Effron, Mark B
Faries, Douglas E
Zettler, Marjorie
Mauri, Laura
Yeh, Robert W
Peterson, Eric D
Wang, Tracy Y
Treatment With Adenosine Diphosphate Receptor Inhibitors–Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Investigators
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Abstract
IMPORTANCE:There is increasing interest in performing comparative effectiveness analyses in large observational databases, yet these analyses must adjust for treatment selection issues. OBJECTIVES:To conduct comparative safety and efficacy analyses of prasugrel vs clopidogrel bisulfate after percutaneous coronary intervention and to evaluate inverse probability of treatment weighting (a propensity score method) and instrumental variable methods. DESIGN, SETTING, AND PARTICIPANTS:This study used data from the Treatment With Adenosine Diphosphate Receptor Inhibitors-Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) study. Included in the study were patients undergoing percutaneous coronary intervention for myocardial infarction, 26.0% of whom received prasugrel. The study dates were April 4, 2010, to October 31, 2012. EXPOSURES:Choice of initial antiplatelet agent (prasugrel or clopidogrel). MAIN OUTCOMES AND MEASURES:Safety and efficacy outcomes included 1-year composite major adverse cardiovascular events, moderate to severe bleeding, and stent thrombosis. Hospitalizations for pneumonia, bone fractures, and planned percutaneous coronary intervention were used as the falsification end points. RESULTS:The study cohort comprised 11 784 participants (mean [SD] age, 60.0 [11.6] years, and 28.0% were female). Using inverse probability of treatment weighting adjustment, prasugrel and clopidogrel had similar major adverse cardiovascular events (hazard ratio [HR], 0.98; 95% CI, 0.83-1.16) and bleeding outcomes (1.18; 0.77-1.80), but prasugrel had a lower rate of stent thrombosis (0.51; 0.31-0.85). Using instrumental variable methods, prasugrel use was associated with a lower rate of the major adverse cardiovascular event end point (HR, 0.68; 95% CI, 0.47-1.00) but nonsignificant differences in the rates of bleeding (0.95; 0.41-2.08) and stent thrombosis (0.67; 0.16-2.00). There was no significant treatment difference noted in any of the falsification end-point rates when analyses were performed using inverse probability of treatment weighting, although the bone fracture end point approached statistical significance. Nevertheless, a lower rate of pneumonia-related hospitalizations was noted in the prasugrel-treated patients when analyses were performed using instrumental variable methods. CONCLUSIONS AND RELEVANCE:Conclusions regarding the safety and efficacy of antiplatelet therapy varied depending on analytic technique, and none were concordant with the results from randomized trials. In addition, both statistical strategies demonstrated concerning associations when tested in the falsification analyses. A high level of scrutiny and careful attention to assumptions and validity are required when interpreting complex analyses of observational data.
Type
Journal article
Subject
Treatment With Adenosine Diphosphate Receptor Inhibitors–Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Investigators
Humans
Ticlopidine
Adenosine Diphosphate
Platelet Aggregation Inhibitors
Treatment Outcome
Aged
Middle Aged
Female
Male
Percutaneous Coronary Intervention
Prasugrel Hydrochloride
Clopidogrel
Permalink
https://hdl.handle.net/10161/21690
Published Version (Please cite this version)
10.1001/jamacardio.2016.1783
Publication Info
Federspiel, Jerome J; Anstrom, Kevin J; Xian, Ying; McCoy, Lisa A; Effron, Mark B; Faries, Douglas E; ... Treatment With Adenosine Diphosphate Receptor Inhibitors–Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Investigators (2016). Comparing Inverse Probability of Treatment Weighting and Instrumental Variable Methods for the Evaluation of Adenosine Diphosphate Receptor Inhibitors After Percutaneous Coronary Intervention. JAMA cardiology, 1(6). pp. 655-665. 10.1001/jamacardio.2016.1783. Retrieved from https://hdl.handle.net/10161/21690.
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Scholars@Duke

Anstrom

Kevin J. Anstrom

Adjunct Professor in the Department of Biostatistics & Bioinformatics
My research interests include clinical trial design, causal inference, coordinating centers, data monitoring, and pragmatic clinical research.
Federspiel

Jerome Federspiel

House Staff
Dr. Federspiel is a maternal fetal medicine fellow at Duke University. His clinical and research interests focus on the care of people with cardiovascular and hematologic complications of pregnancy.
Peterson

Eric David Peterson

Fred Cobb, M.D. Distinguished Professor of Medicine
Dr Peterson is the Fred Cobb Distinguished Professor of Medicine in the Division of Cardiology, a DukeMed Scholar, and the Past Executive Director of the Duke Clinical Research Institute (DCRI), Durham, NC, USA. Dr Peterson is the Principal Investigator of the National Institute of Health, Lung and Blood Institute (NHLBI) Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT) Trial  He is also the Principal I
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.
Wang

Tracy Yu-Ping Wang

Professor of Medicine

Ying Xian

Adjunct Associate Professor in the Department of Neurology
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