Comparing Inverse Probability of Treatment Weighting and Instrumental Variable Methods for the Evaluation of Adenosine Diphosphate Receptor Inhibitors After Percutaneous Coronary Intervention.
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 articleSubject
Treatment With Adenosine Diphosphate Receptor Inhibitors–Longitudinal Assessment of
Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) InvestigatorsHumans
Ticlopidine
Adenosine Diphosphate
Platelet Aggregation Inhibitors
Treatment Outcome
Aged
Middle Aged
Female
Male
Percutaneous Coronary Intervention
Prasugrel Hydrochloride
Clopidogrel
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https://hdl.handle.net/10161/21690Published Version (Please cite this version)
10.1001/jamacardio.2016.1783Publication 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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
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.
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.
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.
Tracy Yu-Ping Wang
Professor of Medicine
Ying Xian
Adjunct Associate Professor in the Department of Neurology
Alphabetical list of authors with Scholars@Duke profiles.

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