Rationale and design of the Affordability and Real-world Antiplatelet Treatment Effectiveness after Myocardial Infarction Study (ARTEMIS): A multicenter, cluster-randomized trial of P2Y12 receptor inhibitor copayment reduction after myocardial infarction

Jacob A. Doll, Tracy Y. Wang, Niteesh K. Choudhry, Christopher P. Cannon, David J. Cohen, Gregg C. Fonarow, Timothy D. Henry, Durgesh D. Bhandary, Naeem Khan, Linda D. Davidson-Ray, Kevin Anstrom, Eric D. Peterson

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Background The use of oral P2Y12 receptor inhibitors after acute myocardial infarction (MI) can reduce risks of subsequent major adverse cardiovascular events (composite of all-cause death, recurrent MI, and stroke), yet medication persistence is suboptimal. Although copayment cost has been implicated as a factor influencing medication persistence, it remains unclear whether reducing or eliminating these costs can improve medication persistence and/or downstream clinical outcomes. Design ARTEMIS is a multicenter, cluster-randomized clinical trial designed to examine whether eliminating patient copayment for P2Y12 receptor inhibitor therapy affects medication persistence and clinical outcomes. We will enroll approximately 11,000 patients hospitalized for acute ST-elevation and non-ST-elevation MI at 300 hospitals. Choice and duration of treatment with a P2Y12 receptor inhibitor will be determined by the treating physician. Hospitals randomized to the copayment intervention will provide vouchers to cover patients' copayments for their P2Y12 receptor inhibitor for up to 1 year after discharge. The coprimary end points are 1-year P2Y12 receptor inhibitor persistence and major adverse cardiovascular events. Secondary end points include choice of P2Y12 receptor inhibitor, patient-reported outcomes, and postdischarge cost of care. Conclusion ARTEMIS will be the largest randomized assessment of a medication copayment reduction intervention on medication persistence, clinical outcomes, treatment selection, and cost of care after acute MI.

Original languageEnglish (US)
Pages (from-to)33-41
Number of pages9
JournalAmerican Heart Journal
Volume177
DOIs
StatePublished - Jul 2016

Bibliographical note

Funding Information:
Dr Doll reports no relevant disclosures. Dr Wang reports research grant support from Eli Lilly, Daiichi Sankyo, Astra Zeneca, Bristol Myers Squibb, Boston Scientific, Gilead, Glaxo Smith Kline, and Regeneron, and consulting services from Eli Lilly, Astra Zeneca, and Premier. Dr Choudhry reports being the Principal Investigator on unrestricted research grants to study medication adherence payable to his institution (Brigham and Women's Hospital and Harvard Medical School) from the National Heart Lung and Blood Institute, CVS Caremark, Sanofi, Astra Zeneca, Merck, and the PhRMA foundation. He receives no personal compensation from any of these sources or from other entities with potentially relevant financial interests. Dr Cannon reports grants from Accumetrics, Arisaph (>10K), Astra Zeneeca (>10K), Boehringer-Ingelheim (>10K), GlaxoSmithKline (>10K), Janssen (>10K), Merck (>10K), and Takeda (>10 K), and consulting fees from Boehringer-Ingelheim, Bristol Myers Squibb, CSL Behring, Essentialis, GlaxoSmithKline, Kowa, Merck, Takeda, Lipimedix (>10 K), Pfizer, Regeneron (>10 K), and Sanofi (>10K). Dr Cohen reports receiving research grant support from Astra Zeneca (significant), Eli Lilly (significant), and Daiichi Sankyo (significant); speaking honoraria from Astra Zeneca (modest); and consulting income from Astra Zeneca (modest) and Eli Lilly (modest). Dr Fonarow reports funding from Astra Zeneca and Janssen (both modest). Dr Henry reports no relevant disclosures. Dr Bhandary reports being an employee of AstraZeneca. Dr Khan reports being an employee of AstraZeneca. Ms Davidson-Ray reports no relevant disclosures. Dr Anstrom has received research support from the National Institutes of Health (significant), Merck (significant), Bayer (significant), AstraZeneca (significant), Bristol-Meyers Squibb (significant), Eli Lilly & Company (significant), Boehringer Ingelheim (significant), Pulmonary Fibrosis Foundation (significant), and Medtronic (significant); has served as a consultant for Abbott Vascular (modest), AstraZeneca (modest), Bristol-Meyers Squibb (modest), Gilead (modest), Janssen (modest), Pfizer (modest), and GlaxoSmithKline (modest); and has served on data monitoring committees for National Institutes of Health (modest), Forest (modest), Pfizer (modest), and GlaxoSmithKline (modest). Dr Peterson reports institutional grant support from the American College of Cardiology, American Heart Association, Eli Lilly, and Janssen, and consulting fees (including CME) from Merck & Co, Boehringer Ingelheim, Genentech, Janssen, and Sanofi-Aventis.

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© 2016 Elsevier Inc. All rights reserved.

Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.

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