Jacob A Doll1, Tracy Y Wang2, Niteesh K Choudhry3, Christopher P Cannon3, David J Cohen4, Gregg C Fonarow5, Timothy D Henry6, Durgesh D Bhandary7, Naeem Khan7, Linda D Davidson-Ray2, Kevin Anstrom2, Eric D Peterson2. 1. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. Electronic address: jacob.doll@dm.duke.edu. 2. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. 3. Brigham and Women's Hospital and Harvard Medical School, Boston, MA. 4. Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City School of Medicine, Kansas City, MO. 5. Ronald Reagan UCLA Medical Center, Los Angeles, CA. 6. Cedars Sinai Heart Institute, Los Angeles, CA. 7. AstraZeneca, Wilmington, DE.
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.
RCT Entities:
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.
Authors: Alexander C Fanaroff; Ghazala Haque; Betsy Thomas; Allegra E Stone; Lynn M Perkins; Matthew Wilson; W Schuyler Jones; Chiara Melloni; Kenneth W Mahaffey; Karen P Alexander; Renato D Lopes Journal: Trials Date: 2020-04-09 Impact factor: 2.279
Authors: Jacob A Doll; Lisa A Kaltenbach; Kevin J Anstrom; Christopher P Cannon; Timothy D Henry; Gregg C Fonarow; Niteesh K Choudhry; Eileen Fonseca; Narinder Bhalla; James M Eudicone; Eric D Peterson; Tracy Y Wang Journal: J Am Heart Assoc Date: 2020-04-17 Impact factor: 5.501