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.
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.


METHODS
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.


CONCLUSIONS
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.
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. Electronic address: jacob.doll@dm.duke.edu.
Jacob A
JA
Doll
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Tracy Y
TY
Wang
Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Niteesh K
NK
Choudhry
Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Christopher P
CP
Cannon
Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City School of Medicine, Kansas City, MO.
David J
DJ
Cohen
Ronald Reagan UCLA Medical Center, Los Angeles, CA.
Gregg C
GC
Fonarow
Cedars Sinai Heart Institute, Los Angeles, CA.
Timothy D
TD
Henry
AstraZeneca, Wilmington, DE.
Durgesh D
DD
Bhandary
AstraZeneca, Wilmington, DE.
Naeem
N
Khan
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Linda D
LD
Davidson-Ray
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Kevin
K
Anstrom
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Eric D
ED
Peterson
D000241:Adenosine / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D000077144:Clopidogrel; D017047:Cost Sharing; D016527:Drug Costs; D005378:Financial Support; D017048:Health Care Costs; D005102:Health Expenditures; D006801:Humans; D016015:Logistic Models; D055118:Medication Adherence; D009026:Mortality; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000188:drug therapy*; D058921:Purinergic P2Y Receptor Antagonists / Q000191:economics* / Q000627:therapeutic use; D012008:Recurrence; D055502:Secondary Prevention; D020521:Stroke / Q000453:epidemiology; D000077486:Ticagrelor; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome
D058921:Purinergic P2Y Receptor Antagonists; D000077144:Clopidogrel; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine