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Comment & Response
October 22/29, 2019

P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Percutaneous Coronary Intervention—Reply

Author Affiliations
  • 1Division of Cardiology, Samsung Medical Center, Seoul, Korea
JAMA. 2019;322(16):1607-1608. doi:10.1001/jama.2019.13163

In Reply We agree with Drs McCaw and Wei that the intention-to-treat analysis might dilute the true difference in the event rates between the P2Y12 inhibitor monotherapy group and the DAPT group in the SMART-CHOICE (Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents) trial.1 Considering that 8.9% of patients in the P2Y12 inhibitor monotherapy group received aspirin at 1 year, to estimate the effects of treatment as received is of great importance. The most frequently used method for this purpose is a per-protocol analysis, in which only patients completing the assigned treatment are included.2 Therefore, we do not agree with McCaw and Wei’s claim that the per-protocol analysis does not preserve randomization. The noninferiority criterion was met in the per-protocol analysis as previously reported.1