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Comment & Response
November 5, 2019

One vs 12 Months of Dual Antiplatelet Therapy for Patients After Percutaneous Coronary Intervention

Author Affiliations
  • 1Addenbrookes Hospital, University of Cambridge, Cambridge, England
JAMA. 2019;322(17):1715. doi:10.1001/jama.2019.14223

To the Editor The STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent 2) study reported noninferiority and superiority of 1 month vs 12 months of dual antiplatelet therapy (DAPT) on cardiovascular and bleeding events in patients receiving everolimus-eluting stents.1

However, this study has some weaknesses. The noninferiority margin of 50% was questionably large, given that the primary outcome included severely debilitating complications such as death, myocardial infarction, stent thrombosis, major bleeding, and stroke. In other words, the investigators were willing to accept 50% more complications in the intervention group and still consider it noninferior. Furthermore, the anticipated event rate fell short of the true event rate (4.6% vs 3.7%), which decreases statistical power because the sample size calculation was based on a 4.6% event rate. Also, even though the study was designed to test 1 month vs 12 months of DAPT, 49.9% of patients in the intervention group received DAPT for between 38 and 60 days; therefore, a more reasonable conclusion should have been that 1 to 2 months of DAPT was noninferior to 12 months.