Patient Selection and Clinical Outcomes in the STOPDAPT-2 Trial An All-Comer Single-Center Registry During the Enrollment Period of the STOPDAPT-2 Randomized Controlled Trial

Background: We sought to evaluate the impact of patient selection for the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) on clinical outcomes in a registry from a single center that participated in the STOPDAPT-2 trial. Methods: Among 2190 consecutive patients who underwent percutaneous coronary intervention using stent in Kokura Memorial Hospital during the enrollment period of the STOPDAPT-2 trial, 521 patients had exclusion criteria such as in-hospital major complications, anticoagulant use, or prior intracranial bleeding (ineligible group). Among 1669 patients who met the eligibility criteria (eligible group), 582 were enrolled (enrolled group) and 1087 were not enrolled (nonenrolled group) in the STOPDAPT-2 trial. The primary outcome measure was defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction major and minor bleeding. Results: Compared with the enrolled group, patients in the nonenrolled group more often had high bleeding risk according to the Academic Research Consortium for High Bleeding Risk definition (52.6% versus 41.2%; P<0.001) and were frailer according to the Canadian Study of Health and Aging Clinical Frailty Scale (intermediate, 21.4% versus 14.1%; high, 6.4% versus 2.1%; P<0.001). The cumulative 1-year incidences of the primary outcome measure, all-cause death, and major bleeding were significantly higher in the nonenrolled group than in the enrolled group (7.2% versus 4.5%, P=0.03; 4.1% versus 0.9%, P<0.001; and 4.3% versus 2.1%, P=0.03, respectively) and in the ineligible group than in the eligible group (21.2% versus 6.3%, P<0.001; 9.9% versus 3.0%, P<0.001; and 13.5% versus 3.5%, P<0.001, respectively). Conclusions: Patients who were ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial had different risk profiles and clinical outcomes, suggesting important implications in applying the trial results in daily clinical practice.

Automated summary

The patients in the nonenrolled and ineligible groups in the STOPDAPT-2 trial were more likely to have high bleeding risk and frailty, with significantly higher incidences of primary outcomes compared to the enrolled and eligible groups. This suggests different risk profiles and clinical outcomes among patients selected for the trial, highlighting the implications for applying trial results in daily clinical practice.