Why the study?
The authors sought to evaluate the impact of patient selection for the STOPDAPT-2 trial on clinical outcomes in a real-world single-center registry.
Do clinical outcomes and risk profiles differ among patients who are ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial?
Do clinical outcomes and risk profiles differ among patients who are ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial?
Significant differences in risk profiles and outcomes between trial-enrolled patients and real-world non-enrolled or ineligible patients highlight the importance of considering selection bias when applying trial results to daily clinical practice.
Selection bias may limit generalizability of STOPDAPT-2 results; leaves open questions on optimal DAPT strategies in underrepresented patients.
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: <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.
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Kanenawa et al. (2021) studied this question.
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