Patient Selection and Clinical Outcomes in the STOPDAPT-2 Trial

Abstract

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.

Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

“…However, thrombotic risk of patients with ACS is known to attenuate over time . Moreover, the prevalence of patients with high bleeding risk is much higher in real clinical practice than in clinical trials . Therefore, de-escalation of antithrombotic therapy in parallel with time-dependent attenuation of thrombotic risk might be a reasonable approach in patients with ACS.…”

Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight From the STOPDAPT-2 Trial

“…14 Furthermore, a considerable number of patients eligible for the study were not enrolled because of physician’s choice or patient refusal despite the all-comer study design, who were reported to have higher risk for both cardiovascular and bleeding event than those actually enrolled. 16 Therefore, the favorable results of 1-month DAPT in patients with complex PCI should be regarded as hypothesis-generating, and the safety and efficacy of clopidogrel monotherapy after very short DAPT in patients with complex PCI should be confirmed in larger studies. Second, we set 90 days as the time period for screening the staged PCI.…”

Understanding Antithrombotic Agents for Rehabilitation Therapy: A Comprehensive Narrative Review

“…DAPT continuation at 12 months in the 2015-2017 PENDULUM (Platelet Reactivity in Patients with Drug Eluting Stent and Balancing Risk of Bleeding and Ischemic Event) study of PCI cases (6,267 patients) was 70-80% [ 13 ]. In addition, the 12-month DAPT continuation rate for patients who met the enrollment criteria in the STOPDAPT-2 trial but were not enrolled (2016-2017) was 73% [ 14 ]. Thus, in DAPT, physician prescribing bias in clinical practice tends to be longer-term than guideline recommendations.…”