Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial

Abstract

Previously we briefly reported the effect of 1-month dual antiplatelet therapy (DAPT) for patients with high bleeding risk (HBR) receiving percutaneous coronary intervention (PCI) in the STOPDAPT-2 trial, but full analysis data has not been available. We conducted post-hoc subgroup analysis regarding the effect of very short DAPT for HBR patients in STOPDAPT-2 trial. The primary endpoint was a 1-year composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and bleeding (TIMI major/minor bleeding) outcomes. Major secondary endpoints were 1-year cardiovascular composite endpoint and bleeding endpoint. HBR was defined by the academic research consortium (ARC) HBR criteria. Among the 3009 study patients, 1054 (35.0%) were classified as HBR and 1955 (65.0%) were as non-HBR. There were no significant interactions between HBR/non-HBR subgroups and the assigned DAPT group on the primary endpoint (HBR; 3.48% vs. 5.98%, HR 0.57, 95%CI 0.32-1.03, and non-HBR; 1.81% vs.2.36%, HR 0.78, 95%CI 0.42-1.45; P for interaction=0.48), the major secondary cardiovascular endpoint (HBR; 3.07% vs. 4.03%, HR 0.77, 95%CI 0.40-1.48, and non-HBR; 1.41% vs. 1.61%, HR 0.89, 95%CI 0.43-1.84; P for interaction=0.77), and the major secondary bleeding endpoint (HBR; 0.41% vs. 2.71%, HR 0.15, 95%CI 0.03-0.65, and 6 non-HBR; 0.40% vs. 0.85%, HR 0.48, 95%CI 0.14-1.58; P for interaction=0.22). In conclusion, the effects of 1-month DAPT for the primary and major secondary endpoints were consistent in HBR and non-HBR patients without any significant interactions. The benefit of 1-month DAPT in reducing major bleeding was numerically greater in HBR patients.

Impact of 6‐ versus 12‐month dual antiplatelet therapy on clinical prognosis in patients with high bleeding risk: Insights from the 4‐year results of the I LOVE IT 2 study

“…Moreover, compared with the STOPDAPT 2 20 study from East Asia and a Swiss study, 18 the 1-year incidence of BARC type 3 or 5 bleeding in HBR patients in this study was relatively low (1.4% in our study compared to 3.26% in the STOPDAPT 2 study and 6.4% in the Swiss study).…”

Prevalence of the Academic Research Consortium for High Bleeding Risk Criteria and Prognostic Value of a Simplified Definition

“…For such HBR patients, the optimal intensity and duration of DAPT represent a remarkable challenge. [21][22][23][24] Nevertheless, the rate of DAPT discontinuation was relatively lower compared with that recommended in the current guideline and not different between the HBR and non-HBR groups during the long follow-up period. This tendency was in line with that in a large multicenter trial in Japan and it may be explained the fear of ST in the first-generation DES era, which lasted number of ARC-HBR major or minor criteria increased (≥2 majors: 24.3%, 1 major: 17.0%, ≥2 minors: 11.7%, non-HBR: 5.7%, P<0.0001).…”

JCS 2020 Guideline Focused Update on Antithrombotic Therapy in Patients With Coronary Artery Disease

“…A subanalysis of the STOPDAPT-2 trial 46 also reported the results of a comparison between HBR and non-HBR patients stratified by the ARC-HBR criteria, suggesting that the benefit of 1 month of DAPT over 12 months of DAPT was greater in HBR patients. 8 These results indicated, both at the registry level and clinical trial level, that the ARC-HBR criteria can be adequately applied in Japan.…”

“…There are also reports that support the application of the HBR concept in Japanese patients. 7,8 For these reasons, we have adopted the HBR concept 5,6 as a basic strategy. In addition, a Japanese version of the HBR criteria that takes into account risk factors such as low body weight, frailty, heart failure, and dialysis was proposed by consensus among the guideline development team.…”