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

• DOI: 10.1007/s12928-020-00651-9
• Publication Date: 2020-02-21T08:02:32Z
• Authors: Hirotoshi Watanabe; Takenori Domei; Takeshi Morimoto; Masahiro Natsuaki; Hiroki Shiomi; Toshiaki Toyota; Masanobu Ohya; Satoru Suwa; Kensuke Takagi; Mamoru Nanasato; Yoshiki Hata; Masahiro Yagi; Nobuhiro Suematsu; Takafumi Yokomatsu; Itaru Takamisawa; Masayuki Doi; Toshiyuki Noda; Hideki Okayama; Yoshitane Seino; Tomohisa Tada; Hiroki Sakamoto; Kiyoshi Hibi; Mitsuru Abe; Kazuya Kawai; Koichi Nakao; Kenji Ando; Kengo Tanabe; Yuji Ikari; Keiichi Igarashi ...; Yoshihiro Morino; Ken Kozuma; Kazushige Kadota; Yutaka Furukawa; Yoshihisa Nakagawa; Takeshi Kimura
• Keywords: Male; Antiplatelet therapy; Bleeding; 610; Drug-Eluting Stents; Hemorrhage; Coronary Artery Disease; Middle Aged; Percutaneous coronary intervention; 3. Good health; 03 medical and health sciences; Percutaneous Coronary Intervention; 0302 clinical medicine; Humans; Drug Therapy, Combination; Female; Coronary stent; High bleeding risk; Platelet Aggregation Inhibitors; Aged

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 have 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 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.Clinical trial registration Short and optimal duration of dual antiplatelet therapy after everolimus-eluting cobalt-chromium stent-2 [STOPDAPT-2]; NCT02619760.