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

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 Hanaoka, Yoshihiro Morino, Ken Kozuma, Kazushige Kadota, Yutaka Furukawa, Yoshihisa Nakagawa, Takeshi Kimura, STOPDAPT-2 investigators, 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 Hanaoka, Yoshihiro Morino, Ken Kozuma, Kazushige Kadota, Yutaka Furukawa, Yoshihisa Nakagawa, Takeshi Kimura, STOPDAPT-2 investigators

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 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.

Keywords: Antiplatelet therapy; Bleeding; Coronary stent; High bleeding risk; Percutaneous coronary intervention.

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