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Randomized Controlled Trial
. 2021 Jan;36(1):91-103.
doi: 10.1007/s12928-020-00651-9. Epub 2020 Feb 21.

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  1 , Takenori Domei  2 , Takeshi Morimoto  3 , Masahiro Natsuaki  4 , Hiroki Shiomi  1 , Toshiaki Toyota  5 , Masanobu Ohya  6 , Satoru Suwa  7 , Kensuke Takagi  8 , Mamoru Nanasato  9 , Yoshiki Hata  10 , Masahiro Yagi  11 , Nobuhiro Suematsu  12 , Takafumi Yokomatsu  13 , Itaru Takamisawa  9 , Masayuki Doi  14 , Toshiyuki Noda  15 , Hideki Okayama  16 , Yoshitane Seino  17 , Tomohisa Tada  18 , Hiroki Sakamoto  18 , Kiyoshi Hibi  19 , Mitsuru Abe  20 , Kazuya Kawai  21 , Koichi Nakao  22 , Kenji Ando  2 , Kengo Tanabe  23 , Yuji Ikari  24 , Keiichi Igarashi Hanaoka  25 , Yoshihiro Morino  26 , Ken Kozuma  27 , Kazushige Kadota  6 , Yutaka Furukawa  5 , Yoshihisa Nakagawa  28 , Takeshi Kimura  29 ; STOPDAPT-2 investigators
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Free article
Randomized Controlled Trial

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 et al. Cardiovasc Interv Ther. 2021 Jan.
Free article

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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