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

• Published in: Cardiovascular intervention and therapeutics Vol. 36; no. 1; pp. 91 - 103
• Main Authors: Watanabe, Hirotoshi, Domei, Takenori, Morimoto, Takeshi, Natsuaki, Masahiro, Shiomi, Hiroki, Toyota, Toshiaki, Ohya, Masanobu, Suwa, Satoru, Takagi, Kensuke, Nanasato, Mamoru, Hata, Yoshiki, Yagi, Masahiro, Suematsu, Nobuhiro, Yokomatsu, Takafumi, Takamisawa, Itaru, Doi, Masayuki, Noda, Toshiyuki, Okayama, Hideki, Seino, Yoshitane, Tada, Tomohisa, Sakamoto, Hiroki, Hibi, Kiyoshi, Abe, Mitsuru, Kawai, Kazuya, Nakao, Koichi, Ando, Kenji, Tanabe, Kengo, Ikari, Yuji, Hanaoka, Keiichi Igarashi, Morino, Yoshihiro, Kozuma, Ken, Kadota, Kazushige, Furukawa, Yutaka, Nakagawa, Yoshihisa, Kimura, Takeshi
• Format: Journal Article
• Language: English
• Published: Singapore Springer Singapore 2021
• Subjects: Aged; Cardiology; Coronary Artery Disease - therapy; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage - prevention & control; Humans; Interventional Radiology; Male; Medicine; Medicine & Public Health; Middle Aged; Original Article; Percutaneous Coronary Intervention - methods; Platelet Aggregation Inhibitors - therapeutic use; Antiplatelet therapy; Percutaneous coronary intervention; Coronary stent; Bleeding; High bleeding risk
• ISSN: 1868-4300; 1868-4297
• DOI: 10.1007/s12928-020-00651-9

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.