Aspirin-free strategy for percutaneous coronary intervention in acute coronary syndrome based on the subtypes of acute coronary syndrome and high bleeding risk: the STOPDAPT-3 trial
Authors: Obayashi Yuki , Natsuaki Masahiro , Watanabe Hirotoshi , Morimoto Takeshi , Yamamoto Ko , Nishikawa Ryusuke , Ando Kenji , Suwa Satoru , Isawa Tsuyoshi , Takenaka Hiroyuki , Ishikawa Tetsuya , Tokuyama Hideo , Sakamoto Hiroki , Fujita Takanari , Nanasato Mamoru , Okayama Hideki , Nishikura Tenjin , Kirigaya Hidekuni , Nishida Koji , Ono Koh , Kimura Takeshi ,   for the STOPDAPT-3 investigators, Ando Kenji , Suwa Satoru , Isawa Tsuyoshi , Takenaka Hiroyuki , Ishikawa Tetsuya , Wakabayashi Kohei , Onishi Yuko , Hibi Kiyoshi , Kawai Kazuya , Ono Koh , Yoshida Ruka , Suzuki Hiroshi , Nakazawa Gaku , Kusuyama Takanori , Morishima Itsuro , Tokuyama Hideo , Sakamoto Hiroki , Fujita Takanari , Nanasato Mamoru , Okayama Hideki , Tamura Toshihiro , Kawahatsu Kando , Hayashi Fujio , Akao Masaharu , Serikawa Takeshi , Kadota Kazushige , Hata Yoshiki , Akashi Yoshihiro J , Matsuoka Shunzo , Tanaka Hiroyuki , Yamada Minoru , Wakatsuki Tetsuzo , Nozaki Yoichi , Kobayashi Yoshio , Kato Ryuichi , Ikari Yuji , Kurita Tairo , Kaitani Kazuaki , Sugimoto Atsuhiko , Ogata Nobuhiko , Yokomatsu Takafumi , Uehara Hiroki , Doijiri Tatsuki , Kozuma Ken , Nishida Yasunori , Yamaguchi Junichi , Morino Yoshihiro , Tanigawa Takashi , Nakano Yukiko , Makiguchi Noriko , Noda Toshiyuki , Shiode Nobuo , Abe Koji , Abe Shichiro , Tabuchi Isao , Ishihara Shozo , Kinoshita Makoto , Higuchi Motoaki , Takaya Tomofumi , Miura Shin-Ichiro , Tsubakimoto Yoshinori , Tsujita Kenichi , Kumagai Koji , Tanabe Kengo , Inoko Moriaki , Nakagami Takuo , Tomita Hirofumi , Nakano Masatsugu , Yumoto Kazuhiko , Wakeyama Takatoshi , Kaneko Takeo , Doi Masayuki 
Published: January 2024

Abstract

Background and aims
High bleeding risk (HBR) and acute coronary syndrome (ACS) subtypes are critical in determining bleeding and cardiovascular event risk after percutaneous coronary intervention (PCI).

Methods and results
In 4476 ACS patients enrolled in the STOPDAPT-3, where the no-aspirin and dual antiplatelet therapy (DAPT) strategies after PCI were randomly compared, the pre-specified subgroup analyses were conducted based on HBR/non-HBR and ST-segment elevation myocardial infarction (STEMI)/non-ST-segment elevation ACS (NSTE-ACS). The co-primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5, and the co-primary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke at 1 month. Irrespective of the subgroups, the effect of no-aspirin compared with DAPT was not significant for the bleeding endpoint (HBR [N = 1803]: 7.27 and 7.91%, hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.65–1.28; non-HBR [N = 2673]: 3.40 and 3.65%, HR 0.93, 95% CI 0.62–1.39; Pinteraction = 0.94; STEMI [N = 2553]: 6.58 and 6.56%, HR 1.00, 95% CI 0.74–1.35; NSTE-ACS [N = 1923]: 2.94 and 3.64%, HR 0.80, 95% CI 0.49–1.32; Pinteraction = 0.45), and for the cardiovascular endpoint (HBR: 7.87 and 5.75%, HR 1.39, 95% CI 0.97–1.99; non-HBR: 2.56 and 2.67%, HR 0.96, 95% CI 0.60–1.53; Pinteraction = 0.22; STEMI: 6.07 and 5.46%, HR 1.11, 95% CI 0.81–1.54; NSTE-ACS: 3.03 and 1.71%, HR 1.78, 95% CI 0.97–3.27; Pinteraction = 0.18).

Conclusion
In patients with ACS undergoing PCI, the no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of HBR and ACS subtypes. The numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events was observed in patients with HBR and in patients with NSTE-ACS.