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

Yuki Obayashi; Masahiro Natsuaki; Hirotoshi Watanabe; Takeshi Morimoto; Ko Yamamoto; Ryusuke Nishikawa; Kenji Ando; Satoru Suwa; Tsuyoshi Isawa; Hiroyuki Takenaka; Tetsuya Ishikawa; Hideo Tokuyama; Hiroki Sakamoto; Takanari Fujita; Mamoru Nanasato; Hideki Okayama; Tenjin Nishikura; Hidekuni Kirigaya; Koji Nishida; Koh Ono; Takeshi Kimura

doi:10.1093/ehjcvp/pvae009

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

Eur Heart J Cardiovasc Pharmacother. 2024 Jan 29:pvae009. doi: 10.1093/ehjcvp/pvae009. Online ahead of print.

Authors

Yuki Obayashi¹, Masahiro Natsuaki², Hirotoshi Watanabe³, Takeshi Morimoto⁴, Ko Yamamoto⁵, Ryusuke Nishikawa¹, Kenji Ando⁵, Satoru Suwa⁶, Tsuyoshi Isawa⁷, Hiroyuki Takenaka³, Tetsuya Ishikawa⁸, Hideo Tokuyama⁹, Hiroki Sakamoto¹⁰, Takanari Fujita¹¹, Mamoru Nanasato¹², Hideki Okayama¹³, Tenjin Nishikura¹⁴, Hidekuni Kirigaya¹⁵, Koji Nishida¹⁶, Koh Ono¹, Takeshi Kimura³

Affiliations

¹ Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
² Department of Cardiovascular Medicine, Saga University, Saga, Japan.
³ Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.
⁴ Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
⁵ Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.
⁶ Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan.
⁷ Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.
⁸ Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.
⁹ Department of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital, Kawaguchi, Japan.
¹⁰ Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan.
¹¹ Division of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.
¹² Department of Cardiology, Sakakibara Heart Institute, Fuchu, Japan.
¹³ Department of Cardiology, Ehime Prefectural Central Hospital, Matsuyama, Japan.
¹⁴ Department of Cardiology, Showa University Koto Toyosu Hospital, Tokyo, Japan.
¹⁵ Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.
¹⁶ Division of Cardiology, Chikamori Hospital, Kochi, Japan.

PMID: 38285607
DOI: 10.1093/ehjcvp/pvae009

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: 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 BARC type 3 or 5, and the co-primary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke at 1 month.

Results: 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%, HR 0.91, 95%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).

Conclusions: In patients with ACS undergoing PCI, the no-aspirin strategy compared to 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.

Keywords: Acute coronary syndrome; Antiplatelet therapy; High bleeding risk; Non-ST-segment elevation acute coronary syndrome; ST-segment elevation myocardial infarction.