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.

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

Journal

European heart journal. Cardiovascular pharmacotherapy
ISSN: 2055-6845
Titre abrégé: Eur Heart J Cardiovasc Pharmacother
Pays: England
ID NLM: 101669491

Informations de publication

Date de publication:
29 Jan 2024
Historique:
medline: 29 1 2024
pubmed: 29 1 2024
entrez: 29 1 2024
Statut: aheadofprint

Résumé

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

Sections du résumé

BACKGROUND AND AIMS OBJECTIVE
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 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 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 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.

Identifiants

pubmed: 38285607
pii: 7591315
doi: 10.1093/ehjcvp/pvae009
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.

Auteurs

Yuki Obayashi (Y)

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Masahiro Natsuaki (M)

Department of Cardiovascular Medicine, Saga University, Saga, Japan.

Hirotoshi Watanabe (H)

Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.

Takeshi Morimoto (T)

Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.

Ko Yamamoto (K)

Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.

Ryusuke Nishikawa (R)

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Kenji Ando (K)

Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.

Satoru Suwa (S)

Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan.

Tsuyoshi Isawa (T)

Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.

Hiroyuki Takenaka (H)

Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.

Tetsuya Ishikawa (T)

Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.

Hideo Tokuyama (H)

Department of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital, Kawaguchi, Japan.

Hiroki Sakamoto (H)

Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan.

Takanari Fujita (T)

Division of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.

Mamoru Nanasato (M)

Department of Cardiology, Sakakibara Heart Institute, Fuchu, Japan.

Hideki Okayama (H)

Department of Cardiology, Ehime Prefectural Central Hospital, Matsuyama, Japan.

Tenjin Nishikura (T)

Department of Cardiology, Showa University Koto Toyosu Hospital, Tokyo, Japan.

Hidekuni Kirigaya (H)

Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.

Koji Nishida (K)

Division of Cardiology, Chikamori Hospital, Kochi, Japan.

Koh Ono (K)

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Takeshi Kimura (T)

Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.

Classifications MeSH