An aspirin-free strategy for percutaneous coronary intervention in patients with diabetes: a pre-specified subgroup analysis of the STOPDAPT-3 trial
Year: 2024
Type: article
Abstract: AIMS: Safety of aspirin-free strategy immediately after percutaneous coronary intervention (PCI) for cardiovascular events in patients with diabetes was unknown. METHODS AND RESULTS: We conducted the prespecified subgroup analysis on diabetes in the STOPDAPT-3 trial, which randomly compared prasugrel (3.75 mg/day) monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The co-primary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month. Of 5966 study patients, there were 2715 patients (45.5%) with diabetes. Patients with diabetes more often had chronic coronary syndrome, heart failure or cardiogenic shock, and comorbidities than those without. Patients with diabetes compared to those without had higher incidences of major bleeding and cardiovascular events. Regardless of diabetes, the effect of no-aspirin relative to DAPT was not different for the co-primary bleeding (diabetes: 5.05% vs. 5.47%; HR, 0.92; 95%CI, 0.66-1.28 and non-diabetes: 3.99% vs. 4.07%; HR, 0.98; 95%CI, 0.69-1.38; P for interaction = 0.81) and cardiovascular (diabetes: 5.54% vs. 5.15%; HR, 1.08; 95%CI, 0.78-1.49 and non-diabetes: 2.95% vs. 2.47%; HR, 1.20; 95%CI, 0.79-1.82; P for interaction = 0.70) endpoints. The incidences of subacute definite or probable stent thrombosis and any coronary revascularization were higher in the no-aspirin group than in the DAPT group regardless of diabetes. CONCLUSIONS: The effects of an aspirin-free prasugrel monotherapy (3.75 mg/day) relative to DAPT for major bleeding and cardiovascular events were not different regardless of diabetes.
Authors: Ko Yamamoto, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Yuki Obayashi, Ryusuke Nishikawa, Kenji Ando, Satoru Suwa, Tsuyoshi Isawa, Hiroyuki Takenaka, Tetsuya Ishikawa, Yuji Ikari, Tairo Kurita, Kazuaki Kaitani, Atsuhiko Sugimoto, Nobuhiko Ogata, Akihiro Ikuta, Katsushi Hashimoto, Yuki Ishibashi, Kazunori Masuda, Tomonori Miyabe, Koh Ono, Takeshi Kimura
Institutions: Kokura Memorial Hospital, Saga University, Hirakata Kohsai Hospital, Hyogo Medical University, Kyoto University, Juntendo University Shizuoka Hospital, Sendai Kousei Hospital, Dokkyo Medical University Saitama Medical Center, Tokai University Hospital, Mie University Hospital, Otsu Red Cross Hospital, Sagamihara Kyodo Hospital, Ageo Central General Hospital, Kurashiki Central Hospital, St. Marianna University School of Medicine, St. Marianna University Hospital, Uji-Tokushukai Medical Center, Tokyo Metropolitan Tama Medical Center
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: Abbott Japan
OpenAlex ID: W4403745723