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
Author:
Obayashi Yuki1ORCID, Natsuaki Masahiro2, Watanabe Hirotoshi3, Morimoto Takeshi4ORCID, Yamamoto Ko5, Nishikawa Ryusuke1, Ando Kenji5, Suwa Satoru6, Isawa Tsuyoshi7ORCID, Takenaka Hiroyuki3, Ishikawa Tetsuya8, Tokuyama Hideo9, Sakamoto Hiroki10, Fujita Takanari11, Nanasato Mamoru12ORCID, Okayama Hideki13, Nishikura Tenjin14, Kirigaya Hidekuni15, Nishida Koji16, Ono Koh1ORCID, Kimura Takeshi3ORCID, , 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
Affiliation:
1. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University , Kyoto 606-8507 , Japan 2. Department of Cardiovascular Medicine, Saga University , Saga 849-8501 , Japan 3. Division of Cardiology, Hirakata Kohsai Hospital , Hirakata 573-0153 , Japan 4. Department of Clinical Epidemiology, Hyogo Medical University , Nishinomiya 663-8501 , Japan 5. Department of Cardiology, Kokura Memorial Hospital , Kitakyusyu 802-8555 , Japan 6. Department of Cardiology, Juntendo University Shizuoka Hospital , Izunokuni 410-2295 , Japan 7. Department of Cardiology, Sendai Kousei Hospital , Sendai 980-0873 , Japan 8. Department of Cardiology, Dokkyo Medical University Saitama Medical Center , Koshigaya 343-8555 , Japan 9. Department of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital , Kawaguchi 333-0842 , Japan 10. Department of Cardiology, Shizuoka General Hospital , Shizuoka 420-8527 , Japan 11. Division of Cardiology, Japanese Red Cross Wakayama Medical Center , Wakayama 640-8558 , Japan 12. Department of Cardiology, Sakakibara Heart Institute , Fuchu 183-0003 , Japan 13. Department of Cardiology, Ehime Prefectural Central Hospital , Matsuyama 790-0024 , Japan 14. Department of Cardiology, Showa University Koto Toyosu Hospital , Tokyo 135-8577 , Japan 15. Division of Cardiology, Yokohama City University Medical Center , Yokohama 232-0024 , Japan 16. Division of Cardiology, Chikamori Hospital , Kochi 780-8522 , Japan
Abstract
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.
Publisher
Oxford University Press (OUP)
Cited by
2 articles.
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