An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial
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- Masahiro Natsuaki
- Department of Cardiovascular Medicine, Saga University, Japan (M.N.).
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- Hirotoshi Watanabe
- Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan (H.W., H.T., T.Y., T.K.).
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- Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T.M.).
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- Ko Yamamoto
- Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan (K.Y., K.A., T.D.).
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- Yuki Obayashi
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (Y. Obayashi, R.N., K.O.).
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- Ryusuke Nishikawa
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (Y. Obayashi, R.N., K.O.).
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- Kenji Ando
- Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan (K.Y., K.A., T.D.).
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- Takenori Domei
- Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan (K.Y., K.A., T.D.).
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- Satoru Suwa
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan (S.S., M.O.).
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- Manabu Ogita
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan (S.S., M.O.).
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- Tsuyoshi Isawa
- Department of Cardiology, Sendai Kousei Hospital, Japan (T. Isawa).
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- Hiroyuki Takenaka
- Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan (H.W., H.T., T.Y., T.K.).
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- Takashi Yamamoto
- Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan (H.W., H.T., T.Y., T.K.).
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- Tetsuya Ishikawa
- Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan (T. Ishikawa, I.H.).
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- Itaru Hisauchi
- Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan (T. Ishikawa, I.H.).
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- Kohei Wakabayashi
- Department of Cardiology, Showa University Koto Toyosu Hospital, Tokyo, Japan (K.W.).
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- Yuko Onishi
- Department of Cardiology, Hiratsuka Kyosai Hospital, Japan (Y. Onishi).
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- Kiyoshi Hibi
- Division of Cardiology, Yokohama City University Medical Center, Japan (K.H.).
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- Kazuya Kawai
- Division of Cardiology, Chikamori Hospital, Kochi, Japan (K.K.).
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- Ruka Yoshida
- Division of Cardiology, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan (R.Y.).
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- Hiroshi Suzuki
- Division of Cardiology, Showa University Fujigaoka Hospital, Yokohama, Japan (H.S.).
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- Gaku Nakazawa
- Department of Cardiology, Kindai University Faculty of Medicine, Osakasayama, Japan (G.N.).
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- Takanori Kusuyama
- Division of Cardiology, Tsukazaki Hospital, Himeji, Japan (T. Kusuvama).
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- Itsuro Morishima
- Department of Cardiology, Ogaki Municipal Hospital, Japan (I.M.).
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- Koh Ono
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (Y. Obayashi, R.N., K.O.).
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- Takeshi Kimura
- Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan (H.W., H.T., T.Y., T.K.).
説明
<jats:sec> <jats:title>BACKGROUND:</jats:title> <jats:p>Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS:</jats:title> <jats:p>We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81–100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS:</jats:title> <jats:p> The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75–1.20]; <jats:italic>P</jats:italic> <jats:sub>superiority</jats:sub> =0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87–1.45]; <jats:italic>P</jats:italic> <jats:sub>non</jats:sub> <jats:sub>inferiority</jats:sub> =0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01–3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26–9.23]) in the no-aspirin group compared with the DAPT group. </jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS:</jats:title> <jats:p>The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events.</jats:p> </jats:sec> <jats:sec> <jats:title>REGISTRATION:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> ; Unique identifier: NCT04609111. </jats:p> </jats:sec>
収録刊行物
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- Circulation
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Circulation 149 (8), 585-600, 2024-02-20
Ovid Technologies (Wolters Kluwer Health)