Keitaro Akita1, Taku Inohara2,3, Kyohei Yamaji4, Shun Kohsaka2, Yohei Numasawa5, Hideki Ishii6, Tetsuya Amano7, Kazushige Kadota8, Masato Nakamura9, Yuichiro Maekawa1. 1. Division of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu 431-3192, Japan. 2. Department of Cardiology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan. 3. Division of Cardiology, Vancouver General Hospital, Vancouver, British Columbia V6N 3S9, Canada. 4. Division of Cardiology, Kokura Memorial Hospital, Kitakyushu 802-8555, Japan. 5. Department of Cardiology, Japanese Red Cross Ashikaga Hospital, Ashikaga 326-0843, Japan. 6. Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya 466-8560, Japan. 7. Department of Cardiology, Aichi Medical University, Nagakute 480-1195, Japan. 8. Department of Cardiology, Kurashiki Central Hospital, Kurashiki 710-8602, Japan. 9. Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center, Tokyo 153-8515, Japan.
Abstract
AIMS: In Japan, reduced-dose prasugrel (loading/maintenance dose, 20/3.75 mg) has been approved for use in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), because of the higher bleeding risk among East Asians. However, its safety in the real-world population has not been investigated. We aimed to evaluate the effectiveness and safety of reduced-dose prasugrel vs. standard-dose clopidogrel in ACS patients undergoing PCI. METHODS AND RESULTS: Acute coronary syndrome patients who underwent PCI in 2016, who were treated with either reduced-dose prasugrel or standard-dose clopidogrel in addition to aspirin, were identified from the nationwide Japanese PCI registry. The primary outcome was in-hospital mortality following PCI. Secondary outcomes included stent thrombosis and bleeding complication after PCI. Among 62 737 ACS patients who underwent PCI at any of 986 participating centres across Japan (clopidogrel 31.9%; prasugrel 68.1%), we identified 12 016 propensity score-matched pairs (24 032 patients; age 69.4 ± 12.2 years; female 24.9%; ST-elevation myocardial infarction 42.3%). Compared with standard-dose clopidogrel, reduced-dose prasugrel was associated with increased risk of bleeding [odds ratio (OR) 1.65, 95% confidence interval (CI) 1.10-2.51; P = 0.016], but both had similar rates of mortality (OR 1.11, 95% CI 0.89-1.38; P = 0.371) and stent thrombosis (OR 1.29, 95% CI 0.73-2.30; P = 0.387) as well as similar falsification endpoints of cardiac tamponade and emergent operation. CONCLUSION: In Japanese ACS patients undergoing PCI, the risk of bleeding is higher when using reduced-dose prasugrel than when using standard-dose clopidogrel, but there is no significant difference in in-hospital mortality and incidence of stent thrombosis between the two antiplatelet regimens. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: In Japan, reduced-dose prasugrel (loading/maintenance dose, 20/3.75 mg) has been approved for use in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), because of the higher bleeding risk among East Asians. However, its safety in the real-world population has not been investigated. We aimed to evaluate the effectiveness and safety of reduced-dose prasugrel vs. standard-dose clopidogrel in ACS patients undergoing PCI. METHODS AND RESULTS: Acute coronary syndrome patients who underwent PCI in 2016, who were treated with either reduced-dose prasugrel or standard-dose clopidogrel in addition to aspirin, were identified from the nationwide Japanese PCI registry. The primary outcome was in-hospital mortality following PCI. Secondary outcomes included stent thrombosis and bleeding complication after PCI. Among 62 737 ACS patients who underwent PCI at any of 986 participating centres across Japan (clopidogrel 31.9%; prasugrel 68.1%), we identified 12 016 propensity score-matched pairs (24 032 patients; age 69.4 ± 12.2 years; female 24.9%; ST-elevation myocardial infarction 42.3%). Compared with standard-dose clopidogrel, reduced-dose prasugrel was associated with increased risk of bleeding [odds ratio (OR) 1.65, 95% confidence interval (CI) 1.10-2.51; P = 0.016], but both had similar rates of mortality (OR 1.11, 95% CI 0.89-1.38; P = 0.371) and stent thrombosis (OR 1.29, 95% CI 0.73-2.30; P = 0.387) as well as similar falsification endpoints of cardiac tamponade and emergent operation. CONCLUSION: In Japanese ACS patients undergoing PCI, the risk of bleeding is higher when using reduced-dose prasugrel than when using standard-dose clopidogrel, but there is no significant difference in in-hospital mortality and incidence of stent thrombosis between the two antiplatelet regimens. Published on behalf of the European Society of Cardiology. All rights reserved.