Key result
Reduced-dose prasugrel is linked to higher bleeding risk but similar in-hospital mortality vs standard-dose clopidogrel.
Why the study?
Reduced-dose prasugrel was approved in Japan for ACS patients undergoing PCI, but its real-world safety had not been investigated.
Does reduced-dose prasugrel improve in-hospital outcomes compared to standard-dose clopidogrel in Japanese ACS patients undergoing PCI?
Observational (n=62,737)
Yes
Does reduced-dose prasugrel improve in-hospital outcomes compared to standard-dose clopidogrel in Japanese ACS patients undergoing PCI?
Odds Ratio: 1.11 (95% CI 0.89–1.38)
p-value: p=0.371
In Japanese ACS patients undergoing PCI, reduced-dose prasugrel was associated with a higher risk of bleeding but similar in-hospital mortality and stent thrombosis compared to standard-dose clopidogrel.
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.
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Akita et al. (2019) conducted an observational in Acute coronary syndromes (ACS) undergoing PCI (n=62,737). Reduced-dose prasugrel vs. Standard-dose clopidogrel was evaluated on In-hospital mortality following PCI (OR 1.11, 95% CI 0.89-1.38, p=0.371). Reduced-dose prasugrel was associated with increased bleeding risk compared to standard-dose clopidogrel, but similar in-hospital mortality (OR 1.11; 95% CI 0.89-1.38; P=0.371).
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