Impact of reduced-dose prasugrel vs. standard-dose clopidogrel on in-hospital outcomes of percutaneous coronary intervention in 62 737 patients with acute coronary syndromes: a nationwide registry study in 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.

• Authors: Keitaro Akita, Taku Inohara, Kyohei Yamaji, Shun Kohsaka, Yohei Numasawa, Hideki Ishii, Tetsuya Amano, Kazushige Kadota, Masato Nakamura, Yuichiro Maekawa
• Journal: European heart journal. Cardiovascular pharmacotherapy (Eur Heart J Cardiovasc Pharmacother) Vol. 6 Issue 4 Pg. 231-238 (07 01 2020) ISSN: 2055-6845 [Electronic] England
• PMID: 31593213 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: [email protected].

Chemical References

• Platelet Aggregation Inhibitors
• Clopidogrel
• Prasugrel Hydrochloride

Topics

• Acute Coronary Syndrome (diagnosis, mortality, therapy)
• Aged
• Aged, 80 and over
• Clopidogrel (administration & dosage, adverse effects)
• Coronary Thrombosis (mortality, prevention & control)
• Databases, Factual
• Female
• Hemorrhage (chemically induced)
• Hospital Mortality
• Hospitalization
• Humans
• Incidence
• Japan (epidemiology)
• Male
• Middle Aged
• Percutaneous Coronary Intervention (adverse effects, mortality)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Prasugrel Hydrochloride (administration & dosage, adverse effects)
• Propensity Score
• Prospective Studies
• Registries
• Risk Assessment
• Risk Factors
• ST Elevation Myocardial Infarction (diagnosis, mortality, therapy)
• Time Factors
• Treatment Outcome