P3694Multicenter research of bleeding risk between low dose prasugrel and standard dose clopidogrel in patients with coronary artery disease undergoing percutaneous coronary intervention

Abstract

Background: Lower loading and maintenance doses of prasugrel have been established for Japanese patients (loading dose [LD]/maintenance dose [MD], 20/3.75mg) compared to those for Western patients (LD/MD, 60/10mg), considering the higher average age, lower body weight, and increased bleeding risk with other thrombotic agents in Japanese patients. Although it has been reported that even low‐dose prasugrel achieves stronger antiplatelet effect and fewer cardiovascular events compared to standard‐dose clopidogrel in Japanese patients, there are limited data comparing the safety between low‐dose prasugrel and standard‐dose clopidogrel. Purpose: The aim of this study was to evaluate the risk of adverse events induced by prasugrel compared to clopidogrel in patients who underwent percutaneous coronary intervention (PCI) in common clinical settings. Methods: Data from 1,031 consecutive patients with coronary artery disease undergoing PCI in our hospitals from May 2014 to April 2016, who received aspirin plus either clopidogrel (619 patients) or prasugrel (412 patients), were analyzed, retrospectively. The choice of clopidogrel or prasugrel was left to the operator's discretion. Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke. Adverse events were defined as a composite of bleeding, hepatopathy, leukopenia, thorombopenia, exanthema, and MACE. Results: The average follow‐up period was 143 days in the prasugrel group and 263 days in the clopidogrel group. MACE and adverse events were occurred in 3.6% and 28.7% of patients with clopidogrel and in 6.3% and 35.4% of patients with prasugrel, with no statistical significances by log‐rank test. Whereas the incidences of overall bleeding and serious bleeding (BARC type 3 and 5) tended to be more frequent in the clopidogrel group than in the prasugrel group (32.5% vs. 27.3%, p=0.072, and 8.0% vs. 5.0%, p=0.051, respectively), Kaplan‐Meier analysis demonstrated significantly more overall bleeding (log rank test: p<0.001) and serious bleeding events (log rank test: p=0.01) in the prasugrel group compared to the clopidogrel group. Conclusion: Bleeding risks, including serious events, were significantly higher in patients under dual antiplatelet therapy even with low‐dose prasugrel compared to that with standard‐dose clopidogrel after PCI in common clinical settings.