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Re-evaluation of Bleeding Events in the Japanese PRASFIT-Elective and PRASFIT-ACS Clinical Trials using the Bleeding Academic Research Consortium Criteria

Shunichi Miyazaki, Takaaki Isshiki, Takeshi Kimura, Hisao Ogawa, Hiroyoshi Yokoi, Masakatsu Nishikawa, Masato Nakamura, Yuko Tanaka, and Shigeru Saito, on behalf of the PRASFIT-ACS Investigators and PRASFIT-Elective Investigators

Background: In 2011, the Bleeding Academic Research Consortium (BARC) criteria were published to standardize the assessment of bleeding events following PCI. However, the status of bleeding events as assessed using the BARC criteria is not established in Japan. The aim of this post-hoc analysis of the PRASFIT-ACS and PRASFIT-Elective trials was to re-classify the bleeding events from the Thrombolysis in Myocardial Infarction (TIMI) criteria into the BARC criteria. Methods: Bleeding events had previously been assessed in both trials using the TIMI criteria. In the post-hoc analysis, the BARC criteria were applied retrospectively to each category of bleeding. Results: In PRASFIT-ACS, the incidences of severe bleeds (combined type 3 or 5 bleeds according to BARC criteria) were 43/685 [6.3%] with prasugrel and 37/678 [5.5%] with clopidogrel [HR 1.071; 95% CI 0.668–1.667]. Types 3 or 5 events occurred at a higher rate closer to the time of PCI, and then plateaued. In PRASFIT-Elective, Type 3 bleeding occurred in 10/370 (2.7%) patients in the prasugrel group and 12/372 (3.2%) in the clopidogrel group. There was a higher incidence of bleeding events in PRASFIT-ACS than in PRASFIT-Elective, particularly more severe bleeds (combination of type 3 or 5 events). Conclusions: The results obtained with the BARC criteria were similar to those reported using the original TIMI criteria. The incidences of type 3 or 5 events according to the BARC criteria were similar in the prasugrel and clopidogrel groups. Medical interventions might be needed during the acute period of PCI for ACS to reduce the risk of type 2 bleeding events in patients with low platelet aggregation.