alexa Re-evaluation of Bleeding Events in the Japanese PRASFI
ISSN: 2329-6607

Cardiovascular Pharmacology: Open Access
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Research Article

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

Shunichi Miyazaki1*, Takaaki Isshiki2, Takeshi Kimura3, Hisao Ogawa4, Hiroyoshi Yokoi5, Masakatsu Nishikawa6, Masato Nakamura7, Yuko Tanaka8, and Shigeru Saito9, on behalf of the PRASFIT-ACS Investigators and PRASFIT-Elective Investigators

1Department of Medicine, Faculty of Medicine, Kinki University, Osaka, Japan

2Ageo Central General Hospital, Ageo, Japan

3Graduate School of Medicine, Kyoto University, Kyoto, Japan

4Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto and National Cerebral and Cardiovascular Center, Suita, Osaka, Japan

5Fukuoka Sanno Hospital, Fukuoka, and International University of Health and Welfare, Tochigi, Japan

6Clinical Research Support Center, Mie University Hospital, Mie, Japan

7Division of Cardiovascular Medicine, Ohashi Medical Center, Toho University, Tokyo, Japan

8Clinical Data and Biostatistics Department, R&D Division, Daiichi Sankyo Co., Ltd, Tokyo, Japan

9Division of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan

*Corresponding Author:
Dr. Shunichi Miyazaki
Division of Cardiology, Department of Medicine
Faculty of Medicine, Kinki University, 377-2 Ohnohigashi
Osakasayama, Osaka 589-8511, Japan
Tel: +81-72-366-0221
Fax: +81-72-366- 0206
E-mail: [email protected]

Received date: October 26, 2015; Accepted date: November 02, 2015; Published date: November 09, 2015

Citation: Miyazaki S, Isshiki T, Kimura T, Ogawa H, Yokoi H, et al. (2015) Reevaluation of Bleeding Events in the Japanese PRASFIT-Elective and PRASFITACS Clinical Trials using the Bleeding Academic Research Consortium Criteria. Cardiovasc Pharm Open Access 4:162. doi:10.4172/2329-6607.1000162

Copyright: © 2015 Miyazaki S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

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.

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