Author + information
- Received October 12, 2011
- Revision received March 12, 2012
- Accepted March 13, 2012
- Published online July 31, 2012.
- Peter K. Smith, MD⁎,⁎ (, )
- Lawrence T. Goodnough, MD†,
- Jerrold H. Levy, MD‡,
- Robert S. Poston, MD§,
- Mary A. Short, MSN∥,
- Govinda J. Weerakkody, PhD∥ and
- LeRoy A. LeNarz, MD∥
- ↵⁎Reprint requests and correspondence:
Dr. Peter K. Smith, Box 3442, Duke University Medical Center, Erwin Road, Durham, North Carolina 27710
Objectives The objective of this study was to characterize the bleeding, transfusion, and other outcomes of patients related to the timing of prasugrel or clopidogrel withdrawal before coronary artery bypass grafting (CABG).
Background There is little evidence to guide clinical decision making regarding the use of prasugrel in patients who may need urgent or emergency CABG. Experience with performing CABG in the presence of clopidogrel has raised concern about perioperative bleeding complications that are unresolved.
Methods A subset of the TRITON–TIMI 38 study (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel–Thrombolysis In Myocardial Infarction 38), in which patients with acute coronary syndrome were randomized to treatment with aspirin and either clopidogrel or prasugrel, underwent isolated CABG (N = 346). A supplemental case report form was designed and administered, and the data combined with the existing TRITON–TIMI 38 database. Baseline imbalances were corrected for using elements of the European System for Cardiac Operative Risk Evaluation and The Society of Thoracic Surgeons predictive algorithm.
Results A significantly higher mean 12-h chest tube blood loss (655 ± 580 ml vs. 503 ± 378 ml; p = 0.050) was observed with prasugrel compared with clopidogrel, without significant differences in red blood cell transfusion (2.1 U vs. 1.7 U; p = 0.442) or the total donor exposure (4.4 U vs. 3.0 U; p = 0.463). All-cause mortality was significantly reduced with prasugrel (2.31%) compared with 8.67% with clopidogrel (adjusted odds ratio: 0.26; p = 0.025).
Conclusions Despite an increase in observed bleeding, platelet transfusion, and surgical re-exploration for bleeding, prasugrel was associated with a lower rate of death after CABG compared with clopidogrel. (A Comparison of Prasugrel [CS-747] and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention; NCT00097591)
This work was sponsored by Daiichi Sankyo, Inc. and Eli Lilly and Company and is related to study protocol H7T-MC-TAAL. Dr. Smith was supported by National Heart, Lung, and Blood Institute grant U01-HL088953. Ms. Short, Dr. Weerakkody, and Dr. LeNarz are employees of and report equity ownership or stock options in Eli Lilly and Company. Drs. Smith, Goodnough, Levy, and Poston have received honoraria as consultants for Eli Lilly and Company. Dr. Smith has also served as a consultant to Bayer Corporation, Baxter Corporation, and Cubist Pharmaceuticals. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 12, 2011.
- Revision received March 12, 2012.
- Accepted March 13, 2012.
- American College of Cardiology Foundation