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Author Notes:

Corresponding Author: Peter K Smith, MD Box 3442 Duke University Medical Center Durham, NC 27710 Phone: (919) 684-2890 Fax: (919) 681-7905; smith058@mc.duke.edu

P.K. Smith, L.T. Goodnough, J.H. Levy, and R.S. Poston participated in the surgery advisory board which led to requests for additional data collection.

M.A. Short, G.J. Weerakkody and L.A. LeNarz developed supplemental case report forms and a statistical analysis plan with the assistance of P.K. Smith and L.T. Goodnough.

G.J. Weerakkody conducted statistical analyses.

P.K. Smith, M.A. Short, and G.J. Weerakkody wrote the first draft of the manuscript.

All authors participated in the conception and design of the study, interpretation of data, reviewed each manuscript draft critically for intellectual content, and approved the final version.

The TRITONTIMI 38 Publications Committee approved of the conduct of this analyses and reviewed the manuscript prior to submission.

No payment was received for manuscript development.

The authors would like to thank B Liu, MS (i3 Global) for statistical support and L.H. Muhlbaier, PhD (Duke University Medical Center) for his independent statistical replication of the analyses.

The authors also thank B.G. Utterback, MS and A.G. Leishman, PhD (both Eli Lilly and Company) for writing and project management support of the manuscript, and J A. Sherman, AAS (Eli Lilly and Company) for assistance with the figures.

M.A. Short, G.J. Weerakkody, and L.A. LeNarz are employees of and report equity ownership or stock options in Eli Lilly and Company.

P.K. Smith, L.T. Goodnough, J.H. Levy and R.S. Poston have received honoraria as consultants for Eli Lilly and Company.

P.K. Smith has also served as a consultant to Bayer Corporation, Baxter Corporation and Cubist Pharmaceuticals.

Subject:

Research Funding:

This work was sponsored by Daiichi Sankyo, Inc., Parsippany, NJ and Eli Lilly and Company, Indianapolis, IN and is related to study protocol H7T-MC-TAAL, listed on ClinicalTrials.gov; NCT 00097591.

Dr. Smith was supported by NHLBI U01-HL088953.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • acute coronary syndrome
  • clopidogrel
  • coronary artery bypass grafting
  • mortality
  • prasugrel
  • ST-SEGMENT ELEVATION
  • BLEEDING COMPLICATIONS
  • MYOCARDIAL-INFARCTION
  • PLATELET INHIBITION
  • CARDIAC-SURGERY
  • FOCUSED UPDATE
  • CLOPIDOGREL
  • INTERVENTION
  • OUTCOMES
  • ASPIRIN

Mortality Benefit with Prasugrel in the TRITON-TIMI 38 Coronary Artery Bypass Grafting (CABG) Cohort: Risk-Adjusted Retrospective Data Analysis

Tools:

Journal Title:

Journal of the American College of Cardiology

Volume:

Volume 60, Number 5

Publisher:

, Pages 388-396

Type of Work:

Article | Post-print: After Peer Review

Abstract:

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 Ri sk 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)

Copyright information:

© 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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