Journal article
Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial
European heart journal, v 32(23), pp 2933-2944
01 Dec 2011
PMID: 22090660
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Aims More intense platelet-directed therapy for acute coronary syndrome (ACS) may increase bleeding risk. The aim of the current analysis was to determine the rate, clinical impact, and predictors of major and fatal bleeding complications in the PLATO study.
Methods and results PLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a non-thienopyridine, reversibly binding platelet P2Y(12) receptor antagonist, or clopidogrel in addition to aspirin. Patients randomized to ticagrelor and clopidogrel had similar rates of PLATO major bleeding (11.6 vs. 11.2%; P = 0.43), TIMI major bleeding (7.9 vs. 7.7%, P=0.56) and GUSTO severe bleeding (2.9 vs. 3.1%, P = 0.22). Procedure-related bleeding rates were also similar. Non-CABG major bleeding (4.5 vs. 3.8%, P = 0.02) and non-procedure-related major bleeding (3.1 vs. 2.3%, P = 0.05) were more common in ticagrelor-treated patients, primarily after 30 days on treatment. Fatal bleeding and transfusion rates did not differ between groups. There were no significant interactions for major bleeding or combined minor plus major bleeding between treatment groups and age >= 75 years, weight,60 kg, region, chronic kidney disease, creatinine clearance <60 mL/min, aspirin dose >325 mg on the day of randomization, pre-randomization clopidogrel administration, or clopidogrel loading dose.
Conclusion Ticagrelor compared with clopidogrel was associated with similar total major bleeding but increased non-CABG and non-procedure-related major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups.
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Details
- Title
- Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial
- Creators
- Richard C. Becker - Clinical Research InstituteJean Pierre Bassand - Observatoire de BesançonAndrzej Budaj - Grochowski HospitalDaniel M. Wojdyla - Clinical Research InstituteStefan K. James - Uppsala UniversityJan H. Cornel - Medisch Centrum AlkmaarJohn French - Liverpool HospitalClaes Held - Uppsala UniversityJay Horrow - AstraZenecaSteen Husted - Aarhus University HospitalJose Lopez-Sendon - Autonomous University of MadridRiitta Lassila - Helsinki University HospitalKenneth W. Mahaffey - Clinical Research InstituteRobert F. Storey - University of SheffieldRobert A. Harrington - Clinical Research InstituteLars Wallentin - Uppsala University
- Publication Details
- European heart journal, v 32(23), pp 2933-2944
- Publisher
- Oxford Univ Press
- Number of pages
- 12
- Grant note
- Regado Biosciences Medscape Eli-Lilly; Eli Lilly Sanofi-Aventis Argolyn Bioscience Eli Lilly Abbott Vascular; Abbott Laboratories William Beaumont Hospital Momenta Pharmaceutical; Johnson & Johnson Pfizer The Medicines Company Proctor and Gamble; Procter & Gamble Guidant CardioKinetix Scios Eli Lilly/Daiichi Sankyo alliance; Eli Lilly Eisai; Eisai Co Ltd Cordis Boehringer Ingelheim Portola Pharmaceutical Bristol-Myers Squibb Alexion; AstraZeneca Boeringher-Ingelheim The Medicine Company Johnson and Johnson; Johnson & Johnson; Johnson & Johnson USA Luitpold Pharmaceutical WebMD Bayer and Regado Biosciences Regado Biotechnologies Medtronic Cierra Edwards Lifesciences Amgen Innocoll Pharmaceuticals MSD Portola Pharmaceuticals AstraZeneca Schering-Plough/Merck; Merck & Company; Schering Plough Corporation Forest Labs KCI Medical Pozen Athera Biotechnologies Merck; Merck & Company Novartis Duke University School of Medicine Sanofi-Aventis/Bristol-Myers Squibb; Sanofi-Aventis; Bristol-Myers Squibb Teva; Teva Pharmaceutical Industries Adolor Schering-Plough; Merck & Company; Schering Plough Corporation Amylin GlaxoSmithKline Bayer; Bayer AG Brigham Women's Hospital Dynabyte Daiichi Sankyo; Daiichi Sankyo Company Limited Genentech; Roche Holding Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Anesthesiology and Perioperative Medicine
- Web of Science ID
- WOS:000297647400008
- Scopus ID
- 2-s2.0-82955187874
- Other Identifier
- 991020785752604721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems