Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study.

Aged Aspirin / therapeutic use Coronary Artery Bypass Double-Blind Method Drug Therapy, Combination Factor Xa Inhibitors / therapeutic use Female Fibrinolytic Agents / therapeutic use Graft Occlusion, Vascular / prevention & control Humans Male Middle Aged Rivaroxaban / therapeutic use Treatment Outcome
anticoagulation cardiac surgery coronary artery disease graft failures

Journal

Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365

Informations de publication

Date de publication:
22 01 2019
Historique:
received: 13 08 2018
revised: 03 10 2018
accepted: 08 10 2018
entrez: 19 1 2019
pubmed: 19 1 2019
medline: 19 11 2019
Statut: ppublish

Résumé

Patients with recent coronary artery bypass graft (CABG) surgery are at risk for early graft failure, which is associated with a risk of myocardial infarction and death. In the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) trial, rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced the primary major adverse cardiovascular events (MACE) outcome of cardiovascular death, stroke, or myocardial infarction. Rivaroxaban 5 mg twice daily alone did not significantly reduce MACE. This pre-planned substudy sought to determine whether the COMPASS treatments are more effective than aspirin alone for preventing graft failure and MACE after CABG surgery. The substudy randomized 1,448 COMPASS trial patients 4 to 14 days after CABG surgery to receive the combination of rivaroxaban plus aspirin, rivaroxaban alone, or aspirin alone. The primary outcome was graft failure, diagnosed by computed tomography angiogram 1 year after surgery. The combination of rivaroxaban and aspirin and the regimen of rivaroxaban alone did not reduce the graft failure rates compared with aspirin alone (combination vs. aspirin: 113 [9.1%] vs. 91 [8.0%] failed grafts; odds ratio [OR]: 1.13; 95% confidence interval [CI]: 0.82 to 1.57; p = 0.45; rivaroxaban alone vs. aspirin: 92 [7.8%] vs. 92 [8.0%] failed grafts; OR: 0.95; 95% CI: 0.67 to 1.33; p = 0.75). Compared with aspirin, the combination was associated with fewer MACE (12 [2.4%] vs. 16 [3.5%]; hazard ratio [HR]: 0.69; 95% CI: 0.33 to 1.47; p = 0.34), whereas rivaroxaban alone was not (16 [3.3%] vs. 16 [3.5%]; HR: 0.99, CI: 0.50 to 1.99; p = 0.98). There was no fatal bleeding or tamponade within 30 days of randomization. The combination of rivaroxaban 2.5 mg twice daily plus aspirin or rivaroxaban 5 mg twice daily alone compared with aspirin alone did not reduce graft failure in patients with recent CABG surgery, but the combination of rivaroxaban 2.5 mg twice daily plus aspirin was associated with similar reductions in MACE, as observed in the larger COMPASS trial. (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS [COMPASS]; NCT01776424).

Sections du résumé

BACKGROUND
Patients with recent coronary artery bypass graft (CABG) surgery are at risk for early graft failure, which is associated with a risk of myocardial infarction and death. In the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) trial, rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced the primary major adverse cardiovascular events (MACE) outcome of cardiovascular death, stroke, or myocardial infarction. Rivaroxaban 5 mg twice daily alone did not significantly reduce MACE.
OBJECTIVES
This pre-planned substudy sought to determine whether the COMPASS treatments are more effective than aspirin alone for preventing graft failure and MACE after CABG surgery.
METHODS
The substudy randomized 1,448 COMPASS trial patients 4 to 14 days after CABG surgery to receive the combination of rivaroxaban plus aspirin, rivaroxaban alone, or aspirin alone. The primary outcome was graft failure, diagnosed by computed tomography angiogram 1 year after surgery.
RESULTS
The combination of rivaroxaban and aspirin and the regimen of rivaroxaban alone did not reduce the graft failure rates compared with aspirin alone (combination vs. aspirin: 113 [9.1%] vs. 91 [8.0%] failed grafts; odds ratio [OR]: 1.13; 95% confidence interval [CI]: 0.82 to 1.57; p = 0.45; rivaroxaban alone vs. aspirin: 92 [7.8%] vs. 92 [8.0%] failed grafts; OR: 0.95; 95% CI: 0.67 to 1.33; p = 0.75). Compared with aspirin, the combination was associated with fewer MACE (12 [2.4%] vs. 16 [3.5%]; hazard ratio [HR]: 0.69; 95% CI: 0.33 to 1.47; p = 0.34), whereas rivaroxaban alone was not (16 [3.3%] vs. 16 [3.5%]; HR: 0.99, CI: 0.50 to 1.99; p = 0.98). There was no fatal bleeding or tamponade within 30 days of randomization.
CONCLUSIONS
The combination of rivaroxaban 2.5 mg twice daily plus aspirin or rivaroxaban 5 mg twice daily alone compared with aspirin alone did not reduce graft failure in patients with recent CABG surgery, but the combination of rivaroxaban 2.5 mg twice daily plus aspirin was associated with similar reductions in MACE, as observed in the larger COMPASS trial. (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS [COMPASS]; NCT01776424).

Identifiants

DOI: 10.1016/j.jacc.2018.10.048 PMID: 30654882
pubmed: 30654882
pii: S0735-1097(18)39066-1
doi: 10.1016/j.jacc.2018.10.048
pii:
doi:

Substances chimiques

Factor Xa Inhibitors 0
Fibrinolytic Agents 0
Rivaroxaban 9NDF7JZ4M3
Aspirin R16CO5Y76E

Banques de données

ClinicalTrials.gov
['NCT01776424']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

121-130

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Auteurs

Andre Lamy (A)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; CADENCE Research Group, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: alamy1@mac.com.

John Eikelboom (J)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Tej Sheth (T)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Stuart Connolly (S)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Jackie Bosch (J)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

Keith A A Fox (KAA)

Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.

Jun Zhu (J)

FuWai Hospital, Beijing, China.

Eva Lonn (E)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Gilles Dagenais (G)

Institut Universitaire de Cardiologie et de Pnemologie de Québec, Quebec City, Quebec, Canada.

Petr Widimsky (P)

Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic.

Kelly R H Branch (KRH)

University of Washington Medical Center, Seattle, Washington.

Deepak L Bhatt (DL)

Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts.

Zhe Zheng (Z)

FuWai Hospital, Beijing, China.

Zbynek Straka (Z)

Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic.

Francois Dagenais (F)

Quebec Heart and Lung University Institute, Laval University, Quebec City, Quebec, Canada.

Ye Kong (Y)

Shanghai Chest Hospital Affiliated with Shanghai Jiao Tong University, Shanghai, China.

Tamara Marsden (T)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

Shun Fu Lee (SF)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

Ingrid Copland (I)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

Salim Yusuf (S)

Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Composés chimiques organiques › Hydrocarbures › Hydrocarbures cycliques › Hydrocarbures aromatiques › Dérivés du benzène › Phénols › Hydroxybenzoates › Salicylates › Acide acétylsalicylique › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie thoracique › Procédures de chirurgie cardiaque › Revascularisation myocardique › Pontage aortocoronarien › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Association de médicaments › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents hématologiques › Anticoagulants › Antithrombiniques › Inhibiteurs du facteur Xa › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents hématologiques › Fibrinolytiques › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Complications postopératoires › Occlusion du greffon vasculaire › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Thiophènes › Rivaroxaban › Rivaroxaban, Aspirin, or Both to Prevent Early...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Rivaroxaban, Aspirin, or Both to Prevent Early...