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Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes.
- Source :
-
Journal of the American College of Cardiology [J Am Coll Cardiol] 2018 Mar 20; Vol. 71 (11), pp. 1231-1242. - Publication Year :
- 2018
-
Abstract
- Background: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs).<br />Objectives: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management.<br />Methods: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding).<br />Results: Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site.<br />Conclusions: In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).<br /> (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Coronary Artery Bypass methods
Electrocardiography methods
Female
Hematologic Agents administration & dosage
Hematologic Agents adverse effects
Hematologic Agents classification
Hemorrhage chemically induced
Hemorrhage prevention & control
Humans
Intraoperative Care methods
Male
Middle Aged
Percutaneous Coronary Intervention methods
Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors
Recombinant Proteins administration & dosage
Recombinant Proteins adverse effects
Treatment Outcome
Acute Coronary Syndrome diagnosis
Acute Coronary Syndrome drug therapy
Acute Coronary Syndrome surgery
Coronary Artery Bypass adverse effects
Heparin administration & dosage
Heparin adverse effects
Hirudins administration & dosage
Hirudins adverse effects
Peptide Fragments administration & dosage
Peptide Fragments adverse effects
Percutaneous Coronary Intervention adverse effects
Postoperative Complications classification
Postoperative Complications etiology
Subjects
Details
- Language :
- English
- ISSN :
- 1558-3597
- Volume :
- 71
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Journal of the American College of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 29544607
- Full Text :
- https://doi.org/10.1016/j.jacc.2018.01.033