"Bivalirudin versus Heparin in Acute Coronary Syndrome". The New England Journal of Medicine. 2015.
Links to original sources: Wiki Journal Post Full Journal Article
In patients with an acute coronary syndrome undergoing percutaneous coronary intervention (PCI), are bivalirudin and a post-PCI bivalirudin infusion superior to unfractionated heparin in reducing major adverse cardiovascular and clinical events?
In patients with acute coronary syndrome undergoing PCI, bivalirudin did not significantly reduce the rates of major adverse cardiovascular events or net adverse clinical events compared with unfractionated heparin. A post-PCI bivalirudin infusion also did not significantly lower the rate of the composite outcome of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events compared with no post-PCI infusion.
Evidence on the efficacy and safety of bivalirudin versus unfractionated heparin for patients with acute coronary syndrome undergoing PCI has been conflicting. The MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial aimed to clarify whether bivalirudin is superior to unfractionated heparin. The trial found no significant difference between bivalirudin and unfractionated heparin groups in the rates of major adverse cardiovascular events or net adverse clinical events. It also did not find significant benefit in the use of a post-PCI bivalirudin infusion over no post-PCI infusion.
As of the last knowledge update, guidelines do not specifically recommend bivalirudin over heparin for anticoagulation in the setting of acute coronary syndrome undergoing PCI.
- Multicenter, open-label, randomized trial - N=7,213 patients with acute coronary syndrome undergoing PCI - Bivalirudin with or without post-PCI infusion (n=3,610) vs. Unfractionated heparin (n=3,603) - Setting: 78 centers in Italy, the Netherlands, Spain, and Sweden - Enrollment: 2011-2014 - Mean follow-up: 30 days - Analysis: Intention-to-treat - Primary outcome for bivalirudin vs heparin: major adverse cardiovascular events (death, myocardial infarction, or stroke) and net adverse clinical events (major bleeding or a major adverse cardiovascular event) - Primary outcome for post-PCI bivalirudin infusion vs no infusion: composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events
- Inclusion criteria: Patients with ST-segment elevation myocardial infarction (STEMI) or non–ST-segment elevation acute coronary syndrome planned for PCI - Exclusion criteria: Not specifically stated but detailed inclusion and exclusion are provided in the Supplementary Appendix of the original article - Baseline characteristics: A mix of patients with STEMI (55.6%) and non–ST-segment elevation acute coronary syndrome (44.4%). Killip class > I at presentation in 698 patients (9.7%).
- Bivalirudin group: 0.75 mg/kg bolus, followed by 1.75 mg/kg/h infusion during PCI, with the option of additional post-PCI infusion - Unfractionated heparin group: 70-100 units/kg dose (50-70 if with glycoprotein IIb/IIIa inhibitors)
- Major adverse cardiovascular events with bivalirudin vs heparin: 10.3% vs 10.9% (RR 0.94; 95% CI, 0.81 to 1.09; P=0.44) - Net adverse clinical events with bivalirudin vs heparin: 11.2% vs 12.4% (RR 0.89; 95% CI, 0.78 to 1.03; P=0.12) - Post-PCI bivalirudin infusion vs no infusion: 11.0% vs 11.9% for primary composite outcome (RR 0.91; 95% CI, 0.74 to 1.11; P=0.34) - Death from any cause and cardiac death were lower in the bivalirudin group compared with the heparin group - Definite stent thrombosis was higher in the bivalirudin group compared with heparin group
- Lack of blinding may have introduced bias - Discretion over glycoprotein IIb/IIIa inhibitors and post-PCI bivalirudin regimen increases variability in treatment - Secondary endpoints such as death and stent thrombosis were not corrected for multiple testing
Funded by the Medicines Company and Terumo Medical
- Original publication in The New England Journal of Medicine - Supplementary Appendix for further methodology and results