Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes

Abstract

BACKGROUNDConflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODSWe randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTSThe rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P = 0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P = 0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P = 0.34). CONCLUSIONSIn patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.)

Antithrombotic therapy for acute coronary syndrome: Past, present and future

“…level (5). A number of clinical trials (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) have led to fast and great advancements in the development of effective anticoagulant and antiplatelet drugs (23). ▶ Figure 2 highlights a selection of important large-scale trials that studied antiplatelet and/or anticoagulant treatment strategies.…”

Review and Updates in Regenerative and Personalized Medicine, Preclinical Animal Models, and Clinical Care in Cardiovascular Medicine

“…Finally, a novel pharmacomechanical strategy based on the use of transradial access site and bivalirudin infusion has been proposed at the time of PCI for ACS patients in the MATRIX trial [68]. The MATRIX trial showed that radial as compared with femoral access reduced net adverse clinical events, through a reduction in major bleeding and all-cause mortality [69], while no significant differences were observed with bivalirudin as compared with unfractionated heparin [70].…”

Heparin versus bivalirudin for percutaneous coronary intervention: has the debate come to an end?

“…Second, the more frequent use of a radial access for PCI, which is associated with lower bleeding risk as compared with femoral access (16). Randomized trials conducted in this era of potent P2Y 12 antagonists with a more prevalent use of radial access have shown no difference in the risk of composite ischemic events, albeit that the risk of stent thrombosis (particularly acute stent thrombosis) was consistently higher with bivalirudin, but these trials have yielded inconsistent results as regards to the bleeding benefit which was previously noted with bivalirudin (17)(18)(19)(20). In a meta-analysis of randomized trials comparing both agents for patients undergoing PCI via radial access, bivalirudin was not associated with a lower risk of bleeding compared with unfractionated heparin (21).…”