Abstract

plus GP IIb/IIIa inhibitor (7.7% and 7.3%, respectively). There were also similar rates of major bleeding (5.3% and 5.7%). As compared with heparin plus GP IIb/IIIa inhibitor, bivalirudin, alone, led to noninferior rates of ischemia (7.8% and 7.3%, respectively; P=0.32), and significantly reduced major bleeding (3.0% vs. 5.7%; P<0.001). [7] Bivalirudin also underwent evaluation in the setting of STEMI patients. In the Bivalirudin during Primary PCI in Acute Myocardial Infarction(HORIZONS-AMI trial) [8]. This was a multicenter trial that enrolled 3602 patients with ST-segment elevation myocardial infarction who were undergoing primary PCI. The patients were randomized to a regimen of heparin plus a GP IIb/IIIa inhibitor versus bivalirudin alone. Treatment with bivalirudin alone, as compared with heparin plus GP IIb/IIIa inhibitors was associated with a significant reduction in the 30-day primary endpoint of net adverse clinical events which was predominantly driven by a lower rate of major bleeding. It also lowered 30-day rates of death from cardiac causes (1.8% vs. 2.9% P=0.03) as well as death from all causes (2.1% vs. 3.1% P=0.047). Follow up at one, two, and three years showed that the reduction in the incidence of net adverse clinical events and major bleeding was robustly maintained in the bivalirudin monotherapy group. [8] Conclusion Bivalirudin represents an attractive option as an antithrombotic agent in the cardiac catheterization laboratory. It has several advantages over heparin, and based upon evidence from many clinical trials, it has been proven to be safer than and at least as effective as heparin in the STEMI, NSTEMI/UA, and elective PCI population. We expect that the use of this agent as an antithrombotic therapy during PCI will continue to gain traction in the next few years.

Highlights

  • Bivalirudin is a reversible direct thrombin inhibitor

  • The composite endpoint of death, MI or revascularization was lower in the bivalirudin arm at 90 days with absolute benefits being sustained through 180 days

  • In the Randomized Evaluation of percutaneous coronary intervention (PCI) Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, patients were assigned to either bivalirudin, with provisional use of GP IIb/IIIa inhibitor or low-dose unfractionated heparin (UFH) plus planned GP IIb/IIIa inhibitor

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Summary

Introduction

Bivalirudin (angiomax) is a reversible direct thrombin inhibitor. Bivalirudin clinical studies have demonstrated consistent positive outcomes in patients with stable angina, unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). The composite endpoint of death, MI or revascularization was lower in the bivalirudin arm at 90 days with absolute benefits being sustained through 180 days.

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