Bivalirudin Started During Emergency Transport for Primary PCI

Study Questions:

What was the safety and efficacy of bivalirudin started in the ambulance among patients being transported for primary percutaneous coronary intervention (PCI)?

Methods:

The EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial investigators randomized 2,218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). Bivalirudin was started in the ambulance and continued for 4 hours after PCI. The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding.

Results:

Bivalirudin reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk [RR], 0.60; 95% confidence interval [CI], 0.43-0.82; p = 0.001) and the principal secondary outcome (6.6% vs. 9.2%; RR, 0.72; 95% CI, 0.54-0.96; p = 0.02). This was mainly due to a reduction in major bleeding (2.6% vs. 6.0%; RR, 0.43; 95% CI, 0.28-0.66; p < 0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37-27.24; p = 0.007). There was no significant difference in rates of death with either approach (2.9% vs. 3.1%). Bivalirudin use was associated with a lower need for transfusion (2.1% vs. 3.9%, p = 0.02).

Conclusions:

The authors concluded that bivalirudin initiated in the ambulance and continued for 4 hours was associated with a lower risk of bleeding in patients undergoing primary PCI for STEMI.

Perspective:

This study again confirmed the antibleeding efficacy of bivalirudin in primary PCI, which was offset by a higher risk of stent thrombosis. The lack of a survival difference between the two strategies suggests that either of the two therapies can be used in the appropriate setting and one could use heparin + glycoprotein IIb/IIIa inhibitor in patients deemed to be at high risk of stent thrombosis, and bivalirudin in those at greater risk of bleeding.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and ACS, Aortic Surgery, Interventions and ACS

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Thrombosis, Heparin, Low-Molecular-Weight, Coronary Artery Bypass, Stents, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex


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