Bivalirudin Started During Emergency Transport for Primary PCI
What was the safety and efficacy of bivalirudin started in the ambulance among patients being transported for primary percutaneous coronary intervention (PCI)?
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.
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).
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.
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.
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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