Original title: Bivalirudin Started during Emergency Transport for Primary PCI. Reference: Philippe G. Steg, et;al. NEJM 2013; Octubre 30:1-11

Primary PCI is the preferred treatment for AMI within the first 12 hours of symptom onset and outcomes have been improving with the incorporation of new strategies and technology. This study randomized 2218 STEMI patients started with bivalirudin during emergency transport for primary PCI vs. heparin (either unfractionated or low-molecular-weight with optional glycoprotein IIb/IIIa inhibitors 

The primary outcome at 30 days was a composite of death or major bleeding not associated with surgery. Secondary outcome was a composite of death, re-infarction, or non-CABG major bleeding. The baseline characteristics of patients were generally well matched between the two groups, although there were higher rates of diabetes and previous myocardial infarction in the control group 

The median time between study-drug initiation and coronary angiography was 50 minutes. There was similar use of femoral arterial access and radial access. Glycoprotein IIb/IIIa inhibitors were used in 11.5% of patients in the bivalirudin group and 69.1% in the control group, in addition to heparin.

There was similar use of femoral arterial access and radial access. Aspiration thrombectomy was performed in nearly one third of patients and the median duration of bivalirudin infusion was 268 minutes (250-292).

The primary outcome occurred in 5.1% of the patients in the bivalirudin group and 8.5% in the control group (RR for bivalirudin, 0.60; 95% CI 0.43 to 0.82; p=0.001). Secondary outcome was 6.6% for bivalirudin vs 9.2% for heparin (p=0.02). Major bleeding saw the greatest reduction with bivalirudin 2.6% vs 6% (p<0.001). Stent thrombosis within 24 hs was greater in the bivalirudin group (1.6% vs. 0.5%; p=0.02), with no difference at 30 days; there were no fatal cases. 

Conclusion

The use of bivalirudin in pre hospital phase in STEMI patients referred to primary PCI improves clinical outcomes at 30 days with major bleeding reduction but with higher rates of acute stent thrombosis.

Comment

This study shows, as well as the HORIZONS-AMI, that bivalirudin is effective and it can be used in the pre hospital phase with a significant reductionof major bleeding at the expense of higher rates of acute stent thrombosis. This strategy in addition to early prescription of antiplatelets and an efficient pre hospital system will certainly improve primary PCI outcomes even further. 

Courtesy of Dr. Carlos Fava
Interventional cardiologist
Favaloro Foundation – Argentina

Dr. Carlos Fava para SOLACI.ORG