Bivalirudin is not superior to heparin with regard to mortality, recurrent myocardial infarction (MI), or major bleeding events in patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) undergoing percutaneous coronary intervention (PCI), according to findings from a multicenter registry-based randomized clinical trial published in the New England Journal of Medicine and presented at the 2017 European Society of Cardiology Congress held from August 26-30 in Barcelona, Spain.1,2
In this open-label trial (VALIDATE-SWEDEHEART; ClinicalTrials.gov identifier: NCT02311231, patients with STEMI (n=3005) or NSTEMI (n=3001) were randomly assigned to either bivalirudin or heparin during PCI. Patients were receiving a potent P2Y12 inhibitor without current or planned glycoprotein IIb/IIIa inhibitor use. The primary end point was designated as a composite of all-cause death, major bleeding, or MI at 180 days.
There was no significant difference between the bivalirudin and heparin groups with regard to the primary end point at 30 days (7.2% and 8.0%, respectively; hazard ratio [HR], 0.89; 95% CI, 0.74-1.07; P =.21) and 180 days (12.3% and 12.8%, respectively; HR, 0.96; 95% CI, 0.83-1.10; P =.54). Slight differences were observed in the rate of definite stent thrombosis between the 2 groups (0.4% and 0.7%; HR, 0.54; 95% CI, 0.27-1.10; P =.09), but these differences did not reach statistical significance. No significant differences were found in separate analyses of each individual components of the primary end point.
Patients who were screened but not enrolled in this trial had a higher risk for a primary end point event compared with patients who were enrolled, which implies that the findings may not be entirely representative of all patients with MI undergoing PCI. The open-label nature of this trial and the methods used to obtain follow-up data represent 2 other limitations of the trial’s design that may have contributed to biases or overlooked outcome events.
The investigators noted that the use of the radial artery access PCI approach in the majority of patients “may have contributed to the very low rate of bleeding events in both treatment groups.”
- Erlinge D, Omerovic E, Frobert O, et al. Bivalirudin versus heparin monotherapy in myocardial infarction. European Society of Cardiology Congress 2017; August 26-30, 2017; Barcelona, Spain.
- Erlinge D, Omerovic E, Frobert O, et al. Bivalirudin versus heparin monotherapy in myocardial infarction [published online August 28, 2017]. N Engl J Med. doi:10.1056/NEJMoa1706443