Bivalirudin yielded similar 30-day mortality rates to heparin following percutaneous coronary intervention (PCI) in heart attack patients, but showed a bleeding and mortality benefit in some other patients, new study results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2020 suggested.
“Individual randomized controlled trials of periprocedural anticoagulation with bivalirudin versus heparin during PCI in acute myocardial infarction have reported conflicting results,” Gregg W. Stone, MD, of Director of Academic Affairs at Mount Sinai Health System and Professor of Medicine at the Zena and Michael A. Weiner Cardiovascular Institute of the Ichan School of Medicine at Mount Sinai, said in a presentation. “Study-level meta-analysis lack granularity to adjust for confounders, explore heterogeneity, or identify subgroups that may particularly benefit or be harmed.”
The researchers pooled individual patient data from eight clinical trials of heparin vs. bivalirudin in patients with myocardial infarction (both STEMI and NSTEMI). The trials included in the analysis were MATRIX, VALIDATE-SWEDEHEART, EUROMAX, BRIGHT, HEAT-PPCI, ISAR-REACT 4, ACUITY, and HORIZONS-AMI. The final patient cohort for the analysis was 27,409, of whom 13,346 were randomized to bivalirudin and 14,063 were randomized to heparin. A total of 15,254 patients had STEMI and 12,155 had NSTEMI. The primary outcome was 30-day risk of all-cause death and the safety endpoint was 30-day risk of serious bleeding.
According to the results, the overall 30-day mortality rates were similar between the two study groups (1.9% vs. 2.1%, respectively) for bivalirudin vs. heparin and it showed lower rates of serious bleeding as well (3.4% vs. 5.7%, respectively). There were similar results for bivalirudin when given as a post-PCI infusion in both STEMI and NSTEMI patients.
“In patients with STEMI undergoing primary PCI, bivalirudin use was associated with reductions in the 30-day rates of mortality, serious bleeding and NACE, despite increased rates of MI and stent thrombosis compared with heparin. The mortality benefit of bivalirudin in STEMI was pronounced in patients treated with a post-PCI bivalirudin infusion (low-dose or high-dose); a high-dose infusion mitigated the MI and stent thrombosis risk,” Dr. Stone said in a press release. “In patients with NSTEMI undergoing PCI, bivalirudin use was associated with a reduction in the 30-day rate of serious bleeding but similar rates of mortality, MI, and stent thrombosis compared with heparin.”
Stone G. Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin Versus Heparin in Acute Myocardial Infarction. Presented at TCT 2020.