Abstract 13699: Bivalirudin versus Heparin in Patients With NSTEMI Undergoing PCI: Individual-Patient-Data Pooled Analysis of the 5 Major Randomized Trials

Abstract

Background: Whether there are treatment tradeoffs between bivalirudin and heparin in patients with NSTEMI undergoing PCI is controversial. Study-level meta-analyses lack granularity to provide conclusive answers or assess subgroups. Methods: We performed an individual-patient-data pooled analysis from all 5 large (n >1000) RCTs of bivalirudin vs heparin in NSTEMI patients undergoing PCI (MATRIX, VALIDATE-SWEDEHEART, ISAR-REACT 4, ACUITY, BRIGHT). The primary efficacy outcome was the 30-day rate of all-cause mortality. Other prespecified outcomes included 30-day serious bleeding, 1-year mortality, and 30-day and 1-year MACCE, and net adverse clinical events (NACE). Subgroup analyses were performed according to access site and post-PCI bivalirudin infusion. Results: A total of 12,155 patients with NSTEMI undergoing PCI were randomized to bivalirudin alone (n=6,040, 52.3% with a post-PCI infusion) or to heparin (n=6,115, 53.2% with planned use of a GPIIb/IIIa inhibitor). Thirty-day mortality was not significantly different between bivalirudin vs heparin (aHR: 1.21; 95% CI: 0.84-1.73). There was a lower risk of 30-day serious bleeding with bivalirudin vs heparin (aHR: 0.63; 95% CI: 0.52, 0.76). At 1-year follow-up, there was no significant difference between bivalirudin and heparin for all-cause mortality (aHR: 0.97; 95% CI: 0.79, 1.19), MACCE (aHR: 1.03; 95% CI: 0.94, 1.13) or NACE (aHR: 0.92 0.84, 1.00). There were no significant differences between bivalirudin or heparin in the rates of MI or stent thrombosis (Table). Findings were consistent irrespective of access site (femoral vs radial), and post-PCI infusion of bivalirudin. Conclusions: In patients with NSTEMI undergoing PCI, procedural anticoagulation with bivalirudin was not associated with improvements in 30-day or 1-year mortality or MACCE compared with heparin with or without GPIIb/IIIa inhibitor, although serious bleeding was reduced. Full analyses will be presented at AHA 2022.