Bivalirudin for primary percutaneous coronary interventions: outcome assessment in the Ottawa STEMI registry
Registry study published in Circulation Cardiovascular Interventions (2012)
Abstract
BACKGROUND: Data from randomized trials has demonstrated the superiority of bivalirudin to glycoprotein IIb/IIIa inhibitors plus heparin in patients undergoing primary percutaneous coronary intervention. Real-world performance of bivalirudin in primary percutaneous coronary intervention and the benefit of bivalirudin over heparin remain unknown in an era of routine dual antiplatelet therapy. METHODS AND RESULTS: From July 2004 to December 2010, 2317 consecutive patients were indexed in the University of Ottawa Heart Institute ST-segment-elevation myocardial infarction registry. During this period 748 patients received bivalirudin, 699 patients received glycoprotein IIb/IIIa inhibitors, and 676 patients received unfractionated heparin alone. The primary outcome was the rate of noncoronary artery bypass graft related thrombolysis in myocardial infarction major bleeding. Bivalirudin significantly reduced the primary outcome compared with heparin plus glycoprotein IIb/IIIa inhibitors (2.7% versus 7.3%, adjusted OR 2.96, 95% CI: 1.61-5.45, P<0.001) and the composite end point of death, stroke, reinfarction and major bleed (OR 1.66, 95% CI: 1.12-2.45, P=0.01). Compared with heparin alone, a reduction in major bleeds (OR 1.21, 95% CI: 0.60-2.44, P=0.59) or the composite end point (1.05, 95% CI: 0.68-1.63, P=0.83) with bivalirudin could not be demonstrated. Notably, major bleeding was associated with a 5-fold increase in the risk of mortality both in-hospital (3.5% versus 20.6%) and out to 180 days (5.6% versus 25.8%). CONCLUSIONS: Bivalirudin use compared with glycoprotein IIb/IIIa inhibitors plus heparin as an antithrombotic strategy in primary percutaneous coronary intervention results in less major bleeding in contemporary practice. A benefit of bivalirudin over heparin could not be established with this registry and requires additional investigations to either confirm or refute.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Ottawa STEMI registry of 2317 patients comparing bivalirudin (n=748) vs heparin+GPI (n=699) vs heparin alone (n=676): bivalirudin reduced TIMI major bleeding (2.7% vs 7.3%, OR 2.96, p<0.001) and the composite end point of death, stroke, reinfarction, major bleed.
Why This Matters for Hirudotherapy
This registry study of 2317 consecutive ST-segment-elevation myocardial infarction patients compared bivalirudin against glycoprotein IIb/IIIa inhibitors plus heparin and against heparin alone during primary percutaneous coronary intervention, with the primary outcome being non-CABG-related major bleeding. Bivalirudin is a synthetic direct thrombin inhibitor modeled on hirudin, the potent anticoagulant in medicinal leech saliva, so this study is directly relevant to ASH as it documents real-world clinical performance of a drug rooted in the leech secretome. The study found bivalirudin significantly reduced major bleeding (2.7% vs 7.3%) and composite adverse outcomes compared with heparin plus glycoprotein IIb/IIIa inhibitors, but could not establish superiority over heparin alone. As a retrospective registry analysis rather than a randomized trial, these findings reflect contemporary practice patterns but warrant confirmation through further investigation.
Citation
Bivalirudin for primary percutaneous coronary interventions: outcome assessment in the Ottawa STEMI registry.
Hibbert B et al. · Circulation Cardiovascular Interventions, 2012
Added to ASH library: May 27, 2026 · Site last updated: June 18, 2026