Bivalirudin or Heparin in Patients Undergoing Invasive Management of AcuteCoronarySyndromes
Randomized controlled trial published in J Am Coll Cardiol (2018)
Abstract
BACKGROUND: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs). OBJECTIVES: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding). RESULTS: Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site. CONCLUSIONS: In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs).
Why This Matters for Hirudotherapy
This MATRIX trial randomized 7,213 acute coronary syndrome patients undergoing invasive management to bivalirudin versus unfractionated heparin (UFH), with or without glycoprotein IIb/IIIa inhibitors at operator discretion. At 30 days, bivalirudin did not significantly reduce the coprimary endpoints of major adverse cardiovascular events or net adverse clinical events, but it did significantly reduce bleeding complications—particularly severe, fatal, and non-access-site bleeds—irrespective of planned GPI use. For ASH, this study is directly relevant because bivalirudin is a synthetic direct thrombin inhibitor derived from hirudin, the anticoagulant in medicinal leech saliva, and this large randomized trial provides high-quality clinical evidence on the safety profile of a leech-secretome-derived compound in modern interventional cardiology. An honest caveat is that this trial evaluates a pharmaceutical hirudin analog administered during percutaneous coronary intervention, not hirudotherapy itself, and bivalirudin showed no ischemic outcome advantage over heparin.
Citation
Bivalirudin or Heparin in Patients Undergoing Invasive Management of AcuteCoronarySyndromes.
Gargiulo G et al. · J Am Coll Cardiol, 2018
Added to ASH library: May 27, 2026 · Site last updated: June 18, 2026