Post-Procedural Bivalirudin Infusion atFull or Low Regimen in Patients WithAcute Coronary Syndrome
Randomized controlled trial published in J Am Coll Cardiol (2019)
Abstract
BACKGROUND: The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear. OBJECTIVES: The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation. METHODS: The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding). RESULTS: Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups. CONCLUSIONS: In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (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
The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear.
Why This Matters for Hirudotherapy
This randomized controlled trial within the MATRIX program assessed whether a full-dose (1.75 mg/kg/h) or low-dose (0.25 mg/kg/h) post-PCI bivalirudin infusion improved outcomes in 3,610 acute coronary syndrome patients. The primary composite endpoint did not differ significantly with or without post-PCI bivalirudin infusion overall, but a full-dose post-PCI regimen was associated with a significant reduction in the primary endpoint compared to low-dose or no infusion after multivariable and propensity score adjustment. The abstract makes no reference to leeches, hirudin, or leech-derived substances, and provides no basis for any connection to hirudotherapy or the leech secretome. This clinical pharmacotherapy trial has no demonstrable relevance to ASH's domain.
Citation
Post-Procedural Bivalirudin Infusion atFull or Low Regimen in Patients WithAcute Coronary Syndrome.
Gargiulo G et al. · J Am Coll Cardiol, 2019
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