Safety and Efficacy of Bivalirudin as a Heparin Alternative in Patients Undergoing Carotid Artery Stenting
Observational / propensity-matched published in Ann Vasc Surg (2025)
Abstract
BACKGROUND: Transfemoral carotid artery stenting (TFCAS) and transcarotid artery revascularization (TCAR) are commonly used to treat carotid stenosis. However, the need for heparin alternatives during these procedures and their impact on outcomes remain unclear. This study evaluates the safety and efficacy of bivalirudin, the most commonly used heparin alternative, compared to heparin. METHODS: The Vascular Quality Initiative registry was queried for carotid artery stenting procedures performed from 2010 to 2022. Propensity-matched analyses compared outcomes between patients receiving intraprocedural heparin and those receiving bivalirudin. Primary outcomes were postoperative neurological events, including stroke or transient ischemic attack, and bleeding. Secondary outcomes included 30-day rates of reintervention and myocardial infarction, and mortality at 30 days and 1 year. RESULTS: Among 80,172 carotid artery stenting procedures, 2,789 (3.47%) were performed with bivalirudin. In the heparin group, 24,797 (34.1%) underwent TFCAS with distal embolic protection, while 47,961 (65.9%) underwent TCAR with flow reversal. In the bivalirudin group, 2,494 (91.2%) underwent TFCAS, and 240 (8.8%) underwent TCAR. Propensity matching created 2 cohorts of 957 patients each. There were no significant differences in neurological events (odds ratio, [OR]: 1.44, 95% confidence interval [CI]: 0.72-2.86; P = 0.30), bleeding (OR: 1.0, 95% CI: 0.53-1.90; P = 1.00), 30-day mortality (OR: 2.05, 95% CI: 0.62-6.85; P = 0.24), or 1-year mortality (OR: 1.37, 95% CI: 0.84-2.24; P = 0.21). CONCLUSION: Bivalirudin is a safe and effective alternative to heparin for patients with contraindications to heparin undergoing carotid artery stenting. These findings suggest no significant differences in outcomes, supporting bivalirudin as a viable anticoagulation option.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Propensity-matched analysis from the Vascular Quality Initiative registry (80,172 procedures, 2,789 with bivalirudin) showing no significant differences in neurological events, bleeding, or mortality between bivalirudin and heparin during carotid stenting.
Why This Matters for Hirudotherapy
This retrospective registry study evaluated bivalirudin — a direct thrombin inhibitor structurally derived from hirudin, the signature anticoagulant of the medicinal leech secretome — as an alternative to heparin during carotid artery stenting. Among 80,172 procedures, propensity-matched cohorts of 957 patients each showed no significant differences in postoperative neurological events (stroke/TIA), bleeding, or mortality at 30 days or 1 year. For hirudotherapy and ASH, these findings offer meaningful clinical validation that a leech-derived anticoagulant class performs comparably to heparin in a major endovascular setting, reinforcing the translational relevance of the leech secretome beyond traditional topical leech applications. An important caveat is that the observational registry design, despite propensity matching, cannot fully eliminate selection bias, and bivalirudin recipients were predominantly undergoing transfemoral rather than transcarotid approaches, which may limit generalizability across procedural contexts.
Citation
Safety and Efficacy of Bivalirudin as a Heparin Alternative in Patients Undergoing Carotid Artery Stenting.
Kania TA et al. · Annals of vascular surgery, 2025
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