Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve Implantation.
Research article published in The Canadian journal of cardiology (2015)
Abstract
BACKGROUND: We aimed to compare safety and efficacy of the direct thrombin inhibitor bivalirudin with unfractionated heparin (UFH) during transcatheter aortic valve implantation (TAVI). METHODS: In this retrospective analysis, 461 patients underwent TAVI between 2007 and 2012; 339 patients received bivalirudin, and 122 patients received UFH. In the bivalirudin group, the Sapien XT valve was implanted in 159 (46.9%) patients, and 180 (53.1%) received a Medtronic CoreValve. In the UFH group, only the Medtronic CoreValve was implanted. The primary outcome of interest was the incidence of any bleeding. Secondary outcomes of interest were all-cause mortality and cardiovascular mortality at 72 hours after the procedure and at 30 days. RESULTS: No significant difference between the groups was observed for life-threatening bleeding (2.4% for bivalirudin vs 3.3% for UFH; P = 0.59), major bleeding (8.3% vs 8.2%, respectively; P = 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P = 0.76). At 72 hours after the procedure, all-cause mortality was 3.0% in the bivalirudin group and 3.3% for the UFH group (P = 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P = 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P = 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P = 0.33). Device success (Valve Academic Research Consortium 2 composite end point) was 94.0% in the bivalirudin-treated and 92.6% in the UFH-treated patients (P = 0.60). The early safety at 30 days was 85.3% in the bivalirudin-treated group compared with 83.6% in the UFH-treated group (P = 0.65). CONCLUSIONS: Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve Implantation.
Why This Matters for Hirudotherapy
This retrospective analysis compared the direct thrombin inhibitor bivalirudin with unfractionated heparin (UFH) in 461 patients undergoing transcatheter aortic valve implantation (TAVI), with 339 receiving bivalirudin and 122 receiving UFH. No significant differences were observed between groups in life-threatening, major, or minor bleeding, nor in all-cause or cardiovascular mortality at 72 hours or 30 days; device success and early safety at 30 days were also comparable. For ASH, this study holds relevance because bivalirudin is a synthetic analog of hirudin, the hallmark anticoagulant in medicinal leech saliva, and clinical evidence of its performance in high-risk interventional cardiology procedures helps contextualize the translational value of leech-secretome-derived anticoagulants. However, as a retrospective analysis with unequal group sizes and different valve types implanted across groups, the study cannot establish definitive comparative efficacy and may be subject to confounding.
Citation
Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve Implantation.
Lange et al. · The Canadian journal of cardiology, 2015
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