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Clinical safety of bivalirudin in patients undergoing carotid stenting
Bryan D Cogar1, Siddharth A Wayangankar, Mazen Abu-Fadel
1Integris Baptist Medical Center, University of Oklahoma, Oklahoma City, Oklahoma 73112, USA.
Insights
Bivalirudin demonstrates safety and efficacy in carotid artery stenting (CAS) procedures, showing rates of minor bleeding and transfusion comparable to established anticoagulation methods. This study suggests bivalirudin is a viable option for anticoagulation during CAS.
Area of Science:
- Cardiovascular Interventions
- Vascular Surgery
- Pharmacology
Background:
- Carotid artery stenting (CAS) traditionally used unfractionated heparin (UFH) for anticoagulation, primarily in high-risk patients.
- Bivalirudin, a direct thrombin inhibitor, has shown promise in reducing adverse events in coronary interventions.
- Limited data existed on bivalirudin's safety and efficacy specifically for CAS prior to this study.
Purpose of the Study:
- To evaluate the safety and efficacy of bivalirudin as an anticoagulation strategy during carotid artery stenting (CAS).
- To assess the 30-day incidence of major adverse events, including death, stroke, and bleeding complications, in patients undergoing CAS with bivalirudin.
Main Methods:
- Retrospective analysis of 331 patients (365 lesions) undergoing CAS between February 2007 and September 2010.
- Patients received bivalirudin for anticoagulation during CAS procedures performed by experienced operators.
- Primary endpoints included 30-day mortality, stroke, TIMI major/minor bleeding, and transfusion rates, collected via chart review.
Main Results:
- No deaths, strokes, or TIMI major bleeding events were recorded in the 365 procedures.
- The incidence of TIMI minor bleeding was 2.19% (8/365).
- The rate of blood transfusion was 1.64% (6/365).
Conclusions:
- Bivalirudin use in CAS was associated with favorable outcomes, with no major adverse events like stroke or death.
- The observed rates of minor bleeding and transfusion were within acceptable ranges for carotid artery revascularization.
- Bivalirudin appears to be a safe anticoagulation option for CAS, with a safety profile comparable to its use in percutaneous coronary interventions.
Background:
Prior to June 2011, carotid artery stenting (CAS) had been limited to patients deemed high risk for surgical revascularization due to medical or anatomic reasons. Intraprocedural anticoagulation for CAS has traditionally been carried out with unfractionated heparin (UFH). The direct thrombin inhibitor bivalirudin has emerged as a possible alternative choice for anticoagulation in this patient population. In patients undergoing coronary interventions, bivalirudin has been shown in large prospective analysis to reduce major adverse events and hemorrhagic complications (TIMI major bleeding rates, 0.6%-3.1%; TIMI minor bleeding rates, 1.3%-3.7%). As of now, the safety and efficacy of bivalirudin for use during carotid stenting has not been rigorously evaluated. To date, the published evidence in favor of bivalirudin for CAS exists in small retrospective analyses and two prospective studies.
Methods:
We present a retrospective analysis of 331 patients with a total of 365 carotid artery lesions undergoing CAS between February 2007 and September 2010. The procedures were performed by five experienced operators from four separate sites within the same metropolitan area. Patients were included who received bivalirudin as the anticoagulation strategy and underwent CAS. The primary endpoints of the study were 30-day incidence of death, stroke, TIMI major bleeding (defined as ≥5 g/dL Hgb drop or intracranial hemorrhage), TIMI minor bleeding (defined as ≥3 g/dL Hgb drop), and blood transfusion. All data were collected by retrospective chart review.
Results:
A total of 365 CAS procedures were performed. There were no deaths, strokes, or TIMI major bleeds. There was a 2.19% incidence of TIMI minor bleeding (8/365) and a 1.64% rate of blood transfusion (6/365).
Conclusions:
In our patient population, the major endpoints of stroke, death, MI, major and minor bleeding rates were well within those previously reported overall for carotid artery revascularization. Hence, we conclude that bivalirudin may be safe for use in CAS procedures with a safety profile similar to that validated in percutaneous coronary interventions.
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