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Published on: February 28, 2012
Arteriotomy closure device safety after percutaneous coronary intervention in the direct thrombin inhibitor era: a
Gus Theodos1, Chad Raymond, Matthew C Becker
1Cleveland Clinic, Cleveland, Ohio 44195, USA.
Insights
Bivalirudin use during percutaneous coronary intervention (PCI) significantly reduces vascular complications compared to heparin. Arteriotomy closure devices (ACDs) like Perclose and Angio-Seal are safer than manual compression for PCI patients.
Area of Science:
- Interventional Cardiology
- Vascular Surgery
- Pharmacology
Background:
- Arteriotomy closure devices (ACDs) and manual compression show similar complication risks in percutaneous coronary intervention (PCI) with heparin-based anticoagulation.
- Bivalirudin is increasingly used as the primary anticoagulant for PCI.
- This study evaluates vascular complication risks with specific ACDs (Angio-Seal, Perclose) versus manual compression when using bivalirudin.
Purpose of the Study:
- To assess the safety and vascular complication risk of arteriotomy closure devices (ACDs) when used with bivalirudin during PCI.
- To compare the efficacy of Angio-Seal, Perclose, and manual compression for groin hemostasis in bivalirudin-treated patients.
Main Methods:
- Retrospective analysis of 14,354 consecutive PCI patients from 2000-2008.
- Patients were stratified by anticoagulation (bivalirudin vs. heparin + GP IIb/IIIa inhibitors) and closure method.
- Multivariable analysis was employed to adjust for baseline differences and identify predictors of complications.
Main Results:
- Patients receiving bivalirudin had significantly lower overall complication rates (2.9% vs. 8.7%, P < 0.001).
- Perclose demonstrated fewer complications than Angio-Seal and manual compression (3.9% vs. 5.6% vs. 9.0%, P < 0.001).
- Independent predictors of complications included age ≥ 65, female gender, BMI ≤ 26, and operator experience.
Conclusions:
- Adjunctive bivalirudin use in PCI is associated with a reduced incidence of vascular complications.
- Perclose and Angio-Seal devices offer significantly lower complication rates than manual compression.
- Female patients aged 65 and older represent the highest-risk demographic for vascular complications.
Objectives:
To investigate the safety and risk of vascular complications of arteriotomy closure devices (ACD) with the direct thrombin inhibitor bivalirudin in patients undergoing percutaneous coronary intervention (PCI).
Background:
ACDs and manual compression have been shown to have a similar risk of complications in the setting of PCI with heparin ± glycoprotein (GP) IIb/IIIa inhibitor usage. In many centers bivalirudin is becoming the most frequent type of anticoagulation used during PCI. We sought to determine the risk of vascular complications using Angio-Seal, Perclose, and manual compression for groin hemostasis using predominantly bivalirudin.
Methods:
Our institution's interventional database retrospectively identified 14,354 consecutive patients undergoing PCI from 2000 to 2008. Patients were grouped by the adjunctive anticoagulation used (bivalirudin vs. heparin + GP IIb/IIIa inhibitors) as well as ACD employed. The incidence of complications was evaluated using multivariable analysis to account for baseline differences between groups.
Results:
Patients undergoing PCI with adjunctive bivalirudin had significantly fewer complications overall, regardless of closure method (2.9% vs. 8.7%, P < 0.001). The Perclose group had significantly fewer complications than the Angio-Seal and manual compression groups (3.9% vs. 5.6% vs. 9.0%, P < 0.001) respectively; the Angio-Seal group had significantly fewer complications than manual compression. Multivariable analysis also identified age ≥ 65, female gender, BMI ≤ 26, and operator as independent predictors of complications.
Conclusions:
The use of adjunctive bivalirudin during PCI was associated with fewer vascular complications. In addition, the Perclose and Angio-Seal devices had significantly fewer complications than manual compression and women ≥ 65 are at highest risk.
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