Arteriotomy closure device safety after percutaneous coronary intervention in the direct thrombin inhibitor era: A comparative study

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.