Percutaneous Transluminal Angioplasty

There is limited experience using bivalirudin in the performance of PTA involving the renal or other peripheral arteries. Allie et al. (2003) performed 180 renal and 75 iliac artery PTAs for patients with severe arterial disease using bivalirudin as the only anticoagulant. Procedural success was achieved in 100% of patients, and no adverse thrombotic events were reported. The authors did note a decrease in sheath removal time, time to ambulation, and length of hospital stay. A decrease in vascular access complications was also seen. Shammas et al. (2003) performed PTA on 48 consecutive patients for lower extremity claudication or ulceration. Although there were two serious in-hospital procedural complications, no patient needed emergent revascularization, nor suffered death or limb loss. Allie and colleagues (2004) also assessed the safety and efficacy of bivalirudin in 505 patients undergoing percutaneous peripheral intervention (PPI) for renal, iliac or femoral disease at 26 centers. Procedural success was achieved in 95% of patients and ischemic events and major hemorrhage rates were low.

Bivalirudin has also been used in carotid artery stenting (Lee et al., 2005; Lin et al., 2005; Finks, 2006). Lee et al. compared bivalirudin to heparin in 46 consecutive patients undergoing carotid artery stenting. Procedural success was 100% in the 24 patients receiving bivalirudin and there were no episodes of major bleeding, vascular complications, strokes, or death. Lin and colleagues performed 200 carotid artery stent procedures on 182 patients, the first 54 receiving heparin anticoagulation. Their protocol was changed, based on results from the REPLACE-2 trial for the next 128 consecutive individuals, resulting in a significant decrease in hemorrhagic complications (Lin et al., 2005). Although none of the series listed above were randomized or double-blind, the authors concluded that bivalirudin was safe, effective, and a reasonable alternative to heparin in peripheral interventions. In addition, the data appear favorable showing lower major bleeding rates and adverse events compared to heparin.

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