BACKGROUND: Predictors of complications in peripheral percutaneous interventions (PPI) with bivalirudin as a base anticoagulant have not yet been defined. The Angiomax Peripheral Procedure Registry of Vascular Events (APPROVE) offers a unique opportunity to analyze predictors of complications with bivalirudin in PPI. METHODS: APPROVE was a prospective, open-label, multi-center clinical trial that assessed the feasibility of bivalirudin in renal, iliac and femoral interventions. Bivalirudin was administered intravenously at a dose of 0.75 mg per kg bolus followed by an infusion of 1.75 mg per kg per hour for the duration of the procedure. Glycoprotein (GP) IIb-IIIa inhibitors were permitted at the discretion of the treating physician. Multiple independent variables were included in a Logistic Regression model to determine predictors of the combined endpoints of ischemic (death, amputation, unplanned urgent revascularization at the treated site, myocardial infarction) and major bleeding or major bleeding alone, assessed during hospitalization and at 30 days. RESULTS: Predictors of in-hospital ischemic and major bleed events were congestive heart failure (p = 0.0173) and exchanges to larger sheath size (ELS) (p = 0.0045). The strongest predictor of major bleeding alone at discharge (p = 0.0041) and at 30 days (p = 0.0016) was the number of ELS. Also, female gender (p = 0.08) and low weight (stratified by gender with < 80 kg versus > 92 kg for males and < 62 kg versus > 77 kg for females) (p = 0.096) showed a trend toward predicting major bleeding at 30 days. Of 505 patients in APPROVE, 26 patients required more than one sheath exchange. Of these, 24 were ELS. Despite this small number, these patients accounted for most of the major bleeding events that occurred (11.5% versus 1.7% in-hospital bleeding for the patients with ELS versus single sheath use respectively, and 15.4% versus 3.1% for 30-day bleeding). GP IIb-IIIa inhibitors (n = 22) use and thrombotic lesions (3%) were not predictors of ischemic and/or bleeding complications. CONCLUSION: ELS during PPI is a strong predictor of bleeding events when bivalirudin is used as a base anticoagulant. Female gender and low weight also tend to contribute to major bleeding.
BACKGROUND: Predictors of complications in peripheral percutaneous interventions (PPI) with bivalirudin as a base anticoagulant have not yet been defined. The Angiomax Peripheral Procedure Registry of Vascular Events (APPROVE) offers a unique opportunity to analyze predictors of complications with bivalirudin in PPI. METHODS: APPROVE was a prospective, open-label, multi-center clinical trial that assessed the feasibility of bivalirudin in renal, iliac and femoral interventions. Bivalirudin was administered intravenously at a dose of 0.75 mg per kg bolus followed by an infusion of 1.75 mg per kg per hour for the duration of the procedure. Glycoprotein (GP) IIb-IIIa inhibitors were permitted at the discretion of the treating physician. Multiple independent variables were included in a Logistic Regression model to determine predictors of the combined endpoints of ischemic (death, amputation, unplanned urgent revascularization at the treated site, myocardial infarction) and major bleeding or major bleeding alone, assessed during hospitalization and at 30 days. RESULTS: Predictors of in-hospital ischemic and major bleed events were congestive heart failure (p = 0.0173) and exchanges to larger sheath size (ELS) (p = 0.0045). The strongest predictor of major bleeding alone at discharge (p = 0.0041) and at 30 days (p = 0.0016) was the number of ELS. Also, female gender (p = 0.08) and low weight (stratified by gender with < 80 kg versus > 92 kg for males and < 62 kg versus > 77 kg for females) (p = 0.096) showed a trend toward predicting major bleeding at 30 days. Of 505 patients in APPROVE, 26 patients required more than one sheath exchange. Of these, 24 were ELS. Despite this small number, these patients accounted for most of the major bleeding events that occurred (11.5% versus 1.7% in-hospital bleeding for the patients with ELS versus single sheath use respectively, and 15.4% versus 3.1% for 30-day bleeding). GP IIb-IIIa inhibitors (n = 22) use and thrombotic lesions (3%) were not predictors of ischemic and/or bleeding complications. CONCLUSION:ELS during PPI is a strong predictor of bleeding events when bivalirudin is used as a base anticoagulant. Female gender and low weight also tend to contribute to major bleeding.