hirudin and Renal-Artery-Obstruction

High-risk patient characteristics and complexity of percutaneous peripheral intervention (PPI) procedures suggest a need for predictable and reliable anticoagulation. We undertook this study to assess the safety and efficacy of bivalirudin as the procedural anticoagulant in patients undergoing PPI of the renal, iliac, or femoral artery.. This was a prospective, open-label, single arm study inpatients undergoing PPI of the renal, iliac, or femoral vessels to assessbivalirudin as the sole procedural anticoagulant (0.75 mg/kg bolus/1.75 mg/kg/hr infusion). The primary endpoint was procedural success defined as residual stenosis < 20%. Secondary endpoints included ischemic events (death, myocardial infarction, unplanned revascularization, and amputation), and bleeding complications, as well as ACT values and times to sheath removal, ambulation, and discharge.. 505 patients were enrolled at 26 sites. Procedural success was achieved in 95.0% of patients. Ischemic events were low (1.4%) and similar between vessel types. Protocol-defined major hemorrhage and TIMI major hemorrhage rates were 2.2% and 0.4%, respectively. Mean ACTs were similar among treatment groups (renal 353.8 seconds(s); iliac 335.9s, femoral, 343.5s).. Bivalirudin provided consistent anticoagulation and similar outcomes in all vessel types treated at the dose tested. Ischemic and bleeding event rates were low, demonstrating the safe use of bivalirudin as a procedural anticoagulant in PPI.

Topics: Aged; Angioplasty, Balloon; Arterial Occlusive Diseases; Catheterization, Peripheral; Combined Modality Therapy; Female; Femoral Artery; Follow-Up Studies; Hirudins; Humans; Iliac Artery; Length of Stay; Male; Middle Aged; Peptide Fragments; Peripheral Vascular Diseases; Prospective Studies; Recombinant Proteins; Renal Artery Obstruction; Risk Assessment; Single-Blind Method; Survival Rate; Time Factors; Treatment Outcome; Vascular Patency

Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Catheterization; Clopidogrel; Embolism; Fibrinolytic Agents; Heparin; Hirudins; Humans; Peptide Fragments; Platelet Aggregation Inhibitors; Recombinant Proteins; Renal Artery Obstruction; Ticlopidine

Topics: Anticoagulants; Female; Fibrinolytic Agents; Heparin; Hirudins; Humans; Middle Aged; Recombinant Proteins; Renal Artery Obstruction; Renal Insufficiency; Syndrome; Thrombocytopenia; Thrombosis

Percutaneous peripheral interventions (PPI) are often complex procedures performed on high-risk patients with a significant thrombus burden. Although there is no approved anticoagulant for use in PPI, heparin is commonly used but is associated with several limitations. The APPROVE data provide a foundation for further study of bivalirudin in the setting of PPI.

Topics: Anticoagulants; Constriction, Pathologic; Endovascular Procedures; Heparin; Hirudins; Humans; Iliac Artery; Peptide Fragments; Peripheral Arterial Disease; Recombinant Proteins; Renal Artery Obstruction

Many heparin (UFH) limitations are overcome by bivalirudin (Angiomax ). The pharmacokinetic profile of bivalirudin appears well suited for percutaneous peripheral intervention (PPI), yet few data exist regarding its safety and feasibility in this setting.. One hundred and eighty renal and 75 iliac PPIs performed between May 2001 and June 2002 with bivalirudin as anticoagulation were compared to a historical UFH control. Variables evaluated included thrombotic events, intracranial bleeding, major surgical complications, sheath removal time, vascular access complication, time to ambulate and length of stay (LOS). Follow-up included 6-month renal and iliac duplex ultrasound and ankle-brachial index.. Procedural success was achieved in 100% of patients treated with bivalirudin, with no thrombotic events, intracranial bleeding or major surgical complications observed. Procedural success was achieved in 179/180 (99%) renal and 74/75 (98.6%) iliac patients treated with UFH. Significant differences were observed for sheath removal time < 60 minutes (84% versus 59%; p < 0.0001), time to ambulation < 6 hours (75.5% versus 58%; p < 0.0005) and LOS < 24 hours (85.5% versus 72%; p = 0.002) in bivalirudin-treated renal PPI patients versus UFH-treated patients, respectively. Significant differences were also observed in favor of bivalirudin for the iliac PPIs for sheath removal time < 60 minutes (p = 0.012) and time to ambulation < 6 hours (p = 0.039). Following 6-month renal and iliac duplex ultrasound, repeat PPI was required in 7/180 (3.9%) and 9/180 (5%) of renal, and 3/75 (4%) and 4/75 (5.3%) of iliac patients treated with bivalirudin or UFH, respectively.. Bivalirudin is a safe and feasible alternative anticoagulant in renal and iliac PPI and may offer decreased sheath removal time, time to ambulation and LOS. A larger prospective randomized multicenter trial is warranted.

Topics: Aged; Anticoagulants; Arterial Occlusive Diseases; Case-Control Studies; Cohort Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Heparin, Low-Molecular-Weight; Hirudins; Humans; Iliac Artery; Infusions, Intravenous; Male; Middle Aged; Peptide Fragments; Peripheral Vascular Diseases; Recombinant Proteins; Renal Artery Obstruction; Retrospective Studies; Risk Assessment; Treatment Outcome; Vascular Patency