bivalirudin and Arterial-Occlusive-Diseases

Replacing heparin with bivalirudin has been beneficial in patients undergoing coronary intervention and coronary artery bypass. The use of this alternative anticoagulant during peripheral bypass operations has not been studied. Concerns over distal thrombosis using this direct thrombin inhibitor (DTI) prompted a single-arm, open-label, pilot prospective trial of bivalirudin in patients undergoing lower extremity bypass to assess perioperative safety and efficacy.. Between 2006 and 2007, 18 patients met criteria for enrollment and underwent primary lower extremity bypass using bivalirudin. All patients had severe symptomatic atherosclerotic disease requiring lower extremity bypass. Bivalirudin at a bolus dose of 0.75 mg/kg and continuous infusion of 1.75 mg/kg/hr was used as the sole anticoagulant.. Patients (mean age, 67 years) underwent femoral-popliteal (n = 14) or femoral-tibial (n = 4) bypass preferentially using saphenous vein (83%). Mean operative time was 261 minutes, with bivalirudin infusion time of 95 +/- 26 minutes (mean +/- standard deviation). Reliable anticoagulation was achieved with weight-based dosing with activated clotting time values at baseline (systemic) of 131 +/- 92 seconds, during infusion (systemic) of 347 +/- 36 seconds, and from the distal vasculature (limb) of 345 +/- 66 seconds. Distal limb bivalirudin levels were stable at 9755 +/- 3860 ng/mL during clamp occlusion. Mean estimated blood loss was 332 +/- 191 mL with four patients (22%) requiring blood products. One patient required revision of the proximal anastomosis during the initial hospitalization. At 30 days, all bypass operations were patent with improvement of mean ankle-brachial index from 0.57 to 0.81. There were no deaths, myocardial infarctions, or amputations in the 30-day postoperative period. Based on the Thrombolysis in Myocardial Infarction classification for bleeding, one patient had major bleeding (>2 units of packed red blood cells), and three patients had minor bleeding within the first 30 days.. Bivalirudin is a safe and effective anticoagulant for lower extremity bypass operations. Thrombosis beyond the distal clamp was not seen. A comparative trial to standard anticoagulation is warranted.

Topics: Aged; Ankle Brachial Index; Anticoagulants; Arterial Occlusive Diseases; Blood Loss, Surgical; Hemorrhage; Hirudins; Humans; Infusions, Intravenous; Lower Extremity; Ohio; Peptide Fragments; Pilot Projects; Prospective Studies; Recombinant Proteins; Reoperation; Saphenous Vein; Thrombin; Thrombosis; Time Factors; Treatment Outcome; Vascular Patency; Vascular Surgical Procedures

The present study evaluated the combined use of unfractionated heparin (UFH) and bivalirudin during ad hoc transradial interventional procedures.. As a result of its proven efficacy in recent clinical trials, the direct thrombin inhibitor bivalirudin is now increasingly utilized as the anticoagulant of choice for coronary interventions. However, it is currently not packaged for diagnostic procedures. Patients undergoing ad hoc transradial procedures thus need unfractionated heparin during the diagnostic catheterization to protect against radial occlusion. It is unclear how the transition to bivalirudin should be undertaken if a subsequent intervention were performed.. A total of 117 patients underwent ad hoc transradial procedures. Fifty-one patients underwent diagnostic catheterizations receiving only 5,000 Units of UFH in divided doses: (1) Group 1H (n = 26), 2,500 U after sheath insertion and 2,500 U at conclusion; (2) Group 2H (n = 25), 1,000 U followed by 4,000 U. Sixty-six patients subsequently underwent interventions as part of the same procedure and received standard bivalirudin (B) dosing in addition to the initial UHF dose: Group 1B (n = 40), 2,500 Units of UFH plus B; Group 2B (n = 26), 1,000 Units of UFH plus B. The primary endpoint was postprocedure radial occlusion; secondary endpoints were any major adverse cardiac event (MACE) and any bleeding complication.. One patient (1%) had postprocedure radial occlusion, but this recanalized at 1 month. There were no deaths, and urgent target lesion revascularization was not required. Non-Q wave myocardial infarction occurred in 7.5%, all in Group 1B. No bleeding complications occurred.. The administration of bivalirudin after a reduced heparin dose in patients undergoing ad hoc transradial interventional procedures was not associated with adverse events in this small pilot study.

Topics: Aged; Anticoagulants; Arterial Occlusive Diseases; Cardiac Catheterization; Chemotherapy, Adjuvant; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Heparin; Hirudins; Humans; Incidence; Inpatients; Male; Middle Aged; Myocardial Infarction; Peptide Fragments; Pilot Projects; Prospective Studies; Radial Artery; Recombinant Proteins; Whole Blood Coagulation Time

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

Anticoagulant therapy is required to prevent radial artery occlusion (RAO) after transradial catheterization. There is no data comparing bivalirudin to standard heparin.. We studied 400 consecutive patients. In case of diagnostic angiography-only (n = 200), they received an intravenous bolus of heparin (70 U kg(-1)) immediately before sheath removal whereas in case of angiography followed by ad hoc percutaneous coronary intervention (n = 200), they received bivalirudin (bolus 0.75 mg kg(-1), followed by infusion at 1.75 mg/kg/h). RAO was assessed 4-8 weeks later using two-dimensional echography-doppler and reverse Allen's test with pulse oximetry.. At follow-up, 21 of the 400 (5.3%) patients were found to have RAO with no significant difference between the two groups (3.5% bivalirudin vs. 7.0% heparin, P = 0.18). Patients with RAO had a significantly lower weight compared to patients without RAO (78 ± 13 kg vs. 86 ± 18 kg, P = 0.011). By multivariate analysis, a weight <84 kg (OR: 2.78, 95% CI 1.08-8.00, P = 0.032) and a procedure duration ≤20 min (OR: 7.52, 95% CI 1.57-36.0, P = 0.011) remained strong independent predictors of RAO. All cases of radial occlusion were asymptomatic and without clinical sequelae.. Delayed administration of bivalirudin or heparin for transradial catheterization provides similar efficacy in preventing RAO. Because of its low cost, a single bolus of heparin can be preferred in case of diagnostic angiography whereas bivalirudin can be contemplated in case of ad hoc percutaneous coronary intervention. © 2010 Wiley-Liss, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Anticoagulants; Arterial Occlusive Diseases; Cardiac Catheterization; Chi-Square Distribution; Constriction, Pathologic; Coronary Angiography; Echocardiography, Doppler; Female; Heparin; Hirudins; Humans; Infusions, Intravenous; Injections, Intravenous; Logistic Models; Male; Middle Aged; Odds Ratio; Oximetry; Patient Selection; Peptide Fragments; Radial Artery; Recombinant Proteins; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Anticoagulants; Arterial Occlusive Diseases; Cardiac Catheterization; Constriction, Pathologic; Coronary Angiography; Heparin; Hirudins; Humans; Infusions, Intravenous; Injections, Intravenous; Peptide Fragments; Radial Artery; Recombinant Proteins; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

The objective of this retrospective chart review was to evaluate the safety and feasibility of using the direct thrombin inhibitor bivalirudin as the procedural anticoagulant in patients undergoing percutaneous peripheral intervention (PPI).. Patients with peripheral artery disease are in general a high-risk population that requires safe and reliable anticoagulation with complete thrombin inhibition. Bivalirudin, a direct thrombin inhibitor, has been shown to be as effective as heparin, but with fewer bleeding events in PCI trials, and recent data suggest that bivalirudin may provide the same benefits in PPI.. This was a retrospective chart review of patients who underwent PPI with bivalirudin as the foundation anticoagulant. Bivalirudin was administered as a 0.75 mg per kg bolus, followed by a 1.75 mg per kg per hour infusion for the duration of the procedure. The primary endpoint was procedural success defined as residual stenosis less than or equal to 20%. Ischemic and hemorrhagic events were collected, as well as time-to-sheath removal, ambulation and discharge.. Data were collected for 150 patients. Procedural success was achieved in 98.5%. Ischemic events were low: death (2.0%), myocardial infarction (0.0%), urgent revascularization (0.8%). Major and minor hemorrhage occurred in 4.7% and 2.0% of patients, respectively. Time-to-sheath removal, ambulation and discharge were short.. Bivalirudin provided effective anticoagulation in these generally high-risk patients undergoing PPI. Ischemic and bleeding events were low and comparable to those reported in the literature, suggesting that bivalirudin is safe to use in this population.

Topics: Aged; Angioplasty; Anticoagulants; Antithrombins; Arterial Occlusive Diseases; Feasibility Studies; Female; Hemorrhage; Hirudins; Humans; Incidence; Ischemia; Male; Medical Records; Middle Aged; Peptide Fragments; Platelet Glycoprotein GPIIb-IIIa Complex; Recombinant Proteins; Retrospective Studies; Treatment Outcome; Urokinase-Type Plasminogen Activator

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