In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry

J Endovasc Ther. 2010 Feb;17(1):31-6. doi: 10.1583/09-2810.1.

Abstract

Purpose: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI).

Methods: Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated.

Results: Procedural success (<30% residual narrowing) was achieved in 359 (97.3%) patients receiving bivalirudin. Adverse events included stroke (1, 0.3%), acute renal failure (1, 0.3%), major bleeding (3, 0.8%), distal embolization (11, 3.0%), vascular access complications (2, 0.5%), and minor amputation (2, 0.5%).

Conclusion: Bivalirudin had an excellent safety profile in a real-life cohort of patients undergoing PPI, including high-risk patients with critical limb ischemia and TASC D lesions. In-hospital major bleeding and other adverse events were infrequent. A randomized trial of bivalirudin versus UFH is needed to verify these results and establish bivalirudin as a standard anticoagulant in PPI.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty* / adverse effects
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use*
  • Chi-Square Distribution
  • Constriction, Pathologic
  • Female
  • Hemorrhage / chemically induced
  • Heparin / adverse effects
  • Heparin / therapeutic use*
  • Hirudins / adverse effects
  • Humans
  • Inpatients* / statistics & numerical data
  • Iowa
  • Ischemia / diagnostic imaging
  • Ischemia / etiology
  • Ischemia / therapy*
  • Logistic Models
  • Male
  • Middle Aged
  • Peptide Fragments / adverse effects
  • Peptide Fragments / therapeutic use*
  • Peripheral Vascular Diseases / complications
  • Peripheral Vascular Diseases / diagnostic imaging
  • Peripheral Vascular Diseases / therapy*
  • Radiography
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Anticoagulants
  • Hirudins
  • Peptide Fragments
  • Recombinant Proteins
  • Heparin
  • bivalirudin