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J Am Coll Cardiol Intv, 2009; 2:871-876, doi:10.1016/j.jcin.2009.06.015
© 2009 by the American College of Cardiology Foundation
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Clinical Research

Comparison of Safety and Efficacy of Bivalirudin Versus Unfractionated Heparin in Percutaneous Peripheral Intervention

A Single-Center Experience

Imran R. Sheikh, MD*, S. Hinan Ahmed, MD*, Naoyo Mori, PhD{dagger}, Anjan Gupta, MD*, Mark Mewissen, MD*, Suhail Allaqaband, MD*, Tanvir Bajwa, MD*,*

* Aurora Cardiovascular Services, Aurora Sinai/St. Luke's Medical Centers, University of Wisconsin School of Medicine and Public Health-Milwaukee Clinical Campus, Milwaukee, Wisconsin
{dagger} Center for Urban Population Health, University of Wisconsin-Milwaukee, Milwaukee, Wisconsin

* Reprint requests and correspondence: Dr. Tanvir Bajwa, 2801 West Kinnickinnic River Parkway, #777, Milwaukee, Wisconsin 53215 (Email: bdanek{at}hrtcare.com).

Objectives: The aim of this study was to determine the efficacy and safety of bivalirudin versus low-dose unfractionated heparin (UFH) in percutaneous peripheral intervention (PPI).

Background: Anticoagulation strategies used in PPI are based primarily on studies of percutaneous coronary intervention where higher doses of heparin are used usually in combination with a glycoprotein IIb/IIIa inhibitor. There are no studies comparing bivalirudin alone versus low-dose heparin in PPI.

Methods: Consecutive patients who underwent PPI at our institution were treated with either bivalirudin or low-dose UFH. Patients were assessed prospectively during index hospital stay for procedural success and bleeding complications. Of 236 patients, 111 were dosed with UFH at 50 U/kg (goal activated clotting time of 180 to 240 s), and 125 were dosed with bivalirudin at 0.75-mg/kg/h bolus followed by a 1.75-mg/kg infusion. Procedural success was defined as <20% post-procedure residual stenosis with no flow-limiting dissections or intravascular thrombus formation and major bleeding as intracranial or retroperitoneal hemorrhage or a fall in hemoglobin ≥5 g/dl. Anticoagulation cost analysis was conducted.

Results: Procedural success and major bleeding rates were similar with bivalirudin versus heparin (98% vs. 99% and 2.4% vs. 0.9%, respectively). There were no differences in minor bleeding, time to ambulation, and length of hospital stay. The hospital cost for bivalirudin was $547 and <$1.22 for heparin (10,000 U). Two activated clotting time levels cost $4.00.

Conclusions: Low-dose UFH is as effective and safe as bivalirudin when used as an anticoagulation strategy in patients undergoing PPI, and low-dose UFH is less costly than bivalirudin. Larger randomized studies are required to further evaluate these findings.

Key Words: bivalirudin • heparin • percutaneous peripheral intervention

Abbreviations and Acronyms
  ACT = activated clotting time
  GP = glycoprotein
  PCI = percutaneous coronary intervention
  PPI = percutaneous peripheral intervention
  PRBC = packed red blood cells
  UFH = unfractionated heparin






 
   
 
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