Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in percutaneous peripheral intervention: a single-center experience.

Abstract

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 >or=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.

• Authors: Imran R Sheikh, S Hinan Ahmed, Naoyo Mori, Anjan Gupta, Mark Mewissen, Suhail Allaqaband, Tanvir Bajwa
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 2 Issue 9 Pg. 871-6 (Sep 2009) ISSN: 1876-7605 [Electronic] United States
• PMID: 19778776 (Publication Type: Comparative Study, Journal Article)

Chemical References

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

Topics

• Aged
• Aged, 80 and over
• Angioplasty (adverse effects, economics, instrumentation)
• Anticoagulants (adverse effects, economics, therapeutic use)
• Cost-Benefit Analysis
• Drug Costs
• Female
• Hemorrhage (chemically induced)
• Heparin (adverse effects, economics, therapeutic use)
• Hirudins (adverse effects, economics)
• Hospital Costs
• Humans
• Length of Stay
• Male
• Middle Aged
• Peptide Fragments (adverse effects, economics, therapeutic use)
• Peripheral Vascular Diseases (drug therapy, economics, therapy)
• Prospective Studies
• Recombinant Proteins (adverse effects, economics, therapeutic use)
• Stents
• Thrombosis (etiology, prevention & control)
• Time Factors
• Treatment Outcome
• Walking