Randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease

Am Heart J. 2003 Apr;145(4):614-21. doi: 10.1067/mhj.2003.189.

Abstract

Background: We compared the efficacy and safety of the low-molecular weight heparin enoxaparin with unfractionated heparin (UFH) for the prevention of venous thromboembolic disease in patients with heart failure or severe respiratory disease.

Methods: This was a multicenter, controlled, randomized, open study in which patients received either enoxaparin (40 mg once daily) or UFH (5000 IU 3 times daily) for 10 +/- 2 days in 64 medical departments in Germany. Patients were stratified and enrolled according to their underlying disease: severe respiratory disease or heart failure. The primary efficacy parameter was a thromboembolic event up to 1 day after the treatment period.

Results: Of the 665 patients enrolled, 451 patients were able to be evaluated in the primary efficacy analysis. The incidence of thromboembolic events was 8.4% with enoxaparin and 10.4% with UFH. Enoxaparin was at least as effective as UFH, with a 1-sided equivalence region of -4% (90% CI -2.5-6.5, P =.015). Enoxaparin was associated with fewer deaths, less bleeding, and significantly fewer adverse events (45.8% vs 53.8%, P =.044).

Conclusions: Enoxaparin is at least as effective as UFH in the prevention of thromboembolic events in patients with heart failure or severe respiratory disease. Its beneficial safety profile and once-daily administration is advantageous for inpatient and outpatient use.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / administration & dosage
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use*
  • Drug Administration Schedule
  • Enoxaparin / administration & dosage
  • Enoxaparin / adverse effects
  • Enoxaparin / therapeutic use*
  • Female
  • Heart Failure / complications*
  • Hemorrhage / chemically induced
  • Heparin / administration & dosage
  • Heparin / adverse effects
  • Heparin / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Respiratory Tract Diseases / complications*
  • Thromboembolism / complications
  • Thromboembolism / prevention & control*
  • Venous Thrombosis / complications
  • Venous Thrombosis / prevention & control*

Substances

  • Anticoagulants
  • Enoxaparin
  • Heparin