 |
|
Subcutaneous Adjusted-Dose Unfractionated Heparin vs Fixed-Dose Low-Molecular-Weight Heparin in the Initial Treatment of Venous Thromboembolism
Writing Committee for the Galilei Investigators*
Arch Intern Med. 2004;164:1077-1083.
Background Few reports have addressed the value of unfractionated heparin (UFH) or low-molecular-weight heparin in treating the full spectrum of patients with venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism.
Methods In an open, multicenter clinical trial, 720 consecutive patients with acute symptomatic VTE, including 119 noncritically ill patients (16.5%) with pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm (preceded by an intravenous loading dose), or fixed-dose (adjusted only to body weight) subcutaneous nadroparin calcium. Oral anticoagulant therapy was started concomitantly and continued for at least 3 months. We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up.
Results Fifteen (4.2%) of the 360 patients assigned to UFH had recurrent thromboembolic events, as compared with 14 (3.9%) of the 360 patients assigned to nadroparin (absolute difference between rates, 0.3%; 95% confidence interval, –2.5% to 3.1%). Four patients assigned to UFH (1.1%) and 3 patients assigned to nadroparin (0.8%) had episodes of major bleeding (absolute difference between rates, 0.3%; 95% confidence interval, –1.2% to 1.7%). Overall mortality was 3.3% in each group.
Conclusions Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE, including those with pulmonary embolism and recurrent VTE.
*The Writing Committee members for the Galilei Study who had complete access to the raw data needed for this report and who bear authorship responsibility for this report are Paolo Prandoni, MD, PhD; Marino Carnovali, MD; and Antonio Marchiori, MD. The Writing Committee for this article has no relevant financial interest in this article. From the Department of Medical and Surgical Sciences, Università di Padova, Padova (Drs Prandoni and Marchiori), and Area Strategica di Patologia Vascolare, Ospedale di Rho-Passirana, Milan (Dr Carnovali), Italy.
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Parenteral Anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
Hirsh et al.
Chest 2008;133:141S-159S.
ABSTRACT
| FULL TEXT
Hemorrhagic Complications of Anticoagulant and Thrombolytic Treatment: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
Schulman et al.
Chest 2008;133:257S-298S.
ABSTRACT
| FULL TEXT
Antithrombotic Therapy for Venous Thromboembolic Disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
Kearon et al.
Chest 2008;133:454S-545S.
ABSTRACT
| FULL TEXT
BET 2. SUBCUTANEOUS HEPARIN IS AS GOOD AS LOW-MOLECULAR-WEIGHT HEPARIN IN THE ACUTE TREATMENT OF THROMBO-EMBOLIC DISEASE
Munro and English
Emerg. Med. J. 2008;25:287-289.
FULL TEXT
Clinical Predictors for Fatal Pulmonary Embolism in 15 520 Patients With Venous Thromboembolism: Findings From the Registro Informatizado de la Enfermedad TromboEmbolica venosa (RIETE) Registry
Laporte et al.
Circulation 2008;117:1711-1716.
ABSTRACT
| FULL TEXT
No Difference in Risk for Thrombocytopenia During Treatment of Pulmonary Embolism and Deep Venous Thrombosis With Either Low-Molecular-Weight Heparin or Unfractionated Heparin: A Metaanalysis
Morris et al.
Chest 2007;132:1131-1139.
ABSTRACT
| FULL TEXT
Trials That Matter: Can Patients with Venous Thromboembolism Be Treated with Fixed-Dose Subcutaneous Unfractionated Heparin?
Goldhaber and Berkwits
ANN INTERN MED 2006;145:929-931.
FULL TEXT
Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism.
Kearon et al.
JAMA 2006;296:935-942.
ABSTRACT
| FULL TEXT
Subcutaneous unfractionated heparin vs low-molecular-weight heparin for acute thromboembolic disease: issues of efficacy and cost.
Carson
JAMA 2006;296:991-993.
FULL TEXT
Management of venous thromboembolism: [Traitement de la maladie thromboembolique veineuse].
de Moerloose et al.
Canadian J. Anesthesia 2006;53:S80-S88.
ABSTRACT
| FULL TEXT
How I treat venous thromboembolism in patients with cancer
Prandoni
Blood 2005;106:4027-4033.
ABSTRACT
| FULL TEXT
23 Apr 2004 to 23 Jul 2004
Evid. Based Nurs. 2004;7:e4-e4.
FULL TEXT
|
