Self-managed long-term low-molecular-weight heparin therapy: the balance of benefits and harms.

Abstract

PURPOSE:

A substantial clinical need exists for an alternate to vitamin K antagonists for treating deep vein thrombosis in many patients. Long-term low-molecular-weight heparin (LMWH), body-weight adjusted, avoids anticoagulant monitoring and may be associated with less bleeding. We evaluated the effectiveness and safety of long-term LMWH compared with vitamin K antagonist therapy in a broad spectrum of patients with proximal vein thrombosis.

METHODS:

We performed a multicenter, randomized, open-label clinical trial using objective outcome measures comparing therapy for 3 months. Outcomes were assessed at 3 and 12 months.

RESULTS:

Of 737 patients, 18 of 369 receiving tinzaparin (4.9%) had recurrent venous thromboembolism at 3 months compared with 21 of 368 (5.7%) receiving usual care (absolute difference, -0.8%, 95% confidence interval -4.1-2.4). Hemorrhagic complications occurred less frequently in the LMWH group largely because of less minor bleeding: 48 of 369 patients (13.0%) versus 73 of 368 patients (19.8%) receiving usual-care anticoagulation (absolute difference -6.8%; P = .011; risk ratio = 0.66). New major bleeding events ceased early (by day 23, P = .034) for patients receiving LMWH but persisted throughout the study treatment interval for patients receiving vitamin K antagonist therapy. No mortality advantage was shown for LMWH.

CONCLUSION:

Our study shows that LMWH is similar in effectiveness to the usual-care vitamin K antagonist treatment for preventing recurrent venous thromboembolism in a broad spectrum of patients. It causes less harm and enhances the clinicians' therapeutic options for patients with proximal deep vein thrombosis. Our findings reported here suggest the possibility of a broader role for long-term LMWH in selected patients.

• Authors: Russell D Hull, Graham F Pineo, Rollin F Brant, Andrew F Mah, Natasha Burke, Richard Dear, Turnly Wong, Roy Cook, Susan Solymoss, Man-Chiu Poon, Gary Raskob, LITE Trial Investigators
• Journal: The American journal of medicine (Am J Med) Vol. 120 Issue 1 Pg. 72-82 (Jan 2007) ISSN: 1555-7162 [Electronic] United States
• PMID: 17208082 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Fibrinolytic Agents
• Heparin, Low-Molecular-Weight
• Vitamin K
• Warfarin
• Tinzaparin

Topics

• Anticoagulants (administration & dosage, therapeutic use)
• Cause of Death
• Female
• Fibrinolytic Agents (administration & dosage, adverse effects, therapeutic use)
• Hemorrhage (epidemiology)
• Heparin, Low-Molecular-Weight (administration & dosage, adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Recurrence
• Self Administration
• Tinzaparin
• Treatment Outcome
• Venous Thrombosis (drug therapy)
• Vitamin K (antagonists & inhibitors)
• Warfarin (administration & dosage, therapeutic use)