Self-Managed Long-Term Low-Molecular-Weight Heparin Therapy: The Balance of Benefits and Harms - 09/08/11
, Graham F. Pineo, MD a, Rollin F. Brant, PhD b, Andrew F. Mah, BSc a, Natasha Burke, BSc a, Richard Dear, MD a, Turnly Wong, MD c, Roy Cook, MD a, Susan Solymoss, MD d, Man-Chiu Poon, MD, MSc a, Gary Raskob, PhD eLITE Trial Investigators
Requests for reprints should be addressed to Russell D. Hull, MBBS, MSc, Thrombosis Research Unit, 601 South Tower, Foothills Hospital, 1403 29th Street NW, Calgary, Alberta, Canada T2N 2T9.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.
Le texte complet de cet article est disponible en PDF.Keywords : Long-term low-molecular-weight heparin, Broad spectrum of patients, Usual-care anticoagulation, Vitamin K antagonist therapy
Plan
| The study was supported by a Medical Research Council (now Canadian Institutes for Health Research) and Industry grant (Leo Pharmaceutical Products Ltd A/S of Denmark). Additional funding was provided by Pharmion and Dupont Pharmaceuticals. Leo provided study drug and drug safety monitoring. The funding organization(s) and sponsor(s) did not have a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation or approval of the article. |
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| Study design Table and participating sites Appendix available online. |
Vol 120 - N° 1
P. 72 - janvier 2007 Retour au numéro
Article précédent
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