IMPROVING RECANALIZATION OF DEEP VEINS AND THE «OUTCOMES» OF VENOUS THROMBOEMBOLIC COMPLICATIONS IN PROLONGED THERAPY WITH ENOXAPARIN

Vorobyeva N.M., Panchenko E.P., Dobrovolsky A.B., Titaeva E.V., Ermolina О.V., Balakhonova Т.V., Kirienko A.I.
Laboratory for Clinical Problems of Atherosclerosis, Federal State Facility «Russian Cardiological Research and Production Complex» under the RF Ministry of Public Health and Social Development, Department of Faculty Surgery, Russian State Medical University named after N.I. Pirogov,
Moscow, Russia

Objective. The study was aimed at comparing efficacy and safety of two different approaches to initial anticoagulant therapy: a standard approach (non-fractionated heparin [NFH] for not less than 5 days followed by changing over to warfarin) and an alternative one, i. е., prolongation of treatment with therapeutic doses of enoxaparin for up to one month with switching to warfarin, also assessing the effect of initial anticoagulant therapy on the «outcomes» of venous thromboembolic complications (VTECs) during 12 months of treatment.

Materials and methods. We followed up a total of one hundred and eleven patients after endured episodes of deep vein thrombosis (DVT) and/or pulmonary artery thromboembolism (PATE). Group One patients (n=80) received the standard therapy (NFH for not less than 5 days followed by changing over to warfarin). For Group Two patients (n=31), NFH was replaced by therapeutic doses of enoxaparin (1 mg/kg each 12 hours) for at least 30 days, with the patients then transferred to warfarin according to the standard regimen. Ultrasonographic duplex scanning of limb vessels was performed at baseline, 1, 3, 6 and 12 months after initiation of therapy. The patients were followed up for 12 months. The following end points were taken into account: DVT/PATE relapses, haemorrhagic complications.

Results. Improved patency of deep veins one month after initiation of treatment was observed in the both groups, however efficacy of enoxaparin turned out to be superior to that of the standard therapy in relation to a decreased number of occlusive thrombosis of veins – 9 versus 41 (p=0.005). Commencing from month two of treatment patients from the both groups began taking warfarin, however the number of occlusive thromboses of deep veins during 12 months of treatment was considerably lower as compared with that in the enoxaparin group, i. е. 1 versus 21 (p=0.013) after 3 months; with 1 vs 11 (p=0.009) after 6 months, and 0 vs 8 (p=0.013) after 12 months. The rate of DVT relapses and haemorrhagic complications during the first month of treatment was similar in the both groups. Starting from month two of therapy there were no DVT relapses in the enoxaparin group.

Conclusions. Enoxaparin within the first month of treatment in patients having developed VTEC, with similar DVT complication rate, appeared to be superior to the standard therapy with NFH and warfarin in achieving recanalization of occlusively thrombosed veins, with its advantages in improving patency of deep veins preserving within 12 months. The use of enoxaparin was also associated with lower rate of DVT relapses during 12 months of treatment.

KEY WORDS: enoxaparin, non-fractionated heparin, warfarin, venous thromboembolic complications.

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