الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Summary
The Low molecular weight heparin (LMWH) and vitamin K antagonists are considered as the first line management option for the prevention and treatment of deep venous thromboembolism for several decades as warfarin was the only oral anticoagulation option; but new oral anticoagulants have the potential to change the management of lower limb DVT.
The aims of the present study were to study the short term outcome of two regimens; enoxaparin plus vitamin k antagonist versus novel oral anticoagulants in the treatment of acute deep venous thrombosis regarding improvement of clinical condition, time needed for resolution of symptoms of DVT, duplex follow up data such as rate of recanalization of the affected veins, efficiency and complications of each drug group.
This prospective comparative randomized study included 60 patients with lower limb venous thromboembolism. They were divided according to the regimen of treatment into two equal groups; the Clexane / Marevan group and the Revarospire group. Patients were recruited and assessed for eligibility from Department of General Surgery at Vascular Surgery unit Beni-Suef University Hospital.
Regarding the demographic characteristics of the studied cases, the present study revealed that the mean age in patients in the Clexane / Marevan group and the Revarospire groupwas 44.43±15.17 vs. 44.57±15.39, respectively. Moreover, females were 56.7% vs. 70%, respectively; the most common cause of DVT was oral contraceptive pills followed by post-operative caesarean section followed by bed ridden. Moreover, the lower limb VTE incidence was idiopathic in 40% vs. 53.3% and secondary in 60% vs. 46.7%, respectively with no statistically significant differences between the studied groups (P value>0.05).
Regarding the clinical presentation, the present study revealed that pain was present in both revarospire and clexane / marevan groups (93.3% vs. 86.7%, respectively) with no statistically significant differences between the studied cases.
The results of the present study revealed that a dosage of revarospire 15 mg twice daily for 3 weeks, followed by 20 mg once daily for 6 months, had similar efficacy compared with standard treatment withEnoxaparin/Warfarin across patients with normal renal function. In terms of edema scoring and edema extent, there was no statistically significant difference between the studied groups (P value>0.05). In terms of improvement of symptoms, the present results revealed that within the revarospire group, more patients have improved symptoms within one week compared with the Enoxaparin/Warfarin group (60% vs. 43.3%, respectively) with no statistically significant difference between the studied groups (P value>0.05).
In terms of recanalization, the present results revealed that there was no statistically significant difference between the revarospiretreatment group and the clexane / marevantreatment group after 1 month, 3 months and 6 months of treatment (P value >0.05).At one month follow-up, there was no recanalization in 53.3% of cases in the revarospire group versus 40% in the clexane / marevan group (P value=0.301). At 3 months follow-up, recanalization more than 50% was observed in 46.7% of cases in the revarospire group versus 43.3% in the clexane / marevan group (P value=0.795). At 6th month follow-up, partial recanalization, near total recanalization and complete recanalization were achieved in 40%, 46.7% and 13.3%, respectively among the revarospire group and in 46.7%, 40% and 13.3% respectively among the clexane / marevan group (P value=0.857).
In terms of complications, the present study revealed that regarding bleeding, the incidences of bleeding were lower among the revarospire compared with clexane / marevan group (13.35 vs. 26.7%). Moreover,there were no major bleeding events during the trial.The combined outcomes of clinically relevant non-major bleeding were numerically lower with revarospire(4 patients) compared with clexane / marevan group (7 patients). Such differences were not statistically significant (P value>0.05). Regarding toxicity, one patient in the clexane / marevan group showed marevan toxicity.