Long-term efficacy and safety of once-daily enoxaparin plus warfarin for the outpatient ambulatory treatment of lower-limb deep vein thrombosis in the TROMBOTEK trial

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dc.authorid0000-0002-2767-2830en_US
dc.authorid0000-0001-5427-550Xen_US
dc.contributor.authorKurtoğlu, Mehmet
dc.contributor.authorKöksoy, Cüneyt
dc.contributor.authorHasan, Ekim
dc.contributor.authorAkçalı, Yiğit
dc.contributor.authorKarabay, Özalp
dc.date.accessioned2024-07-12T21:05:00Z
dc.date.available2024-07-12T21:05:00Z
dc.date.issued2010en_US
dc.departmentFakülteler, Tıp Fakültesien_US
dc.description.abstractObjective: The present study was designed to evaluate the long-term efficacy and safety of once-daily enoxaparin plus warfarin for the outpatient ambulatory treatment of lower-limb deep venous thrombosis (DVT). Methods: A total of 246 patients, comprising 128 men (mean age, 54.28 16.48 years) and 118 women (mean age, 50.11 16.47 years) with symptomatic lower extremity DVT, were included in this open-label, single-arm, multicenter, phase IV clinical trial conducted at 14 centers in Turkey. All patients were administered subcutaneous enoxaparin (1.5 mg/kg, once-daily) until international normalized ratio (INR) levels reached to 2 to 3, followed by oral warfarin (5 mg/d) for at least 3 months and elastic compression stockings (30-40 mm Hg). Clinical signs (leg circumference), symptoms (edema, pain, tenderness), recanalization rates upon duplex ultrasound examination, laboratory findings (D-dimer and INR levels), and postthrombotic syndrome status with CEAP classification were the efficacy parameters evaluated every 3 months during 18 months of follow-up. Safety end points included minor and major bleeding as well as serious adverse events. Results: Ambulatory treatment with enoxaparin plus warfarin significantly reduced physical symptoms, including tenderness, edema, pain (P < .001), and the circumference of the affected leg (P < .001). The leg circumference difference in almost all patients was <1.5 cm at the end of 18 months (P < .001). Recanalization rates for occluded iliofemoral vein were 76.1% at 3 months and 86.5% at 18 months (P < .001). An early and significant decrease obtained in D-dimer levels on day 10 continued to decline significantly until month 6 and remained unchanged afterwards (P < .001). Of four patients diagnosed with major bleeding during oral anticoagulant use, three recovered with conservative treatment (reduction in hemoglobin levels in 2 developed at visit 2 [day 10] and intracranial bleeding in 1 developed at visit 3 [day 30]), and one patient required a hysterectomy after menorrhagia developed at visit 7 (month 18). Two of the 65 (9.9%) adverse events documented were serious adverse events, but none of the serious adverse events leading to death were related to the study medications. Conclusion: Ambulatory treatment with enoxaparin plus warfarin seems to be effective in symptomatic healing and in clinical improvement by reducing thrombus formation and organization at all levels of lower extremity venous system with DVT, without a significant major bleeding risk. Therefore, the results of our conventional conservative treatment are in line with 1A level evidence reported in the recent American College of Chest Physicians guideline. ( J Vasc Surg 2010; 52:1262-71.)en_US
dc.identifier.citationKurtoglu, M., Koksoy, C., Hasan, E., Akcalı, Y., Karabay, O., Filizcan, U., & TROMBOTEK Study Group (2010). Long-term efficacy and safety of once-daily enoxaparin plus warfarin for the outpatient ambulatory treatment of lower-limb deep vein thrombosis in the TROMBOTEK trial. Journal of vascular surgery, Elsevier. 52(5), s. 1262–1270.en_US
dc.identifier.endpage1270en_US
dc.identifier.issn0741-5214
dc.identifier.issue5en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage1262en_US
dc.identifier.urihttps://linkinghub.elsevier.com/retrieve/pii/S0741-5214(10)01404-7
dc.identifier.urihttps://hdl.handle.net/20.500.12415/3862
dc.identifier.volume52en_US
dc.institutionauthorFilizcan, Uğur
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.ispartofJournal of Vascular Surgeryen_US
dc.relation.isversionof10.1016/j.jvs.2010.06.070en_US
dc.relation.publicationcategoryUluslararası Hakemli Dergide Makale - Kurum Öğretim Elemanıen_US
dc.rightsCC0 1.0 Universal*
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.rights.urihttp://creativecommons.org/publicdomain/zero/1.0/*
dc.snmzKY02089
dc.titleLong-term efficacy and safety of once-daily enoxaparin plus warfarin for the outpatient ambulatory treatment of lower-limb deep vein thrombosis in the TROMBOTEK trialen_US
dc.typeArticle
dspace.entity.typePublication

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