Dataset Information

Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis (ARM-DVT): Methods of a prospective single-arm management study.

ABSTRACT: Background:Upper extremity deep vein thrombosis (UEDVT) constitutes approximately 10% of all deep vein thromboses (DVTs). The incidence of UEDVT is increasing in association with use of peripherally inserted central venous catheters. Treatment for UEDVT is derived largely from evidence for treatment of lower extremity DVT. Limited evidence exists for the use of a direct oral anticoagulant for the treatment of UEDVT. Population:Sequential patients identified within the Intermountain Healthcare System and University of Utah Healthcare system with symptomatic UEDVT defined as the formation of thrombus within the internal jugular, subclavian, axillary, brachial, ulnar, or radial veins of the arm. Intervention:Apixaban 10 mg PO twice daily for 7 days followed by apixaban 5 mg twice daily for 11 weeks. Comparison:The historical literature review rate of venous thrombosis reported for recurrent clinically overt objective venous thromboembolism (VTE) and VTE-related death. If the confidence interval for the observed rate excludes the threshold event rate of 4%, we will conclude that treatment with apixaban is noninferior and therefore a clinically valid approach to treat UEDVT. Sample Size:We elected a sample size of 375 patients so that an exact 95% confidence interval would exclude an event rate of VTE in the observation cohort of 4%. Outcome:Ninety-day rate of new or recurrent objectively confirmed symptomatic venous thrombosis and VTE-related death. The primary safety outcome is the composite of major and clinically relevant nonmajor bleeding.

SUBMITTER: Woller SC

PROVIDER: S-EPMC6611360 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis (ARM-DVT): Methods of a prospective single-arm management study.

Woller Scott C SC Stevens Scott M SM Johnson Stacy A SA Bledsoe Joseph R JR Galovic Brian B Lloyd James F JF Wilson Emily L EL Armbruster Brent B Evans R Scott RS

Research and practice in thrombosis and haemostasis 20190513 3

<h4>Background</h4>Upper extremity deep vein thrombosis (UEDVT) constitutes approximately 10% of all deep vein thromboses (DVTs). The incidence of UEDVT is increasing in association with use of peripherally inserted central venous catheters. Treatment for UEDVT is derived largely from evidence for treatment of lower extremity DVT. Limited evidence exists for the use of a direct oral anticoagulant for the treatment of UEDVT.<h4>Population</h4>Sequential patients identified within the Intermountai ...[more]

PMID: 31294320

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Project description:BackgroundUpper extremity venous thrombosis (UEVT) represents about 10% of venous thrombo-embolic disease. This is mainly explained by the increasing use of central venous line, for oncologic or nutritional care. The factors associated with venous recanalization are not known.ObjectiveThe aim of this study was to investigate prognosis factor associated with venous recanalization after UEVT.MethodsThis study included patients with UEVT diagnosed with duplex ultra-sonography (DUS) from January 2015 to December 2017 with DUS evaluations during follow-up. A multivariate Cox proportional-hazards-model analysis was performed to identify predictive factors of UEVT complete recanalization.ResultsThis study included 494 UEVT, 304 proximal UEVT and 190 distal UEVT. The median age was 58 years, 39.5% were women. Clinical context was: hematological malignancy (40.7%), solid cancer (14.2%), infectious or inflammatory context (49.9%) and presence of venous catheters or pacemaker leads in 86.4%. The rate of recanalization without sequelae of UEVT was 38%. For all UEVT, in multivariate analysis, factors associated with complete vein recanalization were: thrombosis associated with central venous catheter (CVC) (HR:2.40, [1.45;3.95], p<0.001), UEVT limited to a venous segment (HR:1.94, [1.26;3.00], p = 0.003), occlusive thrombosis (HR:0.48 [0.34;0.67], p<0.0001), the presence of a PICC Line (HR:2.29, [1.48;3.52], p<0.001), a thrombosis of deep and distal topography (HR:1.70, [1.10;2.63], p = 0.02) or superficial thrombosis of the forearm (HR:2.79, [1.52;5.12], p<0.001). For deep and proximal UEVT, non-occlusive UEVT (HR:2.23, [1.49;3.33], p<0.0001), thrombosis associated with CVC (HR:1.58, [1.01;2.47], p = 0.04) and infectious or inflammatory context (HR:1.63, [1.10;2.41], p = 0.01) were factors associated with complete vein recanalization.ConclusionIn this study, factors associated with UEVT recanalization were UEVT limited to a venous segment, thrombosis associated with CVC, a thrombosis of deep and distal thrombosis topography and superficial thrombosis of the forearm. Occlusive thrombosis was associated with the absence of UEVT recanalization.

Dataset Information

Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis (ARM-DVT): Methods of a prospective single-arm management study.

Publications

Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis (ARM-DVT): Methods of a prospective single-arm management study.

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