A Comparison of Three Months of Anticoagulation with Extended Anticoagulation for a First Episode of Idiopathic Venous Thromboembolism

Kearon, Clive; Gent, Michael; Hirsh, Jack; Weitz, Jeffrey I.; Kovacs, Michael J.; Anderson, David R.; Turpie, Alexander G.G.; Green, David; Ginsberg, Jeffrey S.; Wells, Philip S.; MacKinnon, Betsy; Johnston, Marilyn; Douketis, James D.; Roberts, Robin S.; Nguyen, P.; Kassis, Jeannine; Dolan, Sean; Demers, Christine; Desjardins, Louis; Solymoss, Susan; Trowbridge, Arthur A.; Julian, Jim A.

doi:10.1056/nejm199903253401201

Cited by 1,023 publications

(830 citation statements)

References 21 publications

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“…According to Kearon et al., extended therapy with warfarin decreased the risk of recurrent VTE by 95% compared to placebo ( P < .001), with only a small non‐significant increase in the risk of major bleeding (3.8% vs none for placebo; P = .09) 26. Their trial evaluated warfarin therapy for 24 months versus placebo in patients who had completed 3 months of anticoagulant therapy due to an initial VTE.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism

Berger

Seheult

Laliberté

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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Essentials Clinical trials demonstrated the gain of extended anticoagulation among patients with VTE.In a real‐world setting, we evaluated outcomes of extended rivaroxaban use for unprovoked VTE.Extended rivaroxaban treatment lowered the risk of recurrent VTE among unprovoked VTE patients.Extended rivaroxaban treatment was not associated with increased risk of major bleeding. BackgroundRandomized trial data demonstrate the gain of extended duration anticoagulation in patients with venous thromboembolic events (VTE); however, real‐world data are limited.ObjectivesAssess the risk of recurrent VTE and major bleeding in a real‐world setting of patients who experienced unprovoked VTE and received extended treatment with rivaroxaban.Methods US claims databases (February 2011–April 2015) were used in this retrospective study. The study population included adult patients initiated on rivaroxaban within 7 days after their first unprovoked VTE (ie, deep vein thrombosis, pulmonary embolism) and received ≥3 months continuous rivaroxaban treatment (index date: end of 3‐month treatment). Patients who were treated beyond 3 months formed the continued cohort and the remainder formed the discontinued cohort (ie, discontinued at 3 months). Adjusted Kaplan‐Meier rates for recurrent VTE and major bleeding events were compared between cohorts with confounders being controlled through a propensity score weighting approach.ResultsPatients in the continued cohort (N = 3763) had significantly lower rates of recurrent VTE than those who discontinued (N = 1051): 0.57% vs 1.19% (P = .042), 1.07% vs 2.10% (P = .017), and 1.45% vs 2.60% (P = .023) at 3, 6, and 12 months, respectively. No significant differences in the rate of major bleeding were observed between cohorts. A sensitivity analysis among unprovoked VTE patients receiving rivaroxaban for ≥6 months showed similar results.ConclusionsContinued rivaroxaban treatment beyond an initial 3‐ or 6‐month treatment period significantly lowered the risk of recurrent VTE without a significant increase of major bleeding, compared to treatment discontinued at 3 or 6 months.

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Section: Discussionmentioning

confidence: 99%

Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism

Berger

Seheult

Laliberté

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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“…After duplicates were removed, 928 citations were screened for inclusion. Of those, 890 and 27 citations were excluded at the abstract and full text level, respectively, leaving 11 citations reporting 12 unique trials [9][10][11][12][13][14][15][16][17][18][19] (Table 1). Rivaroxaban 12 and idraparinux 16 were each evaluated in comparison to placebo in individual trials ( Figure 2).…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…13 VKAs were compared to either placebo or control (i.e., discontinuation of VKA therapy with no placebo administration) in five trials. 9,10,[17][18][19] Finally, aspirin was compared to placebo in two trials. 14,15 Six trials were judged to…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…[11][12][13][14][15] Two trials had low risk of bias in all domains except the blinding of outcomes assessment in which the risk of bias was unclear. 16,19 The remaining four trials, which all evaluated the active intervention of VKA, had unclear randomization procedures. 9,10,17,18 Three of these trials had high risk of bias because the trials were not blinded to participants and personnel.…”

Section: Accepted M Manuscriptmentioning

confidence: 99%

“…9,17,18 The 10 trials in our base-case analysis represent a total of 11,079 patients. [11][12][13][14][15][16][17][18][19] With the exception of one trial that enrolled exclusively patients with an index DVT, the index event was (0.03 to 1.08)]. We could not evaluate the composite bleeding outcome since this data was not reported in trials evaluating VKAs and we were unable to evaluate heterogeneity as there were…”

Section: Accepted M Manuscriptmentioning

confidence: 99%

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Comparative efficacy and safety of anticoagulants and aspirin for extended treatment of venous thromboembolism: A network meta-analysis

Sobieraj

Coleman

Pasupuleti

et al. 2015

Thrombosis Research

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This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT Abstract (305 words)Objective: To systematically review the literature and to quantitatively evaluate the efficacy and safety of extended pharmacologic treatment of venous thromboembolism (VTE) through network meta-analysis (NMA).Methods: A systematic literature search (MEDLINE, Embase, Cochrane CENTRAL, throughSeptember 2014) and searching of reference lists of included studies and relevant reviews was conducted to identify randomized controlled trials of patients who completed initial anticoagulant treatment for VTE and then randomized for the extension study; compared extension of anticoagulant treatment to placebo or active control; and reported at least one outcome of interest (VTE or a composite of major bleeding or clinically relevant non-major bleeding). A random-effects Frequentist approach to NMA was used to calculate relative risks with 95% confidence intervals.Results: Ten trials (n=11,079) were included. Risk of bias (assessed with the Cochrane tool) was low in most domains assessed across the included trials. Apixaban (2.5mg and 5mg), dabigatran, rivaroxaban, idraparinux and vitamin K antagonists (VKA) each significantly reduced the risk of VTE recurrence compared to placebo, ranging from a 73% reduction with idraparinux to 86% with VKAs. With exception of idraparinux, all active therapies significantly reduced VTE recurrence risk versus aspirin, ranging from a 73% reduction with either apixaban 2.5mg or rivaroxaban to 80% with VKAs. Apixaban and aspirin were the only therapies that did not increase composite bleeding risk significantly compared to placebo. All active therapies except aspirin increased risk of composite bleeding by 2 to 4-fold compared to apixaban 2.5mg, with no difference found between the two apixaban doses. A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPTConclusion: Extended treatment of VTE is a reasonable approach to provide continued protection from VTE recurrence although bleeding risk is variable across therapeutic options.Our results indicate that apixaban, dabigatran, rivaroxaban, idraparinux and VKAs all reduced VTE recurrence when compared to placebo. Apixaban appears to have a more favorable safety profile compared to other therapies.

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A Population-Based Study of the Effectiveness of Inferior Vena Cava Filter Use Among Patients With Venous Thromboembolism

White¹,

Zhou²,

Kim³

et al. 2000

Arch Intern Med

199

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A Comparison of Three Months of Anticoagulation with Extended Anticoagulation for a First Episode of Idiopathic Venous Thromboembolism

Abstract: Patients with a first episode of idiopathic venous thromboembolism should be treated with anticoagulant agents for longer than three months.

Cited by 1,023 publications

References 21 publications

Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism

Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism

Comparative efficacy and safety of anticoagulants and aspirin for extended treatment of venous thromboembolism: A network meta-analysis

A Population-Based Study of the Effectiveness of Inferior Vena Cava Filter Use Among Patients With Venous Thromboembolism

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