Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism

Schulman, Sam; Kearon, Clive; Kakkar, Ajay K.; Schellong, Sebastian; Eriksson, Henry; Baanstra, David; Kvamme, Anne Mathilde; Friedman, Jeffrey; Mismetti, Patrick; Goldhaber, Samuel Z.

doi:10.1097/01.sa.0000433313.08275.7d

Cited by 78 publications

(186 citation statements)

References 8 publications

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“…[2][3][4][5][6][24][25][26] Study Participants and Interventions Table 2 summarizes the characteristics of the included studies and participants. Of the eight included studies, four compared rivaroxaban with vitamin K antagonists (two compared rivaroxaban with warfarin, 2,4 two compared rivaroxaban with acenocoumarol 3,25 ), three studies compared dabigatran with warfarin, 1,6,24 and one study compared apixaban with warfarin. 5 Four trials involved anticoagulation for atrial fibrillation 2,4-6 and four for treatment of VTE disease.…”

Section: Resultsmentioning

confidence: 99%

“…5 Four trials involved anticoagulation for atrial fibrillation 2,4-6 and four for treatment of VTE disease. 1,3,24,25 The dosing regimens for each of the NOACs varied according to the trial (Table 2). VKA doses were titrated to a target international normalized ratio (INR) of 2-3 in all trials, but one trial modified the INR target to 1.6-2.5 for patients aged 70 years or older.…”

Section: Resultsmentioning

confidence: 99%

“…[4][5][6] Recurrent thromboembolism was defined in all trials as the composite of deep vein thrombosis or nonfatal or fatal pulmonary embolism. 1,3,24,25 The primary bleeding outcome consisted of bleeding events: major bleeding or a combined bleeding endpoint (major bleeding or CRNB events) if the study did not report major bleeding as an adverse event in the CKD subgroup or if the study provided insufficient information to allow calculation of major bleeding events. The secondary bleeding outcomes were major bleeding events, the combination of major bleeding and CRNB events, and intracranial hemorrhage (for patients enrolled in the atrial fibrillation trials).…”

Section: Outcome Measuresmentioning

confidence: 99%

“…Furthermore, they have demonstrated similar or greater efficacy and safety in relation to conventional anticoagulants in large trials. [1][2][3][4][5][6] NOACs differ from traditional oral VKAs mechanistically and pharmacokinetically.…”

mentioning

confidence: 99%

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Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Harel¹,

Sholzberg

Shah³

et al. 2014

Journal of the American Society of Nephrology

101

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Novel oral anticoagulants (NOACs) (rivaroxaban, dabigatran, apixaban) have been approved by international regulatory agencies to treat atrial fibrillation and venous thromboembolism in patients with kidney dysfunction. However, altered metabolism of these drugs in the setting of impaired kidney function may subject patients with CKD to alterations in their efficacy and a higher risk of bleeding. This article examined the efficacy and safety of the NOACs versus vitamin K antagonists (VKAs) for atrial fibrillation and venous thromboembolism in patients with CKD. A systematic review and meta-analyses of randomized controlled trials were conducted to estimate relative risk (RR) with 95% confidence interval (95% CIs) using a random-effects model. MEDLINE, Embase, and the Cochrane Library were searched to identify articles published up to March 2013. We selected published randomized controlled trials of NOACs compared with VKAs of at least 4 weeks' duration that enrolled patients with CKD (defined as creatinine clearance of 30-50 ml/min) and reported data on comparative efficacy and bleeding events. Eight randomized controlled trials were eligible. There was no significant difference in the primary efficacy outcomes of stroke and systemic thromboembolism (four trials, 9693 participants; RR, 0.64 [95% CI, 0.39 to 1.04]) and recurrent thromboembolism or thromboembolism-related death (four trials, 891 participants; RR, 0.97 [95% CI, 0.43 to 2.15]) with NOACs versus VKAs. The risk of major bleeding or the combined endpoint of major bleeding or clinically relevant nonmajor bleeding (primary safety outcome) (eight trials, 10,616 participants; RR 0.89 [95% CI, 0.68 to 1.16]) was similar between the groups. The use of NOACs in select patients with CKD demonstrates efficacy and safety similar to those with VKAs. Proactive postmarketing surveillance and further studies are pivotal to further define the rational use of these agents.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Outcome Measuresmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Harel¹,

Sholzberg

Shah³

et al. 2014

Journal of the American Society of Nephrology

101

View full text Add to dashboard Cite

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“…In an analysis of 1626 patients with an initial VTE, unprovoked VTE (adjusted hazard ratio, 2.3; 95% confidence interval, 1.82-2.9) was a more powerful predictor of recurrent VTE than thrombophilia status (adjusted hazard ratio, 1.44; 95% confidence interval, 1.03-2.03) and increasing age (adjusted hazard ratio, 1.14; Extending anticoagulation with either warfarin 9,10 or a direct oral anticoagulant [11][12][13] reduces the risk of recurrent VTE by 60% to 90% over placebo in patients with unprovoked VTE who have completed limited-duration anticoagulation. Low-dose aspirin in patients with unprovoked VTE who have completed limited-duration anticoagulation also reduces the risk of recurrent VTE.…”

Section: Impact On Recurrent Vtementioning

confidence: 99%

Thrombophilia Testing, Recurrent Thrombosis, and Women’s Health

Piazza

2014

Circulation

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Follow a stepwise strategy for thrombophilia testing that considers the clinical scenario (when to test), the implications of testing (why to test), and then the overall approach to testing (how to test).Use a selective strategy that focuses on the highest-yield thrombophilia testing first.Defer testing for deficiencies of protein C, protein S, and antithrombin because low levels do not necessarily indicate true thrombophilia in the setting of acute thrombosis and anticoagulation.Remind patients that a negative thrombophilia evaluation does not exclude thrombophilia because there are many hypercoagulable conditions that have yet to be identified and for which testing does not exist.Consider deferring thrombophilia testing to the follow-up outpatient visit when there will be more time for discussion and when the patient will have recovered psychologically from the acute thrombotic event.

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Direct oral anticoagulants for unusual‐site venous thromboembolism

Riva

Ageno

2021

Research and Practice in Thrombosis and Haemostasis

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Direct oral anticoagulants (DOACs) are currently the preferred oral anticoagulant treatment for most of the patients with deep vein thrombosis of the lower extremities and/or pulmonary embolism. DOACs have several advantages over vitamin K antagonists, such as availability of fixed dosages, fewer drug interactions, faster onset of action, shorter half‐life, and lower risk of major and intracranial bleeding. Although the evidence on the use of DOACs in patients with unusual‐site venous thromboembolism (VTE) is limited to a few, small randomized controlled trials, these drugs are increasingly used in clinical practice, and several observational cohort studies have been published recently. This narrative review will describe the latest evidence for the use of the DOACs in patients with thrombosis in atypical locations (splanchnic, cerebral, upper extremity, ovarian, and renal vein thrombosis) and will provide some practical advice for their use in patients with unusual‐site VTE.

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Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism

Cited by 78 publications

References 8 publications

Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Comparisons between Novel Oral Anticoagulants and Vitamin K Antagonists in Patients with CKD

Thrombophilia Testing, Recurrent Thrombosis, and Women’s Health

Direct oral anticoagulants for unusual‐site venous thromboembolism

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