Effectiveness and Safety of Apixaban versus Warfarin as Outpatient Treatment of Venous Thromboembolism in U.S. Clinical Practice

Weycker, Derek; Li, Xiaoyan; Wygant, Gail; Lee, Theodore; Hamilton, Melissa; Luo, Xuemei; Vo, Lien; Mardekian, Jack; Pan, Xiangbin; Burns, Leah; Atwood, Mark; Hanau, Ahuva; Cohen, Alexander T.

doi:10.1055/s-0038-1673689

Cited by 36 publications

(46 citation statements)

References 37 publications

(36 reference statements)

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“…Data are summarized in Tables 3, 4 and 5. We offer main results from different models of anticoagulant therapy for the three more frequent indications: atrial fibrillation [8,11,, recurrent venous thromboembolism [8,10,23,24,[44][45][46][47][48] and mechanical heart valves [8,23,24,[49][50][51].…”

Section: Discussionmentioning

confidence: 99%

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up

Corrochano

Jiménez

Millon

et al. 2020

BMC Cardiovasc Disord

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Background: Patient self-management (PSM) of vitamin K antagonists (VKA) seems a very promising model of care for oral anticoagulation in terms of efficacy and safety. In comparison with other management models of VKA therapy, the number of scientific publications supporting the advantages of PSM is more limited. Currently, most of the scarce information comes from randomized clinical trials. Moreover, a small number of studies have assessed PSM of VKA therapy in real life conditions. Methods: We analyzed clinical outcomes of 927 patients in a single center (6018.6 patient-years of follow-up). Recruitment took place between 2002 and 2017. All patients followed a structured training program, conducted by specialized nurses. Results: Fifty percent of individuals had a mechanical heart valve (MHV), 23% suffered from recurrent venous thromboembolism (VTE) or high-risk thrombophilia, and 13% received VKA therapy because of atrial fibrillation (AF). Median follow-up was 6.5 years (range 0.1-15.97 years), median age was 58.1 years (IQR 48-65.9) and 46.5% were women. The incidence of major complications (either hemorrhagic or thromboembolic) was 1.87% patient-years (pt-ys) with a 95% CI of 1.54-2.27. The incidence of major thromboembolic events was 0.86% pt-ys (95% CI 0.64-1.13) and that of major hemorrhagic events was 1.01% pt-ys (95% CI 0.77-1.31). The incidence of intracranial bleeding was 0.22% pt-ys (95% CI 0.12-0.38). In terms of clinical indication for VKA therapy, the incidence of total major complications was 2.4% pt-ys, 2.0% pt-ys, 0.9% pt-ys and 1.34% pt-ys for MHV, AF, VTE and other (including valvulopathies and myocardiopathies), respectively. Clinical outcomes were worse in patients with multiple comorbidities, previous major complications during conventional VKA therapy, and in older individuals. The percentage of time in therapeutic range (TTR) was available in 861 (93%) patients. Overall, the mean (SD) of TTR was 63.6 ± 13.4%, being higher in men (66.2 ± 13.1%) than women (60.6 ± 13.2%), p < 0.05.

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Section: Discussionmentioning

confidence: 99%

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up

Corrochano

Jiménez

Millon

et al. 2020

BMC Cardiovasc Disord

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“…Clinical outcomes including recurrent VTE, MB, and CRNM bleeding were evaluated. Definitions of these clinical outcomes were based on previous publications [ 17 , 18 , 19 , 20 ]. Recurrent VTE was defined by primary/first-listed diagnosis in an inpatient setting, excluding admissions that occurred within 7 days of the index VTE encounter.…”

Section: Methodsmentioning

confidence: 99%

Effectiveness and Safety of Apixaban vs. Warfarin in Venous Thromboembolism Patients with Obesity and Morbid Obesity

Cohen

Sah

Lee

et al. 2021

JCM

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This study integrated 5 United States healthcare claims databases to evaluate the risk of recurrent venous thromboembolism (VTE) and major bleeding (MB) among VTE patients who initiated apixaban vs. warfarin, stratified by obesity. Obese and morbidly obese patients were identified based on diagnosis codes. Stabilized inverse probability treatment weighting (IPTW) was conducted to balance observed patient characteristics between treatment cohorts. An interaction analysis was conducted to evaluate treatment effects of apixaban vs. warfarin according to obesity status. Cox proportional hazard models were used to evaluate the risk of recurrent VTE and MB among IPTW weighted obese and morbidly obese patients. A total of 112,024 non-obese patients and 43,095 obese patients were identified, of whom 19,751 were morbidly obese. When stratified by obesity status post-IPTW, no significant interactions were observed for effects of apixaban vs. warfarin on recurrent VTE or MB (interaction p > 0.10). Among IPTW obese and morbidly obese patients, apixaban was associated with a significantly lower risk of recurrent VTE (obese: 0.73 [0.64–0.84]; morbidly obese: 0.65 [0.53–0.80]) and MB (obese: 0.73 [0.62–0.85]; morbidly obese: 0.68 [0.54–0.86]) as compared with warfarin. In this large sample of obese and morbidly obese VTE patients, apixaban had a significantly lower risk of recurrent VTE and MB vs. warfarin.

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“…The safety of DOACs versus warfarin has been demonstrated in multiple randomized controlled trials and meta-analyses validating a reduction in major and minor bleeding events. 8-20 Particularly, the reduction in intracranial hemorrhagic events with the use of a DOAC versus warfarin in the treatment of VTE lends to the interest of using these agents in CVT treatment. 21…”

Section: Introductionmentioning

confidence: 99%

A Single-Center Retrospective Evaluation of the Use of Oral Factor Xa Inhibitors in Patients With Cerebral Venous Thrombosis

et al. 2020

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Background: Clinical practice guidelines recommend that cerebral venous thrombosis (CVT) be managed with long-term anticoagulant therapy using warfarin or low-molecular-weight heparin (LMWH) for 3 to 12 months. However, oral factor Xa inhibitors may offer preferable alternative treatment options for these patients. Objective: The primary objective was to determine the effectiveness and safety of rivaroxaban or apixaban compared with warfarin or enoxaparin as long-term anticoagulation therapy for patients with a new diagnosis of CVT. Methods: This was a single-center retrospective review of patients with newly diagnosed CVT who received acute and maintenance anticoagulation treatment. Study groups compared patients who received warfarin, enoxaparin, or an oral factor Xa inhibitor as their maintenance anticoagulant. The primary outcome was recurrent thrombotic events while on anticoagulation. Secondary outcomes included modified Rankin Scale, improved cerebral venous sinus opacification, duration of anticoagulant therapy, bleeding events during anticoagulant therapy, and adverse effects. Results: A total of 119 patients were included in the analysis: warfarin (89), enoxaparin (11), and oral factor Xa inhibitor (19). The risk of recurrent thrombotic events were 11.2%, 0%, and 10.5% in the warfarin, enoxaparin, and oral factor Xa inhibitor treatment groups, respectively ( P = 0.7635). There were no significant between-group differences observed regarding any of the secondary outcomes. Conclusions: Although the sample size is limited, these findings indicate that oral factor Xa inhibitors are a reasonable treatment option for patients with CVT. There was a trend toward more persistent symptoms in patients on warfarin, suggesting a potential improvement in recovery among patients that received an oral factor Xa inhibitor.

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Effectiveness and Safety of Apixaban versus Warfarin as Outpatient Treatment of Venous Thromboembolism in U.S. Clinical Practice

Cited by 36 publications

References 37 publications

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up

Effectiveness and Safety of Apixaban vs. Warfarin in Venous Thromboembolism Patients with Obesity and Morbid Obesity

A Single-Center Retrospective Evaluation of the Use of Oral Factor Xa Inhibitors in Patients With Cerebral Venous Thrombosis

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