Extended Anticoagulation for VTE

Mai, Vicky; Guay, Charles-Antoine; Perreault, Laurie; Bonnet, Sébastien; Bertoletti, Laurent; Lacasse, Yves; Jardel, S.; Lega, Jean‐Christophe; Provencher, Steeve

doi:10.1016/j.chest.2019.02.402

Cited by 26 publications

(11 citation statements)

References 45 publications

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“…Regarding arterial events, however, it must be noted that the event rates in both groups are very low and unlike venous events, these arterial events are based on clinical information provided by the investigator and rather than objectively proven diagnoses. In contrast to Mai et al 16 we could not confirm a general reduction of bleeding (both major and overall) in favor of DOACs. However, our findings of reduced fatal bleedings in the DOAC group should be reemphasized.…”

Section: Discussioncontrasting

confidence: 99%

“…The authors found that DOACs were associated with a reduction in overall (risk ratio [RR], 0.48; 95% CI, 0.27–0.86; p = 0.01) and VTE-related (RR, 0.36; 95% CI, 0.15–0.89; p = 0.03) mortality, whereas VKAs were not. 16 This meta-analysis also described that VKAs and DOACs similarly prevented recurrent VTE, 16 which we can confirm through our real-world observations, i.e. the risk of recurrent VTE, as well as arterial events such as myocardial infarction and stroke, was not significantly different between treatment groups in GARFIELD-VTE.…”

Section: Discussionsupporting

confidence: 77%

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On-treatment Comparative Effectiveness of Vitamin K Antagonists and Direct Oral Anticoagulants in GARFIELD-VTE, and Focus on Cancer and Renal Disease

Haas

Farjat

Pieper

et al. 2022

TH Open

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Background Direct oral anticoagulants (DOACs) provide a safe, effective alternative to vitamin K antagonists (VKAs) for venous thromboembolism (VTE) treatment, as shown via intention-to-treat comparative effectiveness analysis. However, on-treatment analysis is imperative in observational studies because anticoagulation choice and duration are at investigators' discretion. Objectives The aim of the study is to compare the effectiveness of DOACs and VKAs on 12-month outcomes in VTE patients using on-treatment analysis. Methods The Global Anticoagulant Registry in the FIELD - VTE (GARFIELD-VTE) is a world-wide, prospective, non-interventional study observing treatment of VTE in routine clinical practice. Results In total, 8,034 patients received VKAs (n = 3,043, 37.9%) or DOACs (n = 4,991, 62.1%). After adjustment for baseline characteristics and follow-up bleeding events, and accounting for possible time-varying confounding, all-cause mortality was significantly lower with DOACs than VKAs (hazard ratio: 0.58 [95% confidence interval 0.42–0.79]). Furthermore, patients receiving VKAs were more likely to die of VTE complications (4.9 vs. 2.2%) or bleeding (4.9 vs. 0.0%). There was no significant difference in rates of recurrent VTE (hazard ratio: 0.74 [0.55–1.01]), major bleeding (hazard ratio: 0.76 [0.47–1.24]), or overall bleeding (hazard ratio: 0.87 [0.72–1.05]) with DOACs or VKAs. Unadjusted analyses suggested that VKA patients with active cancer or renal insufficiency were more likely to die than patients treated with DOAC (52.51 [37.33–73.86] vs. 26.52 [19.37–36.29] and 9.97 [7.51–13.23] vs. 4.70 [3.25–6.81] per 100 person-years, respectively). Conclusion DOACs and VKAs had similar rates of recurrent VTE and major bleeding. However, DOACs were associated with reduced all-cause mortality and a lower likelihood of death from VTE or bleeding compared with VKAs.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionsupporting

confidence: 77%

On-treatment Comparative Effectiveness of Vitamin K Antagonists and Direct Oral Anticoagulants in GARFIELD-VTE, and Focus on Cancer and Renal Disease

Haas

Farjat

Pieper

et al. 2022

TH Open

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“…23 Another systematic review and meta-analysis including 18 studies investigating the effectiveness and safety of NOACs and vitamin K antagonists during extended anticoagulation after VTE showed that NOACs for extended anticoagulation were associated with a significant reduction in overall mortality (RR 0.48 95% CI 0.27;0.86) compared with placebo. 24 Importantly though, due to heterogeneity of the enrolled patients in the extension trials, caution should be made when trying to make indirect effect comparisons.…”

Section: Discussionmentioning

confidence: 99%

Characteristics of patients receiving extended treatment after incident venous thromboembolism

Albertsen

Jensen

Abdelgawwad

et al. 2021

Basic Clin Pharma Tox

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Given high recurrence risk after venous thromboembolism (VTE), guidelines recommend extended dose rivaroxaban (10 mg OD) or apixaban (2.5 mg BID) to be considered after 6 months of initial treatment. This study aimed to provide insight into clinical practice regarding the use of extended preventive treatment and to describe duration of the initial treatment. Linkage of nationwide health registers identified all in-and outpatients with VTE from April 2017 through 2018. Hazard ratios (HR) with 95% confidence intervals (CIs) were calculated adjusting for other VTE-related factors. The study included 6030 patients with VTE. Among rivaroxaban users, 2.2%(n = 113) received the extended 10-mg dose after mean 9.4 (SD 3.1) months of standard treatment. For apixaban, 4.7% (n = 40) received extended 2.5-mg dose after mean 8.0 months (SD 3.9). After adjustments, incident pulmonary embolism (HR 1.81 95% CI 1.12;2.91) and trauma/fracture (HR 1.42 95% CI 0.46;4.43) were associated with switching to extended dose, whereas patients with unprovoked VTE were less likely to receive the extended dose (HR 0.68 95% CI 0.30;1.55).Less than 3% of patients with incident VTE received extended treatment after initial standard treatment. Even though international guidelines suggest that the risk-benefit balance is in favour of extended VTE treatment, this was yet to be translated into clinical practice as of 2018. Studies using contemporary data are warranted to investigate routine clinical practice of extended treatment for VTE recurrence.

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“…Whilst long-term anticoagulation is clearly recommended for patients with recurrent unprovoked VTE, the optimal duration for patients with VTE not meeting this criterion is less clear. For example, the need for anticoagulation after the first episode of unprovoked major VTE is unclear, although a number of clinical trials have shown benefits in continuing anticoagulation with the risk of VTE reduced by 80% [19][20][21]. However, given that 70% of patients with their first episode of VTE do not have a recurrence during the first five years, it would mean that these patients have potentially received unnecessary anticoagulation treatment.…”

Section: Risk Factors Risk Ratiomentioning

confidence: 99%

“…Major bleeding events associated with DOACs have consistently been shown to be fewer compared to VKAs. A meta-analysis of randomised controlled trials involving DOACs for extended anticoagulation following VTE found an incidence of major bleeding of 0.48 per 100 patient years compared to 2.89 per 100 patient years for VKAs [21]. Real-life registry data in atrial fibrillation patients have also confirmed reduced bleeding on DOACs compared to VKAs [29,30].…”

Section: Risk Factors Risk Ratiomentioning

confidence: 99%

Individualised Risk Assessments for Recurrent Venous Thromboembolism: New Frontiers in the Era of Direct Oral Anticoagulants

Wang

Lim

2021

Hemato

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Venous thromboembolism (VTE) is a leading cause of morbidity and mortality and is associated with high recurrence rates. The introduction of direct oral anticoagulants (DOACs) in the 2010s has changed the landscape of VTE management. DOACs have become the preferred anticoagulant therapy for their ease of use, predictable pharmacokinetics, and improved safety profile. Increasingly, guidelines have recommended long term anticoagulation for some indications such as following first unprovoked major VTE, although an objective individualised risk assessment for VTE recurrence remains elusive. The balance of preventing VTE recurrence needs to be weighed against the not insignificant bleeding risk, which is cumulative with prolonged use. Hence, there is a need for an individualised, targeted approach for assessing the risk of VTE recurrence, especially in those patients in whom the balance between benefit and risk of long-term anticoagulation is not clear. Clinical factors alone do not provide the level of discrimination required on an individual level. Laboratory data from global coagulation assays and biomarkers may provide enhanced risk assessment ability and are an active area of research. A review of the prediction models and biomarkers for assessing VTE recurrence risk is provided, with an emphasis on contemporary developments in the era of DOACs and global coagulation assays.

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Extended Anticoagulation for VTE

Cited by 26 publications

References 45 publications

On-treatment Comparative Effectiveness of Vitamin K Antagonists and Direct Oral Anticoagulants in GARFIELD-VTE, and Focus on Cancer and Renal Disease

On-treatment Comparative Effectiveness of Vitamin K Antagonists and Direct Oral Anticoagulants in GARFIELD-VTE, and Focus on Cancer and Renal Disease

Characteristics of patients receiving extended treatment after incident venous thromboembolism

Individualised Risk Assessments for Recurrent Venous Thromboembolism: New Frontiers in the Era of Direct Oral Anticoagulants

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