Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Li, Ang; Kuderer, Nicole M.; García, David; Khorana, Alok A.; Wells, Philip S.; Carrier, Marc; Lyman, Gary H.

doi:10.1111/jth.14613

Cited by 46 publications

(45 citation statements)

References 44 publications

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“…Considered together, these trials showed a significant benefit of the oral anticoagulants for the prevention of VTE with an acceptable incidence of major bleeding. Recently, at least two meta-analyses have assessed the role of DOACs in this setting [36,48]. Beccatini et al [36] included three randomized clinical trials and describe a significant reduction of VTE with DOACs [odds ratio (OR) 0.49; 95% CI 0.33-0.74].…”

Section: Prophylaxis Of Vte In Ambulatory Cancer Patients During Systmentioning

confidence: 99%

SEOM clinical guideline of venous thromboembolism (VTE) and cancer (2019)

et al. 2020

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In 2011, the Spanish Society of Medical Oncology (SEOM) first published a clinical guideline of venous thromboembolism (VTE) and cancer. This guideline was updated in 2014, and since then, multiple studies and clinical trials have changed the landscape of the treatment and prophylaxis of VTE in cancer patients. To incorporate the most recent evidence, including data from direct oral anticoagulants (DOACs) randomized clinical trials, SEOM presents a new update of the guideline.

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Section: Prophylaxis Of Vte In Ambulatory Cancer Patients During Systmentioning

confidence: 99%

SEOM clinical guideline of venous thromboembolism (VTE) and cancer (2019)

et al. 2020

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“…A similar pattern of clinical outcomes was observed over 6 months and over 5 years (see Supporting Table 5). The absolute differences in all clinical outcomes, including overall VTE, PE, DVT, MB, CRNMB, and mortality, were all within the 95% CI of previously reported outcomes from the meta‐analysis at 6 months . Minor variations in outcomes were likely driven by the inclusion of a drug nonadherence/discontinuation factor in the Markov model, which led to small attenuations of the absolute risk reductions of the primary outcomes.…”

Section: Resultsmentioning

confidence: 59%

“…Subgroup meta-analyses were performed for patients with Khorana scores ≥3 and 2 after outcomes were obtained directly from the trial authors. 13 Because of the low case fatality associated with PE, MB, and ICH, pooled estimates were derived from 2 prophylaxis trials and 1 treatment trial (Hokusai-VTE Cancer). 15…”

Section: Model Input: Measurement Of Effectivenessmentioning

confidence: 99%

“…The absolute differences in all clinical outcomes, including overall VTE, PE, DVT, MB, CRNMB, and mortality, were all within the 95% CI of previously reported outcomes from the meta-analysis at 6 months. 13 Minor variations in outcomes were likely driven by the inclusion of a drug nonadherence/discontinuation factor in the Markov model, which led to small attenuations of the absolute risk reductions of the primary outcomes. Over a lifetime, the intervention group had a mean total cost of $9899 per person, 6.51 life-years, and 4.79 QALYs.…”

Section: Base-case Cost-effectiveness Analysismentioning

confidence: 99%

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Cost‐effectiveness analysis of low‐dose direct oral anticoagulant (DOAC) for the prevention of cancer‐associated thrombosis in the United States

Carlson

Kuderer

et al. 2020

Cancer

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Background Randomized controlled trials (RCTs) have demonstrated that low‐dose direct oral anticoagulants (DOACs), including rivaroxaban and apixaban, may help reduce the incidence of cancer‐associated venous thromboembolism (VTE). Methods A cost‐utility analysis was performed from the health sector perspective using a Markov state‐transition model in patients with cancer who are at intermediate‐to‐high risk for VTE. Transition probability, relative risk, cost, and utility inputs were obtained from a meta‐analysis of the RCTs and relevant epidemiology studies. Differences in cost, quality‐adjusted life‐years (QALYs), and the incremental cost‐effectiveness ratio (ICER) per patient were calculated over a lifetime horizon. One‐way, probabilistic, and scenario sensitivity analyses were conducted. Results In patients with cancer at intermediate‐to‐high risk for VTE, treatment with low‐dose DOAC thromboprophylaxis for 6 months, compared with placebo, was associated with 32 per 1000 fewer VTE and 11 per 1000 more major bleeding episodes over a lifetime. The incremental cost and QALY increases were $1445 and 0.12, respectively, with an ICER of $11,947 per QALY gained. Key drivers of ICER variations included the relative risks of VTE and bleeding as well as drug cost. This strategy was 94% cost effective at the threshold of $50,000 per QALY. The selection of patients with Khorana scores ≥3 yielded the greatest value, with an ICER of $5794 per QALY gained. Conclusions Low‐dose DOAC thromboprophylaxis for 6 months appears to be cost‐effective in patients with cancer who are at intermediate‐to‐high risk for VTE. The implementation of this strategy in patients with Khorana scores ≥3 may lead to the highest cost‐benefit ratio.

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“…A pooled analysis of the two studies has nevertheless been performed and showed a 6-month VTE risk reduction of 0.56 (95%CI 0.35-0.89) on DOACs, with a non-significant increase in major bleeding (1.96; 95%CI 0.80-4.82) [53]. In terms of absolute difference, this corresponded to a VTE risk reduction of 4% (95%CI 0.01-0.07, NNT 25) at the cost of a 1% (95%CI 0.0-0.02) increase (albeit statistically non-significant) in major bleeding (NNH 100).…”

Section: Use Of Doac For Vte Preventionmentioning

confidence: 99%

Preventing Venous Thromboembolism in Ambulatory Patients with Cancer: A Narrative Review

Rossel

Robert‐Ebadi

Marti

2020

Cancers

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Venous thromboembolism (VTE) is frequent among patients with cancer. Ambulatory cancer patients starting chemotherapy have a 5% to 10% risk of cancer associated thrombosis (CAT) within the first year after cancer diagnosis. This risk may vary according to patient characteristics, cancer location, cancer stage, or the type of chemotherapeutic regimen. Landmark studies evaluating thrombophrophylaxis with low molecular weight heparin (LMWH) for ambulatory cancer patients have shown a relative reduction in the rate of symptomatic VTE of about one half. However, the absolute risk reduction is modest among unselected patients given a rather low risk of events resulting in a number needed to treat (NNT) of 40 to 50. Moreover, this modest benefit is mitigated by a trend towards an increased risk of bleeding, and the economic and patient burden due to daily injections of LMWH. For these reasons, routine thromboprophylaxis is not recommended by expert societies. Advances in VTE risk stratification among cancer patients, and growing evidence regarding efficacy and safety of direct oral anticoagulants (DOACs) for the treatment and prevention of CAT have led to reconsider the paradigms of this risk–benefit assessment. This narrative review aims to summarize the recent evidence provided by randomized trials comparing DOACs to placebo in ambulatory cancer patients and its impact on expert recommendations and clinical practice.

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Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Cited by 46 publications

References 44 publications

SEOM clinical guideline of venous thromboembolism (VTE) and cancer (2019)

SEOM clinical guideline of venous thromboembolism (VTE) and cancer (2019)

Cost‐effectiveness analysis of low‐dose direct oral anticoagulant (DOAC) for the prevention of cancer‐associated thrombosis in the United States

Preventing Venous Thromboembolism in Ambulatory Patients with Cancer: A Narrative Review

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