Thrombosis and bleedings in a cohort of cancer patients treated with apixaban for venous thromboembolism

Hannevik, Trine-Lise; Brekke, Jorunn; Enden, Tone; Frøen, Hege; Garresori, Herish; Jacobsen, Einar; Paulsen, Petter Quist; Porojnicu, Alina Carmen; Ree, Anne Hansen; Torfoss, Dag; Velle, Elin Osvik; Wik, Hilde Skuterud; Ghanima, Waleed; Sandset, Per Morten; Dahm, Anders Erik Astrup

doi:10.1016/j.thromres.2020.08.042

Cited by 6 publications

(14 citation statements)

References 24 publications

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“…During the first 6 months of full‐dose anticoagulation 12 of 298 patients had recurrent VTE (4.0%, 95% CI 2.1–6.9), as previously reported 21 . During the next 30 months with low‐dose apixaban 14 of 196 (7.1%, 95% CI 4.0–11.7) patients experienced recurrent VTE (Table 2).…”

Section: Resultssupporting

confidence: 72%

“…During the first 6 months of full‐dose anticoagulation 16 patients experienced major bleeding (5.4%, 95% CI 3.1–8.6) and 26 patients experienced one or more episodes of CRNMB (8.7%, 95% CI 5.8–12.5) 21 . During the next 30 months of low‐dose apixaban treatment six patients (3.1%, 95% CI: 1.1–6.5) experienced major bleeding and 16 (8.2%, CI 4.7–12.9) patients experienced CRNMB (Table 2).…”

Section: Resultsmentioning

confidence: 99%

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Low dose apixaban as secondary prophylaxis of venous thromboembolism in cancer patients – 30 months follow‐up

Larsen

Garresori

Brekke

et al. 2022

Journal of Thrombosis and Haemostasis

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Background There are no data on the effect of low‐dose anticoagulation as secondary prophylaxis for venous thromboembolism (VTE) in cancer patients. We assessed the efficacy and safety of low‐dose apixaban for 30 months, after initial 6 months of full‐dose treatment. Methods We included 298 patients with cancer and any type of VTE in a single arm interventional clinical trial. All patients were treated with full‐dose apixaban (5 mg twice daily) for 6 months. Total 196 patients with active cancer after 6 months treatment continued with apixaban 2.5 mg twice daily for another 30 months. The main endpoints were recurrent VTE, major bleeding and clinically relevant non‐major bleeding. Results During the 30 months of treatment with low‐dose apixaban 14 (7.6%; 95% confidence interval (CI) 4.0%–11.7%) patients experienced recurrent VTE, six (3.1%; 95% CI 1.1%–6.5%) experienced major bleeding and 16 (8.1%, 95% CI: 4.7%–12.8%) experienced clinically relevant non‐major bleeding. The incidence rate per person month of recurrent VTE was 0.8% (95% CI 0.41–1.6) at 2–6 months with full‐dose apixaban, and 1.0% (95% CI 0.5–1.9) at 7–12 months with low‐dose apixaban. The incidence rate of major bleeding was 1.1% (95% CI 0.6–2.0) at 2–6 months, and 0.3% (95% CI 0.1–1.0) at 7–12 months. Between 12 and 36 months the incidence rate of recurrent VTE and major bleedings remained low. Conclusion Dose reduction of apixaban to 2.5 mg twice daily seems safe after 6 months of full‐dose treatment. After 12 months the incidence rate of recurrent VTE and major bleeding remained low.

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Section: Resultssupporting

confidence: 72%

Section: Resultsmentioning

confidence: 99%

Low dose apixaban as secondary prophylaxis of venous thromboembolism in cancer patients – 30 months follow‐up

Larsen

Garresori

Brekke

et al. 2022

Journal of Thrombosis and Haemostasis

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“…On the other hand, none of the studies on apixaban show any increased major bleedings in patients with gastrointestinal cancer. The Cap study did not have a control arm with dalteparin, but the frequency of major bleedings was no higher in gastrointestinal cancer than in other cancers [23,25].…”

Section: Doac and Major Bleedings In Patients With Gastrointestinal And Genitourinary Cancermentioning

confidence: 99%

“…Thrombosis in the veins of the upper extremities, abdomen and brain, were only included in the two academic studies Adam-VTE and Cap [21,23]. The Adam-VTE study included 39 VTEs at unusual sites, but reported no data on the recurrence rate for this subgroup of VTEs.…”

Section: Vte At Unusual Sitesmentioning

confidence: 99%

“…In the Adam-VTE study testing apixaban versus dalteparin for VTE in cancer patients, there was one arterial thrombosis each in the apixaban arm and the dalteparin arm [21]. The singlearmed interventional Cap study found a somewhat surprising 4% arterial thrombosis in patients taking apixaban, although most of those were ischemic strokes in patients with pancreatic cancer [23]. In summary, arterial thrombosis in cancer patients is only partly investigated.…”

Section: Anticoagulation and Protection Against Arterial Thrombosis In Cancer Patientsmentioning

confidence: 99%

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Cancer and Thrombosis: New Treatments, New Challenges

Dahm

2021

Medical Sciences

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The direct-acting oral anticoagulant (DOAC) has become an alternative to low-molecular-weight heparin (LMWH) for treatment and prophylaxis of venous thromboembolism (VTE) in cancer patients. The clinicians are, however, faced with difficult decisions regarding DOAC treatment: Which patients cannot use DOACs? Should incidental VTE be treated similar to symptomatic VTE? Is it safe to give DOACs to patients with gastrointestinal or urogenital cancers? How about drug–drug interactions? Should all cancer patients receive thromboprophylaxis? Is arterial thrombosis a problem? The current article reviews the available literature regarding these questions and aims to provide practical solutions based on data from the clinical trials and new guidelines.

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