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Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
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SELECT-D extension: Treatment of cancer-associated VTE 12 month outcomes of placebo vs Xarelto® randomisation of the SELECT-D trial.

Major Studies

 
Background

  • The SELECT-D trial demonstrated that Xarelto had a greater effect on reduction in VTE vs dalteparin, but increased bleeding compared with dalteparin in cancer patients at 6 months
  • Uncertainty around optimal duration of anticoagulation use remains in patients with active cancer

Objective

  • To assess VTE recurrence and bleeding, with anticoagulation or not, beyond 6 months in a long-term extension of the SELECT-D trial

Study design

  • At around 6 months post-randomisation in the SELECT-D trial, patients with CAT with residual DVT  or had presented with a PE were randomly assigned to Xarelto 20 mg OD or placebo.

SELECT-D extension Studies

Endpoints

Primary efficacy outcome

  •  VTE recurrence at 12 months after first randomisation

  • Major bleeding

  • CRNMB

  • Overall survival

  • VTE recurrence at 12 months for the patient subgroup with no RVDT

Key Findings

  • After 6 months only 4% of patients treated with Xarelto had a VTE recurrence (HR 0.32; 95% CI, 0.06-1.58) vs placebo (14%). There was a numerically lower cumulative VTE recurrence rate for Xarelto versus placebo

  • The trial was underpowered to detect a statistically significant reduction in recurrent VTE with extended anticoagulation beyond 6 months

  • Major bleeding rates were 0% with placebo and 5% with Xarelto (95% CI, 1–18)

  • CRNMB were 0% with placebo and 4% with Xarelto (95% CI, 1–17)

  • After 6 months, OS for Xarelto-treated patients was 89% (95% CI, 75–95) and 87% (95% CI, 73–94) for placebo patients (HR=1.16; 95% CI, 0.36–3.81)

  • Absence of RVDT defined a low VTE recurrence risk group (log rank P=.03)

     

     

 

CAT, cancer-associated thrombosis ; CI, confidence interval; CRNMB, clinically relevant non-major bleeding; DVT , deep vein thrombosis; HR, hazard ratio; OD, once daily; OS, overall survival; PE , pulmonary embolism; RVDT, residual deep vein thrombosis; VTE , venous thromboembolism.

 

PP-XAR-ALL-1827-1

    • 1
      Marshall A, et al. J Thromb Haemost. 2020. doi: 10.1111/jth.14752
    • a
      Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism. 
    • b
      Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal…
    • c
      Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage. 
    • d
      Formation of a clot inside a blood vessel.