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Published on: June 15, 2020
Apixaban to Prevent Venous Thromboembolism in Patients with Cancer
Marc Carrier1, Karim Abou-Nassar1, Ranjeeta Mallick1
1From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.
Apixaban significantly reduced venous thromboembolism in ambulatory cancer patients at high risk. However, apixaban also increased the risk of major bleeding events compared to placebo.
Area of Science:
- Oncology
- Hematology
- Clinical Trials
Background:
- Active cancer patients face a higher risk of venous thromboembolism (VTE), leading to significant morbidity and mortality.
- The Khorana score is validated for identifying cancer patients at elevated risk for VTE.
- Thromboprophylaxis may benefit high-risk cancer patients to prevent VTE.
Purpose of the Study:
- To assess the efficacy and safety of apixaban for VTE prevention in ambulatory cancer patients.
- To evaluate apixaban's role in reducing VTE in intermediate-to-high-risk cancer patients initiating chemotherapy.
Main Methods:
- A randomized, placebo-controlled, double-blind clinical trial was conducted.
- Apixaban (2.5 mg twice daily) was administered to patients with a Khorana score ≥2 starting chemotherapy.
- Primary outcomes included objectively documented VTE and major bleeding episodes over 180 days.
Main Results:
- Venous thromboembolism occurred in 4.2% of patients on apixaban versus 10.2% on placebo (hazard ratio, 0.41; P<0.001).
- Major bleeding occurred in 3.5% of patients on apixaban versus 1.8% on placebo (hazard ratio, 2.00; P=0.046).
Conclusions:
- Apixaban significantly lowered the rate of VTE in high-risk ambulatory cancer patients starting chemotherapy.
- The incidence of major bleeding was higher in the apixaban group compared to the placebo group.
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