"Apixaban for Thromboprophylaxis in Cancer Patients". The New England Journal of Medicine. 2018. 378:711-719. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In ambulatory patients with cancer at intermediate-to-high risk for venous thromboembolism who are starting chemotherapy, does thromboprophylaxis with apixaban reduce the incidence of venous thromboembolism compared with placebo?
Apixaban significantly reduced the incidence of venous thromboembolism in ambulatory patients with cancer at intermediate-to-high risk who were starting chemotherapy, at the expense of an increased risk of major bleeding episodes.
Patients with active cancer have an elevated risk of venous thromboembolism which can lead to significant morbidity and mortality. The AVERT trial evaluated the efficacy and safety of using apixaban, an oral anticoagulant, for thromboprophylaxis in this patient population.
As of this trial's publication, guidelines for thromboprophylaxis in cancer patients were not established based on the findings of this study.
Multicenter, randomized, placebo-controlled, double-blind trial N=574 patients Randomized 1:1 to receive apixaban or placebo Treatment period: 180 days Median follow-up: 183 days
Inclusion Criteria -Newly diagnosed cancer or progression after remission -Initiating new chemotherapy course -Khorana score ≥2 -Age ≥18 years
Exclusion Criteria -Risk factors for significant bleeding -Hepatic disease with coagulopathy -Certain cancer diagnoses (basal-cell/squamous-cell skin cancer, acute leukemia, or myeloproliferative neoplasm) -Planned stem-cell transplantation -Life expectancy <6 months -Renal insufficiency, platelet count <50,000 per cubic millimeter
Baseline Characteristics -Mean age 61 years -58.2% women -Most common cancers: gynecologic (25.8%), lymphoma (25.3%), and pancreatic (13.6%) -22.8% were using antiplatelet or NSAIDs
-Apixaban: 2.5 mg twice daily -Placebo: identical tablets twice daily
Primary Outcome -Venous thromboembolism: 4.2% in apixaban group vs. 10.2% in placebo group (hazard ratio, 0.41; 95% CI, 0.26 to 0.65; P<0.001)
-Major bleeding: 3.5% in apixaban group vs. 1.8% in placebo group (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P=0.046)
-Limited ability to make definitive conclusions about individual tumor types or chemotherapy regimens based on sample size. -Results may be less applicable to patients with significant renal dysfunction.
Supported by Canadian Institutes of Health Research and Bristol-Myers Squibb–Pfizer Alliance.
The full article can be accessed at NEJM.org.