MedicalResearch.com Interview with:
Babak B. Navi MD, MS
Department of Neurology
Weill Cornell Medicine
New York, New York
MedicalResearch.com: What is the background for this study?
Response: About 10% of patients with ischemic stroke have comorbid cancer and these patients face an increased risk of stroke recurrence. Many strokes in patients with cancer are attributed to unconventional mechanisms from acquired hypercoagulability. Therefore, many physicians recommend anticoagulation, especially low molecular weight heparins, for the treatment of cancer-associated stroke. However, hypercoagulable stroke mechanisms, such as nonbacterial thrombotic endocarditis, are rarely definitively diagnosed in cancer patients antemortem; while atherosclerosis, which is generally treated with antiplatelet medicines such as aspirin, is common in cancer patients. In addition, many historic indications for anticoagulation in ischemic stroke have been disproven by randomized trials because any reductions in stroke risk were offset by increased risks of bleeding. Given these considerations, we believed that a randomized trial comparing anticoagulation with enoxaparin to antiplatelet therapy with aspirin was necessary to determine the superior strategy, prompting implementation of the TEACH pilot randomized trial. The primary aim of TEACH was to determine whether the random assignment of different antithrombotic strategies to cancer patients with acute ischemic stroke would be sufficiently feasible and safe to proceed with a larger efficacy trial.
MedicalResearch.com: What are the main findings?
Response: In the first randomized trial evaluating different antithrombotic strategies for cancer-associated stroke, among 469 patients with active solid or hematological cancer and suspected acute ischemic stroke screened at 3 academic centers, about 10% (n=49) were eligible and approximately 40% (n=20) were enrolled, in line with prior stroke clinical trials. The leading reason for enrollment failure was patient aversion to receiving subcutaneous enoxaparin injections, and 40% of patients who were randomized to receive enoxaparin crossed over to using aspirin because of discomfort with the injections. Clinical safety and efficacy outcomes were similar between groups although these analyses were limited by the small number of patients. These data suggest that larger, randomized clinical trials to determine the optimal antithrombotic strategy for cancer-associated stroke may be feasible and safe, although adherence to injectable enoxaparin is poor in these patients.
MedicalResearch.com: What should readers take away from your report?
Response: A randomized clinical trial of anticoagulation versus antiplatelet therapy in patients with cancer and acute ischemic stroke seems feasible and safe. However, long-term compliance with injectable low molecular weight heparins is poor in this population so comparing direct oral anticoagulants to aspirin should be considered for future clinical trials.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Larger, fully powered, multicenter randomized clinical trials comparing anticoagulation with a direct oral anticoagulant versus antiplatelet therapy with aspirin should be performed to determine the optimal antithrombotic strategy for patients with active cancer and acute ischemic stroke.
Disclosures: This study was supported by grants from the National Institutes of Health. There were no financial conflicts of interest.
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Navi BB, Marshall RS, Bobrow D, Singer S, Stone JB, DeSancho MT, DeAngelis LM. Enoxaparin vs Aspirin in Patients With Cancer and Ischemic StrokeThe TEACH Pilot Randomized Clinical Trial. JAMA Neurol. Published online January 08, 2018. doi:10.1001/jamaneurol.2017.4211
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