A Brief Report of Clinical Trials Results from the 2016 International Stroke Conference
April 1, 2016 3 minutes read
By Matthew E. Fink, MD
Professor and Chairman, Department of Neurology, Weill Cornell Medical College; Neurologist-in-Chief, New York Presbyterian Hospital
Dr. Fink reports he is a retained consultant for Procter & Gamble and Pfizer.
The FIND A FIB trial from Switzerland, is a randomized trial of 400 patients with ischemic stroke aged 60 years or older, who were not known to have atrial fibrillation and had normal sinus rhythm at the time of their stroke. One group had standard continuous monitoring of heart rhythm for 24 hours, and the second group had enhanced and prolonged monitoring with three 10-day Holter monitor sessions at the time of the stroke, at 3 months, and at 6 months after the stroke. Atrial fibrillation was found in 13.5% of patients in the group that underwent enhanced and prolonged monitoring and in 4.5% of the control group. Anticoagulation was started when atrial fibrillation was diagnosed; after 1 year, there was a reduced rate of recurrent strokes in the extended monitoring group compared to control (2.5% vs 4.5%).
The ARUBA trial is a randomized trial of unruptured brain arteriovenous malformations, and 5-year results were presented. Two hundred twenty-eight patients were enrolled and randomized to medical management of symptoms or to medical management plus invasive management, which included surgery, endovascular embolization, or radiotherapy. Five-year follow-up showed that the death or stroke rate was 40.6% in the intervention group vs 10.8% in the medical group, with a highly significant difference. Stroke rate was 39.6% vs 9.2%. Medical treatment was found to reduce the risk of stroke or death by 78% compared to intervention.
The CREST trial, carotid endarterectomy vs stenting for treatment of carotid artery stenosis, presented its long-term results of carotid revascularization endarterectomy (CEA) vs stenting (CAS). In this trial, 2502 patients were randomized and followed at 117 centers, following transient ischemic attack, or mild stroke, or asymptomatic with carotid stenosis. After randomization to either CEA or CAS, they were evaluated every 6 months and followed for a median of 10 years. The primary endpoint, any cause of stroke, myocardial infarction, or death, was not significantly different after 10 years between the two groups. In conclusion, the difference between CEA and CAS was not significant for post-procedural stroke.
The IRIS trial was designed to evaluate the effects of pioglitazone, an insulin-sensitizing drug, for secondary stroke prevention in patients with insulin resistance and a recent ischemic stroke or transient ischemic attack. Patients did not have overt diabetes, but had insulin resistance, and were 40 years of age or older. In this trial, 3876 patients were enrolled and the average time for follow-up was 4.8 years. The primary endpoint was fatal or nonfatal stroke or myocardial infarction. Trial results showed that fatal or nonfatal stroke or myocardial infarction occurred in 9% of the pioglitazone-treated patients, and 11.8% of the placebo-controlled group, with a statistically significant difference and P value of 0.007. There were more adverse effects in the pioglitazone group, specifically bone fractures, than in the control group. The conclusion was that targeting insulin resistance with pioglitazone resulted in reduction of secondary stroke and myocardial infarction, but there was a greater risk for fractures.
This article provides an overview of the research presented at the 2016 International Stroke Conference.
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