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7 Stroke Studies to Know
Dear colleagues, my name is Christoph Diener. I am a neurologist from the Department of Neurology at the University of Essen in Germany. Today I would like to report highlights from the European Stroke Conference, which took place at the end of May in London.
Let me start with primary prevention. Results from the ARUBA trial were reported. This is a trial in which patients with asymptomatic arteriovenous malformations were randomized into 2 groups. One group received interventional radiology surgery or radiation and the other group of patients was treated medically. This trial was terminated early by the Data and Safety Monitoring Board (DSMB) due to the very high complication rate of surgery or therapy with radiation. The relative risk in favor of medical or conservative therapy was 0.29, showing a risk increase of 70%.
The next trial was NEST 3. This was a laser treatment trial in which patients with National Institutes of Health Stroke Scale (NIHSS) scores of 7-17 were enrolled. Patients were not supposed to receive tissue plasminogen activator. The study was terminated prematurely by the DSMB for futility. So, this trial for neuroprotective therapy failed.
A positive trial was DESTINY II. This trial investigated hemicraniectomy in patients with a malignant infarct of the middle cerebral artery who were older than 60 years of age. DESTINY I had already shown that younger patients have a clear benefit from hemicraniectomy. In this trial, the outcome was modified Rankin Scale (mRS) scores, 0-4 vs 5 or 6. The trial was stopped by the DSMB, in this case due to efficacy findings. The primary endpoint indicating a good outcome -- an mRS score from 0 to 4 -- occurred in 39% of the surgery group compared with 17% of the conservatively treated group. This was highly statistically significant. The number needed to treat is 5 for the benefit of hemicraniectomy over optimal medical treatment, so this treatment should also be offered to patients above the age of 60.
The next trial that was reported was ARCH. ARCH randomized patients with transient ischemic attack (TIA) or minor stroke who had significant aortic plaques. Patients were randomized to either warfarin or the combination of aspirin and clopidogrel. This trial was stopped because it turned out that the trial would never reach the power for a definite result. The outcome was that there was a small benefit in favor of aspirin plus clopidogrel vs warfarin, which was not statistically significant. Unfortunately, we still don't know what the best treatment is for patients who have aortic plaques with TIA or minor stroke.
The next trial was SPS3. SPS3 randomized patients who had lacunar stroke to either aggressive antihypertensive therapy (target systolic blood pressure < 130 mm Hg) or a more conservative therapy (target systolic blood pressure 131-149 mm Hg). The endpoint was stroke. The trial showed a relative risk reduction of 19% with the more aggressive approach, which just failed statistical significance. Nevertheless, I think that it is very important to treat patients with lacunar stroke aggressively when it comes to long-term blood pressure control.
INTERACT2 was a study that randomized 2839 patients within 6 hours of having cerebral bleeding. Half of the patients achieved systolic blood pressure of < 140 mm Hg, which was achieved by IV treatment with antihypertensive drugs. The control group received standard care. The endpoint was death or major disability. There was an odds ratio of 0.87 in favor of a more aggressive immediate lowering of blood pressure in patients with cerebral bleeds, which just failed significance.
The last important trial was STICHII. This trial investigated immediate hematoma evacuation in patients with a cerebral bleed with medical treatment within 12 hours. The trial had 601 patients. The odds ratio in favor of surgical therapy was not statistically significant. An unfavorable outcome was seen in 59% of patients who received medical therapy and 62% of patients who were operated. This clearly shows that surgery has no benefit for these kinds of patients, with one exception: People who had had superficial hemorrhages and no intraventricular hemorrhages had a benefit from surgery.
Ladies and gentlemen, there are many important new trials. Most of them were already published either in the Lancet Neurology or the New England Journal of Medicine. Thank you very much for listening. I'm Christoph Diener, a stroke neurologist from the University of Essen in Germany.
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