Six Stroke Trials to Know

I am Christoph Diener, from the Department of Neurology at the University of Essen in Germany. Today I want to discuss studies that were presented at the Trials Session at the European Stroke Congress in Nice at the beginning of May of this year.

Altogether this was a very disappointing Congress, because most of the studies presented were negative studies. We seem to have reached a kind of ceiling effect, where additional interventions will not result in a higher benefit. Thus, at this moment, what we are left with is thrombolysis treatment in stroke units.

The first study, presented by Pierre Amarenco^[1] from France, involved the large-scale French TIA registry. The study included 4789 patients who were followed for 1 year. Brain imaging revealed that about one third of these patients suffered a stroke even though their symptoms lasted less than 24 hours. In the 1-year follow-up, the rate of myocardial infarctions, stroke, and vascular deaths was only 6%, which was much lower than what was seen in the past. This study clearly shows the benefit of treating these kinds of patients aggressively.

The United Kingdom's Stroke Oxygenation Supplementation Study^[2] was also presented. This study included 8000 patients with acute stroke who were randomly assigned to 3 oxygenation groups for the first 72 hours after the stroke. One group received normal air, one group received oxygen during the night, and one group received continuous oxygen. As you may expect, they found no difference in oxygen saturation among the 3 groups, and no benefit as measured by modified Rankin scale, after 90 days.

Phil Bath^[3] presented results from ENOS, a study of patients who were admitted to hospital with a systolic blood pressure above 140 and below 220 mm Hg and who had either ischemic or hemorrhagic stroke. These patients were randomly assigned to receive transdermal glyceryl trinitrate, an antihypertensive drug that is very inexpensive and lowers blood pressure very slowly, or placebo. More than 4000 patients were included in this study, and at 90 days there was no difference in the outcomes.

A substudy of ENOS^[3] looked at a very interesting research question: Does it make a difference if you stop antihypertensive treatment in patients who had treated hypertension, or should the antihypertensive treatment be continued? This analysis found no difference between the 2 groups. Obviously, it makes no difference whether antihypertensive treatment is terminated for some time or continued.

SCAST, INTERACT, and CRYSTAL-AF

In the second large clinical trials session, long-term results of the SCAST study^[4] were reported. In this trial, more than 700 patients with hypertension and high blood pressure after acute stroke were randomly assigned to receive candesartan or placebo. The short-term outcomes did not show a difference in favor of candesartan. This remained true when patients were followed for up to 3 years.

The INTERACT study^[5] included patients with cerebellar hemorrhage and high blood pressure, and found a very strong trend towards improvement and better outcomes in patients who were aggressively treated for their high blood pressure. A substudy of INTERACT^[5] comprised patients with bleeding related to antithrombotic therapy. This subgroup of patients benefitted from aggressive lowering of blood pressure. Taken together, it seems that patients with cerebellar hemorrhage benefit from reducing high blood pressure, whereas patients with ischemic stroke have no benefit.

Finally, the results from CRYSTAL-AF^[6] were presented.This is a trial of 441 patients with cryptogenic stroke who were randomly assigned to receive an implantable Reveal recording device, which records symptomatic paroxysmal atrial fibrillation. The control group received intermittent ECG, which is standard of care. There was a clear difference in the detection rate of symptomatic paroxysmal atrial fibrillation: about 10% per year in the intervention group vs 2% per year in the control group. This clearly had implications for treatment, because all patients in whom atrial fibrillation was detected received anticoagulation. This also led to a very strong trend towards lower stroke rate in the group of people who were continuously monitored.

Ladies and gentleman, I think this is a very important result because it means we have to look much more carefully to detect paroxysmal atrial fibrillation in patients with cryptogenic stroke.

In all, this was a rather depressing Congress with very few positive results. I am Christoph Diener, a neurologist from the Department of Neurology at the University of Essen in Germany. Thank you very much for listening.

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Cite this: Six Stroke Trials to Know - Medscape - Jul 08, 2014.