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Endovascular treatment for acute ischemic stroke favorable at 2 years
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New 2-year data from the MR CLEAN trial indicate that patients with acute ischemic stroke who received endovascular treatment, as compared with conventional care, continued to have better functional outcomes.
Initial results of the randomized, multicenter MR CLEAN trial showed that endovascular treatment plus conventional vs. conventional care alone resulted in improved functional recovery at 90 days in patients with acute ischemic stroke. For the new extended follow-up trial, researchers evaluated clinical outcomes at 2 years.
Among the 391 patients for whom 2-year follow-up data were available, those who received endovascular therapy were more likely to have a better distribution of outcomes on the modified Rankin scale — the primary endpoint — compared with those who received conventional treatment (adjusted common OR = 1.68; 95% CI, 1.15-2.45).
Additionally, patients in the conventional therapy group were more likely than those in the control group to have a good outcome, defined as a modified Rankin scale score of 0 to 2 (37.1% vs. 23.9%; adjusted OR = 2.21; 95% CI, 1.3-3.73), and a favorable outcome, defined as a modified Rankin scale score of 0 to 3 (55.2% vs. 40.6%; adjusted OR = 2.13; 95% CI, 1.3-3.43).
However, the researchers noted no significant difference between groups in the likelihood of having an excellent outcome, defined as a score of 0 to 1 (7.2% and 6.1%, respectively; adjusted OR = 1.22; 95% CI, 0.53-2.84).
Quality of life, which was evaluated using the European Quality of Life-5 Dimensions questionnaire, was better in the endovascular treatment group vs. the control group at 2 years (mean score, 0.48 vs. 0.38; mean difference, 0.1; 95% CI, 0.03-0.16). The difference in treatment effect was primarily driven by the dimensions of the questionnaire related to mobility, self-care and usual activities.
All-cause mortality data were available for 469 patients. The cumulative 2-year mortality rates were 26% in the endovascular treatment group and 31% in the control group (adjusted HR = 0.9; 95% CI, 0.6-1.2).
“The beneficial effect of endovascular treatment in patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation was sustained during the course of at least 2 years,” the researchers wrote. – by Melissa Foster
Disclosure: The MR CLEAN trial was partly supported by the Dutch Heart Foundation and through unrestricted grants from AngioCare BV, Covidien/ev3, MEDAC/LAMEPRO, Penumbra and Stryker.
Perspective
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Christopher J. White, MD, MSCAI, FACC, FAHA, FESC, FACP
The findings are confirmatory of other smaller studies that have shown the benefit of endovascular therapy of ischemic stroke is sustained out to 2 years. It is important to know that the results are durable.
They impact practice by further emphasizing the need to make timely endovascular therapy available for acute ischemic stroke. This is not currently being done in the U.S. because of a shortage of manpower, specifically neuroradiologists. Many have suggested that broadening the pool of available operators to interventional cardiology, interventional radiology and neurosurgery would benefit patients.
Knowledge gaps are solving the problem of providing most stroke patients with rapid reperfusion with shorter door-to-balloon times, just like with MI. The current debate is whether to transfer remote patients to a central hub, or alternatively distribute endovascular services to the community hospital. For MI, we found that deploying interventionalists to community hospitals was necessary to meet the goal for door-to-balloon times.
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