MR CLEAN 2-Year Outcomes Published on Endovascular Treatment for Acute Ischemic Stroke
May 24, 2017—In The New England Journal of Medicine (NEJM), Lucie A. van den Berg, MD, et al recently published findings from the extended follow-up trial of MR CLEAN, the multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke that was conducted in The Netherlands (2017;376:1341–1349).
As summarized in NEJM, the MR CLEAN investigators assessed clinical outcomes 2 years after patients were randomly assigned to undergo either endovascular treatment (intervention group) or conventional treatment (control group) for acute ischemic stroke. The primary outcome was the modified Rankin scale score at 2 years, which measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). Secondary outcomes included all-cause mortality and quality of life at 2 years, as measured by means of a health utility index based on the European Quality of Life–5 Dimensions questionnaire (scores range from −0.329 to 1, with higher scores indicating better health).
Of the 500 patients who underwent randomization in the original trial, 2-year data for this extended follow-up trial were available for 391 (78.2%) patients and information on death was available for 459 (91.8%) patients.
The investigators found that the distribution of outcomes on the modified Rankin scale favored endovascular treatment over conventional treatment (adjusted common odds ratio, 1.68; 95% confidence interval [CI], 1.15–2.45; P = .007). There was no significant difference between the treatment groups in the percentage of patients who had an excellent outcome (ie, a modified Rankin scale score of 0 or 1). The mean quality-of-life score was 0.48 among patients randomly assigned to endovascular treatment as compared with 0.38 among patients randomly assigned to conventional treatment (mean difference, 0.10; 95% CI, 0.03–0.16; P = .006). The cumulative 2-year mortality rate was 26% in the intervention group and 31% in the control group (adjusted hazard ratio, 0.9; 95% CI, 0.6–1.2; P = .46), reported the MR CLEAN investigators in NEJM.
The investigators concluded that the beneficial effect of endovascular treatment on functional outcome at 2 years in patients with acute ischemic stroke was similar to that reported at 90 days in the original MR CLEAN trial. As reported in January 2015, the 90-day MR CLEAN data were published by Olvert A. Berkhemer, MD, in NEJM (2015;372:11–20).