Long-term follow-up of patients in a 2014 study confirms that stroke patients recover better if doctors physically remove a clot from a blocked artery instead of just letting the clot-busting drug tPA try to do the job, reports Reuters Health.
The conclusion is based on 500 Dutch patients treated in a landmark study known as MR CLEAN. The findings may encourage more hospitals to adopt the technique.
In earlier results from the study, one third of patients whose treatment included using a device to extract a clot from a brain artery achieved functional independence by the 90-day mark after their strokes compared to 19% given usual care. Now, two years of data show functional independence for 37% of patients with clot removal versus 24% with clot-busting drugs alone.
"We are delighted. It is icing on the cake," said Dr Reza Jahan of the University of California – Los Angeles Stroke Centre, who was not connected with the study. "It confirms the long-term durability" of the technique and it will encourage more centres to use it, he said.
The MR CLEAN study, combined with subsequent positive results released soon afterward, "has made a huge difference" in how doctors treat strokes said study co-author Yvo Roos, a neurologist at the Academic Medical Centre in Amsterdam. "This is now standard care," he is quoted in the report as saying.
Figuring out which hospitals offer the therapy can be difficult for consumers, however. There is no easy to find list of US facilities, known as comprehensive stroke centres, that are certified to offer the treatment whenever needed, the report said.
Jahan said the new study results reinforce efforts to evaluate stroke patients before they even reach a hospital and then immediately get them to one of these comprehensive stroke centres if they are candidates for clot removal.
"It will get these patients to the treatment they need faster, rather than the current model, where they may go to a primary stroke centre to get clot-busting drugs and valuable time is lost trying to transport them to a comprehensive stroke centre," he said.
The findings apply to patients whose strokes were the result of a blockage in the large forward arteries of the brain, which is the most common type of stroke and affects up to 125,000 patients in the US and 90,000 in Europe each year.
Typically, the clot-busting drugs only open the blocked artery in about a third of the cases, which is why doctors have hoped that removing the clot directly would produce better recovery.
Clot removal is expensive – $57,031 for the extraction and for the first 90 days of other stroke treatment, according a recent analysis. Treatment without clot extraction cost $44,752.
With the results showing a long-term benefit with extraction, "this up-front expense is going to be justified because, in the long term, we'll see a reduction in medical care, nursing care, home care and rehabilitation care," Jahan predicted. "We're saving money in the long run. Patients who would have been stuck in a skilled nursing facility for two years, hopefully, are now being sent home."
Quality of life scores at two years were higher in the clot-removal treatment group, with the big differences reported in the categories of mobility, self-care and the ability to do usual activities.
The cumulative rates of death from any cause were comparable in the two groups during the two years after a stroke, at 26% among clot removal patients and 31% among those who didn’t get that treatment.
But Roos and his colleagues note that the difference in mortality rates has grown as time passed
Abstract
Background: Several trials involving patients with acute ischemic stroke have shown better functional outcomes with endovascular treatment than with conventional treatment at 90 days after initiation of treatment. However, results on long-term clinical outcomes are lacking.
Methods: We assessed clinical outcomes 2 years after patients were randomly assigned to receive either endovascular treatment (intervention group) or conventional treatment (control group) for acute ischemic stroke. The primary outcome was the score on the modified Rankin scale at 2 years; this scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). Secondary outcomes included all-cause mortality and the quality of life at 2 years, as measured by means of a health utility index that is based on the European Quality of Life–5 Dimensions questionnaire (scores range from −0.329 to 1, with higher scores indicating better health).
Results: Of the 500 patients who underwent randomization in the original trial, 2-year data for this extended follow-up trial were available for 391 patients (78.2%) and information on death was available for 459 patients (91.8%). 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 to 2.45; P=0.007). There was no significant difference between the treatment groups in the percentage of patients who had an excellent outcome (i.e., 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 to 0.16; P=0.006). The cumulative 2-year mortality rate was 26.0% in the intervention group and 31.0% in the control group (adjusted hazard ratio, 0.9; 95% CI, 0.6 to 1.2; P=0.46).
Conclusions: In this extended follow-up trial, 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 trial. (Funded by the Netherlands Organization for Health Research and Development and others; MR CLEAN Current Controlled Trials number, ISRCTN10888758, and Netherlands Trial Register number, NTR1804, and MR CLEAN extended follow-up trial Netherlands Trial Register number, NTR5073.)
Authors
Lucie A van den Berg, Marcel GW Dijkgraaf, Olvert A Berkhemer, Puck SS Fransen, Debbie Beumer, Hester F Lingsma, Charles BLM Majoie, Diederik WJ Dippel, Aad van der Lugt, Robert J. van Oostenbrugge, Wim H van Zwam, Yvo BWEM Roos
[link url="http://www.reuters.com/article/us-health-stroke-clot-grab-idUSKBN1772TB"]Reuters Health report[/link]
[link url="http://www.nejm.org/doi/full/10.1056/NEJMoa1612136"]New England Journal of Medicine abstract[/link]