This is the low bar for efficacy in stroke; 'good functional status', NOT 100% RECOVERY! Until we get survivors in charge we will never get past the tyranny of low expectations the stroke medical world wants us to accept as good.
Basilar Stroke Thrombectomy Finally Wins for Efficacy in Randomized Trials
Promising results of endovascular therapy outside the anterior circulation
Renewed attempts to show that endovascular therapy can work in basilar artery occlusion stroke did pan out in China, justifying further study in other populations.
The ATTENTION and BAOCHE randomized trials found significantly greater odds of good functional status in people with moderate or severe stroke due to basilar artery occlusion who underwent thrombectomy at experienced Chinese centers. The incidence of people achieving modified Rankin scale (mRS) scores of 0-3 at 90 days reached:
- 46% with thrombectomy vs 23% with medical therapy alone (adjusted RR 2.06, 95% CI 1.46-2.91) in ATTENTION
- 46% vs 24% (adjusted RR 1.81, 95% CI 1.26-2.60) in BAOCHE
ATTENTION counted 340 participants and BAOCHE, 217. Both trials had full manuscripts published in the New England Journal of Medicine.
Notably, unlike some stroke populations in the West, the two Chinese cohorts tended to have a relatively high prevalence of intracranial large artery atherosclerosis -- typically treated with angioplasty or stenting atop any planned thrombectomy -- and low use of IV thrombolysis.
Investigators had also allowed endovascular therapy to be tested relatively late after stroke onset, unlike the older BEST and BASICS trials that had failed to prove a significant benefit to endovascular therapy over best medical care alone.
Based on ATTENTION and BAOCHE, endovascular therapy "appears to be effective in patients with basilar-artery occlusion who have moderate-to-severe neurologic deficits and have limited early ischemic changes up to 24 hours after stroke onset," concluded Wouter Schonewille, MD, of Sint Antonius Hospital in Nieuwegein, the Netherlands.
"Further randomized, controlled trials in basilar-artery stroke are warranted in broader populations to test the efficacy of endovascular therapy in patients with mild deficit and to test the efficacy of intravenous thrombolysis in the extended time window (>4.5 hours after stroke onset)," he wrote in an accompanying editorial.
As for safety, the feared complication of symptomatic intracranial hemorrhage occurred in 5% of the thrombectomy group (and none among controls) in ATTENTION; in BAOCHE, the incidence was 6% (vs 1%). Overall procedural complications occurred in 14% and 11%, respectively, of thrombectomy patients in these two trials.
Mortality at 90 days was significantly reduced with thrombectomy in ATTENTION (37% vs 55%, adjusted RR 0.66, 95% CI 0.52-0.82) but not in BAOCHE (31% vs 42%, adjusted RR 0.75, 95% CI 0.54-1.04).
Schonewille noted that basilar artery occlusion strokes may account for a minority of strokes in clinical practice, but are associated with the highest morbidity and mortality.
ATTENTION was conducted in 2021-2022 at 36 centers in China. Patients were randomized to thrombectomy (n=226) or medical therapy alone (n=114). Mean age was around 67 years, and men accounted for approximately 70% of patients. Median NIH Stroke Scale (NIHSS) score was 24 in both groups at baseline.
Eligible stroke patients were randomized within 12 hours after the estimated time of basilar artery occlusion; ultimately, the delay was a median 5 hours. IV thrombolysis was used in 31% of the patients in the thrombectomy group and in 34% of controls in the trial.
The BAOCHE trial was conducted separately in 2016-2021 and had 217 people randomized 1:1 to thrombectomy or medical therapy alone. Median age was 65 years, and women constituted 27% of the cohort. The median NIHSS score was 20 at baseline.
Eligibility criteria included presentation 6-24 hours after stroke onset; the median was just over 11 hours. IV alteplase was given to 14% of the thrombectomy arm and 21% of those getting medical therapy alone.
The BAOCHE authors cautioned about protocol changes during their trial, namely the change in primary outcome from the original of mRS 0-4 -- an endpoint that would have been neutral for endovascular therapy (adjusted RR 1.21, 95% CI 0.95-1.54). What's more, the trial had been terminated early for efficacy.
Disclosures
ATTENTION was supported by the Program for Innovative Research Team of the First Affiliated Hospital of the University of Science and Technology of China, the Beijing Dingyi Foundation (China Special Fund for Stroke Prevention and Treatment), and the Beijing Healthunion Cardio-Cerebrovascular Disease Prevention and Treatment Foundation.
BAOCHE was funded by a grant from the Chinese National Ministry of Science and Technology.
Schonewille reported personal fees from Nanjing University.
Primary Source
New England Journal of Medicine
Source Reference: Tao C, et al "Trial of endovascular treatment of acute basilar-artery occlusion" New Engl J Med 2022; DOI: 10.1056/NEJMoa2206317.
Secondary Source
New England Journal of Medicine
Source Reference: Jovin TG, et al "Trial of thrombectomy 6 to 24 hours after stroke due to basilar-artery occlusion" New Engl J Med 2022; DOI: 10.1056/NEJMoa2207576.
Additional Source
New England Journal of Medicine
Source Reference: Schonewille WJ "Favorable outcomes in endovascular therapy for basilar-artery occlusion" New Engl J Med 2022; DOI: 10.1056/NEJMe2210737.
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