Trials Will Address Unanswered Questions About Endovascular Therapy
The RACECAT trial, which has not yet been initiated, may provide evidence to address this question. Emergency responders in Catalonia, Spain, will use the Rapid Arterial Occlusion Evaluation (RACE) scale, which has more items than some of the other triage scales, to identify patients with acute stroke and suspected large vessel occlusion. After the responders contact the stroke neurologists on call using a telestroke system, eligible participants will be randomized according to a predetermined sequence to either transfer to the closest local stroke center or direct transfer to an endovascular stroke center. The study allocations will allow for three additional comparisons: between two groups of 12 hours, between metropolitan and provincial areas, and between workdays and weekends. The primary end point is the mRS at 90 days.
Identifying the Best Level of Anesthesia
Other trials will seek to determine whether general anesthesia or planned conscious sedation is more cost-effective in patients who are eligible for either procedure. Researchers previously examined this question in the IMS III trial. Setting aside patients who underwent medically indicated general anesthesia (who had large strokes and many comorbidities and tended to have poor outcomes), the researchers found a trend toward better outcomes among patients who underwent conscious sedation, compared with patients who received general anesthesia. In addition, general anesthesia cost approximately $16,000 more than conscious sedation did.
In the prospective SIESTA trial, patients with acute ischemic stroke were randomized in a 1:1 ratio to a nonintubated state or to an intubated state for endovascular stroke treatment. The primary outcome measure was NIHSS at 24 hours after the intervention. Secondary outcome measures included mRS at three months and inpatient mortality. Conscious sedation was not associated with any advantage over general anesthesia in this small randomized trial, according to the researchers.
In addition, investigators are recruiting patients for the GOLIATH trial, in which patients will be randomized to general anesthesia or local anesthesia. The primary outcome measure will be growth of the ischemic lesion on diffusion-weighted imaging (DWI). Secondary outcome measures will include time from arrival to groin puncture and recanalization, blood pressure during intervention, and mRS.
Thrombectomy With or Without Thrombolysis
Another unanswered question is whether thrombectomy alone provides greater benefit than IV t-PA followed by thrombectomy for patients with acute ischemic stroke. Investigators in the Netherlands are conducting the MR CLEAN NO IV trial to answer this question. They plan to include 500 patients who are taken directly to a comprehensive stroke center. One group will receive IV t-PA plus endovascular treatment, and the other group will receive endovascular treatment alone.
—Erik Greb
Suggested Reading
Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016;387(10029):1723-1731.
Lansberg MG, Cereda CW, Mlynash M, et al. Response to endovascular reperfusion is not time-dependent in patients with salvageable tissue. Neurology. 2015;85(8):708-714.
Schönenberger S, Uhlmann L, Hacke W, et al. Effect of conscious sedation vs general anesthesia on early neurological improvement among patients with ischemic stroke undergoing endovascular thrombectomy: a randomized clinical trial. JAMA. 2016;316(19):1986-1996.
