LOS ANGELES -- Skipping thrombolytics before endovascular thrombectomy couldn't be definitively ruled safe in the SKIP randomized trial.
Direct thrombectomy led to functional independence as measured by a 90-day modified Rankin Scale (mRS) score in 59.4% of patients, which wasn't significantly different from the 57.3% in the group bridged by alteplase (Activase, P=0.78).
However, the difference missed the threshold for non-inferiority, with a 0.63 lower bound for the confidence interval versus the required 0.74, reported Kentaro Suzuki, MD, of Nippon Medical School in Tokyo, at the International Stroke Conference.
"It's an intriguing opening shot, but has not settled the issue, and people should keep practicing per the guidelines until something definitive comes out," commented Jeffrey Saver, MD, of the University of California Los Angeles.
was too underpowered to give a definitive answer, especially for U.S. practice given that the Japanese trial used the 0.6-mg/kg alteplase dose rather than the typical 0.9 mg/kg, he told 鶹ý.
"It's not fully applicable to most tPA [tissue plasminogen activator] practice and one wonders if they would have had better efficacy in the tPA arm if they used the full dose," he said, noting that several trials are coming.
Notably, recanalization rates were substantially higher than expected in both groups, at 92% in the bridging group and 90% in the direct thrombectomy group compared with a 70.5% rate in the pivotal trials of endovascular thrombectomy pooled by the HERMES collaboration.
Still, skipping the tPA reduced intracerebral hemorrhage at 36 hours (34% vs 50% for any severity, P=0.02). Symptomatic intracerebral hemorrhage was similar between groups.
The trial included 204 patients randomized to open-label treatment with mechanical thrombectomy with alteplase beforehand or no alteplase.
Participants were adults under age 86 and met criteria for thrombectomy including time to puncture of less than 4 hours from stroke onset. More men were in the bridging group, although the groups had similar treatment times and pathological assessments.
Limitations included the open-label treatment, exclusion of patients without internal carotid artery or M1 occlusion, and use of only a 0.6 mg/kg dose of alteplase.
Disclosures
The SKIP study was funded by the Japanese Society for Neuroendovascular Therapy.
Suzuki disclosed no relevant relationships with industry. Co-authors disclosed multiple relevant relationships with industry including Nippon Boehringer Ingelheim.
Saver disclosed relevant relationships with Boehringer Ingelheim which distributes alteplase in some regions of the world.
Primary Source
International Stroke Conference
Suzuki K, et al "The Randomized Study of Endovascular Therapy With versus Without Intravenous Tissue Plasminogen Activator in Acute Stroke With ICA and M1 Occlusion (SKIP Study)" ISC 2020; Abstract LB18.