Mechanical clot removal alone may be as effective as joint use with thrombolysis in stroke
Click Here to Manage Email Alerts
Among patients with acute stroke and large-vessel occlusion, adding IV thrombolysis to endovascular therapy may not be necessary, according to findings presented at the International Stroke Conference.
Endovascular therapy alone (direct therapy) was tied to less risk for intracerebral hemorrhage and similar mortality rates compared with endovascular therapy plus IV thrombolysis (bridging therapy), researchers from the SKIP study reported.
However, direct therapy did not meet the noninferiority margin compared with bridging therapy for the primary efficacy endpoint of favorable outcome, defined as a modified Rankin Scale score of 0 to 2 at 90 days, Kentaro Suzuki, MD, neurologist at Nippon Medical School, Tokyo, said during a presentation.
Suzuki and colleagues enrolled 204 patients (mean age, 74 years; 63% men) from 20 centers in Japan who qualified for endovascular therapy for acute stroke, were eligible for IV thrombolysis and were treated within 4.5 hours of stroke onset.
Analyses of patients from the HERMES collaboration of landmark randomized trials of endovascular therapy did not detect differences in outcomes between patients who had direct therapy and patients who had bridge therapy, but “most patients without IV thrombolysis therapy in the HERMES collaboration were ineligible for IV thrombolysis,” Suzuki said. “We needed a randomized controlled trial in eligible IV thrombolysis patients.”
For the primary outcome, the two groups did not vary greatly at 90 days (direct, 59.4%; bridging, 57.3%; OR = 1.09; 95% CI, 0.63-1.9), but the lower bound of the 95% CI exceeded the noninferiority margin of 0.74 (P for noninferiority = .17), Suzuki said during a presentation.
The per-protocol analysis of the primary endpoint was similar, as was a shift analysis of the modified Rankin Scale score in both groups, he said.
“We could not prove noninferiority of direct mechanical thrombectomy to bridging therapy in the SKIP study,” Suzuki said.
The groups did not differ in 90-day mortality (direct, 7.9%; bridging, 8.7%; P = 1), according to the researchers.
The recanalization rate in both groups exceeded 90% vs. 70.5% in patients from the HERMES collaboration, Suzuki noted.
“The frequency of favorable outcome due to high recanalization rate was higher than we expected, so we could not statistically prove noninferiority,” he said.
Intracranial hemorrhage at 36 hours occurred in 33.7% of the direct group and 50.5% of the bridging group (OR = 0.5; 95% CI, 0.28-0.88), Suzuki said. – by Erik Swain
Reference:
Suzuki K, et al. LB18. Presented at: International Stroke Conference; Feb. 19-21, 2020; Los Angeles.
Disclosure: Suzuki reports no relevant financial disclosures.