When performed by itself, endovascular therapy had greater rates of intracranial hemorrhage compared to a combination of both endovascular therapy and intravenous thrombolysis.
Mitchell S. V. Elkind, MD, MS, FAHA, FAAN
Findings from a study of large vessel occlusion treatment methods suggest that outcomes from endovascular therapy (EVT) are similar to those using a bridged combination of EVT and intravenous thrombolysis (IVT). The data were presented at the 2020 International Stroke Conference (ISC), February 19-21, 2020, in Los Angeles, California.1,2
Treatment with EVT, otherwise known as mechanical clot removal, reported similar favorable outcomes at 90 days in 60 of the 101 patients (59.4%), compared to 59 of 103 patients (57.3%) in the bridging therapy group (odds ratio [OR], 1.09; 95% CI, 0.63 to 1.90; the lower boundary exceeded the noninferiority margin of 0.74; P = 0.18 for noninferiority).
“The best strategy is usually to treat with [alteplase] . . . and then if the patient is eligible, the patient goes for endovascular therapy as well. But [we] don’t skip that initial step because sometimes the endovascular therapy gets delayed or doesn’t occur for some reason or another,” Mitchell S. V. Elkind, MD, MS, FAHA, FAAN, president elect, American Heart Association, professor of neurology and epidemiology, Columbia University New York, and attending neurologist, Columbia University Medical Center, New York-Presbyterian Hospital.
The multicenter, prospective, randomized, open-label clinical trial included 204 stroke patients (age, 74 years [range, 67 to 80]; men, 128 [62.7]) across 20 medical centers in Japan. Patients were randomly assigned to either direct EVT or a bridged therapy of both IVT and EVT within 4.5 hours after symptom onset. Patients included in the trial were between 18 to 85 years old, had pre modified Rankin Scale (mRS) within 2 and had a National Institute of Health Stroke Score (NIHSS) more than 6.
Patient scores between 0-2 on the modified Rankin Scale (mRS) were defined as a favorable outcome or having met primary endpoint at 90 days. Additionally, each patient would be evaluated for intracranial hemorrhage as a safety outcome at 36 hours post therapy.
At 90 days, investigators noted a similar rate of death in each group, with 8 participants dying (7.9%) in the EVT group and 9 dying (8.7%) in the bridged group, respectively (P = 1.00). Additionally, the rate of favorable outcomes between 2 groups was not significantly different.
Within 36 hours of onset, the rate of any intracranial hemorrhage were 34 (33.7%) in the direct EVT group and 52 (50.5%) in the bridging therapy group (odds ratio, 0.50; 95% CI, 0.28 to 0.88; P = .02).
Reperfusion rate at mechanical thrombectomy, defined as a score >2B on the Thrombolysis in Cerebral Infarction (TICI) scale for patients in the trial: (OR 0.89, 95% CI 0.51-1.55, P = .78).
Symptomatic ICH on both the National Institute of Neurologic Disorders Score criteria and SIT-MOST criteria at 36 hours: (odds ratio [OR] 0.65; 95% CI, 0.25 to 1.67; P = .48) and (OR 0.75; 95% CI, 0.25 to 2.25; P = .78).
“Current recommendations from the American Heart Association/American Stroke Association recommend using intravenous therapy within the 4.5 hour-time window and then treating with mechanical clot removal, if appropriate.” Elkind said in a statement.
1. Matsumaru Y, Takeuchi M, Morimoto M, 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). Presented at: 2020 International Stroke Conference. February 19-21, 2020; Los Angeles, CA. Abstract LB18.
2. Mechanical clot removal without clot busters may be sufficient stroke treatment [news release]. Los Angeles, CA: American Stroke Association. February 21, 2020. newsroom.heart.org/news/mechanical-clot-removal-without-clot-busters-may-be-sufficient-stroke-treatment?preview=cb19. Accessed February 21, 2020.