NASHVILLE — Compared with intravenous tissue plasminogen activator (IV tPA) alone, rapid treatment with the Solitaire stent retriever in patients with acute ischemic stroke decreased rates of disability and improved survival and independence following stroke.
The results of the multicenter, randomized SWIFT PRIME trial were presented during the International Stroke Conference 2015.
Jeffrey L. Saver, MD, of the Geffen School of Medicine and UCLA Comprehensive Stroke Center in Los Angeles, and colleagues conducted the study to examine whether patients with an acute ischemic stroke due to large vessel occlusion would have less stroke-related disability when treated with the Solitaire device 6 hours from symptom onset plus IV tPA vs. IV tPA alone.
Two revascularization devices were used in the endovascular therapy arm: Solitaire Flow Restoration (FR) and Solitaire 2.
On Nov. 7, 2014, the Data Safety Monitoring Board (DSMB) recommended trial enrollment stop and after a DSMB meeting on Feb. 4, 2015, the trial was halted.
In all, 196 patients were randomly assigned to receive endovascular therapy plus IV tPA (n=98) or IV tPA alone (n=98). Baseline characteristics, including age, gender, race, pre-stroke modified Rankin Score (mRS), and National Institutes of Health Stroke Scale (NIHSS), were similar between groups.
According to data, there was a significant difference in mRS in favor of the endovascular therapy arm (P=.0002). Functional independence, defined as an mRS of 0 to 2 at 90 days, was also improved in the endovascular therapy arm (60.2% vs. 35.5%; P=.0008).
Rates of death at 90 days did not significantly differ between groups (endovascular therapy, 9.2% vs. IV tPA, 12.4%; P=.50), but improvement in NIHSS at 27 hours did, favoring endovascular therapy (8.5% vs. 3.9%; P<.0001).
Safety endpoints, including any adverse event (endovascular therapy, 35.7% vs. IV tPA, 30.9%; P=.54) and symptomatic intracranial hemorrhage (endovascular therapy, 1% vs. IV tPA, 4.1%; P=.21) were similar between groups.
Further analysis revealed that for every 100 patients treated with endovascular therapy, 39 will have better three-month disability outcome and 25 more patients will achieve functional independence at long-term follow-up compared with IV tPA alone.
For more coverage of the International Stroke Conference 2015, go here.
- Saver J et al. Invited Presentation: SWIFT PRIME. Presented at: International Stroke Conference 2015; Feb. 11-13, 2015; Nashville, Tennessee.