Jeffrey L. Saver, MD, University of California, Los Angeles, California, USA, reported results from the Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment [SWIFT PRIME; NCT01657461] study, demonstrating that endovascular treatment with a removable Solitaire stent in combination with intravenous tissue plasminogen activator (IV tPA) was safe and effective at significantly lessening poststroke disability after an acute ischemic stroke with emergent large vessel occlusions in anterior circulation.

Currently, IV tPA is the only Food and Drug Administration–approved, beneficial pharmacologic therapy for patients with an acute ischemic stroke. However, according to Dr Saver, it has several limitations, and endovascular neurothrombectomy presents a promising complimentary reperfusion strategy. Previously, use of the Solitaire stent was reported to be associated with more frequent and faster reperfusion, reduced intracerebral hemorrhage, and better disability outcomes [Pereira VM et al. Stroke. 2013; Dávalos A et al. Stroke. 2012; Saver JL et al. Lancet. 2012].

SWIFT PRIME was a multicenter, international, prospective, randomized, blinded end point study of the Solitaire stent in combination with IV tPA vs IV tPA alone within 6 hours of symptom onset in patients experiencing an acute ischemic stroke due to large vessel occlusion. The primary end point was an evaluation of disability measured by modified Rankin Score (mRS) at 90 days. Study success criteria were a more favorable mRS distribution in the Solitaire plus IV tPA arm and a substantial difference in the number of patients achieving an mRS of 0 to 2 at 90 days.

The study enrolled a total of 196 patients (98 per arm). All baseline characteristics including demographics, disease severity, medical history, and physiologic characteristics were well matched between the treatment arms.

The study met its primary end point with significantly more patients treated with Solitaire plus IV tPA showing less disability (P = .0002). For the secondary clinical end points, the trial demonstrated that 60.2% of patients treated with Solitaire plus IV tPA achieved functional independence (mRS of 0 to 2) at 90 days vs 35.5% of patients treated with IV tPA alone (P = .0008). However, death at 90 days was not statistically significant, with 9.2% of patients dying in the Solitaire plus IV tPA arm vs 12.4% in the IV tPA arm (P = .5). Subgroup analyses showed that treatment with Solitaire plus IV tPA was beneficial compared with IV tPA alone regardless of all evaluated characteristics, including sex, age, occlusion location, time to randomization, and site of care.

Successful reperfusion (≥ 90%) at 27 hours was achieved in 82.8% of patients in the Solitaire plus IV tPA arm vs 40.4% in the IV tPA arm (P < .0001). Also, the mean improvement on the National Institutes of Health Stroke Scale score at 27 hours was 8.5 in the Solitaire plus IV tPA arm vs 3.9 with IV tPA alone (P < .0001).

The safety analysis demonstrated that the complication rate with the Solitaire stent in combination with IV tPA was exceedingly low and its use was safe when compared with IV tPA treatment alone.

Dr Saver concluded that patients with acute ischemic stroke due to large vessel occlusions in anterior circulation significantly benefited from rapid endovascular treatment with the Solitaire stent retriever. Its use was shown to be technically successful, safe, and effective at improving patients’ disability levels 3 months after stroke.