PowerPoint Presentation

Thrombectomy within 8 Hours after Symptom Onset in Ischemic StrokeRFS Journal PrimerBOTTOM LINEIn patients with an acute, anterior circulation stroke and an absence of a large infarct on baseline imaging, mechanical thrombectomy within 8 hours after the onset of symptoms with the Solitaire stent retriever was safe and led to improved clinical outcomes, as compared to medical therapy alone.

MAJOR POINTS Functional independence (score < 2 on the modified Rankin scale) at 90 days increased by 15.5 percentage points in the interventional (thrombectony with IV tPA) group as compared to the control (IV tPA) group. Thrombectomy was associated with a shift toward better clinical outcomes across the entire spectrum of disability on the modified Rankin scale at 90 days.No significant difference in rates of death, symptomatic intracranial hemorrhage, or serious adverse events during 90-day follow up.6.5 patients would need to be treated to prevent one case of functional dependency or death.

CRITICISM Study was ended before formal stopping boundaries were reached due to efficacy.Quick SummaryMulticenter, prospective, randomized, sequential, open-label phase 3 study with blinded evaluationA total of 206 patients were randomized in a 1:1 ratio to received medical therapy (including IV alteplase when eligible) and thrombectomy with the Solitaire stent retriever (intervention group) versus medical therapy alone (control group).Patients were followed for 90 daysINCLUSION CRITERIAOcclusion of intracranial ICA, MCA-M1 segment, or both, as evidenced by CTA, MRA, or angiogramNote: 7 occlusions were in the M2 segment and 1 occlusion was in the M3 segmentWithin 8 hours of symptom onsetBaseline NIHSS prior to randomization > 6 and no significant prestroke disabilityEXCLUSION CRITERIAIV tPA beyond 4.5 hoursImaging criteria: ASPECTS < 7 on noncontract CT or 8 decrease from baseline, or an NIHSS score of 0-2 at 24 hours. NIHSS score and Barthel indexEQ-5D quality of life questionnaireIn the thrombectomy group, post-procedure conventional angiography to identify successful vessel revascularization (grade 2b or 3 on mTICI scale). Primary safety outcomes include rates of death and symptomatic intracranial hemorrhage at 90 daysAll secondary outcome analyses demonstrated improved clinical indices in the intervention group as compared to the control group. Successful revascularization was achieved in 66% of patients in the thrombectomy group.There was no statistically significant difference in adverse events or rates of death.

Outcome

Primary and secondary outcomes demonstrating clinically significant improvement with the intervention group as compared to the control group.OutcomeModified Rankin scale demonstrating a favorable shift in distribution of global disability scores at 90 days.

Scores for the mTICI scale in the intervention group showing successful reperfusion (as defined by a score of 2b or 3) in 66% of patients.

10Outcome

No significant difference in adverse events between the intervention group and control group.CreditsSUMMARY BY:

Alexander Lam M.D., R1 PGY2Department of Radiological SciencesUniversity of California, Irvine Medical Center

Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 Hours after Symptom Onset in Ischemic Stroke. The New England journal of medicine. 2015 Apr 17.

Society of Interventional Radiology3975 Fair Ridge Drive | Suite 400 North Fairfax, VA 22033(703) 460-5583 sirweb.org