Thrombectomy within 8 Hours after

Symptom Onset in Ischemic Stroke

RFS Journal Primer

Quick Summary
BOTTOM LINE

In 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.

Study design
Multicenter, prospective, randomized, sequential, open-label
phase 3 study with blinded evaluation

A 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 days

INCLUSION CRITERIA

Occlusion of intracranial ICA, MCA-M1 segment, or both, as

evidenced by CTA, MRA, or angiogram

Note: 7 occlusions were in the M2 segment and 1 occlusion

was in the M3 segment

Within 8 hours of symptom onset

Baseline NIHSS prior to randomization > 6 and no significant

prestroke disability

EXCLUSION CRITERIA

IV tPA beyond 4.5 hours

Imaging criteria: ASPECTS < 7 on noncontract CT or <6 on DWI.

Presence of hemorrhage, significant mass effect, or tumor. Evidence
of ipsilateral carotid occlusion, high grade stenosis, or arterial
dissection in the extracranial or petrous segment of the ICA that

Study design

Purpose

The aim of the study was to determine the efficacy and safety of
thrombectomy within 8 hours of symptom onset with the Solitaire stent
retriever in conjunction with medical therapy versus medical therapy alone,
among patients with acute ischemic stroke.

Intervention

Thrombectomy was performed with the use of the Solitaire device in 98 of 103
patients who matched the inclusion criteria and were randomized to the
intervention group (5 patients had no occlusion in target artery at time of
procedure).

Ipsilateral carotid stenting was performed in 9 patients.

Outside of the protocol, 1 patient was treated with intracranial angioplasty

after failed attempts with stent retriever and 1 patient received IA
alteplase.

The median time between qualifying image and groin puncture was 67 minutes
(interquartile 47-86).

The time between symptom onset and groin puncture was 269 minutes
(interquartile range, 201-340).

Median time between symptom onset and revascularization was 355 minutes
(interquartile range 269-430).

Median time between groin puncture to revascularization was 59 minutes

(interquartile range 36-95).

Intervention

Patient characteristics

Outcome

Primary outcome was severity of disability at 90 days, according to distribution

of scores on the modified Rankin scale.

Results demonstrate common odds ratio of improvement in the

distribution of the modified Rankin scale score of 1.7, and an absolute
increase of 15.5 percentage points in patients who were functionally
independent.

Secondary outcomes include:

Dramatic response to treatment as noted by a >8 decrease from baseline,

or an NIHSS score of 0-2 at 24 hours.

NIHSS score and Barthel index

EQ-5D quality of life questionnaire

In 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 days

All 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

Outcome

Primary and secondary outcomes demonstrating clinically significant

improvement with the intervention group as compared to the control group.

Outcome
Modified 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.

Outcome

No significant difference in adverse events between the intervention group and

control group.

Credits

SUMMARY BY:
Alexander Lam M.D., R1 PGY2
Department of Radiological Sciences
University 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.

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