Stent-Retriever Thrombectomy after

Intravenous
t-PA vs. t-PA Alone in Stroke
RFS Journal Primer

Quick Summary
BOTTOM LINE

In patients with acute ischemic stroke due to proximal anterior intracranial

circulation occlusion (intracranial carotid artery, first segment of MCA, or both) with
small or moderate ischemic cores, thrombectomy with stent retriever within 6 hours
was safe and effective in achieving reperfusion and substantially reduced the degree
of disability and increased the proportion of patients with functional independence 3
months after stroke.

MAJOR POINTS

Thrombectomy treatment was associated with a favorable shift in distribution of

global disability scores on the modified Rankin scale at 90 days.

An absolute increase of 25 percentage points in proportion of patient who were

functionally independent (modified Rankin scale score, < 2) at 90 days.

No significant difference in rate of adverse events, 90-day mortality, or intracranial

hemorrhage.

For every 2.6 patients who were treated, 1 additional patient had an improved
disability outcome; for every 4.0 patients who were treated, 1 additional patient was
functionally independent at 90-day follow-up.

CRITICISM
Homogenous cohort of patients (location of occlusion(s), presentation <6 hours since

onset of symptoms) may limit generalizations

All sites were tertiary care centers with established stroke intervention programs, which

may also limit generalizability to smaller clinical sites.

Study design
International, multicenter, prospective, randomized, open
clinical trial

A total of 196 patients underwent randomization at 39 centers

98 patients received stent retriever (Solitaire 2 device) with IV tPA

(intervention group). 96 received IV t-PA alone (control group).

The patients were followed for 90 days

INCLUSION CRITERIA

Prestroke modified Rankin score < 1

Acute ischemic stroke with moderate-to-severe neurologic deficits

(NIHSS > 8 and < 30 at time of randomization)

Imaging-confirmed occlusion of the intracranial ICA, the first

segment of the MCA, or both

Received iv tPA within 4.5 hours of onset of stroke symptoms

EXCLUSION CRITERIA

Rapid neurologic improvement prior to study randomization

Imaging exclusion criteria: hemorrhage on presentation, >1/3 of

MCA territory demonstrating hypodensity on CT or hyperintensity on
MRI (or >100 cc of tissue in other territories), basilar artery

Study design
Follow-up

Purpose

The purpose of this study is to evaluate the efficacy and safety of

neurovascular thrombectomy within 6 hours with the Solitaire stent retriever
in conjunction with IV tPA versus IV tPA alone in patients presenting with acute
ischemic stroke.

Intervention

In all patients who matched the inclusion criteria, thrombectomy was performed
with the use of the Solitaire FR (Flow Restoration) or Solitaire 2 device.

Cervical ICA stenting was not allowed, however, angioplasty was permitted to
allow intracranial access.

The study target between qualifying image and groin puncture was within 70
minutes. The max permitted time was 90 minutes. Median time was 57
minutes.

The time between symptom onset and groin puncture was 224 minutes
(interquartile range, 165-275).

The stent was deployed in 87 patients

Reasons for non-deployment: resolution of target occlusion (7 patients), no

target occlusion at entry (2 patients), unable to access target occlusion (2
patients).

Median time between groin puncture and stent deployment was 24 minutes.

Outcome

Clinical assessments performed at baseline, 27 hours after randomization, 30

days, and 90 days.

Primary outcome was the shift in modified Rankin scale score by 90 days
and functional independence as noted by a modified Rankin score of < 2

Secondary outcomes included change in NIHSS score, revascularization

outcome, and mortality

All secondary outcome analyses demonstrated improved clinical indices in the

intervention group as compared to the control group

Outcome

Thrombectomy treatment was associated with a favorable shift in the

distribution of global disability scores on the modified Rankin scale at 90 days
(P<0.001).

The proportion of patients who were functionally independent (modified Rankin

scale score, < 2) at 90 days was higher in the intervention group than in the
control group by an absolute difference of 25 percentage points.

The study was stopped early due to efficacy.

Outcome

No significant difference in safety outcomes as evidenced by no difference in

serious adverse events at 90 days or symptomatic intracranial hemorrhage.

No significant difference in mortality at 90 days between intervention group and

control group.

Credits

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

Saver JL, Goyal M, Bonafe A, et al. Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke.
The New England journal of medicine. 2015 Apr 17.

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