SWIFT PRIME

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Purpose:
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To determine if patients experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV tPA and Solitaire FR within 6 hours of symptom onset, have less stroke-related disability than those patients treated with IV tPA alone.
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Methods:
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Global, multicenter, prospective, randomized, open, blinded endpoint (PROBE) IDE Study
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Intervention: IV rtPA with Solitaire FR Device
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Control: IV rtPA alone
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39 enrolling centers

 

Inclusion Criteria
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Acute ischemic stroke
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Age 18-80
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Pre-stroke mRS<1
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ASPECTS <6
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Baseline NIHSS 8-29 at time of randomization
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Initiation of IV rtPA within 4.5 hours of onset of stroke
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CTA or MRA confirmation of large vessel occlusion in ICA, M1 segment of MCA or carotid terminus
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Endovascular treatment can be initiated within 6 hours of onset of stroke symptoms and within 90 minutes from CTA/MRA to groin puncture

 

If CTA or MRA was part of local standard of care, it was performed at initial evaluation prior to commencing IV rtPA; if not, it was performed after review of the initial imaging and signing of informed consent.
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Initially, CT perfusion or multimodal MRI was required and enrollment was restricted to patients with the target mismatch profile (as assessed by specialized software) and defined as: the ischemic core lesion measured 50 mL or less, the volume of tissue with a time to maximum delay of more than 10 seconds was 100 mL or less, and the mismatch volume was at least 15 mL and the mismatch ratio was more than 1.8.
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Midway through the trial, the inclusion criteria were modified to accommodate sites with limited perfusion imaging capability. Sites with perfusion imaging were encouraged to continue to use the target mismatch criteria. Sites without perfusion imaging used ASPECTS scores (ASPECTS > 6 was required)

 

Results:
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196 patients were randomized after IV rtPA up to 6 hours from onset to groin puncture to Solitaire IA therapy or control.
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Two primary outcomes (shift analysis): mRS at 90 days (p < 0.001) and increased proportion with mRS 0-2 at 90 days -60% in the endovascular group and 35% in the rtPA alone group (risk ration 1.70, 95% CI, 1.23-2.33)
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No differences in death or symptomatic ICH (sICH)
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TICI 2b/3 recanalization: = 88% in the endovascular group.