Evaluation of stroke thrombectomy including patients where IV thrombolysis is contraindicated or has failed: a randomized trial of two novel thrombectomy devices.
BACKGROUND
Study was a PROBE design phase II randomized controlled trial (RCT). We assessed trial feasibility and technical efficacy and safety of two novel thrombectomy devices - ERIC (a retriever device) and SOFIA (a distal access catheter) - used alone or in combination depending on operator preference.


METHODS
Four UK neuroscience centers enrolled adults with proximal large artery occlusion (LAO) stroke on imaging where arterial puncture was achievable within 5.5 hours (8.5 hours for posterior circulation) of symptom onset; National Institutes of Health Stroke Scale (NIHSS) ≥6 with limited ischemic change on CT imaging. Randomization was 2:1 into intervention arm (ERIC and/or SOFIA). Patients and core lab were blinded to allocation. Primary outcome was independent core lab adjudication of reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) scale). Secondary outcomes were modified Rankin score (mRS) at 90 and 365 days (independence and shift analysis), 30-day mortality, symptomatic intracranial hemorrhage (sICH), procedural complications and NIHSS change.


RESULTS
Sixty-six patients were enrolled. TICI 2B/3 reperfusion was achieved in 72% in intervention compared with 90% in control arm on intention to treat (ITT) analysis (P=0.2) and 78% compared with 86% on per protocol analysis (P=0.7). Functional independence at 90 days was 40% (intervention) compared with 43% (control) on ITT analysis (P=1.0). sICH rates were low at 0% and 5%, respectively (P=0.3). The 30-day mortality was 9% intervention compared with 14% control (P=0.7).


CONCLUSIONS
Study indicated feasibility of a phase II RCT trial approach for assessing new thrombectomy devices. In a broad LAO stroke population ERIC and SOFIA were not statistically different from control devices. Larger trials are needed.
['White|Philip M|PM|', 'Gregson|Barbara|B|', 'Cora|Elena Adela|EA|http://orcid.org/0000-0002-1663-6658', 'Dixit|Anand|A|', 'Subramanian|Ganesh|G|', 'Joshi|Yogish|Y|', 'Simister|Robert|R|', 'Lakey|Rachel|R|', 'Maiter|Ahmed|A|', 'Ford|Gary A|GA|']
D000368:Aged D000369:Aged, 80 and over D002545:Brain Ischemia D005260:Female D006801:Humans D007262:Infusions, Intravenous D008297:Male D008875:Middle Aged D011446:Prospective Studies D016037:Single-Blind Method D020521:Stroke D017131:Thrombectomy D015912:Thrombolytic Therapy D017211:Treatment Failure D016896:Treatment Outcome
thrombectomy device catheter technology