Abstract
Background and Purpose: End-of-procedure substantial reperfusion [modified Treatment in Cerebral Ischemia (mTICI) 2b-3], the leading endpoint for thrombectomy studies, has several limitations including a ceiling effect, with recent achieved rates of ~90%. We aimed to identify a more optimal definition of angiographic success along two dimensions: (1) the extent of tissue reperfusion, and (2) the speed of revascularization.Methods: Core-lab adjudicated TICI scores for the first three passes of EmboTrap and the final all-procedures result were analyzed in the ARISE II multicenter study. The clinical impact of extent of reperfusion and speed of reperfusion (first-pass vs. later-pass) were evaluated. Clinical outcomes included 90-day functional independence [modified Rankin Scale (mRS) 0–2], 90-day freedom-from-disability (mRS 0–1), and dramatic early improvement [24-h National Institutes of Health Stroke Scale (NIHSS) improvement ≥ 8 points].Results: Among 161 ARISE II subjects with ICA or MCA M1 occlusions, reperfusion results at procedure end showed substantial reperfusion in 149 (92.5%), excellent reperfusion in 121 (75.2%), and complete reperfusion in 79 (49.1%). Reperfusion rates on first pass were substantial in 81 (50.3%), excellent reperfusion in 62 (38.5%), and complete reperfusion in 44 (27.3%). First-pass excellent reperfusion (first-pass TICI 2c-3) had the greatest nominal predictive value for 90-day mRS 0–2 (sensitivity 58.5%, specificity 68.6%). There was a progressive worsening of outcomes with each additional pass required to achieve TICI 2c-3.Conclusions: First-pass excellent reperfusion (TICI 2c-3), reflecting rapid achievement of extensive reperfusion, is the technical revascularization endpoint that best predicted functional independence in this international multicenter trial and is an attractive candidate for a lead angiographic endpoint for future trials.Clinical Trial Registration: http://www.clinicaltrials.gov, identifier NCT02488915.
Highlights
MATERIALS AND METHODSThe current consensus statement-endorsed benchmark for procedural success after intra-arterial stroke therapy (IAT) is procedure end substantial reperfusion [modified Treatment in Cerebral Ischemia score of 2b or higher], defined as the restoration of anterograde tissue perfusion in more than 50% of the target downstream territory [1, 2]
After adjusting for age, baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline Alberta Stroke Program Early Computed Tomography Score (ASPECTS), vessel occlusion level, atrial fibrillation, and final Treatment in Cerebral Ischemia (TICI) 2c-3 score, first-pass success was an independent predictor of 90-day modified Rankin Scale (mRS) 0–2 [odds ratio (OR) 3.42, P = 0.01]
First-pass TICI 2c-3 was the optimal combination of reperfusion extent and speed for predicting good outcome after IAT
Summary
MATERIALS AND METHODSThe current consensus statement-endorsed benchmark for procedural success after intra-arterial stroke therapy (IAT) is procedure end substantial reperfusion [modified Treatment in Cerebral Ischemia (mTICI) score of 2b or higher], defined as the restoration of anterograde tissue perfusion in more than 50% of the target downstream territory [1, 2]. The impressive clinical benefits observed in recent thrombectomy trials reflected improved reperfusion with second generation devices, most notably stent retrievers [3, 4]. Since these pivotal trials, there has been a further increase in reported rates of substantial reperfusion [5]. There are considerable limitations to using the rate of TICI 2b-3 as a lead technical efficacy endpoint for IAT trials This endpoint counts moderate reperfusion as a success, but when reperfusion is only 50–90% achieved, substantial tissue volumes remain in jeopardy. End-of-procedure substantial reperfusion [modified Treatment in Cerebral Ischemia (mTICI) 2b-3], the leading endpoint for thrombectomy studies, has several limitations including a ceiling effect, with recent achieved rates of ∼90%. We aimed to identify a more optimal definition of angiographic success along two dimensions: [1] the extent of tissue reperfusion, and [2] the speed of revascularization
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