Association of Successful Recanalization and Functional Outcomes in Minor Ischemic Stroke With Proven Occlusion: A Secondary Analysis of TEMPO-2 Trial

BACKGROUND: Complete recanalization of cerebral arteries is strongly associated with good functional outcome in ischemic stroke. We hypothesize that successful recanalization results in better functional outcomes. METHODS: This is a secondary observational cohort analysis of TEMPO-2 (Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion), a randomized controlled trial comparing tenecteplase with standard of care (control) in minor stroke (National Institutes of Health Stroke Scale score ≤5) with intracranial occlusion/focal perfusion abnormality ≤12 hours of onset. Among those enrolled based on computed tomography angiography with visible occlusion, a follow-up computed tomography angiography was done at 4 to 8 hours after randomization. The primary outcome was return to baseline functional outcomes using the modified Rankin Scale score at 90 days. Safety outcomes included stroke progression (National Institutes of Health Stroke Scale score ≥2 worsening), bleeding events, and mortality. Patients with successful recanalization, defined as revised Arterial Occlusive Lesion score ≥2b/3, were compared with those with unsuccessful recanalization on follow-up computed tomography angiography. Regression analysis was used to assess the association of successful recanalization with outcomes after adjusting for age, sex, baseline stroke severity, and onset-to-randomization time. RESULTS: Of the 886 enrolled patients, 517 (58.3%) with follow-up computed tomography angiography were included. Of these, 178 (34.6%) had successful recanalization (122 [68.5%]: tenecteplase, 56 (31.5%): control), and 336 (65.4%) did not achieve successful recanalization (unsuccessful recanalization; 134: tenecteplase, 202: control). Baseline characteristics were similar between patients with and without successful recanalization. Successful recanalization was significantly associated with the primary outcome as compared with unsuccessful recanalization (adjusted risk ratio, 1.21 [95% CI, 1.07-1.34]). Patients with successful recanalization had significantly lower rates of stroke progression as compared with unsuccessful recanalization (2.8% versus 13.1%, adjusted risk ratio, 0.21 [95% CI, 0.08-0.52]). Multivariable analysis showed that tenecteplase treatment was the strongest independent predictor of successful recanalization (odds ratio, 3.48 [95% CI, 2.33-5.18]). CONCLUSIONS: Successful recanalization is a critical determinant of early and 90-day functional recovery in patients with minor stroke with intracranial occlusion, regardless of treatment modality. Tenecteplase significantly increases the odds of achieving successful recanalization compared with standard care. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02398656.