Thrombectomy Shows Late Benefit in Large-Core Stroke: TESLA

Intra-arterial thrombectomy combined with medical management was associated with better functional outcomes at 1 year compared with medical management alone in patients with large-core acute ischemic stroke, a new study showed.Despite the TESLA trial’s failure to demonstrate statistical superiority of its primary outcome at 90 days, the prespecified 1-year analysis showed that patients treated with thrombectomy plus medical management were more likely to achieve functional independence than those who received medical management alone (23.6% vs 6.8%) and independent ambulation (35.4% vs 18.0%).“This extended follow-up of the TESLA trial demonstrated that mechanical thrombectomy for large anterior circulation infarcts selected by NCCT [noncontrast CT] resulted in improved functional outcomes and higher patient-reported quality of life at 1 year compared with MM [medical management] alone,” lead investigator Osama O. Zaidat, MD, MS, director of the Neuroscience and Stroke Program at Mercy Health — St. Vincent Medical Center in Toledo, Ohio, and colleagues wrote.“Recovery or decline after large-core stroke may extend beyond 90 days,” they added.The research letter was published online on August 3 in JAMA.The TESLA TrialPatients with large-core infarcts have historically had poor outcomes after acute ischemic stroke and were often excluded from early thrombectomy trials. More recent randomized trials have demonstrated benefits of endovascular therapy in patients with large-core stroke, but many relied on advanced multimodal imaging for patient selection, potentially limiting access at centers where such imaging is not readily available.The TESLA trial was designed to determine whether thrombectomy could improve outcomes in patients with large-core infarcts using NCCT alone, a more widely available imaging approach, to determine eligibility.TESLA was a multicenter, open-label, blinded endpoint randomized clinical trial conducted at 47 US stroke centers that evaluated whether a simpler NCCT-based selection strategy could identify patients with large-core infarcts who may benefit from thrombectomy.The trial enrolled adults aged 18-85 years who presented within 24 hours of last known well with acute ischemic stroke caused by an internal carotid artery or middle cerebral artery occlusion.Eligible patients had a National Institutes of Health Stroke Scale score of at least 6, an Alberta Stroke Program Early Computed Tomography Score of 2-5 on baseline NCCT, and minimal pre-stroke disability (modified Rankin Scale [mRS]) score 0-1.Of 302 patients randomly assigned, 300 were included in the intention-to-treat analysis: 152 in the thrombectomy plus medical management group (median age, 66 years) and 148 in the medical management-alone group (median age, 68 years). Complete 1-year functional outcome data were available for 144 and 133 patients, respectively; 23 participants were lost to follow-up or withdrew consent.Although the trial’s primary 90-day outcome did not meet the prespecified threshold for superiority, the current research letter reports prespecified 1-year outcomes, including the utility-weighted mRS score.Secondary outcomes included functional independence (mRS 0-2), independent ambulation (mRS 0-3), overall mRS shift, health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index, and all-cause mortality.One-Year Functional OutcomesAt 1 year, patients treated with thrombectomy had a higher mean utility-weighted mRS score compared with those who received medical management alone (3.65 vs 2.78), with an adjusted mean difference of 1.18 points.Functional independence was achieved in 23.6% of patients in the thrombectomy group compared with 6.8% of patients who received medical management alone (risk difference, 16.8%; P < .001).Compared with medical management alone, the likelihood of achieving independent ambulation was also higher with thrombectomy (35.4% vs 18.0%; risk difference, 17.4%; P < .001).An ordinal analysis of mRS scores showed improved functional outcomes among patients who received thrombectomy (common odds ratio, 1.82; P = .005).Patient-reported quality of life was higher in the thrombectomy group, with mean EQ-5D-5L scores of 60.3 compared with 49.3 among patients who received medical management alone (P = .003). Mortality at 1 year was similar between both groups (43.1% vs 46.6%; risk difference, -3.5%; P = .42).The investigators cautioned that the findings should be interpreted in light of the trial’s neutral 90-day primary outcome and the lack of adjustment for multiple comparisons among secondary outcomes.Looking AheadThe findings provide additional evidence that recovery after large-core stroke may continue beyond the acute and 90-day periods typically assessed in clinical trials, the investigators noted.The findings add to evidence that recovery after large-core stroke may continue beyond the 90-day period typically assessed in clinical trials, the investigators noted.However, the results remain exploratory. “These descriptive data suggest longer-term benefit associated with thrombectomy in large-core stroke,” they wrote.The investigators added that NCCT-only selection warrants further study as a potentially lower-barrier approach for stroke systems worldwide. Additional research is needed to determine whether the findings can be generalized to lower-resource settings and other stroke care systems, they noted.Disclosure information for study authors is available in the original study publication. The TESLA trial was funded by unrestricted grants from Medtronic, Cerenovus, Penumbra, Stryker, and Genentech.