Background While mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC).
Methods We conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0–2) were compared between patients meeting and failing TTEC.
Results The sample consisted of 349 (60%) controls fulfilling TTEC and 234 (40%) non-TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47% vs 39%; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9%) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95% CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95% CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95% CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95% CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders.
Conclusions Approximately 40% of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.
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Competing interests ASA is a consultant for Codman, Medtronic, Microvention, Penumbra, Sequent, Siemens, Stryker and has received research support from Sequent and Siemens. BB serves on the speakers' bureaus of Medtronic, Penumbra, Pulsar, Silk Road, and Stryker. LE is a consultant for Codman Neurovascular, Medtronic, MicroVention, Penumbra, Sequent, and Stryker. DF is a consultant for Codman, MicroVention, Penumbra, and Stryker; is a member of the speaker's bureaus for Codman, MicroVention, Penumbra, and Stryker; and is a stock shareholder of Penumbra. MTF is a consultant for Blockade Medical and Medtronic and has received grant funding from Medtronic, MicroVention, NINDS/NIH, Penumbra, and Stryker. JM has received funding support from Medtronic Neurovascular, Microvention, Penumbra, and Stryker Neurovascular; is an investor with Blockade Medical, Cerebrotech, and TSP; and has served as a consultant for Cerebrotech, Endostream, Pulsar, Rebound, and TSP. AT is a consultant for Medtronic, Penumbra, MicroVention, and Stryker and has received research grants from Medtronic, Penumbra, MicroVention, and Stryker. RDT is a consultant for Blockade, Codman, Devora Medical, Medtronic, MicroVention, Penumbra, Pulsar Vascular, Q'Apel, Rebound Medical, and Stryker.
Ethics approval University of Tennessee Acute Stroke Registry.
Provenance and peer review Not commissioned; externally peer reviewed.