Background and purpose The present study was conducted with the objective of evaluating the safety of primary mechanical thrombectomy (MT) in patients with large vessel occlusion (LVO) stroke and comorbidities that preclude treatment with IV thrombolysis (IVT), compared with patients who received standard IVT treatment followed by MT. Secondary objectives were to analyse the recanalization rate and outcomes.
Methods A prospective observational multicenter study (FUN-TPA) that recruited patients treated within 4.5 hours of symptom onset was performed. Treatments were IVT followed by MT if occlusion persisted, or primary MT when IVT was contraindicated. Outcome measures were procedural complications, symptomatic intracranial hemorrhage (SICH), recanalization rate, National Institutes of Health Stroke Scale (NIHSS) score at 7 days, modified Rankin Scale (mRS) score and mortality at 90 days.
Results Of 131 patients, 21 (16%) had medical contraindications for IVT and were treated primarily with MT whereas 110 (84%) underwent IVT, followed by MT in 53 cases (40%). The recanalization rate and procedural complications were similar in the two groups. There were no SICHs after primary MT vs 3 (6%) after IVT+MT. Nine patients (43%) in the primary MT group achieved independence (mRS 0–2) compared with 36 (68%) in the IVT+MT group (p=0.046). Mortality rates in the two groups were 14% (n=3) vs 4% (n=2) (p=0.13). Adjusted ORs for independence in patients receiving standard IVT+MT vs MT in patients with medical contraindications for IVT were 2.8 (95% CI 0.99 to 7.98) and 0.24 (95% CI 0.04 to 1.52) for mortality.
Conclusions MT is safe in patients with potential comorbidity-derived risks that preclude IVT. MT should be offered, aiming for prompt recanalization, to patients with LVO stroke unsuitable for IVT.
Trial registration number NCT02164357; Results.
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Contributors All authors have made substantial contributions to the design of the work; acquisition, analysis, or interpretation of data; drafting the work or revising it critically for important intellectual content. All authors have approved the final version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Individual contributions: MAdL: overall responsibility for the manuscript, study concept and design, data acquisition, statistical analyses and interpretation, drafting the manuscript, final critical review of the manuscript. PM-S: study concept and design, data acquisition, final critical review of the manuscript. AG-P: study design, data acquisition, final critical review of the manuscript. MMK: data acquisition, statistical analysis and interpretation, revision of the manuscript. PC, BES-C, FD-O, GR-A and AG-N: data acquisition, revision of the manuscript. RF, FS-H and EF: radiological data acquisition, revision of the manuscript. ED-T: contribution to design of the work, revision of the manuscript. BF: data acquisition, drafting the manuscript, final critical review of the manuscript.
Funding This work was supported by Fundación Mutua Madrileña.
Competing interests None declared.
Ethics approval Ethical approval was obtained from the Ethics Committee University Hospital Ramón y Cajal and the Spanish Agency for Drugs and Health Products (Agencia Española de Medicamentos y Productos Sanitarios; AEMPS).
Provenance and peer review Not commissioned; internally peer reviewed.
Data sharing statement The study protocol is available upon request from the corresponding author.