Original Title: Eficacia y seguridad de la trombectomía mecánica en el tratamiento del ictus isquémico de más de seis horas de evolución o con hora de inicio desconocida

Authors' objectives: • To assess the efficacy, effectiveness and safety of treatment with mechanical thrombectomy in patients with stroke more than 6 hours after symptom onset or with unknown time since onset selected using neuroimaging criteria. • If there were supportive evidence, to establish a protocol for selecting patients using neuroimaging tests that makes it possible to standardise procedures in this subgroup of stroke patients in clinical practice in the Spanish National Healthcare System and include this treatment on the list of services provided by this system.

Authors' recommendations: • Four studies including a total of 258 patients compared the effectiveness and safety of treatment with mechanical thrombectomy plus the standard medical treatment (MT+SMT) with those of standard medical treatment (SMT) alone in stroke patients treated beyond 6 hours after symptom onset or with unknown time of onset. • Data from these studies indicate that patients selected by neuroimaging criteria treated with MT+SMT have better functional outcomes and are significantly more likely to be functionally independent at 90 days than those who receive SMT alone. • An early response to treatment is 3.8-fold more likely in stroke patients treated beyond 6 hours after symptom onset with MT+SMT who meet the eligibility criteria of the DAWN study. • No significant differences were observed in terms of safety between the use of mechanical thrombectomy and SMT alone in any of the variables analysed. • A list of clinical and radiological criteria are proposed for selecting patients eligible for mechanical thrombectomy. CONCLUSIONS • The use of mechanical thrombectomy together with SMT in patients with stroke treated beyond 6 hours after symptom onset or with an unknown time of onset is justified provided that they meet the neuroimaging selection criteria applied the studies analysed. • Further research is warranted, either through randomised controlled trials or approaches enabling data to be gathered in patients for whom there is currently a paucity of scientific evidence, such as those with mild stroke (NIHSS 0-5) with large vessel occlusion treated within the first 24 hours after symptom onset, and those with anterior stroke with a large area of infarction (for example, an ASPECTS score less than 6 on non-contrast computer tomography or a core volume >70 ml), as well as those for whom there is hardly any evidence, such as those with posterior circulation stroke.

Authors' methods: A systematic review of the scientific evidence was conducted to assess the efficacy and effectiveness mechanical thrombectomy as well as the safety (or morbidity) associated with this technique in the target patients, seeking to provide objective data to support decision making in healthcare and health policies. The criteria proposed for selecting patients eligible for thrombectomy were developed based on evidence from clinical trials that have demonstrated the efficacy of the technique and the most recent clinical practice guidelines.

Project Status: Completed

Year Published: 2020

URL for published report: https://www.euskadi.eus/web01-a2aznscp/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=052554&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>