[Efficacy and safety of the Solitaire® flow restoration blood device]
García-Estepa R, Beltrán-Calvo C, Isabel-Gómez R, Romero-Tabares A
Record ID 32014001018
Spanish
Authors' objectives:
To assess the efficacy and safety of the Solitaire® flow restoration blood device, as a mechanical thrombectomy technique, in the treatment of patients with acute ischemic stroke.
Authors' recommendations:
The evidence collected in this report has a heterogeneous methodological quality. A randomized clinical trial of good quality and 9 non randomized studies have been located. These non randomized studies have different biases that limit their quality.
- The clinical trial showed that:
+ The Solitaire® device had better successful recanalization rates without intracranial haemorrhage than Merci® device.
+ Solitaire® achieved better neurological outcomes than Merci®.
+ Solitaire® achieved best results versus Merci® by reducing the mortality.
+ Solitaire® showed a similar safety profile to Merci®.
- The majority of non randomized studies obtained high percentages of recanalizations and neurological improvements.
- Based on the localized evidence, Solitaire® is an effective and safe mechanical thrombectomy device in the treatment of patients with acute ischemic stroke with thrombolytic treatment failure or patients are not candidates for this treatment, and can be extended in some cases the therapeutic window up to 8 hours.
Details
Project Status:
Completed
URL for project:
https://www.aetsa.org/publicacion/eficacia-y-seguridad-del-dispositivo-de-restauracion-del-flujo-sanguineo-solitaire/
Year Published:
2013
URL for published report:
https://www.aetsa.org/download/publicaciones/antiguas/AETSA_2013_2_Solitaire.pdf
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
Spain
MeSH Terms
- Humans
- Regional Blood Flow
Contact
Organisation Name:
Andalusian Health Technology Assessment Area
Contact Address:
Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309
Contact Name:
aetsa.csalud@juntadeandalucia.es
Contact Email:
aetsa.csalud@juntadeandalucia.es
Copyright:
Andalusian Agency for Health Technology Assessment (AETSA)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.