Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis: a prospective observational study.
OBJECTIVE
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.


BACKGROUND
NCT02164357; Results.
Department of Neurology, Stroke Centre, La Paz University Hospital, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.|Department of Neurology, Stroke Centre, University Hospital Ramón y Cajal, IRYCIS, Universidad de Alcalá de Henares, Madrid, Spain.
María
http://orcid.org/0000-0002-4302-6580
M
Alonso de Leciñana
Department of Neurology, Stroke Centre, La Paz University Hospital, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.
Patricia
P
Martínez-Sánchez
Department of Neurology, Stroke Centre, University Hospital Gregorio Marañón, IiSGM, Universidad Complutense de Madrid, Madrid, Spain.
Andrés
A
García-Pastor
Department of Neurology, Stroke Centre, University Hospital Ramón y Cajal, IRYCIS, Universidad de Alcalá de Henares, Madrid, Spain.
Michal M
MM
Kawiorski
Department of Neurology, Stroke Centre, University Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain.
Patricia
P
Calleja
Department of Neurology, Stroke Centre, La Paz University Hospital, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.
Borja E
BE
Sanz-Cuesta
Department of Neurology, Stroke Centre, University Hospital Gregorio Marañón, IiSGM, Universidad Complutense de Madrid, Madrid, Spain.
Fernando
F
Díaz-Otero
Department of Neuroradiology, Stroke Centre, La Paz University Hospital, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.
Remedios
R
Frutos
Department of Neuroradiology, Infanta Leonor University Hospital, Universidad Rey Juan Carlos, Madrid, Spain.|Department of Neuroradiology, Stroke Center, University Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain.
Fernando
F
Sierra-Hidalgo
Department of Neurology, Stroke Centre, La Paz University Hospital, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.
Gerardo
G
Ruiz-Ares
Department of Neuroradiology, Stroke Centre, University Hospital Ramón y Cajal, IRYCIS, Universidad de Alcalá de Henares, Madrid, Spain.
Eduardo
E
Fandiño
Department of Neurology, Stroke Centre, La Paz University Hospital, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.
Exuperio
E
Díez-Tejedor
Department of Neurology, Stroke Centre, University Hospital Gregorio Marañón, IiSGM, Universidad Complutense de Madrid, Madrid, Spain.
Antonio
A
Gil-Nuñez
Department of Neurology, Stroke Centre, La Paz University Hospital, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.
Blanca
B
Fuentes
D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061605:Administration, Intravenous; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000628:therapy; D000075202:Contraindications; D061185:Mechanical Thrombolysis / Q000009:adverse effects / Q000379:methods; D011446:Prospective Studies; D020521:Stroke / Q000150:complications / Q000628:therapy; D017131:Thrombectomy / Q000009:adverse effects / Q000379:methods; D016896:Treatment Outcome
Stroke; Thrombectomy; Thrombolysis