Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis : a prospective observational study
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
Journal of neurointerventional surgery - 9(2017), 11 vom: 06. Nov., Seite 1041-1046 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Alonso de Leciñana, María [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial |
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| Anmerkungen: |
Date Completed 01.05.2018 Date Revised 02.12.2018 published: Print-Electronic ClinicalTrials.gov: NCT02164357 Citation Status MEDLINE |
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| doi: |
10.1136/neurintsurg-2016-012727 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM265995906 |
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| 100 | 1 | |a Alonso de Leciñana, María |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis |b a prospective observational study |
| 264 | 1 | |c 2017 | |
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| 500 | |a Date Completed 01.05.2018 | ||
| 500 | |a Date Revised 02.12.2018 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02164357 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT02164357; Results | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Stroke | |
| 650 | 4 | |a Thrombectomy | |
| 650 | 4 | |a Thrombolysis | |
| 700 | 1 | |a Martínez-Sánchez, Patricia |e verfasserin |4 aut | |
| 700 | 1 | |a García-Pastor, Andrés |e verfasserin |4 aut | |
| 700 | 1 | |a Kawiorski, Michal M |e verfasserin |4 aut | |
| 700 | 1 | |a Calleja, Patricia |e verfasserin |4 aut | |
| 700 | 1 | |a Sanz-Cuesta, Borja E |e verfasserin |4 aut | |
| 700 | 1 | |a Díaz-Otero, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Frutos, Remedios |e verfasserin |4 aut | |
| 700 | 1 | |a Sierra-Hidalgo, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Ruiz-Ares, Gerardo |e verfasserin |4 aut | |
| 700 | 1 | |a Fandiño, Eduardo |e verfasserin |4 aut | |
| 700 | 1 | |a Díez-Tejedor, Exuperio |e verfasserin |4 aut | |
| 700 | 1 | |a Gil-Nuñez, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Fuentes, Blanca |e verfasserin |4 aut | |
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