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1.
N Engl J Med ; 382(24): 2316-2326, 2020 06 11.
Article in English | MEDLINE | ID: mdl-32521133

ABSTRACT

BACKGROUND: Randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion. These trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries. METHODS: We studied the safety and efficacy of thrombectomy in the public health system of Brazil. In 12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. RESULTS: A total of 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; P = 0.001), favoring thrombectomy. The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6). Asymptomatic intracranial hemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group; symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group. CONCLUSIONS: In this randomized trial conducted in the public health care system of Brazil, endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone. (Funded by the Brazilian Ministry of Health; RESILIENT ClinicalTrials.gov number, NCT02216643.).


Subject(s)
Stroke/surgery , Thrombectomy , Adult , Aged , Aged, 80 and over , Brazil , Combined Modality Therapy , Endovascular Procedures , Female , Fibrinolytic Agents/therapeutic use , Humans , Intracranial Hemorrhages/etiology , Male , Middle Aged , Severity of Illness Index , Single-Blind Method , Stroke/drug therapy , Stroke/mortality , Thrombectomy/adverse effects , Thrombectomy/methods , Time-to-Treatment , Tissue Plasminogen Activator/therapeutic use , Treatment Outcome , Young Adult
2.
Stroke ; 48(3): 774-777, 2017 03.
Article in English | MEDLINE | ID: mdl-28119435

ABSTRACT

BACKGROUND AND PURPOSE: Pseudo-occlusion (PO) of the cervical internal carotid artery (ICA) refers to an isolated occlusion of the intracranial ICA that appears as an extracranial ICA occlusion on computed tomography angiography (CTA) or digital subtraction angiography because of blockage of distal contrast penetration by a stagnant column of unopacified blood. We aim to better characterize this poorly recognized entity. METHODS: Retrospective review of an endovascular database (2010-2015; n=898). Only patients with isolated intracranial ICA occlusions as confirmed by angiographic exploration were included. CTA and digital subtraction angiography images were categorized according to their apparent site of occlusion as (1) extracranial ICA PO or (2) discernible intracranial ICA occlusion. RESULTS: Cervical ICA PO occurred in 21/46 (46%) patients on CTA (17 proximal cervical; 4 midcervical). Fifteen (71%) of these patients also had PO on digital subtraction angiography. A flame-shaped PO mimicking a carotid dissection was seen in 7 (33%) patients on CTA and in 6 (29%) patients on digital subtraction angiography. Patients with and without CTA PO had similar age (64.8±17.1 versus 60.2±15.7 years; P=0.35), sex (male, 47% versus 52%; P=1.00), and intravenous tissue-type plasminogen activator use (38% versus 40%; P=1.00). The rates of modified Treatment In Cerebral Ischemia 2b-3 reperfusion were 71.4% in the PO versus 100% in the non-PO cohorts (P<0.01). The rates of parenchymal hematoma, 90-day modified Rankin Scale score 0-2, and 90-day mortality were 4.8% versus 8% (P=0.66), 40% versus 66.7% (P=0.12), and 25% versus 21% (P=0.77) in PO versus non-PO patients, respectively. Multivariate analysis indicated that PO patients had lower chances of modified Treatment In Cerebral Ischemia 3 reperfusion (odds ratio 0.14; 95% confidence interval 0.02-0.70; P=0.01). CONCLUSIONS: Cervical ICA PO is a relatively common entity and may be associated with decreased reperfusion rates.


Subject(s)
Angiography, Digital Subtraction/adverse effects , Brain Ischemia/diagnosis , Carotid Artery, Internal/diagnostic imaging , Cerebral Angiography/adverse effects , Tissue Plasminogen Activator/therapeutic use , Adult , Aged , Aged, 80 and over , Angiography, Digital Subtraction/methods , Arterial Occlusive Diseases/complications , Arterial Occlusive Diseases/diagnosis , Brain Ischemia/drug therapy , Carotid Artery, Internal/abnormalities , Cerebral Angiography/methods , Cerebral Infarction/complications , Cerebral Infarction/diagnosis , Endovascular Procedures/methods , Female , Humans , Male , Middle Aged , Retrospective Studies
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