RESUMEN
BACKGROUND: The effectiveness of endovascular therapy in patients with stroke caused by basilar-artery occlusion has not been well studied. METHODS: We randomly assigned patients within 6 hours after the estimated time of onset of a stroke due to basilar-artery occlusion, in a 1:1 ratio, to receive endovascular therapy or standard medical care. The primary outcome was a favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death) at 90 days. The primary safety outcomes were symptomatic intracranial hemorrhage within 3 days after the initiation of treatment and mortality at 90 days. RESULTS: A total of 300 patients were enrolled (154 in the endovascular therapy group and 146 in the medical care group). Intravenous thrombolysis was used in 78.6% of the patients in the endovascular group and in 79.5% of those in the medical group. Endovascular treatment was initiated at a median of 4.4 hours after stroke onset. A favorable functional outcome occurred in 68 of 154 patients (44.2%) in the endovascular group and 55 of 146 patients (37.7%) in the medical care group (risk ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.50). Symptomatic intracranial hemorrhage occurred in 4.5% of the patients after endovascular therapy and in 0.7% of those after medical therapy (risk ratio, 6.9; 95% CI, 0.9 to 53.0); mortality at 90 days was 38.3% and 43.2%, respectively (risk ratio, 0.87; 95% CI, 0.68 to 1.12). CONCLUSIONS: Among patients with stroke from basilar-artery occlusion, endovascular therapy and medical therapy did not differ significantly with respect to a favorable functional outcome, but, as reflected by the wide confidence interval for the primary outcome, the results of this trial may not exclude a substantial benefit of endovascular therapy. Larger trials are needed to determine the efficacy and safety of endovascular therapy for basilar-artery occlusion. (Funded by the Dutch Heart Foundation and others; BASICS ClinicalTrials.gov number, NCT01717755; Netherlands Trial Register number, NL2500.).
Asunto(s)
Procedimientos Endovasculares , Fibrinolíticos/uso terapéutico , Accidente Cerebrovascular/cirugía , Trombectomía/métodos , Insuficiencia Vertebrobasilar/complicaciones , Anciano , Arteriopatías Oclusivas/complicaciones , Arteria Basilar/diagnóstico por imagen , Intervalos de Confianza , Femenino , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Método Simple Ciego , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Terapia Trombolítica , Tiempo de Tratamiento , Resultado del TratamientoRESUMEN
We assessed the prevalence of vertebral artery (VA) stenosis or occlusion and its influence on outcome in patients with acute basilar artery occlusion (BAO). We studied 141 patients with acute BAO enrolled in the Basilar Artery International Cooperation Study (BASICS) registry of whom baseline CT angiography (CTA) of the intracranial VAs was available. In 72 patients an additional CTA of the extracranial VAs was available. Adjusted risk ratios (aRRs) for death and poor outcome, defined as a modified Rankin Scale score ≥4, were calculated with Poisson regression in relation to VA occlusion, VA occlusion or stenosis ≥50 %, and bilateral VA occlusion. Sixty-six of 141 (47 %) patients had uni- or bilateral intracranial VA occlusion or stenosis ≥50 %. Of the 72 patients with intra- and extracranial CTA, 46 (64 %) had uni- or bilateral VA occlusion or stenosis ≥50 % and 9 (12 %) had bilateral VA occlusion. Overall, VA occlusion or stenosis ≥50 % was not associated with the risk of poor outcome. Patients with intra- and extracranial CTA and bilateral VA occlusion had a higher risk of poor outcome than patients without bilateral VA occlusion (aRR, 1.23; 95 % CI 1.02-1.50). The risk of death did not depend on the presence of unilateral or bilateral VA occlusion or stenosis ≥50 %. In conclusion, in patients with acute BAO, unilateral VA occlusion or stenosis ≥50 % is frequent, but not associated with an increased risk of poor outcome or death. Patients with BAO and bilateral VA occlusion have a slightly increased risk of poor outcome.
Asunto(s)
Insuficiencia Vertebrobasilar/complicaciones , Insuficiencia Vertebrobasilar/epidemiología , Anciano , Angiografía Cerebral , Femenino , Humanos , Masculino , Prevalencia , Factores de RiesgoRESUMEN
BACKGROUND AND PURPOSE: The frequent use of a longer time window for recanalization therapy in patients with basilar artery occlusion (BAO) in daily practice is not supported by any scientific evidence. We investigated the relationship between time to recanalization therapy and functional outcome in BAO with data from the Basilar Artery International Cooperation Study (BASICS). METHODS: BASICS is a prospective multicenter registry of patients (n=619) with radiologically confirmed BAO. We analyzed patients receiving intravenous thrombolysis or intra-arterial treatment. Patients were divided into 4 groups based on the interval between estimated time of BAO and start of recanalization therapy: ≤3 hours (n=134), >3 to ≤6 hours (n=151), >6 to ≤9 hours (n=56), and >9 hours (n=68). Primary outcome measure was poor functional outcome (modified Rankin scale score 4-6) after 1 month. We calculated adjusted risk ratios with 95% CIs using Poisson regression analyses with the ≤3 hours group as the reference group. RESULTS: Patients had an increased risk of poor functional outcome as time to recanalization therapy became longer (≤3 hours: 62%; >3 to ≤6 hours: 67% [adjusted risk ratio, 1.06; 0.91-1.25]; >6 to ≤9 hours: 77% [adjusted risk ratio, 1.26; 1.06-1.51]; >9 hours: 85% [adjusted risk ratio, 1.47; 1.26-1.72]). CONCLUSIONS: Early recanalization therapy in patients with BAO is associated with a more favorable outcome with a significant increased chance of a poor outcome when recanalization therapy is started >6 hours after estimated time of BAO.
Asunto(s)
Tronco Encefálico/patología , Trastornos Cerebrovasculares/terapia , Fibrinolíticos/administración & dosificación , Recuperación de la Función , Accidente Cerebrovascular/terapia , Insuficiencia Vertebrobasilar/terapia , Anciano , Trastornos Cerebrovasculares/complicaciones , Trastornos Cerebrovasculares/patología , Femenino , Humanos , Masculino , Trombolisis Mecánica/métodos , Persona de Mediana Edad , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/patología , Terapia Trombolítica/métodos , Factores de Tiempo , Insuficiencia Vertebrobasilar/complicaciones , Insuficiencia Vertebrobasilar/patologíaRESUMEN
BACKGROUND: Treatment strategies for acute basilar artery occlusion (BAO) are based on case series and data that have been extrapolated from stroke intervention trials in other cerebrovascular territories, and information on the efficacy of different treatments in unselected patients with BAO is scarce. We therefore assessed outcomes and differences in treatment response after BAO. METHODS: The Basilar Artery International Cooperation Study (BASICS) is a prospective, observational registry of consecutive patients who presented with an acute symptomatic and radiologically confirmed BAO between November 1, 2002, and October 1, 2007. Stroke severity at time of treatment was dichotomised as severe (coma, locked-in state, or tetraplegia) or mild to moderate (any deficit that was less than severe). Outcome was assessed at 1 month. Poor outcome was defined as a modified Rankin scale score of 4 or 5, or death. Patients were divided into three groups according to the treatment they received: antithrombotic treatment only (AT), which comprised antiplatelet drugs or systemic anticoagulation; primary intravenous thrombolysis (IVT), including subsequent intra-arterial thrombolysis; or intra-arterial therapy (IAT), which comprised thrombolysis, mechanical thrombectomy, stenting, or a combination of these approaches. Risk ratios (RR) for treatment effects were adjusted for age, the severity of neurological deficits at the time of treatment, time to treatment, prodromal minor stroke, location of the occlusion, and diabetes. FINDINGS: 619 patients were entered in the registry. 27 patients were excluded from the analyses because they did not receive AT, IVT, or IAT, and all had a poor outcome. Of the 592 patients who were analysed, 183 were treated with only AT, 121 with IVT, and 288 with IAT. Overall, 402 (68%) of the analysed patients had a poor outcome. No statistically significant superiority was found for any treatment strategy. Compared with outcome after AT, patients with a mild-to-moderate deficit (n=245) had about the same risk of poor outcome after IVT (adjusted RR 0.94, 95% CI 0.60-1.45) or after IAT (adjusted RR 1.29, 0.97-1.72) but had a worse outcome after IAT compared with IVT (adjusted RR 1.49, 1.00-2.23). Compared with AT, patients with a severe deficit (n=347) had a lower risk of poor outcome after IVT (adjusted RR 0.88, 0.76-1.01) or IAT (adjusted RR 0.94, 0.86-1.02), whereas outcomes were similar after treatment with IAT or IVT (adjusted RR 1.06, 0.91-1.22). INTERPRETATION: Most patients in the BASICS registry received IAT. Our results do not support unequivocal superiority of IAT over IVT, and the efficacy of IAT versus IVT in patients with an acute BAO needs to be assessed in a randomised controlled trial. FUNDING: Department of Neurology, University Medical Center Utrecht.