Trombectomia percutânea ou trombólise acelerada por ultrassom como tratamento inicial para isquemia aguda de membro: revisão sistemática Cochrane
Data
2022-07-26
Autores
Araujo, Samuel Tomaz 
Orientadores
Cacione, Daniel Guimarães
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: Isquemia de membro aguda (IMA) é uma emergência vascular e tem incidência estimada de 14 por 100.000. O tratamento intervencionista inicial padrão consiste em cirurgia aberta e Trombólise Direcionada por Cateter (TDC). Trombólise Acelerada por Ultrassom (TAU) e Trombectomia Percutânea (TP) têm sido realizadas como técnicas alternativas e propõem-se a reduzir tempo até a revascularização, dose e tempo de infusão de fibrinolíticos, mas os benefícios ainda são incertos. Nesta revisão, comparamos TP ou TAU com tratamento padrão para IMA objetivando avaliar segurança e efetividade. Objetivos: Avaliar segurança e efetividade de TP e TAU no manejo inicial de IMA. Métodos de pesquisa: Os especialistas em informação vascular da Cochrane pesquisaram no Registro Especializado através do CRS-Web, CENTRAL, MEDLINE, Embase, CINAHL, plataforma internacional de registro de ensaios clínicos da Organização Mundial de Saúde (OMS) e ClinicalTrials.gov em 03 de março de 2021. Autores pesquisaram listas de referência de estudos relevantes. Critérios de seleção: Foram incluídos ensaios clínicos randomizados (ECR) ou quasi-randomizados que compararam TP ou TAU com cirurgia aberta, TDC isolada, ausência de tratamento ou outra modalidade de TP ou TAU para o tratamento de IMA. Coleta e análise de dados: Dois autores selecionaram independentemente os estudos, avaliaram risco de viés, extraíram e analisaram dados e graduaram a certeza da evidência (GRADE). Resultados principais: Foi incluído um ECR com 60 participantes, que comparou TAU com o tratamento padrão (TDC). Foram randomizados 32 participantes no grupo TDC e 28 no grupo TAU. O estudo demonstrou não haver diferença entre TAU e TDC isolada para os desfechos analisados (taxa de amputação (RR 1.14, IC 95% 0.17 a 7.59), sangramento maior (RR 1.71, IC 95% 0.31 a 9.53), sucesso clínico (RR 1.00, IC 95% CI 0.94 a 1.07e eventos adversos (RR 5.69, IC 95% 0.28 a 113.72)). Classificamos a certeza da evidência como muito baixa para esses desfechos. Rebaixamos a certeza da evidência para taxa de amputação, sangramento maior, sucesso clínico e eventos adversos em dois níveis devido a sérias limitações no desenho do estudo (alto risco de viés em domínios críticos) e em outros dois níveis devido a imprecisão (pequeno número de participantes e somente um estudo incluído). Outros desfechos de interesse (patência primária e secundária) não foram relatados separadamente (foi avaliada somente patência em 30 dias). Nós não identificamos estudos comparando as outras intervenções planejadas. Conclusão dos autores: Observamos evidências com muito baixo nível de certeza para avaliar segurança e efetividade de TAU em comparação com TDC isolada no manejo inicial de IMA para os desfechos estudados. As limitações desta revisão sistemática foram somente um estudo incluído, pequeno tamanho de amostra, período de seguimento curto e alto risco de viés em domínios críticos. Por essa razão, a aplicabilidade dos resultados é limitada. Estudos de alta qualidade são necessários para permitir uma comparação entre TP ou TAU e cirurgia aberta, TDC isolada, ausência de tratamento ou outras modalidades de TP com relação aos desfechos avaliados.
Background: Acute limb ischaemia (ALI) is a vascular emergency and has an incidence estimated in 14 per 100,000. The standard interventional initial treatment includes conventional open surgery and catheter-directed thrombolysis (CDT). Percutaneous Thrombectomy (PT) and ultrasound-accelerated thrombolysis (USAT) have also been performed as alternative techniques and aim to reduce time to revascularization, dose, and the time of infusion of thrombolytic agents, but the benefits are still uncertain. We compared PT or USAT versus standard treatment for ALI aiming to determine security and effectiveness. Objectives: To assess the safety and effectiveness of PT or USAT for the initial management of ALI. Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialized Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the World Health Organization (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to 3 March 2021. The review authors searched reference lists of relevant studies and papers. Selection criteria: We included randomized controlled trials (RCTs) or quasi-randomized trials that compared PT or USAT with open surgery, thrombolysis alone, no treatment or other PT modality for the treatment of ALI. Data collection and analysis: Two review authors independently selected the studies, assessed risk of bias, extracted data, performed data analysis, and graded the certainty of evidence according to GRADE. Outcomes of interest were primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects. Main results: We included one RCT with 60 participants that compared USAT with CDT (32 participants in CDT group and 28 in USAT group). We found no evidence of difference between USAT and CDT alone for the evaluated outcomes: amputation rate (RR 1.14, 95% CI 0.17 to 7.59), major bleeding (RR 1.71, 95% CI 0.31 to 9.53), clinical success (RR 1.00, 95% CI 0.94 to 1.07), and adverse effects (RR 5.69, 95% CI 0.28 to 113.72). We rated the certainty of the evidence as very low for these outcomes. We downgraded the certainty of the evidence for amputation rate, major bleeding, clinical success, and adverse effects by two levels due to serious limitations in the design (high risk of bias in critical domains) and by two further levels because of imprecision (small number of participants and only one study included). Other outcomes of interest (primary and secondary patency) were not reported separately by the included study. We did not identified studies comparing the other planned interventions. Authors’ conclusions: In this systematic review, we observed there is insufficient evidence to assess the safety and effectiveness of USAT versus CDT alone for ALI, for the evaluated outcomes. Limitations of this systematic review are the single included study, small sample size, short clinical follow-up period and high risk of bias in critical domains. For this reason, the applicability of the results is limited. High-quality studies are needed to enable a comparison of PT or USAT and open surgery, thrombolysis alone, no treatment or other PT modalities for ALI.
Background: Acute limb ischaemia (ALI) is a vascular emergency and has an incidence estimated in 14 per 100,000. The standard interventional initial treatment includes conventional open surgery and catheter-directed thrombolysis (CDT). Percutaneous Thrombectomy (PT) and ultrasound-accelerated thrombolysis (USAT) have also been performed as alternative techniques and aim to reduce time to revascularization, dose, and the time of infusion of thrombolytic agents, but the benefits are still uncertain. We compared PT or USAT versus standard treatment for ALI aiming to determine security and effectiveness. Objectives: To assess the safety and effectiveness of PT or USAT for the initial management of ALI. Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialized Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the World Health Organization (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to 3 March 2021. The review authors searched reference lists of relevant studies and papers. Selection criteria: We included randomized controlled trials (RCTs) or quasi-randomized trials that compared PT or USAT with open surgery, thrombolysis alone, no treatment or other PT modality for the treatment of ALI. Data collection and analysis: Two review authors independently selected the studies, assessed risk of bias, extracted data, performed data analysis, and graded the certainty of evidence according to GRADE. Outcomes of interest were primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects. Main results: We included one RCT with 60 participants that compared USAT with CDT (32 participants in CDT group and 28 in USAT group). We found no evidence of difference between USAT and CDT alone for the evaluated outcomes: amputation rate (RR 1.14, 95% CI 0.17 to 7.59), major bleeding (RR 1.71, 95% CI 0.31 to 9.53), clinical success (RR 1.00, 95% CI 0.94 to 1.07), and adverse effects (RR 5.69, 95% CI 0.28 to 113.72). We rated the certainty of the evidence as very low for these outcomes. We downgraded the certainty of the evidence for amputation rate, major bleeding, clinical success, and adverse effects by two levels due to serious limitations in the design (high risk of bias in critical domains) and by two further levels because of imprecision (small number of participants and only one study included). Other outcomes of interest (primary and secondary patency) were not reported separately by the included study. We did not identified studies comparing the other planned interventions. Authors’ conclusions: In this systematic review, we observed there is insufficient evidence to assess the safety and effectiveness of USAT versus CDT alone for ALI, for the evaluated outcomes. Limitations of this systematic review are the single included study, small sample size, short clinical follow-up period and high risk of bias in critical domains. For this reason, the applicability of the results is limited. High-quality studies are needed to enable a comparison of PT or USAT and open surgery, thrombolysis alone, no treatment or other PT modalities for ALI.
Descrição
Citação
ARAÚJO, S.T. Trombectomia percutânea ou trombólise acelerada por ultrassom como tratamento inicial para isquemia aguda de membro: revisão sistemática Cochrane. São Paulo, 2022. 132 f. Tese (Doutorado em Saúde Baseada em Evidências) - Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). São Paulo, 2022.