Two HEmostasis Methods After TransradIal Catheterization: THEMATIC Randomized Clinical Trial.

OBJECTIVE: The aim of this study was to compare the effect of 2 hemostasis devices on the incidence of radial artery occlusion (RAO) after transradial cardiac catheterization. BACKGROUND: Radial artery occlusion is the most prevalent ischemic complication after radial artery catheterization. There is still no predictive pattern of vessel patency assessment, and the comparative effectiveness of different hemostasis techniques has yet to be established. METHODS: This study used a randomized clinical trial of adult patients undergoing transradial cardiac catheterization. Participants were randomized into an intervention group (hemostasis with the TR Band device) and a control group (hemostasis with a conventional pressure dressing). The primary end point was the incidence of RAO (at discharge and at 30 days post catheterization). RESULTS: Among the 600 patients included (301 in the intervention group and 299 controls), immediate RAO occurred in 24 (8%) in the TR Band group and 19 (6%) in the pressure-dressing group; at 30 days, RAO was present in 5 patients (5%) in the TR Band group and 7 (6%) in the pressure-dressing group. On multivariate analysis, peripheral vascular disease was the only independent predictor of RAO at discharge and at 30 days. ConclusionsThe incidence of RAO was similar in patients who received hemostasis with a TR Band versus a pressure dressing after transradial cardiac catheterization.

Two HEmostasis Methods After TransradIal Catheterization: THEMATIC - protocol for a randomized clinical trial.

OBJECTIVE: Randomized clinical trial protocol to evaluate the incidence of radial artery occlusion with two different arterial compression devices after transradial procedures. METHODS: Barbeau's test will be performed in adults scheduled to undergo transradial interventional procedures. Those with A, B, or C plethysmographic patterns will be selected. At the end of the procedure, patients will be randomly assigned (1:1) to receive patent haemostasis with TR Band™ device or conventional haemostasis with an elastic adhesive bandage. The primary outcome is the incidence of radial artery occlusion. Secondary outcomes are Barbeau's test curve change, additional time to achieve haemostasis, incidence of bleeding at the puncture site, pain severity, development of arteriovenous fistula, radial pseudo aneurysm, any access-site complication requiring vascular surgery intervention and costs between the two devices. DISCUSSION: The results of this trial should provide valuable additional information on the best approach for haemostasis after transradial percutaneous cardiovascular interventions.

Two HEmostasis Methods After TransradIal Catheterization: THEMATIC - protocol for a randomized clinical trial / Dos métodos de hemostasia luego de un cateterismo transradial: THEMATIC - protocolo de ensayo clínico aleatorizado / Dois métodos de hemostasia após cateterismo transradial: THEMATIC - protocolo de ensaio clínico randomizado

Abstract OBJECTIVE Randomized clinical trial protocol to evaluate the incidence of radial artery occlusion with two different arterial compression devices after transradial procedures. METHODS Barbeau's test will be performed in adults scheduled to undergo transradial interventional procedures. Those with A, B, or C plethysmographic patterns will be selected. At the end of the procedure, patients will be randomly assigned (1:1) to receive patent haemostasis with TR Band™ device or conventional haemostasis with an elastic adhesive bandage. The primary outcome is the incidence of radial artery occlusion. Secondary outcomes are Barbeau's test curve change, additional time to achieve haemostasis, incidence of bleeding at the puncture site, pain severity, development of arteriovenous fistula, radial pseudo aneurysm, any access-site complication requiring vascular surgery intervention and costs between the two devices. DISCUSSION The results of this trial should provide valuable additional information on the best approach for haemostasis after transradial percutaneous cardiovascular interventions.

Resumen OBJETIVO Protocolo de ensayo clínico randomizado para evaluar la incidencia de oclusión de la arteria radial con dos dispositivos de compresión arterial después de pasar por procedimientos transradiales. MÉTODO Se realizará el test de Barbeau en adultos que están esperando una intervención transradial. Se seleccionarán aquellos con padrones pletismográficos A, B o C. Al final del procedimiento, se dividirán a los pacientes de forma aleatoria (1:1) para recibir la hemostasia patente con dispositivo TR Band™ o hemostasia convencional con vendaje elástico adhesivo. El resultado primario es la incidencia de oclusión de la arteria radial. Los resultados secundarios son la alteración de la curva del test de Barbeau, tiempo adicional para alcanzar la hemostasia, incidencia de sangrado en el local de la punción, intensidad del dolor, desarrollo de una fístula arteriovenosa, pseudoaneurisma, cualquier complicación en el lugar de acceso que necesite intervención quirúrgica vascular y costos entre ambos dispositivos. DISCUSIÓN Los resultados de este estudio deben proporcionar informaciones adicionales valiosas sobre un mejor enfoque para la hemostasia luego de intervenciones cardiovasculares percutáneas transradiales.

Resumo OBJETIVO Protocolo de ensaio clínico randomizado para avaliar a incidência de oclusão da artéria radial com dois dispositivos diferentes de compressão arterial após procedimentos transradiais. MÉTODOS O teste de Barbeau será realizado em adultos que serão submetidos a procedimentos de intervenção transradial previamente agendados. Aqueles com padrões pletismográficos A, B ou C serão selecionados. No final do procedimento, os pacientes serão distribuídos aleatoriamente (1:1) para receber hemostasia patente com dispositivo TR Band™ ou hemostasia convencional com bandagem elástica adesiva. O desfecho primário é a incidência da oclusão da artéria radial. Os desfechos secundários são alteração da curva do teste de Barbeau, tempo adicional para atingir a hemostasia, incidência de sangramento no local da punção, intensidade da dor, desenvolvimento de fístula arteriovenosa, pseudoaneurisma, qualquer complicação no local de acesso que necessite intervenção cirúrgica vascular e custos entre os dois dispositivos. DISCUSSÃO: Os resultados deste estudo devem fornecer informações adicionais valiosas sobre a melhor abordagem para a hemostasia após intervenções cardiovasculares percutâneas transradiais.