Ensayo clínico sobre la compresión radial guiada por la presión arterial media / Clinical trial of radial artery compression guided by mean arterial pressure

Objetivo. Determinar si un método de compresión guiada por la cifra de la presión arterial media del paciente (experimental), es eficaz, seguro y superior a un método de compresión utilizando 15 ml de aire en el dispositivo (estándar) medido en resultados de oclusión de la arteria radial. Método. El estudio fue aleatorizado, unicéntrico e incluía a pacientes a los que se les realizó cateterismo de la arteria radial para diagnóstico o intervencionismo coronario percutáneo, se les retiró el introductor a la finalización del procedimiento y se les comprimió la arteria radial durante 3h, con dispositivo neumático (TR Band™ de Terumo®). Las arterias se valoraron entre las 24 y 72h tras el procedimiento, por curva de pletismografía con test de flujo inverso, y posteriormente con Doppler bidireccional. Resultados. En 351 pacientes estudiados se midió el porcentaje de oclusión arterial, y en el grupo de estudio experimental ocurrió en 2 (1,1%) frente a 21 pacientes (12%) en el grupo estándar (p=0,0001), sin obtener diferencias en el número de complicaciones. Conclusiones. El método de compresión guiado por las cifras de la presión arterial media del paciente, a la finalización del cateterismo de la arteria radial, es eficaz y seguro, y disminuye la oclusión de la arteria frente al método estándar de compresión con el dispositivo neumático(AU)

Objective. To determine whether a compression procedure guided by the patient's mean arterial pressure value (experimental) is safe and effective and superior to a compression procedure using 15 cubic centimeters of air in the device (standard) in patients undergoing radial artery catheterization. Methods. We performed a randomized, single-center study, which included patients undergoing catheterization of the radial artery for diagnosis or percutaneous coronary intervention, in whom the sheath was removed at the end of procedure and the radial artery was compressed for 3h with a pneumatic device (TR Band™ Terumo®). The arteries were evaluated between 24 and 72h after the procedure, using a plethysmography curve with a reverse flow test followed by bidirectional Doppler. Results. The percentage of arterial occlusion was measured in 351 patients. Arterial occlusion was found in two patients (1.1%) in the experimental group compared with 21 patients (12%) in the standard group (p=0.0001). No differences were found in the number of complications. Conclusions. The compression method, guided by the patient's mean arterial pressure value at the end of catheterization of the radial artery, is safe and effective and reduces arterial occlusion compared with the standard compression method using a pneumatic device(AU)

[Clinical trial of radial artery compression guided by mean arterial pressure]. / Ensayo clínico sobre la compresión radial guiada por la presión arterial media.

OBJECTIVE: To determine whether a compression procedure guided by the patient's mean arterial pressure value (experimental) is safe and effective and superior to a compression procedure using 15 cubic centimeters of air in the device (standard) in patients undergoing radial artery catheterization. METHODS: We performed a randomized, single-center study, which included patients undergoing catheterization of the radial artery for diagnosis or percutaneous coronary intervention, in whom the sheath was removed at the end of procedure and the radial artery was compressed for 3 h with a pneumatic device (TR Band Terumo). The arteries were evaluated between 24 and 72 h after the procedure, using a plethysmography curve with a reverse flow test followed by bidirectional Doppler. RESULTS: The percentage of arterial occlusion was measured in 351 patients. Arterial occlusion was found in two patients (1.1%) in the experimental group compared with 21 patients (12%) in the standard group (p = 0.0001). No differences were found in the number of complications. CONCLUSIONS: The compression method, guided by the patient's mean arterial pressure value at the end of catheterization of the radial artery, is safe and effective and reduces arterial occlusion compared with the standard compression method using a pneumatic device.

Radial compression guided by mean artery pressure versus standard compression with a pneumatic device (RACOMAP).

BACKGROUND: Transradial access is the approach of choice in many laboratories for diagnostic coronariography or percutaneous coronary interventions (PCI) because of its lower vascular complication rate than the femoral approach. However, this approach has a higher rate (5-10%) of asymptomatic radial artery (RA) occlusion. METHODS: We conducted a prospective, controlled, single-centre trial study. We investigated whether the pneumatic compression (using "TR Band of Terumo") of the radial artery guided by the mean artery pressure (MAP) after the procedure (group A) is efficient in reducing radial occlusion in patients under a coronary angiography by transradial access for diagnostic coronariography or PCI compared to use of standard procedure (group B, 15 cm(3) of air in the device). RESULTS: The study was suspended after analyzing the results of 50% of the scheduled patients. An analysis of the results of 351 consecutive random patients in Group A showed significantly (P = 0.0001) lower rate (1.1%) of occlusion than Group B (12.0%) without significant differences in the rate of other complications. Other variables associated with RA occlusion in univariate analysis were previous or active smoker (P < 0.04), absence of anti-aggregant treatment (P < 0.04), and the presence of RA flow postprocedure (PFP, P < 0.001). Independent predictors with logistic regression analysis were PFP (HR = 0.06, 95% CI 0.01-0.2), presence of hematoma (HR = 3.7, 95% CI 1.2-11.0), and standard pneumatic compression in group B patients (HR = 18.8, 95% CI 3.8-92.2). CONCLUSIONS: Use of pneumatic compression guided by MAP is safe and efficient, and it can significantly lower the incidence of radial artery occlusion.