Pedro B Andrade1,2, Luiz A Mattos3, Fábio S Rinaldi1, Igor C Bienert1,2, Robson A Barbosa1, André Labrunie1,4, Marden Tebet3, Vinícius Esteves3, Alexandre Abizaid5, Amanda R Sousa5. 1. Invasive Cardiology, Irmandade da Santa Casa de Misericórdia de Marília, São Paulo, Brazil. 2. Invasive Cardiology, Faculdade Estadual de Medicina de Marília - FAMEMA, São Paulo, Brazil. 3. Invasive Cardiology, Rede D'or São Luiz, São Paulo, Brazil. 4. Invasive Cardiology, Hospital do Coração de Londrina, Paraná, Brazil. 5. Invasive Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Abstract
OBJECTIVES: To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. BACKGROUND: Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. METHODS: Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure. RESULTS: There were no baseline clinical differences between groups, except for a greater prevalence of female patients in the radial group (33.3 vs. 20.0%, P = 0.020). Hemostasis was achieved in the entire radial group with the use of TR Band and in 95% of the procedures in the femoral group with Angio-Seal (P = 0.029). Except for a higher incidence of asymptomatic arterial occlusion in the radial group, there were no differences among the other analyzed outcomes. According to the noninferiority test, the use of Angio-Seal was noninferior to the radial approach, considering the margin of 15% (12.5 vs. 13.3%, difference -0.83%, 95% CI -9.31 - 7.65, P for noninferiority <0.001). CONCLUSIONS: Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach.
RCT Entities:
OBJECTIVES: To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndromepatients undergoing invasive strategy. BACKGROUND: Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. METHODS: Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure. RESULTS: There were no baseline clinical differences between groups, except for a greater prevalence of female patients in the radial group (33.3 vs. 20.0%, P = 0.020). Hemostasis was achieved in the entire radial group with the use of TR Band and in 95% of the procedures in the femoral group with Angio-Seal (P = 0.029). Except for a higher incidence of asymptomatic arterial occlusion in the radial group, there were no differences among the other analyzed outcomes. According to the noninferiority test, the use of Angio-Seal was noninferior to the radial approach, considering the margin of 15% (12.5 vs. 13.3%, difference -0.83%, 95% CI -9.31 - 7.65, P for noninferiority <0.001). CONCLUSIONS: Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach.
Authors: Ahmed A Kolkailah; Rabah S Alreshq; Ahmed M Muhammed; Mohamed E Zahran; Marwah Anas El-Wegoud; Ashraf F Nabhan Journal: Cochrane Database Syst Rev Date: 2018-04-18
Authors: Nicolas W Shammas; Gail A Shammas; Susan Jones-Miller; Mileah Rose Gumpert; Miranda Jade Gumpert; Christine Harb; Majid Z Chammas; W John Shammas; Rommy A Khalafallah; Amy Barzgari; Bassel Bou Dargham; Ghassan E Daher; Rayan Jo Rachwan; Andrew N Shammas Journal: Ther Clin Risk Manag Date: 2017-03-30 Impact factor: 2.423