1. Comparison of a vascular closure device versus the radial approach to reduce access site complications in non-ST-segment elevation acute coronary syndrome patients: The angio-seal versus the radial approach in acute coronary syndrome trial
- Author
-
Robson Alves Barbosa, André Labrunie, Amanda G. M. R. Sousa, Vinicius Esteves, Pedro Beraldo de Andrade, Igor Ribeiro de Castro Bienert, Luiz Alberto Mattos, Alexandre Abizaid, Marden André Tebet, and Fábio Salerno Rinaldi
- Subjects
Male ,Cardiac Catheterization ,medicine.medical_specialty ,Acute coronary syndrome ,Time Factors ,medicine.medical_treatment ,Hemorrhage ,Punctures ,Femoral artery ,030204 cardiovascular system & hematology ,Asymptomatic ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,medicine.artery ,Angioplasty ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Vascular closure device ,030212 general & internal medicine ,Acute Coronary Syndrome ,Radial artery ,Non-ST Elevated Myocardial Infarction ,Aged ,Cardiac catheterization ,Hemostasis ,Hemostatic Techniques ,business.industry ,Age Factors ,Percutaneous coronary intervention ,Equipment Design ,General Medicine ,Middle Aged ,medicine.disease ,Surgery ,Femoral Artery ,Treatment Outcome ,Radial Artery ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Brazil ,Vascular Closure Devices - 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
- Published
- 2016
- Full Text
- View/download PDF