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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Methodology

Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients

Authors: Pedro Beraldo de Andrade, Luiz Alberto Piva e Mattos, Marden André Tebet, Fábio Salerno Rinaldi, Vinícius Cardozo Esteves, Ederlon Ferreira Nogueira, João Ítalo Dias França, Mônica Vieira Athanazio de Andrade, Robson Alves Barbosa, André Labrunie, Alexandre Antônio Cunha Abizaid, Amanda Guerra de Moraes Rego Sousa

Published in: Trials | Issue 1/2013

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Abstract

Background

Arterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease 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, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy.

Methods

ARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair.

Results

Enrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014.

Conclusions

The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS.

Trial registration

ClinicalTrials.gov identifier: NCT01653587
Appendix
Available only for authorised users
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Metadata
Title
Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients
Authors
Pedro Beraldo de Andrade
Luiz Alberto Piva e Mattos
Marden André Tebet
Fábio Salerno Rinaldi
Vinícius Cardozo Esteves
Ederlon Ferreira Nogueira
João Ítalo Dias França
Mônica Vieira Athanazio de Andrade
Robson Alves Barbosa
André Labrunie
Alexandre Antônio Cunha Abizaid
Amanda Guerra de Moraes Rego Sousa
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-435

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