Open Access 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

Pedro Beraldo de Andrade12*, Luiz Alberto Piva e Mattos34, Marden André Tebet5, Fábio Salerno Rinaldi1, Vinícius Cardozo Esteves5, Ederlon Ferreira Nogueira6, João Ítalo Dias França3, Mônica Vieira Athanazio de Andrade1, Robson Alves Barbosa1, André Labrunie16, Alexandre Antônio Cunha Abizaid3 and Amanda Guerra de Moraes Rego Sousa3

Author Affiliations

1 Invasive Cardiology, Santa Casa de Marília, Avenida Vicente Ferreira, 828 - Cascata, Marília, São Paulo 17515-900, Brazil

2 Hospital das Clínicas da Faculdade Estadual de Medicina de Marília, Marília, São Paulo Brazil

3 Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo Brazil

4 Rede D’or de Hospitais do Brasil, São Paulo, São Paulo Brazil

5 Hospital e Maternidade Brasil - Rede D’Or, Santo André, São Paulo Brazil

6 Hospital do Coração de Londrina, Londrina, Paraná, Brazil

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Trials 2013, 14:435  doi:10.1186/1745-6215-14-435

Published: 18 December 2013

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

Keywords:
Radial approach; Femoral approach; Vascular closure device; Angioplasty; Acute coronary syndrome; Access site complication