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 De Andrade,Marden Tebet,Robson Barbosa,João Ítalo França,Ederlon Nogueira,André Labrunie,Alexandre Antônio Abizaid,Fábio Rinaldi,Amanda Guerra De Moraes Rego Sousa,Vinícius Esteves,Mônica Vieira De Andrade,Luiz Alberto E Mattos

doi:10.1186/1745-6215-14-435

Abstract

BackgroundArterial 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.MethodsARISE 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.ResultsEnrollment 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.ConclusionsThe ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS.Trial registrationClinicalTrials.gov identifier: NCT01653587

Highlights

Arterial access is a major site of bleeding complications after invasive coronary procedures
The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS)
In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial [8] involving 13,819 NSTEACS patients submitted to an early invasive strategy and randomized for antithrombotic treatment with unfractionated heparin (UFH) plus IIb-IIIa glycoprotein receptor inhibitor (GPI), bivalirudin plus GPI or bivalirudin alone, the prognostic impact of major bleeding was comparable to that of acute myocardial infarction (AMI) in subsequent mortality (11.7% versus 9.1%, respectively) [9]

Summary

Introduction

Arterial access is a major site of bleeding complications after invasive coronary procedures. 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. Antithrombotic therapy and percutaneous or surgical myocardial revascularization procedures represent the basis of hospital treatment for patients admitted with non-ST-segment elevation acute coronary syndrome (NSTEACS) [1,2]. In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial [8] involving 13,819 NSTEACS patients submitted to an early invasive strategy and randomized for antithrombotic treatment with unfractionated heparin (UFH) plus IIb-IIIa glycoprotein receptor inhibitor (GPI), bivalirudin plus GPI or bivalirudin alone, the prognostic impact of major bleeding was comparable to that of acute myocardial infarction (AMI) in subsequent mortality (11.7% versus 9.1%, respectively) [9]. Authors have reported a major bleeding rate of approximately 9% among NSTEACS patients and 12% among those with ST-segment-elevation AMI, primarily influenced by the presence of comorbidities such as older age, female gender, chronic renal failure, as well as the use of invasive techniques [9,11]

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Conclusion