Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention (ARISE-2)

A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are associated with an increased risk of mortality, re-infarction, and stroke. Although the prognostic value of access site related bleeding complications is still debated, transradial approach is associated with better short-term outcomes and reduced hospital stay as compared to transfemoral approach. The investigators aimed to compare transradial approach with transfemoral approach with systematic achievement of hemostasis by the implantation of a vascular closure device in a national multicentre randomized clinical trial.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Injury of Radial Artery; Complications; Device, Vascular; Injury; Blood Vessel, Femoral, Artery
• Intervention / Treatment: Procedure: Transradial primary percutaneous coronary intervention; Procedure: Transfemoral primary percutaneous coronary intervention

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Marília, São Paulo, Brazil, 17515900
      • Pedro Beraldo de Andrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
• Intention to perform primary percutaneous coronary intervention;
• Signed informed consent;
• Patient eligible for transradial and transfemoral primary percutaneous coronary intervention, being pre-requisites: (a) familiarity of the operator with the radial and femoral techniques using vascular closure devices, (b) agreement of the operator to use the access route determined by the randomization process.

Exclusion Criteria:

• Less than 18 years of age;
• Pregnancy;
• Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists;
• Hypersensitivity to antiplatelet and/or anticoagulant drugs;
• Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100.000 mm3);
• Uncontrolled systemic hypertension;
• Cardiogenic shock;
• Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft;
• Documented chronic peripheral arterial disease preventing the use of the femoral technique;
• Severe concomitant disease with life expectancy below 12 months;
• Participation in drug or devices investigative clinical trials in the last 30 days;
• Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transradial approach; Transradial approach primary percutaneous coronary intervention using the TR Band device to obtain hemostasis (n=125).	Procedure: Transradial primary percutaneous coronary intervention; Transradial coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. To achieve hemostasis in the transradial approach, a radial compression device will be applied, to maintain patent antegrade flow.
Active Comparator: Transfemoral approach; Transfemoral approach primary percutaneous coronary intervention using a vascular closure device to obtain hemostasis (n=125).	Procedure: Transfemoral primary percutaneous coronary intervention; Transfemoral coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. A vascular closure device will be used to achieve hemostasis in the transfemoral approach, preceded by systematic performance of femoral angiography and maintaining absolute bed rest for 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major vascular access site complications	Major vascular complications related to arterial access site will be evaluated during hospitalization by physical examination and duplex ultrassonography and include major bleeding, retroperitoneal hemorrhage, compartment syndrome, pseudoaneurysm, arteriovenous fistula, limb ischemia or need for vascular surgery repair.	48 hours post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success	The success of the device is defined as the attainment of adequate hemostasis at the end of the procedure, without the need to apply other compression methods.	48 hours post-procedure

Collaborators and Investigators

• Sponsor: Irmandade Santa Casa Misericórdia Marília
• Investigators: Principal Investigator: Pedro B Andrade, phD, Irmandade SCMM

Publications and helpful links

General Publications

• de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, Franca JI, de Andrade MV, Barbosa RA, Labrunie A, Abizaid AA, Sousa AG. 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. Trials. 2013 Dec 18;14:435. doi: 10.1186/1745-6215-14-435.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: July 2, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Transradial approach; Transfemoral approach; Vascular closure devices
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Wounds and Injuries; Vascular System Injuries
• Other Study ID Numbers: 50120915.1.0000.5413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO