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

Irmandade Santa Casa Misericórdia Marília

Status and phase

Completed

Phase 4

Conditions

Injury of Radial Artery

Complications; Device, Vascular

Injury; Blood Vessel, Femoral, Artery

Myocardial Infarction

Treatments

Procedure: Transfemoral primary percutaneous coronary intervention

Procedure: Transradial primary percutaneous coronary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02831166

50120915.1.0000.5413

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.