Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI) (STEMI-RADIAL)

Charles University, Czech Republic

Status: Completed

Conditions: ST Elevation Myocardial Infarction

Treatments: Procedure: Access site in primary PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT01136187

STEMI-RADIAL 16-9-2009

Details and patient eligibility

About

Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions. Currently, both radial and femoral approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized, multicenter study.

Enrollment: 707 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years

• Admission for STEMI less than 12 hours after onset of symptoms

  1. Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation ≥ 2 mm in two continuous precordial leads or ST elevations ≥ 1 mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
  2. Patients are planned to be treated with primary PCI

• Ability to sign written informed consent

Exclusion criteria

• Killip IV class or unconsciousness
• Patient disagreement
• Prior aortobifemoral bypass
• Absence of both radial or femoral artery pulsation
• Participation in another clinical trial randomizing ACS patients using antithrombotic drug.
• Negative Allen's test or Barbeau test type D
• Treatment with oral anticoagulants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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707 participants in 2 patient groups

Radial approach

Experimental group

Description:

Primary percutaneous coronary intervention from the radial approach

Treatment:

Procedure: Access site in primary PCI

Femoral approach

Active Comparator group

Description:

Primary percutaneous coronary intervention from the femoral approach

Treatment:

Procedure: Access site in primary PCI