Clinical trial NCT01136187: Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)
Official title: ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach - Randomized Multicenter Study Comparing Radial Versus Femoral Approach in Primary PCI. The STEMI-RADIAL Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: Myocardial infarction
Primary percutaneous coronary intervention
Radial
Bleeding
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: University Hospital Pilsen
name: Regional Hospital Liberec
name: University Hospital Hradec Kralove
name: Na Homolce Hospital
First posted: 2010-06-03
Enrollment: 707
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of bleeding or entry site complications
timeFrame: 30 days
Secondary outcomes:
measure: Occurence of major adverse cardiovascular events
measure: Primary access site failure - conversion to another access
measure: Angiographical procedural success
measure: Contrast media consumption
measure: Procedural and fluoroscopic times
measure: Duration of hospital / ICU stay
measure: TVR/TLR + any new hospitalization
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
city: Liberec
country: Czech Republic
facility: Regional Hospital Liberec
city: Pilsen
country: Czech Republic
facility: University Hospital Pilsen
city: Prague
country: Czech Republic
facility: Na Homolce Hospital
Study officials:
References:
citation: Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.