ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach in a Multicenter Randomized Clinical Trial : The STEMI-RADIAL Trial.
J Am Coll Cardiol. 2013 Nov 6;
Authors: 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
OBJECTIVE: To compare radial and femoral approaches in patients presenting with ST-elevation myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (PCI) by high-volume operators experienced in both access-sites.
BACKGROUND: The exact clinical benefit of the radial compared to the femoral approach remains controversial.
METHODS: STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) was a randomized, multicenter trial. Seven hundred and seven patients referred for STEMI < 12 hours of symptom onset were randomized in 4 high-volume radial centers. The primary endpoint was the cumulative incidence of major bleeding and vascular access site complications at 30 days. The rate of net adverse clinical events (NACE) was defined as a composite of death, myocardial infarction, stroke and major bleeding/vascular complications. Access site crossover, contrast volume, duration of intensive care stay and death at 6 months were secondary endpoints.
RESULTS: The primary endpoint occurred in 1.4% in the radial group (n=348) and 7.2% in the femoral group (n=359), (p=0.0001). The NACE rate was 4.6% vs. 11.0% (p=0.0028), respectively. Crossover from radial to femoral approach was 3.7%. Intensive care stay was significantly reduced in the radial group (2.5±1.7 vs. 3.0±2.9 days, p=0.0038) as well as contrast utilization (170±71 vs. 182±60 ml, p=0.01). Mortality in the radial and femoral groups was 2.3% vs. 3.1% (p= 0.64) at 30 days, and 2.3% vs. 3.6% (p=0.31) at 6 months, respectively.
CONCLUSION: In patients with STEMI undergoing primary PCI by operators experienced in both access-sites, the radial approach was associated with significantly lower incidence of major bleeding and access site complications and superior net clinical benefit. These findings support the use of the radial approach in primary PCI as first choice after proper training.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01136187.
PMID: 24211309 [PubMed - as supplied by publisher]