ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial
Ivo Bernat, David Horak, Josef Stasek, Martin Mates, Jan Pesek, Petr Ostadal, Vlado Hrabos, Jaroslav Dusek, Jiri Koza, Zdenek Sembera, Miroslav Brtko, Ondrej Aschermann, Michal Smid, Pavel Polansky, Abdul Al Mawiri, Jan Vojacek, Josef Bis, Olivier Costerousse, Olivier F Bertrand, Richard Rokyta, Ivo Bernat, David Horak, Josef Stasek, Martin Mates, Jan Pesek, Petr Ostadal, Vlado Hrabos, Jaroslav Dusek, Jiri Koza, Zdenek Sembera, Miroslav Brtko, Ondrej Aschermann, Michal Smid, Pavel Polansky, Abdul Al Mawiri, Jan Vojacek, Josef Bis, Olivier Costerousse, Olivier F Bertrand, Richard Rokyta
Abstract
Objectives: This study sought to compare radial and femoral approaches in patients presenting with ST-segment 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. A total of 707 patients referred for STEMI <12 h 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% of the radial group (n = 348) and 7.2% of the femoral group (n = 359; p = 0.0001). The NACE rate was 4.6% versus 11.0% (p = 0.0028), respectively. Crossover from radial to femoral approach was 3.7%. Intensive care stay (2.5 ± 1.7 days vs. 3.0 ± 2.9 days, p = 0.0038) as well as contrast utilization (170 ± 71 ml vs. 182 ± 60 ml, p = 0.01) were significantly reduced in the radial group. Mortality in the radial and femoral groups was 2.3% versus 3.1% (p = 0.64) at 30 days and 2.3% versus 3.6% (p = 0.31) at 6 months, respectively.
Conclusions: 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 Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention [PCI] [STEMI-RADIAL]; NCT01136187).
Keywords: ST-segment elevation myocardial infarction; coronary intervention; radial approach.
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed