Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial

Key PointsQuestionIs there a survival benefit when radial access is used instead of femoral access among patients with ST-segment elevation myocardial infarction referred for primary percutaneous coronary intervention? FindingsIn this multicenter randomized clinical trial that enrolled 2292 patients referred for primary percutaneous coronary intervention and that was stopped prematurely following a futility analysis, no significant difference in 30-day all-cause mortality (17 [1.5%] vs 15 [1.3%] patients) was found between the use of radial access and femoral access. MeaningThese findings indicate that adequately trained operators may be able to achieve similar results when using either radial access or femoral access for primary percutaneous coronary intervention. ImportanceAmong patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention (PCI), a survival benefit associated with radial access compared with femoral access remains controversial. ObjectiveTo assess whether there is a survival benefit when radial access is used instead of femoral access among patients with STEMI referred for primary PCI. Design, Setting, and ParticipantsThis multicenter, open-label, randomized clinical trial was conducted at 5 PCI centers in Canada. In total, 2292 patients with STEMI referred for primary PCI were enrolled between July 2011 and December 2018, with a 30-day follow-up. The primary analyses were conducted based on the intention-to-treat population. InterventionsPatients were randomized to radial access (n=1136) or to femoral access (n=1156) for PCI. Main Outcomes and MeasuresInitially, the primary outcome was bleeding, but this outcome was modified to 30-day all-cause mortality following the recommendation of the granting agency. Secondary outcomes included recurrent myocardial infarction, stroke, and Thrombolysis in Myocardial Infarction-defined major or minor bleeding. ResultsAmong the 2292 patients enrolled, the mean (SD) age of the patients randomized to radial access was 61.6 (12.3) years and to femoral access was 62.0 (12.1) years, with 883 male patients in the radial access and 901 male patients in the femoral access group. The trial was stopped early following a futility analysis. Primary PCI was performed in 1082 of 1136 patients (95.2%) in the radial access group and 1109 of 1156 patients (95.9%) in the femoral access group. Bivalirudin was administered to 1001 patients (88.1%) in the radial access group and to 1068 patients (92.4%) in the femoral access group, whereas glycoprotein IIb/IIIa inhibitors were administered in only 69 patients (6.1%) in the radial access group and 68 patients (5.9%) in the femoral access group. A vascular closure device was used in 789 patients (68.3%) in the femoral group. The primary outcome, 30-day all-cause mortality, occurred in 17 patients (1.5%) assigned to radial access and in 15 patients (1.3%) assigned to femoral access (relative risk [RR], 1.15; 95% CI, 0.58-2.30; P=.69). There were no significant differences between patients assigned to radial and femoral access in the rates of reinfarction (1.8% vs 1.6%; RR, 1.07; 95% CI, 0.57-2.00; P=.83), stroke (1.0% vs 0.4%; RR, 2.24; 95% CI, 0.78-6.42; P=.12), and bleeding (1.4% vs 2.0%; RR, 0.71; 95% CI, 0.38-1.33; P=.28). Conclusions and RelevanceNo significant differences were found for survival or other clinical end points at 30 days after the use of radial access vs femoral access in patients with STEMI referred for primary PCI. However, small absolute differences in end points cannot be definitively refuted given the premature termination of the trial. Trial RegistrationClinicalTrials.gov identifier: NCT01398254 This multicenter randomized clinical trial conducted in Canada assesses whether 30-day all-cause mortality differs with the use of radial access or femoral access for primary percutaneous coronary intervention among referred patients with ST-segment elevation myocardial infarction. (c) 2020 American Medical Association. All rights reserved.