Radial access for primary PCI in STEMI patients did not significantly differ from femoral access for 30-day all-cause mortality (1.5% vs 1.3%; RR 1.15; 95% CI 0.58-2.30; P=.69).
RCT (n=2,292)
open-label
randomized
Yes
Does radial access improve 30-day all-cause mortality compared to femoral access in patients with STEMI referred for primary PCI?
In patients with STEMI undergoing primary PCI, radial access did not significantly reduce 30-day all-cause mortality compared to femoral access, though the trial was stopped early for futility.
Relative Risk: 1.15 (95% CI 0.58–2.3)
Absolute Event Rate: 1.5% vs 1.3%
p-value: p=.69
Importance: Among 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. Objective: To 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 Participants: This 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. Interventions: Patients were randomized to radial access (n = 1136) or to femoral access (n = 1156) for PCI. Main Outcomes and Measures: Initially, 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. Results: Among 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 Relevance: No 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 Registration: ClinicalTrials.gov identifier: NCT01398254.
May et al. (2020) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=2,292). Radial access vs. Femoral access was evaluated on 30-day all-cause mortality (RR 1.15, 95% CI 0.58-2.30, p=.69). Radial access for primary PCI in STEMI patients did not significantly differ from femoral access for 30-day all-cause mortality (1.5% vs 1.3%; RR 1.15; 95% CI 0.58-2.30; P=.69).