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Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The
Michel Le May1, George Wells1, Derek So1
1Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Insights
Radial access did not show a survival benefit over femoral access for patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). No significant differences in mortality or other clinical outcomes were observed at 30 days.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- Radial access is increasingly used for percutaneous coronary intervention (PCI) due to potential benefits, but its survival advantage over femoral access in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI remains debated.
- This study aimed to clarify the comparative survival benefit of radial versus femoral access in this high-risk patient population.
Purpose of the Study:
- To determine if radial access offers a survival benefit compared to femoral access in patients with STEMI undergoing primary PCI.
- To evaluate differences in mortality, reinfarction, stroke, and bleeding between the two access methods.
Main Methods:
- A multicenter, open-label, randomized clinical trial involving 2292 patients with STEMI referred for primary PCI.
- Patients were randomized to either radial access (n=1136) or femoral access (n=1156).
- The primary outcome was 30-day all-cause mortality, with secondary outcomes including reinfarction, stroke, and bleeding events.
Main Results:
- The trial was stopped early due to futility. 30-day all-cause mortality occurred in 1.5% of the radial access group and 1.3% of the femoral access group (RR, 1.15; 95% CI, 0.58-2.30; P=.69).
- No significant differences were observed between radial and femoral access for rates of reinfarction (1.8% vs 1.6%), stroke (1.0% vs 0.4%), or bleeding (1.4% vs 2.0%).
- Small absolute differences in outcomes could not be definitively ruled out due to the early termination.
Conclusions:
- Radial access and femoral access demonstrate similar 30-day survival and clinical outcomes for patients with STEMI undergoing primary PCI.
- While no significant differences were found, the premature closure of the trial limits the ability to exclude small, potentially meaningful differences in specific endpoints.
- Further research may be needed to definitively establish long-term safety and efficacy profiles.
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.
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