A study published in JAMA Cardiology Jan. 2 suggests physicians may achieve comparable results when using either radial or femoral access for primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation MI (STEMI).
Primary PCI is the gold standard for reperfusion in patients with STEMI, first author Michel Le May, MD, and colleagues wrote in JAMA, and in such cases physicians have little time to decide between access via a patient’s radial or femoral vasculature. Two recent studies—the RIVAL and RIFLE-STEACS trials—reported lower mortality with femoral access, but the research left a lot up in the air.
“Without a clear causal mechanism, the claim of a mortality advantage for radial access over femoral access in patients undergoing primary PCI remains a topic of debate,” Le May, of the University of Ottawa Heart Institute, and co-authors wrote. “The present Safety and Efficacy of Femoral Access vs. Radial Access in STEMI (SAFARI-STEMI) trial aimed to determine if radial access improves survival when compared with femoral access in patients referred for primary PCI.”
Le May and his team conducted their open-label randomized clinical trial at five PCI centers across Canada, enrolling 2,292 patients with STEMI referred for primary PCI between 2011 and 2018. Around half of the population underwent PCI with radial access (1,136 patients), while the other half underwent PCI with femoral access (1,156 patients).
The authors reported that, although their trial was halted early following a futility analysis, primary PCI was achieved in 95.2% of the radial access group and 95.9% of the femoral access group. The blood thinner bivalirudin was administered to 88.1% of patients in the radial access group and 92.4% of patients in the femoral access group, while just 6.1% of radial-access patients and 5.9% of femoral-access patients received glycoprotein IIb/IIIa inhibitors.
Study participants were followed for a month, and Le May et al. said 17 patients in the radial access group and 15 patients in the femoral access group met the team’s primary endpoint of 30-day all-cause mortality. Rates of reinfarction, stroke and bleeding were similar between cohorts:
- Reinfarction: 1.8% of patients in the radial access group vs. 1.6% of patients in the femoral access group)
- Stroke: 1.0% vs. 0.4%
- Bleeding: 1.4% vs. 2.0%
Despite those similarities, the authors said the small absolute reduction in bleeding associated with radial access couldn’t be “definitively refuted given the premature termination of the trial.”
“No single study, including SAFARI-STEMI, will be the last word on PCI access, and it remains to be seen if its results can be generalized to lower-volume centers and less experienced operators,” Ranya N. Sweis, MD, MS, wrote in a related editorial comment. “For now, the weight of the evidence continues to favor a radial-first approach. However, circumstances requiring a femoral approach will always exist, particularly in the current era of large-bore access for structural heart interventions and mechanical support devices.
“The low rates of major bleeding and mortality in SAFARI-STEMI support consistent application of multimodal bleeding reduction strategies to optimize the safety and quality of invasive cardiovascular procedures, regardless of access site.”