Radial Access PCI Reduces Risk of Mortality and Bleeding in VALIDATE-SWEDEHEART

The presentation spurred a debate between proponents and skeptics of the transradial approach, with some stating there is need for more US study.

Radial Access PCI Reduces Risk of Mortality and Bleeding in VALIDATE-SWEDEHEART

WASHINGTON, DC—Patients with acute coronary syndromes undergoing invasive management fare significantly better when treated via the radial artery when compared with femoral-access PCI, according to the results of a prespecified analysis of the VALIDATE-SWEDEHEART trial.

Overall, the primary composite endpoint of death from any cause, myocardial infarction, or major bleeding at 180 days was reduced by 34% in the radial-access PCI arm compared with patients treated with femoral access (P < 0.001). There was no reduction in the risk of myocardial infarction, but the risk of death from any cause was reduced by 58% with radial access and the risk of major bleeding reduced by 43%, both statistically significant.

The bleeding benefit was driven by a statistically significant 77% reduction in the risk of access-site bleeding with the radial strategy (P < 0.001).  

The results, which were presented at CRT 2018, spurred a healthy back-and-forth among proponents of radial access and those a little more reticent to turn away from transfemoral PCI.

For Elmir Omerovic, MD, PhD (Sahlgrenska University Hospital, Gothenburg, Sweden), who presented the VALIDATE-SWEDEHEART data, the “totality of evidence” supports the use of transradial PCI as the default access strategy in ACS. Moreover, he expressed surprise that so many American physicians still had doubts about the benefits of the radial approach in these higher-risk patients.

“The question is, when is it enough with the evidence to switch current practice?” said Omerovic. “From a European perspective, it’s a little bit surprising that you’re so resistant.”

Radial Question Not Completely Settled

The latest European Society of Cardiology guidelines for the treatment of acute coronary syndrome strongly recommended the transradial approach over transfemoral PCI (class I, level of evidence A) on the basis of the RIVAL and MATRIX studies, as well as an updated meta-analysis showing transradial PCI was associated with a significant improvement in a number of clinical outcomes. The US guidelines do not yet make such a strong recommendation for radial access.

Ron Waksman, MD (MedStar Heart & Vascular Institute, Washington, DC), questioned whether the debate surrounding transradial versus transfemoral access in ACS is truly settled. While he is not against radial access, he said existing studies, including MATRIX, have limitations.

From a European perspective, it’s a little bit surprising that you’re so resistant. Elmir Omerovic

“We have to be very, very careful before we push something so aggressively,” said Waksman, referring to changing US guidelines to make a stronger recommendation for the radial approach. “I’m for radial access, but I think we need to be realistic when we’re talking about the guidelines.” He added that while he respects the European studies, he’d like to see a “definitive US study with experienced operators proficient in both radial and femoral access—you need to have solid data based on randomized clinical trials.”

Moderating the late-breaking clinical trial session, Ajay Kirtane, MD (Columbia University Medical Center, New York, NY), said the clinical guidelines are “not sacrosanct” and that physicians can make their own assessment of available data. Kirtane said he doesn’t see any reason to go the femoral route if radial access is available.

“What’s the reason to do femoral?” he asked. ‘What’s your benefit? Is there really a compelling reason that shows there is a downside to doing it radially? I don’t think so.” 

Additionally, there are practical advantages to performing PCI via the radial artery, particularly when a patient comes in after hours. “They often have that sheath in and are lying flat until at least 10 o’clock the next morning,” Kirtane said, referring to transfemoral PCI. “Whereas if you do the case radially, patients are sitting up, they’re not aspirating, they’re eating, and they’re mobilizing faster.”

David Cox, MD (Lehigh Valley Hospital Network, Bethlehem, PA), one of the panel discussants, said he is trying to become a better radial operator, including by doing more MI cases transradially. “But if I have a sick patient in front of me, I still do it femorally, perhaps for the wrong reasons,” he said.   

Sicker Patients Underwent Femoral PCI

In the VALIDATE-SWEDEHEART study, which was presented at the European Society of Cardiology 2017 Congress and published in the New England Journal of Medicine, 3,005 STEMI patients and 3,001 NSTEMI patients were randomly assigned to receive bivalirudin or heparin according to standard practices. The study found no advantage to bivalirudin over heparin monotherapy for a composite endpoint of death from any cause, myocardial infarction, or major bleeding.

The vast majority of patients were treated with radial access PCI, with just 570 individuals undergoing transfemoral PCI. There were significant differences between patients treated with the two strategies, however. Patients undergoing transfemoral PCI were younger and more likely to have diabetes, hypertension, hyperlipidemia, previous MI, previous PCI, and previous CABG. Additionally, 6.8% of patients had Killip class II-IV heart failure compared with just 3.2% of patients treated with transradial PCI.

Cindy Grines, MD (Northwell Health, Manhasset, NY), one of the panel discussants, pointed out the study is “quite confounded” given that higher-risk patients were selected to undergo transfemoral access PCI, adding that no matter what type of analysis is performed, it’s tough to adequately adjust for all these variables.

Additionally, Grines said there’s a concern that physicians who perform the majority of their cases via the radial artery—in Sweden, the case mix is 90% transradial and 10% transfemoral—lose their skills when tasked with going through the groin. “It’s often then that the complication rate of the femoral group ends up being much higher than if you went to a center that did predominantly femoral PCI,” she said.

Responding to the criticisms, Omerovic agreed confounding is a limitation of their analysis. But they performed several sensitivity analyses, he said, including those that excluded patients with Killip class II-IV and those with prior CABG, and “the results support the substantial reduction in risk [with radial PCI].”

Kirtane said that they have also worried about losing their femoral skills given the emphasis on transradial PCI, though he noted there are data to suggest physicians don’t disadvantage their transfemoral capabilities as they do more and more cases via the radial artery.

Photo Credit: Adapted from Burzotta F. Should We Routinely Use Left Radial Approach? Tips for Optimal Left Radial Set Up. Presented at: TCT 2017. October 30, 2017. Denver, CO.

Michael O’Riordan is the Managing Editor for TCTMD. He completed his undergraduate degrees at Queen’s University in Kingston, ON, and…

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  • Omerovic E, on behalf of the VALIDATE-SWEDEHEART trial. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: prespecified subgroup analysis from the VALIDATE-SWEDEHEART trial. Presented at: CRT 2018. March 6, 2018. Washington, DC.

  • Omerovic and Grines report no relevant conflicts of interest.
  • Waksman reports serving on the advisory panel, as a consultant, and/or receiving financial support from Abbott Vascular, Amgen, AstraZeneca, Biosensors International, Biotronik, Boston Scientific, Chiesi, Corindus, Edwards Lifesciences, LifeTech, MedAlliance, Medtronic, and Phillips Volcano.
  • Cox reports serving on the advisory panel and/or as a board member of Boston Scientific, Medtronic, and The Medicines Company.
  • Kirtane reports institutional grant and/or financial/material support paid to Columbia University from Abbott Vascular, Abiomed, Boston Scientific, Eli Lilly, Medtronic, St. Jude Medical, and Vascular Dynamics.