REPORTING FROM THE 2018 CRT MEETING
WASHINGTON (FRONTLINE MEDICAL NEWS) – Radial access should be the preferred approach to percutaneous interventions in acute coronary syndromes in the United States as it is now in Europe, according to an investigator whose data from a randomized trial substudy was the topic of a late-breaker presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center..
It was not just these data, but “the totality of the evidence supports radial access as the first choice in PCI [percutaneous intervention] for acute coronary events,” asserted Elmir Omerovic, MD , professor of cardiology at Sahlgrenska University Hospital, Gothenburg, Sweden.
The data for the prespecified substudy was drawn from the VALIDATE-SWEDEHEART trial, published 6 months ago ( N Engl J Med 2017;377:1132-42 ). In that trial, which randomized patients with ACS undergoing PCI to heparin or bivalirudin, there was no difference between anticoagulation strategies for the primary composite endpoint of death from any cause, myocardial infarction or bleeding from any cause.
Of the 6,006 randomized patients in that study, of which about half had an ST-elevation MI and half had a non–ST-elevation MI event, 5,424 (90%) underwent PCI by the radial route and the remainder by the femoral route. The goal of the prespecified subgroup analysis presented by Dr. Omerovic was to evaluate whether choice of access site had an impact on the primary endpoint or its components.
There was a 34% relative risk reduction (P less than .001) in the primary composite endpoint at the end of 180 days of follow-up “after adjusting basically for all of the important differences that might affect risk,” Dr. Omerovic reported. The long list included type of acute coronary syndrome, age, hypertension, diabetes, and history of vascular events or prior procedures.
Radial access was also linked with a 59% lower risk of mortality and a 43% lower risk of major bleeding (both P less than .001) when compared with femoral access, according to Dr. Omerovic. He attributed most of the difference in bleeding to bleeding events at the access site.
Baseline differences between the two groups indicated that patients undergoing PCI with femoral access were a higher-risk group. Femoral patients had higher rates of diabetes, hyperlipidemia, and hypertension (all P less than .001). They were also older, more likely to be in Killip class II or above, and more likely to have history of prior MI, prior stroke, and prior coronary artery bypass grafting (also all P less than .001).
Dr. Omerovic maintained that proper adjustment was made for these confounders. He also defended his conclusion that radial access should be preferred over femoral access by stressing that the data regarding this question, including those from other studies and from registries, are uniformly consistent. “They all go in the same direction,” he said.
Dr. Omerovic claimed that the key message is that “there should be more radial access performed in the United States.” The 90% radial access in this study is reflective of current practice in Sweden and most other European countries, according to Dr. Omerovic. In contrast, the U.S. rate is closer to 60% by some estimates.
Several U.S. interventionalists on the session panel were not convinced that the VALIDATE-SWEDEHEART data establish superiority for radial access. According to Cindy Grines, MD , chair of cardiology at Hofstra Northwell School of Medicine in Hempstead, N.Y., it is not possible to control for all confounders, and the femoral access patients in this study were an “ultrahigh-risk” group. Just as importantly, she questioned whether fair comparisons could be made in a setting where 90% of interventions are performed by radial access.
“I would always be concerned that if you are performing radial access 90% of the time, you are going to lose your femoral skills,” Dr. Grines said. Like other U.S. interventionalists who commented during an animated discussion, she insisted that a prospective randomized trial, not a subgroup analysis, is needed before declaring radial access preferred.
Dr. Omerovic reports financial relationships with AstraZeneca, Bayer, and Boston Scientific.
SOURCE: Omerovic E. CRT 2018.