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TCT: Radial Access Safer in Ad Hoc PCI

— Randomized trial shows similar efficacy, less bleeding

MedpageToday

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SAN FRANCISCO -- Transradial access was as good as going through the groin for outcomes in ad hoc percutaneous coronary intervention reflecting real-world practice, and modestly reduced bleeding, a randomized trial from China showed.

The primary endpoint of major adverse cardiac or cerebrovascular event (MACCE)-free rate at 12 months came out 95.8% for radial compared to 95.5% for femoral access, which easily met the non-inferiority criterion (P≤0.001), , of Shonan Kamakura General Hospital in Kanagawa, Japan, and colleagues found.

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Transradial access came out superior for the secondary endpoint of freedom from major bleeding complications by the Type 3 or 5 at one week (99.9% versus 99.0%, P<0.001 for superiority), Saito reported here at the opening late-breaking clinical trial session of the .

While the finding of less bleeding was not surprising, it was definitive, Saito suggested.

"After this result, everybody must follow the transradial approach as a first approach," he told reporters at a press conference.

The DRAGON (Determination of the Radial versus Groin Coronary Angioplasty) trial included 2,042 patients getting ad hoc PCI at 25 hospitals in China randomized 2:1 to transradial versus transfemoral access.

In China, transradial accounts for about 95% of procedures, noted Run-Lin Gao, MD, of China's National Center for Cardiovascular Diseases, who commented at the press conference.

So the findings might represent a best-case scenario of experienced radial operators, added press conference moderator and TCT co-director , of Mount Sinai Hospital in New York City. While U.S. practice is increasingly moving toward radial access, it has still only reached about a quarter of procedures, she noted.

Still, Saito suggested that the findings could be "applied very easily to the U.S.," despite differences between the two populations in things like body mass index.

Even in complex cases, there's no reason not to take a transradial-first approach, agreed , of Institut Cardiovasculaire Paris Sud in Massy, France.

, of University Hospitals' Case Medical Center in Cleveland, Ohio, was a little more circumspect.

"There are two sort of diverging paths here," he said at the press conference. "One is that interventions are getting more complex and... one of the things I'd hate to see is our trainees and fellows lose the techniques that you need from transfemoral catheterization to do some cases. Certainly the femoral will still be required for some procedures, but it certainly seems that you could make a very strong case in ST-segment elevation MI that this [transradial access] really should be the standard. That's where I think the data is the most robust."

Disclosures

The DRAGON trial was supported in part by a research grant from Terumo Medical Products.

Saito reported financial interest with Terumo and Boston Scientific.

Primary Source

Transcatheter Cardiovascular Therapeutics

Saito S, et al "A prospective randomized trial of transradial vs transfemoral access in patients undergoing coronary angiography and intervention" TCT 2015; LBCT 3.