DRAGON: Radial Access as Effective as Femoral in PCI, With Less Bleeding

Deborah Brauser

October 13, 2015

SAN FRANCISCO, CA — It might not have roared, but the new DRAGON study did breathe some fire into the ongoing debate of whether a radial or femoral approach is more effective for PCI[1].

The trial, which included more than 1700 consecutive patients from 29 centers in China, showed that those randomly assigned to transradial (TRI) access PCI had similar major adverse cardiac or cerebrovascular event (MACCE)-free rates 1 year later as the transfemoral (TRF) access group, the primary end point.

In addition, the TRI group had significantly fewer major bleeding complications in the week following their PCI (P<0.001), the major secondary end point.

"If TRI provides similar results with less incidence of bleeding, why would you not do TRI?" lead author Dr Shigeru Saito (Shonan Kamakura General Hospital, Kanagawa, Japan) asked attendees of a press conference here at TCT 2015.

Saito told heartwire from Medscape that the TRI approach is used almost 85% of the time in Japan. However, session discussant Dr Daniel I Simon (UH Case Medical Center, Cleveland, OH) reported approximately a 16% to 20% use of TRI in the US, although the rate is increasing.

Simon added to heartwire that "there's certainly an increased awareness that the access point has benefits" in acute coronary syndromes. "So I think you will continue to see the US catch up with the rest of the world" in terms of using TRI, he said.

"If you had to read the tea leaves, I'd say there will be a 50% transradial rate by 2017."

"Real-World" Results

Saito noted that although "TRI is getting more popular all around the world," it has not been clear whether it can provide clinical outcomes similar to a TFI-based approach. "Thus, we initiated the DRAGON trial to show the effectiveness of an ad hoc TRI strategy in the real world."

The investigators originally randomly assigned 2042 PCI patients 2:1 to either a TRI (n=1366) or TFI (n=676) access approach. However, after the CABG-only patients were excluded, the final group numbers were 1212 and 527, respectively. The 12-month follow-up rate was 97.6%.

After inverse probability weighting adjustment, the 1-year MAACE-free event rate was 95.8% for the TRI group vs 95.5% for the TFI group (P for noninferiority <0.001). "The noninferiority was met, as the upper 95% confidence bound was less than the noninferiority margin of 5%," noted Saito.

At 7 days postprocedure, 99.9% of the TRI group was free from major bleeding complications vs 99.0% of the TFI group (P<0.001).

"In a real-world PCI situation with an ad hoc PCI strategy, TRI was as effective as TFI and brought less incidence of bleeding," summarized Saito. He reported that the next step is to investigate very long-term effectiveness of both approaches.

First-Line Strategy?

"I congratulate the investigators on these outstanding results," said Simon after the presentation. "And it was incredible how low bleeding was in both groups."

Comoderator Dr Roxana Mehran (Mount Sinai School of Medicine, New York, NY) noted that "this was on a heparin-alone strategy with good technique." But she asked if there are enough data yet on transradial access to make it the first-line strategy for PCI. Saito answered, "Yes, of course. And if it's not working, we can switch to transfemoral."

Dr Run-Lin Gao (Beijing Fu Wai Hospital, China) agreed, noting that TRI is performed roughly 95% of the time in his center in China. Discussant Dr Marie-Claude Morice (Institut Cardiovascular Paris Sud, Massy, France) reported that TRI is very popular in her country, and its use continues to increase. "I'd say much more than half of the procedures performed are transradial."

"So what are we doing wrong?" Mehran asked discussant Simon. He noted that interventions are getting more and more complex. "One of the things I'd hate to see is trainees and fellows lose the technique for transfemoral catheterization that you need in some cases," he said.

"The femoral will still be required for some procedures, but it certainly seems that you can make a very strong case in [STEMI] that radial should be the standard," said Simon.

"Expertise Matters"

After the study's presentation at TCT's first late-breaking clinical-trials session, Dr Dean J Kereiakes (Christ Hospital Heart and Vascular Center, Cincinnati, OH) said he is "still predominantly femoral" but stressed that "we should be trained both ways. Nobody's really trained that way anymore, but people should be proficient at both sites."

Discussant Dr Stephen G Ellis (Cleveland Clinic, OH) agreed. However, "I think the totality of data is quite persuasive for the radial approach, although it can't be applied to all patients. I think here in the US we are behind."

Dr Martin B Leon (New York-Presbyterian Hospital/Columbia University Medical Center) agreed, but added, "I don't think it's just a matter of what the clinical data show. It's a matter of patient preference, resource consumption, and running a high-volume laboratory and trying to get patients moving more quickly."

Dr Sanjit S Jolly (McMaster University, Hamilton, ON) noted that one of the most important lessons from both his RIVAL study and the current DRAGON study is that experience and expertise matters. "The more you do, the better you get. So you might as well offer [transradial] to all of your patients," he said.

DRAGON was funded in part by a grant from Terumo Medical Products. Saito reported financial interest with Terumo and Boston Scientific.

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