SAN FRANCISCO – In addition to being noninferior in 1-year major adverse cardiac or cerebrovascular events (MACCE), transradial intervention (TRI) reduced the incidence of bleeding complications at 1 week when compared with transfemoral intervention (TFI).

Shigeru Saito, MD, of the Shonan Kamakura General Hospital in Kanagawa, Japan, presented the results of the prospective, randomized DRAGON study at Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

“The objective of the study was to determine the clinical benefit of the transradial approach compared with the transfemoral approach in patients receiving ad-hoc percutaneous coronary intervention (PCI) in the real-world practice,” Saito said at a press conference.


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In the study, Saito and colleagues enrolled 2,042 patients from 25 hospitals in China and randomly assigned them 2:1 to either TRI or TFI. After excluding patients who went on to receive coronary artery bypass graft surgery, the study population included 1,212 patients who underwent TRI and 527 patients who underwent TFI.

The primary endpoint was freedom from MACCE at 12 months and the secondary endpoint was the 7-day rate of freedom from major bleeding complications, defined as Bleeding Academic Research Consortium (BARC) type 3 or 5.

At 1 year, TRI was noninferior to TFI in the rate of freedom from MACCE (TRI, 95.8% vs. TFI, 95.5%; noninferiority P<.001).

In addition, TRI was superior to TFI with regard to the rate of the secondary endpoint (TRI, 99.9% vs. TFI, 99%; superiority P<.001).

“In [a] real-world PCI situation with ad-hoc PCI strategy, TRI is as effective as TFI in terms of 12-month MACCE, and TRI brings less incidence of bleeding complications at 1 week after PCI,” Saito concluded.

Study discussant Daniel I. Simon, MD, of the University Hospitals Case Medical Center, Cleveland, added that as transradial access for PCI patients continues to gain momentum in the United States, it still remains important for trainees and fellows to learn the techniques necessary to perform transfemoral catheterization.

“The femoral [approach] will still be required for some procedures,” Simon said during a press conference. “But it certainly seems that you can make a very strong case in ST-segment-elevation MI that [TRI] really should be the standard because that is where the data are most robust.”

Disclosures: The DRAGON trial was supported in part by a research grant from Terumo Medical Products (Shanghai, China).

Reference

1. Saito S et al. Late-Breaking Trials and First Report Investigations I. Presented at: 27th Annual Transcatheter Cardiovascular Therapeutics scientific symposium; October 10-15, 2015; San Francisco.