Results of the DRAGON Trial Presented at TCT 2015
SAN FRANCISCO – October 12, 2015 – Results from a prospective randomized trial of transradial (TRI) versus transfemoral (TFO) access in patients undergoing percutaneous coronary intervention found that TRI was non-inferior in terms of clinical effectiveness at one year and superior in reducing major bleeding complications at seven days compared to TFI.
Findings from the DRAGON study were presented today at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.
Traditionally, PCI has been performed by accessing the heart with a catheter that is inserted into the femoral artery in the groin. A more recent technique which accesses the heart from the transradial artery in the arm has been gaining popularity. To examine the effectiveness of the TRI approach, the DRAGON study enrolled 2,042 patients who were assigned by a 2:1 randomization to the TRF group (n=1,366) or TFI group (n=676). The 12-month follow-up rate was 97.6% [TRI (N=1,212); TFI (N=527)].
The primary endpoint of the study was the major adverse cardiac or cerebrovascular event (MACCE) free rate at 12 months post-procedure. After adjustment, the MAACE-free rate after one year for TRI was 95.8% compared to 95.5% for TFI. The difference [95% Cl] between TFI and TRI was -0.3%( [-1.7%; 1.0%] Pnoninferiority=<0.001.) Therefore, non-inferiority was met as the upper 95% confidence bound was less than the non-inferiority margin of 5%.
For the secondary endpoint of freedom from major bleeding complications (BARC definition type three or five) at seven days post-procedure, rates were 99.9% vs. 99.0% (after adjustment). The difference [95% Cl] between TFI and TRI was -0.9% ([-1.4%; -0.4%], Psuperiority<0.001).
“The results of the DRAGON study show that in real world clinical practice the transradial approach is as effective as the transfemoral approach for angioplasty after one year,” said lead investigator Shigeru Saito, MD. Dr. Saito is the Director of Cardiology and Catheterization Laboratories and Vice-Director at Shonan Kamakura General Hospital in Kanagawa, Japan.
“In addition, the transradial approach is associated with less major bleeding at one week post procedure. For some patients undergoing PCI, the transradial approach may be more desirable.”
The DRAGON trial was supported in part by a research grant from Terumo Medical Products (Shanghai). Dr. Saito reported financial interest with Terumo and Boston Scientific.