Feature | Radial Access | October 18, 2015

Radial Access Has Similar Ischemic Outcomes, Lower Bleeding to Femoral at One Year

Results of the DRAGON trial presented at TCT 2015

transradial access, TRI, DRAGON trial, TCT 2015, non-inferiority, transfemoral access, TFO

October 18, 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 at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

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 percent [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 percent compared to 95.5 percent for TFI. The difference [95 percent Cl] between TFI and TRI was -0.3 percent ( [-1.7 percent; 1 percent] Pnoninferiority=<0.001.) Therefore, non-inferiority was met as the upper 95 percent confidence bound was less than the non-inferiority margin of 5 percent.

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 percent vs. 99 percent (after adjustment). The difference [95 percent Cl] between TFI and TRI was -0.9 percent ([-1.4 percent; -0.4 percent], 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, M.D. 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). Saito reported financial interest with Terumo and Boston Scientific.

For more information: www.tctconference.com

Related Content

cardiologist Ted Feldman, M.D., at TCT 2017.
Feature | TCT | September 21, 2018
September 21, 2018 – The Cardiovascular Research Foundation (CRF) has announced the 15 late-breaking trials and 12 la
Interventional cardiology, cath lab technology, TCT, transcatheter cardiovascular therapeutics. #TCT #TCT18 #TCT2018
Feature | TCT | September 14, 2018 | Dave Fornell, Editor
The volume of information attendees receive at the annual...
Videos | TCT | November 15, 2017
DAIC Editor Dave Fornell shows some of the innovations displayed on the expo floor at the 2017 Transcatheter Cardiova
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | TCT | November 09, 2017
November 9, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has select
Key Interventional Cardiology and structural heart Technologies to Prepare for TCT 2017.
Feature | TCT | October 26, 2017 | Dave Fornell
Here is an aggregation of DAIC content for all major cardiovascular technology news and advances this past year. These...
Videos | TCT | November 18, 2016
DAIC Editor Dave Fornell takes a video tour of some of the most innovative new interventional cardiology technologies
Videos | TCT | November 05, 2015
DAIC Editor Dave Fornell offers his choices for the most innovative new interventional cardiovascular technologies pr
Videos | TCT | November 05, 2015
Tom Watson, clinical analyst for MDBuyLine, and DAIC Dave Fornell discuss some of the technology trends at the 2015 T
Amaranth Fortitute Bioresorbable stent

The Amaranth Fortitute bioresorbable stent was among several fully bioresorbing platforms discussed in sessions, late breaking trial data presentations and on the expo floor at TCT 2015.

Feature | TCT | October 19, 2015 | Tom Watson, BS, RCVT, Clinical Analyst, MD Buyline
There were several overarching technology trends seen at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) ann
Overlay Init