DRAGON: Transradial as Effective as Transfemoral in Ad Hoc PCI, With Less Risk of Bleeding
Results from the real-world DRAGON study, presented in
a late-breaking clinical trial session at TCT 2015, show that in patients
undergoing ad hoc PCI, transradial access results in similar MACCE but less
major bleeding compared with a transfemoral approach.
The study included 2,042 patients randomized to
transradial or transfemoral access before both PCI and diagnostic
catheterization, so some patients ended up receiving other therapy instead of
PCI, said Shigeru Saito, MD, of Shonan Kamakura General Hospital, Kamakura,
Japan.
At 12 months, 1,212 patients who underwent transradial PCI and 527 patients who underwent transfemoral PCI were available for analysis. For the primary endpoint of MACCE-free rate at 12 months, the transradial approach demonstrated noninferiority to transfemoral (Figure).
Additionally, the transradial
approach was superior to the transfemoral approach for the secondary endpoint
of freedom from major bleeding complications at 7 days (99.9% vs. 99%;
difference –0.9%; P < .001).
Randomization issues
According to Saito, the DRAGON study was undertaken because “it is not yet clear whether ad hoc [transradial intervention] can provide clinical outcomes similar to [transfemoral intervention].”
He noted that because randomization between the radial and the femoral approach was made before assessing the feasibility of CABG or medical therapy, there might have been some bias favoring transfemoral intervention.
In addition, due in part to the time of randomization and because some patients
refused the approach to which they were randomized, the groups initially
differed in some baseline characteristics, which necessitated inverse
probability weighing, Saito said. At initial randomization, patients in the
transradial group were more likely to be male (P = .001), younger (P
= .001), taller (P < .001), heavier (P < .001), have higher
BMI (P = .049) and be current smokers (P = .033). After inverse
probability weighing, among those characteristics, only the difference in
smoking remained.
Disclosures:
- Saito reports receiving consultant/honoraria fees from Boston Scientific Corporation and Terumo Medical Corporation.
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