Determination of the RAdial versus GrOiN coronary angioplasty - DRAGON

Oct 12, 2015
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Terumo
Date Presented:
10/12/2015
Original Posted Date:
10/12/2015
References

Description:

The goal of the trial was to assess the safety and efficacy of transradial access (TRA) compared with transfemoral access (TFA) in unselected patients undergoing percutaneous coronary intervention (PCI).

Contribution to the Literature: The DRAGON trial showed that TRA is noninferior to TFA for ischemic outcomes and superior for bleeding outcomes at 7 days in Japanese patients presenting for coronary angiography and undergoing ad hoc PCI.

Study Design

Japanese patients referred for coronary angiography and possibly needing ad hoc PCI were randomized in a 2:1 ratio to either TRA (n = 1,212) or TFA (n = 527).

Inclusion criterion was the need for PCI.

  • Total number of enrollees: 1,739
  • Duration of follow-up: 1 year
  • Mean patient age: 62 years
  • Percentage female: 29%

Other salient features/characteristics:

  • Smoker: 35%
  • Diabetes: 25%
  • Prior PCI: 13%
  • Stable angina: 62%; myocardial infarction: 36%
  • Lesion number: 1.3; number of stents: 1.2
  • Bifurcation: 9.5%

Principal Findings:

The primary outcome, major adverse cardiac event (MACE)-free rate at 12 months, was similar between TRA and TFA arms (96.1% vs. 94.4%, respectively; hazard ratio 0.707, 95% confidence interval 0.44-1.13, p for noninferiority < 0.001, p for superiority = 0.13). Despite randomization, important baseline differences were noted. Results were similar on inverse probability treatment weighting propensity analysis.

Secondary outcome was major bleeding at 7 days (0.1% vs. 1%, p for superiority < 0.001).

Interpretation:

The results of this trial indicate that TRA is noninferior to TFA for ischemic outcomes and superior for bleeding outcomes at 7 days in Japanese patients presenting for coronary angiography and undergoing ad hoc PCI. The results of the trial are qualitatively similar to the larger RIVAL trial and other smaller trials. In this trial, since randomization occurred prior to angiography, there was an imbalance between the two arms in baseline characteristics. This required a propensity-based analysis to adjust for these differences.

References:

Presented by Dr. Shigeru Saito at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 12, 2015.

Keywords: Angina, Stable, Angioplasty, Balloon, Coronary, Coronary Angiography, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Stents, Transcatheter Cardiovascular Therapeutics


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