Abstract
[Figure: see text].
Highlights
Physiological assessment with pressure wire pullback can characterize coronary artery disease (CAD) with a focal or diffuse pattern
This was to ensure that patients with a clinically representative range of values for Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) were randomized so that the placebo-controlled efficacy of percutaneous coronary intervention (PCI) could be investigated across a full range of FFR and iFR values to investigate the cut-points for improvement in angina
When assessed with invasive physiology, focal stenoses were associated with significantly lower pre-randomization FFR and iFR values than diffusely diseased vessels
Summary
One hundred sixty-four patients in ORBITA underwent blinded instantaneous wave-free ratio (iFR) pullback assessment before randomization. The ORBITA trial was approved by the London-Central Research Ethics Committee; the design of the trial has been previously described.[6] All subjects gave informed consent. The data, analytical methods, and study materials will not be made available to other researchers. Patients underwent auditory isolation with over-the-ear headphones playing music. Invasive physiological assessments were completed with the primary operator, a consultant interventional cardiologist, blinded to their results as previously discussed.[7] In brief, this was to ensure that patients with a clinically representative range of values for FFR and iFR were randomized so that the placebo-controlled efficacy of PCI could be investigated across a full range of FFR and iFR values to investigate the cut-points for improvement in angina
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