Discordance Between Resting and Hyperemic Indices of Coronary Stenosis Severity: The VERIFY 2 Study (A Comparative Study of Resting Coronary Pressure Gradient, Instantaneous Wave-Free Ratio and Fractional Flow Reserve in an Unselected Population Referred for Invasive Angiography)

Circ Cardiovasc Interv. 2016 Nov;9(11):e004016. doi: 10.1161/CIRCINTERVENTIONS.116.004016.

Abstract

Background: Distal coronary to aortic pressure ratio (Pd/Pa) and instantaneous wave-free ratio (iFR) are indices of functional significance of a coronary stenosis measured without hyperemia. It has been suggested that iFR has superior diagnostic accuracy to Pd/Pa when compared with fractional flow reserve (FFR).We hypothesized that in comparison with FFR, revascularization decisions based on either binary cutoff values for iFR and Pd/Pa or hybrid strategies incorporating iFR or Pd/Pa will result in similar levels of disagreement.

Methods and results: This is a prospective study in consecutive patients undergoing FFR for clinical indications using proprietary software to calculate iFR. We measured Pd/Pa, iFR, FFR, and hyperemic iFR. Diagnostic accuracy versus FFR ≤0.80 was calculated using binary cutoff values of ≤0.90 for iFR and ≤0.92 for Pd/Pa, and adenosine zones for iFR of 0.86 to 0.93 and Pd/Pa of 0.87 to 0.94 in the hybrid strategy. One hundred ninety-seven patients with 257 stenoses (mean diameter stenosis 48%) were studied. Using binary cutoffs, diagnostic accuracy was similar for iFR and resting Pd/Pa with misclassification rates of 21% versus 20.2% (P=0.85). In the hybrid analysis, 54% of iFR cases and 53% of Pd/Pa cases were outside the adenosine zone and rates of misclassification were 9.4% versus 11.9% (P=0.55).

Conclusions: Binary cutoff values for iFR and Pd/Pa result in misclassification of 1 in 5 lesions. Using a hybrid strategy, approximately half of the patients do not receive adenosine, but 1 in 10 lesions are still misclassified. The use of nonhyperemic indices of stenosis severity cannot be recommended for decision making in the catheterization laboratory.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02377310.

Keywords: adenosine; coronary stenosis; fractional flow reserve, myocardial; hyperemia; percutaneous coronary intervention.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenosine / administration & dosage*
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Algorithms
  • Area Under Curve
  • Arterial Pressure*
  • Cardiac Catheterization*
  • Coronary Angiography*
  • Coronary Stenosis / diagnosis*
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / physiopathology
  • Coronary Vessels / diagnostic imaging*
  • Coronary Vessels / physiopathology
  • Female
  • Fractional Flow Reserve, Myocardial*
  • Humans
  • Hyperemia / physiopathology*
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prognosis
  • Prospective Studies
  • ROC Curve
  • Reproducibility of Results
  • Rest
  • Severity of Illness Index
  • Signal Processing, Computer-Assisted
  • Software
  • Vasodilator Agents / administration & dosage*
  • Young Adult

Substances

  • Vasodilator Agents
  • Adenosine

Associated data

  • ClinicalTrials.gov/NCT02377310