Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study

J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.

Abstract

Objectives: The purpose of this study was to investigate the appropriateness of stenting a functionally nonsignificant stenosis.

Background: Percutaneous coronary intervention (PCI) of an intermediate stenosis without evidence of ischemia is often performed, but its benefit is unproven. Coronary pressure-derived fractional flow reserve (FFR) is an invasive index used to identify a stenosis responsible for reversible ischemia.

Methods: In 325 patients scheduled for PCI of an intermediate stenosis, FFR was measured just before the planned intervention. If FFR was >or =0.75, patients were randomly assigned to deferral (Defer group; n = 91) or performance (Perform group; n = 90) of PCI. If FFR was <0.75, PCI was performed as planned (Reference group; n = 144). Clinical follow-up was 5 years.

Results: There were no differences in baseline clinical characteristics between the 3 groups. Complete follow-up was obtained in 98% of the patients. Event-free survival was not different between the Defer and Perform groups (80% and 73%, respectively; p = 0.52), but was significantly worse in the Reference group (63%; p = 0.03). The composite rate of cardiac death and acute myocardial infarction in the Defer, Perform, and Reference groups was 3.3%, 7.9%, and 15.7%, respectively (p = 0.21 for Defer vs. Perform group; p = 0.003 for the Reference vs. both other groups). The percentage of patients free from chest pain at follow-up was not different between the Defer and Perform groups.

Conclusions: Five-year outcome after deferral of PCI of an intermediate coronary stenosis based on FFR >/=0.75 is excellent. The risk of cardiac death or myocardial infarction related to this stenosis is <1% per year and not decreased by stenting.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angina, Unstable / therapy
  • Angioplasty, Balloon, Coronary / methods*
  • Blood Flow Velocity
  • Chest Pain / epidemiology
  • Chest Pain / therapy
  • Coronary Angiography
  • Coronary Circulation
  • Coronary Stenosis / mortality
  • Coronary Stenosis / physiopathology
  • Coronary Stenosis / therapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Hypolipidemic Agents / therapeutic use
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Platelet Aggregation Inhibitors / therapeutic use
  • Prospective Studies
  • Severity of Illness Index
  • Stents*

Substances

  • Hypolipidemic Agents
  • Platelet Aggregation Inhibitors