Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial

Eur Heart J. 2015 Dec 1;36(45):3182-8. doi: 10.1093/eurheartj/ehv452. Epub 2015 Sep 23.


Aims: Stenting an angiographically intermediate but functionally non-significant stenosis is controversial. Nevertheless, it has been questioned if deferral of a functionally non-significant lesion on the basis of fractional flow reserve (FFR) measurement, is safe, especially on the long term. Five-year follow-up of the DEFER trial showed that outcome after deferral of percutaneous coronary intervention (PCI) of an intermediate coronary stenosis based on FFR ≥ 0.75 is excellent and was not improved by stenting. The aim of this study was to investigate the validity of this position on the very long term.

Methods and results: In 325 patients scheduled for PCI of an intermediate stenosis, FFR was measured just before the planned intervention. If FFR was ≥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 15 years. There were no differences in baseline clinical characteristics between the randomized groups. Complete 15-year follow-up was obtained in 92% of patients. After 15 years of follow-up, the rate of death was not different between the three groups: 33.0% in the Defer group, 31.1% in the Perform group, and 36.1% in the Reference group (Defer vs. Perform, RR 1.06, 95% CI: 0.69-1.62, P = 0.79). The rate of myocardial infarction was significantly lower in the Defer group (2.2%) compared with the Perform group (10.0%), RR 0.22, 95% CI: 0.05-0.99, P = 0.03.

Conclusion: Deferral of PCI of a functionally non-significant stenosis is associated with a favourable very long-term follow-up without signs of late 'catch-up' phenomenon.

Keywords: Coronary artery disease; Fractional flow reserve; Long-term follow-up; Percutaneous coronary intervention.

Publication types

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

MeSH terms

  • Coronary Stenosis / mortality
  • Coronary Stenosis / physiopathology
  • Coronary Stenosis / surgery*
  • Female
  • Follow-Up Studies
  • Fractional Flow Reserve, Myocardial / physiology*
  • Humans
  • Male
  • Middle Aged
  • Myocardial Revascularization / mortality
  • Percutaneous Coronary Intervention*
  • Recurrence
  • Reoperation
  • Stents*
  • Treatment Outcome
  • Watchful Waiting*