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J Am Coll Cardiol, 2007; 49:2105-2111, doi:10.1016/j.jacc.2007.01.087 (Published online 11 May 2007).
© 2007 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Percutaneous Coronary Intervention of Functionally Nonsignificant Stenosis

5-Year Follow-Up of the DEFER Study

Nico H.J. Pijls, MD, PhD*,*, Pepijn van Schaardenburgh, MD*, Ganesh Manoharan, MD{dagger}, Eric Boersma, PhD{ddagger}, Jan-Willem Bech, MD, PhD*, Marcel van’t Veer, MSc*, Frits Bär, MD, PhD§, Jan Hoorntje, MD, PhD||, Jacques Koolen, MD, PhD*, William Wijns, MD, PhD{dagger} and Bernard de Bruyne, MD, PhD{dagger}

* Catharina Hospital Eindhoven, Eindhoven, the Netherlands
{dagger} Cardiovascular Center Aalst, Aalst, Belgium
{ddagger} Thoraxcentrum Rotterdam, Rotterdam, the Netherlands
§ Academic Hospital Maastricht, Maastricht, the Netherlands
|| Isala Clinics Zwolle, Zwolle, the Netherlands.

Manuscript received October 4, 2006; revised manuscript received January 29, 2007, accepted January 30, 2007.

* Reprint requests and correspondence: Dr. Nico H. J. Pijls, Catharina Hospital, Department of Cardiology, Michelangelo Avenue 2, P.O. Box 1350, 5602 ZA Eindhoven, the Netherlands. (Email: nico.pijls{at}inter.nl.net).

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 ≥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.

Abbreviations and Acronyms
  AMI = acute myocardial infarction
  FFR = fractional flow reserve
  PCI = percutaneous coronary intervention
  SPECT = single-photon emission computed tomography




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