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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, Eric Boersma, PhD, 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 and Bernard de Bruyne, MD, PhD

^_* Catharina Hospital Eindhoven, Eindhoven, the Netherlands
Cardiovascular Center Aalst, Aalst, Belgium
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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