Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study

Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.


Aims: ILUMIEN I is the largest prospective, non-randomized, observational study of percutaneous coronary intervention (PCI) procedural practice in patients undergoing intra-procedural pre- and post-PCI fractional flow reserve (FFR) and optical coherence tomography (OCT). We report on the impact of OCT on physician decision-making and the association with post-PCI FFR values and early clinical events.

Methods and results: Optical coherence tomography and documentary FFR were performed pre- and post-PCI in 418 patients (with 467 stenoses) with stable or unstable angina or NSTEMI. Based on pre-PCI OCT, the procedure was altered in 55% of patients (57% of all stenoses) by selecting different stent lengths (shorter in 25%, longer in 43%). After clinically satisfactory stent implantation using angiographic guidance, post-PCI FFR and OCT were repeated. Optical coherence tomography abnormalities deemed unsatisfactory by the implanting physician were identified: 14.5% malapposition, 7.6% under-expansion, 2.7% edge dissection and prompted further stent optimization based on OCT in 25% of patients (27% of all stenoses) using additional in-stent post-dilatation (81%, 101/124) or placement of 20 new stents (12%). Optimization subgroups were identified post hoc: stent placement without reaction to OCT findings (n = 137), change in PCI planning by pre-PCI OCT (n = 165), post-PCI optimization based on post-PCI OCT (n = 41), change in PCI planning, and post-PCI optimization based on OCT (n = 65). Post-PCI FFR values were significantly different (P = 0.003) between optimization groups (lower in cases with pre- and post-PCI reaction to OCT) but no longer different after post-PCI stent optimization. MACE events at 30 days were low: death 0.25%, MI 7.7%, repeat PCI 1.7%, and stent thrombosis 0.25%.

Conclusion: Physician decision-making was affected by OCT imaging prior to PCI in 57% and post-PCI in 27% of all cases. CLINICALTRIALS.

Gov identifier: NCT01663896, Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (ILUMIEN I).

Keywords: Fractional flow reserve; Optical coherence tomography; Percutaneous coronary intervention; Periprocedural myocardial infarction; Stent.

Publication types

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

MeSH terms

  • Angina Pectoris / etiology
  • Clinical Decision-Making
  • Coronary Angiography / methods
  • Coronary Stenosis / diagnosis
  • Coronary Stenosis / physiopathology
  • Coronary Stenosis / surgery*
  • Female
  • Fractional Flow Reserve, Myocardial / physiology
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / methods*
  • Practice Patterns, Physicians'
  • Prospective Studies
  • Stents
  • Tomography, Optical Coherence / methods

Associated data

  • ClinicalTrials.gov/NCT01663896