title: Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study.
abstract: OBJECTIVE
  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.
  
  
  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%.
  
  
  CONCLUSIONS
  Physician decision-making was affected by OCT imaging prior to PCI in 57% and post-PCI in 27% of all cases. CLINICALTRIALS.
  NCT01663896, Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (ILUMIEN I).
authors.affiliation: Cardiovascular Research Center, OLV Hospital, Moorselbaan 164, Aalst B 9300, Belgium william.wijns@olvz-aalst.be william.wyns@gmail.com.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Shite
authors.affiliation: Baptist Health Lexington, Lexington, KY, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jones
authors.affiliation: University of Hong Kong, Queen Mary Hospital, Hospital Authority, Pok Fu Lam, Hong Kong.
authors.forename: Stephen W L
authors.initials: SW
authors.lastname: Lee
authors.affiliation: Scripps Clinic, La Jolla, CA, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Price
authors.affiliation: Centro Cardiologico Monzino, IRCCS, Milan, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Fabbiocchi
authors.affiliation: Cardiovascular Research Center, OLV Hospital, Moorselbaan 164, Aalst B 9300, Belgium.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Barbato
authors.affiliation: Wakayama Medical University, Wakayama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Akasaka
authors.affiliation: University Hospitals Case Medical Center, Harrington Heart and Vascular Institute, Cleveland, OH, USA.
authors.forename: Hiram
authors.initials: H
authors.lastname: Bezerra
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: David
authors.initials: D
authors.lastname: Holmes
mesh_terms: D000787:Angina Pectoris / Q000209:etiology; D000066491:Clinical Decision-Making; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D053805:Fractional Flow Reserve, Myocardial / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D015607:Stents; D041623:Tomography, Optical Coherence / Q000379:methods
keywords: Fractional flow reserve; Optical coherence tomography; Percutaneous coronary intervention; Periprocedural myocardial infarction; Stent