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

William Wijns, Junya Shite, Michael R Jones, Stephen W L Lee, Matthew J Price, Franco Fabbiocchi, Emanuele Barbato, Takashi Akasaka, Hiram Bezerra, David Holmes, William Wijns, Junya Shite, Michael R Jones, Stephen W L Lee, Matthew J Price, Franco Fabbiocchi, Emanuele Barbato, Takashi Akasaka, Hiram Bezerra, David Holmes

Abstract

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.

© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Consort diagram: study flowchart, procedural steps, and patient disposal. FFR, fractional flow reserve; OCT, optical coherence tomography; PCI, percutaneous coronary intervention.
Figure 2
Figure 2
Impact of optical coherence tomography (OCT) on percutaneous coronary intervention (PCI) planning and procedural technique. Per-patient rates of fractional flow reserve (FFR) and optical coherence tomography pre- and post-percutaneous coronary intervention.
Figure 3
Figure 3
Changes in distal fractional flow reserve (FFR) from post-percutaneous coronary intervention (PCI) to final measurement after optical coherence tomography (OCT)-driven percutaneous coronary intervention optimization. Individual (left, panel A) and group (right, panel B) changes are shown in the subset of optimized subjects with paired measurements (n = 70, P = 0.1209).

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