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OCT Imaging During PCI and Physician Decision-Making
Study Questions:
What is the impact of optical coherence tomography (OCT) on physician decision-making and the association with post–percutaneous coronary intervention (PCI) fractional flow reserve (FFR) values and early clinical events?
Methods:
In the ILUMIEN I study, OCT and documentary FFR were performed pre- and post-PCI in 418 patients (with 467 stenoses) with stable or unstable angina or non−ST-segment elevation myocardial infarction (NSTEMI). The study objective was to define guidance parameters for stent optimization. Data analysis was performed on a per subject basis, unless specified otherwise (lesion or stent-related variables are shown on a per stenosis basis). Demographic variables, procedure characteristics, adverse event rates, and additional characteristics were analyzed. Continuous and categorical variables were assessed using an ANOVA F-test and Fishers Exact MCMC p-values, respectively.
Results:
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. OCT abnormalities deemed unsatisfactory by the implanting physician were identified: 14.5% malapposition, 7.6% underexpansion, 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. Major adverse cardiac events (MACE) at 30 days were low: death 0.25%, MI 7.7%, repeat PCI 1.7%, and stent thrombosis 0.25%.
Conclusions:
The authors concluded that physician decision-making was affected by OCT imaging prior to PCI in 57% and post-PCI in 27% of all cases.
Perspective:
This prospective, nonrandomized, observational study of PCI procedural practice in patients undergoing pre- and post-PCI FFR and OCT reported that both physician decision-making and procedural strategy were influenced by OCT findings either pre-PCI and/or post-PCI in the majority of patients. Prospective randomized trials to assess the clinical superiority of OCT-guided PCI versus sole angiographic guidance focusing on hard clinical endpoints such as reductions in mortality, stent thrombosis, or repeat revascularization in the longer-term are indicated.
Keywords: Angina, Unstable, Constriction, Pathologic, Diagnostic Imaging, Dilatation, Fractional Flow Reserve, Myocardial, Myocardial Infarction, Percutaneous Coronary Intervention, Stents, Thrombosis, Tomography, Optical Coherence
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