TY - JOUR
T1 - Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making
T2 - ILUMIEN i study
AU - Wijns, William
AU - Shite, Junya
AU - Jones, Michael R.
AU - Lee, Stephen W.L.
AU - Price, Matthew J.
AU - Fabbiocchi, Franco
AU - Barbato, Emanuele
AU - Akasaka, Takashi
AU - Bezerra, Hiram
AU - Holmes, David
N1 - Publisher Copyright:
© 2015 The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2015/12/14
Y1 - 2015/12/14
N2 - 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).
AB - 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).
KW - Fractional flow reserve
KW - Optical coherence tomography
KW - Percutaneous coronary intervention
KW - Periprocedural myocardial infarction
KW - Stent
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U2 - 10.1093/eurheartj/ehv367
DO - 10.1093/eurheartj/ehv367
M3 - Article
C2 - 26242713
AN - SCOPUS:84946816395
SN - 0195-668X
VL - 36
SP - 3346
EP - 3355
JO - European heart journal
JF - European heart journal
IS - 47
ER -