Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial

Abstract

Aims: In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact on clinical outcomes is unknown. The aim of the present study was to report the 12-month clinical follow-up data from the ILUMIEN III study.

Methods and results: OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes among the groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT.

Conclusions: In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12 months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit of OCT-guided PCI.

Trial registration: NCT02471586.

Conflict of interest statement

Z.A. Ali reports institutional research grants to Columbia University and the Cardiovascular Research Foundation from Abbott and Cardiovascular Systems Inc., being a consultant for Abbott, Abiomed, Acist Medical, Amgen, AstraZeneca, Boston Scientific, Cardinal Health, and Opsens Medical, and holding equity in Shockwave Medical. A. Maehara reports institutional grant support from Abbott Vascular and Boston Scientific, and reports being a consultant for Conavi Medical Inc. G. Guagliumi reports institutional research grant support from Abbott Vascular, Boston Scientific, and Infraredx, and being a consultant for Abbott Vascular and Boston Scientific. T. Akasaka reports honoraria and grants from Abbott Vascular Japan, and institutional grants from Boston Scientific, Nipro, and Terumo. M. Matsumura reports being a consultant for Terumo Corporation. G.S. Mintz reports honoraria from Boston Scientific, Philips, Terumo, and Medtronic. Z. Zhang: reports being an employee of Abbott. R.J. Rapoza reports being an employee of Abbott. N.E.J. West reports being an employee/stockholder of Abbott. G.W. Stone reports receiving speaker or other honoraria from Cook, Terumo, Qool Therapeutics and Orchestra Biomed, being a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Matrizyme, and holding equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, and Valfix. The other authors have no conflicts of interest to declare.

Figures

Figure 1.

Trial flow diagram. *These non-randomly allocated patients were used to show the investigators’ ability to follow the prescribed OCT guidance procedure. IVUS: intravascular ultrasound; OCT: optical coherence tomography; PCI: percutaneous coronary intervention

Figure 2.

Time-to-first-event curves for target lesion failure and major adverse cardiovascular events up to one-year follow-up. A) The rates of target lesion failure (composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation). B) The rates of major adverse cardiovascular events (composite of death, myocardial infarction, stent thrombosis, or repeat revascularisation). Event rates were based on Kaplan-Meier estimates. IVUS: intravascular ultrasound; OCT: optical coherence tomography