Coronary interventions

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

EuroIntervention 2021;16:1085-1091. DOI: 10.4244/EIJ-D-20-00498

Ziad Ali
Ziad A. Ali1,2,3, MD, DPhil; Keyvan Karimi Galougahi4, MD, PhD; Akiko Maehara1,2, MD; Richard A. Shlofmitz3, MD; Franco Fabbiocchi5, MD; Giulio Guagliumi6, MD; Fernando Alfonso7, MD; Takashi Akasaka8, MD; Mitsuaki Matsumura2, BS; Gary S. Mintz2, MD; Ori Ben-Yehuda1,2, MD; Zhen Zhang9, PhD; Richard R. Rapoza9, PhD; Nick E.J. West9, MD; Gregg W. Stone2,10, MD
1. Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA; 2. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; 3. St. Francis Hospital, Roslyn, New York, NY, USA; 4. Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia; 5. Centro Cardiologico Monzino, IRCCS, Milan, Italy; 6. Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy; 7. Hospital Universitario de La Princesa, IIS-IP, CIBERCV, Madrid, Spain; 8. Wakayama Medical University, Wakayama, Japan; 9. Abbott Vascular, Santa Clara, CA, USA; 10. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA

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

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clinical trialsintravascular ultrasoundoptical coherence tomographypercutaneous coronary intervention
Coronary interventionsStents and scaffolds
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