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
Ziad Ali1,; Keyvan Karimi Galougahi2; Akiko Maehara3; Richard A Shlofmitz4; Franco Fabbiocchi5; Giulio Guagliumi6; Fernando Alfonso7; Takashi Akasaka8; Mitsuaki Matsumura9; Gary S Mintz9; Ori Ben-Yehuda3; Zhen Zhang10; Richard J Rapoza10; Nick E.J. West10; Gregg W Stone11;
1. Centre for Interventional Vascular Therapy, Division of Cardiology, New York-Presbyterian Hospital/Columbia University Medical Centre, New York, NY USA; Clinical Trials Centre, Cardiovascular Research Foundation, New York, NY, USA; St. Francis Hospital, Roslyn, NY, USA, United States 2. Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia 3. Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA 4. St. Francis Hospital, Roslyn, NY, USA 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. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA 10. Abbott Vascular, Santa Clara, CA 11. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
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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 clinical outcomes is unknown.
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 between 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 for OCT-guided PCI.