TY - JOUR
T1 - Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation
T2 - One-year results from the ILUMIEN III: OPTIMIZE PCI trial
AU - Ali, Ziad A.
AU - Galougahi, Keyvan Karimi
AU - Maehara, Akiko
AU - Shlofmitz, Richard A.
AU - Fabbiocchi, Franco
AU - Guagliumi, Giulio
AU - Alfonso, Fernando
AU - Akasaka, Takashi
AU - Matsumura, Mitsuaki
AU - Mintz, Gary S.
AU - Ben-Yehuda, Ori
AU - Zhang, Zhen
AU - Rapoza, Richard J.
AU - West, Nick E.J.
AU - Stone, Gregg W.
N1 - Publisher Copyright:
© Europa Digital & Publishing 2021. All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Intravascular ultrasound
KW - Optical coherence tomography
KW - Percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85100280341&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-20-00498
DO - 10.4244/EIJ-D-20-00498
M3 - Article
C2 - 32540793
AN - SCOPUS:85100280341
SN - 1774-024X
VL - 16
SP - 1085
EP - 1091
JO - EuroIntervention
JF - EuroIntervention
IS - 13
ER -