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.
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.
Authors: Makoto Araki; Seung-Jung Park; Harold L Dauerman; Shiro Uemura; Jung-Sun Kim; Carlo Di Mario; Thomas W Johnson; Giulio Guagliumi; Adnan Kastrati; Michael Joner; Niels Ramsing Holm; Fernando Alfonso; William Wijns; Tom Adriaenssens; Holger Nef; Gilles Rioufol; Nicolas Amabile; Geraud Souteyrand; Nicolas Meneveau; Edouard Gerbaud; Maksymilian P Opolski; Nieves Gonzalo; Guillermo J Tearney; Brett Bouma; Aaron D Aguirre; Gary S Mintz; Gregg W Stone; Christos V Bourantas; Lorenz Räber; Sebastiano Gili; Kyoichi Mizuno; Shigeki Kimura; Toshiro Shinke; Myeong-Ki Hong; Yangsoo Jang; Jin Man Cho; Bryan P Yan; Italo Porto; Giampaolo Niccoli; Rocco A Montone; Vikas Thondapu; Michail I Papafaklis; Lampros K Michalis; Harmony Reynolds; Jacqueline Saw; Peter Libby; Giora Weisz; Mario Iannaccone; Tommaso Gori; Konstantinos Toutouzas; Taishi Yonetsu; Yoshiyasu Minami; Masamichi Takano; O Christopher Raffel; Osamu Kurihara; Tsunenari Soeda; Tomoyo Sugiyama; Hyung Oh Kim; Tetsumin Lee; Takumi Higuma; Akihiro Nakajima; Erika Yamamoto; Krzysztof L Bryniarski; Luca Di Vito; Rocco Vergallo; Francesco Fracassi; Michele Russo; Lena M Seegers; Iris McNulty; Sangjoon Park; Marc Feldman; Javier Escaned; Francesco Prati; Eloisa Arbustini; Fausto J Pinto; Ron Waksman; Hector M Garcia-Garcia; Akiko Maehara; Ziad Ali; Aloke V Finn; Renu Virmani; Annapoorna S Kini; Joost Daemen; Teruyoshi Kume; Kiyoshi Hibi; Atsushi Tanaka; Takashi Akasaka; Takashi Kubo; Satoshi Yasuda; Kevin Croce; Juan F Granada; Amir Lerman; Abhiram Prasad; Evelyn Regar; Yoshihiko Saito; Mullasari Ajit Sankardas; Vijayakumar Subban; Neil J Weissman; Yundai Chen; Bo Yu; Stephen J Nicholls; Peter Barlis; Nick E J West; Armin Arbab-Zadeh; Jong Chul Ye; Jouke Dijkstra; Hang Lee; Jagat Narula; Filippo Crea; Sunao Nakamura; Tsunekazu Kakuta; James Fujimoto; Valentin Fuster; Ik-Kyung Jang Journal: Nat Rev Cardiol Date: 2022-04-21 Impact factor: 49.421
Authors: Piotr Baruś; Jakub Modrzewski; Karolina Gumiężna; Piotr Dunaj; Marcin Głód; Adrian Bednarek; Wojciech Wańha; Tomasz Roleder; Janusz Kochman; Mariusz Tomaniak Journal: J Clin Med Date: 2022-07-13 Impact factor: 4.964
Authors: Rafał Januszek; Wojciech Siłka; Karol Sabatowski; Krzysztof Piotr Malinowski; Grzegorz Heba; Sławomir Surowiec; Michał Chyrchel; Łukasz Rzeszutko; Leszek Bryniarski; Andrzej Surdacki; Krzysztof Bartuś; Stanisław Bartuś Journal: J Cardiovasc Dev Dis Date: 2022-07-06