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1. Author Correction: Optical coherence tomography in coronary atherosclerosis assessment and intervention

Author

Araki, Makoto, Park, Seung-Jung, Dauerman, Harold L., Uemura, Shiro, Kim, Jung-Sun, Di Mario, Carlo, Johnson, Thomas W., Guagliumi, Giulio, Kastrati, Adnan, Joner, Michael, Holm, Niels Ramsing, Alfonso, Fernando, Wijns, William, Adriaenssens, Tom, Nef, Holger, Rioufol, Gilles, Amabile, Nicolas, Souteyrand, Geraud, Meneveau, Nicolas, Gerbaud, Edouard, Opolski, Maksymilian P., Gonzalo, Nieves, Tearney, Guillermo J., Bouma, Brett, Aguirre, Aaron D., Mintz, Gary S., Stone, Gregg W., Bourantas, Christos V., Räber, Lorenz, Gili, Sebastiano, Mizuno, Kyoichi, Kimura, Shigeki, Shinke, Toshiro, Hong, Myeong-Ki, Jang, Yangsoo, Cho, Jin Man, Yan, Bryan P., Porto, Italo, Niccoli, Giampaolo, Montone, Rocco A., Thondapu, Vikas, Papafaklis, Michail I., Michalis, Lampros K., Reynolds, Harmony, Saw, Jacqueline, Libby, Peter, Weisz, Giora, Iannaccone, Mario, Gori, Tommaso, Toutouzas, Konstantinos, Yonetsu, Taishi, Minami, Yoshiyasu, Takano, Masamichi, Raffel, O. Christopher, Kurihara, Osamu, Soeda, Tsunenari, Sugiyama, Tomoyo, Kim, Hyung Oh, Lee, Tetsumin, Higuma, Takumi, Nakajima, Akihiro, Yamamoto, Erika, Bryniarski, Krzysztof L., Di Vito, Luca, Vergallo, Rocco, Fracassi, Francesco, Russo, Michele, Seegers, Lena M., McNulty, Iris, Park, Sangjoon, Feldman, Marc, Escaned, Javier, Prati, Francesco, Arbustini, Eloisa, Pinto, Fausto J., Waksman, Ron, Garcia-Garcia, Hector M., Maehara, Akiko, Ali, Ziad, Finn, Aloke V., Virmani, Renu, Kini, Annapoorna S., Daemen, Joost, Kume, Teruyoshi, Hibi, Kiyoshi, Tanaka, Atsushi, Akasaka, Takashi, Kubo, Takashi, Yasuda, Satoshi, Croce, Kevin, Granada, Juan F., Lerman, Amir, Prasad, Abhiram, Regar, Evelyn, Saito, Yoshihiko, Sankardas, Mullasari Ajit, Subban, Vijayakumar, Weissman, Neil J., Chen, Yundai, Yu, Bo, Nicholls, Stephen J., Barlis, Peter, West, Nick E. J., Arbab-Zadeh, Armin, Ye, Jong Chul, Dijkstra, Jouke, Lee, Hang, Narula, Jagat, Crea, Filippo, Nakamura, Sunao, Kakuta, Tsunekazu, Fujimoto, James, Fuster, Valentin, and Jang, Ik-Kyung

Published
2024
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2. OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy

Author

Ali, Ziad A., Landmesser, Ulf, Maehara, Akiko, Shin, Doosup, Sakai, Koshiro, Matsumura, Mitsuaki, Shlofmitz, Richard A., Leistner, David, Canova, Paolo, Alfonso, Fernando, Fabbiocchi, Franco, Guagliumi, Giulio, Price, Matthew J., Hill, Jonathan M., Akasaka, Takashi, Prati, Francesco, Bezerra, Hiram G., Wijns, William, McGreevy, Robert J., McNutt, Robert W., Nie, Hong, Phalakornkule, Kanitha, Buccola, Jana, and Stone, Gregg W.

Published
2024
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3. Sex-specific features of optical coherence tomography detected plaque vulnerability related to clinical outcomes: insights from the CLIMA study

Author

Biccirè, Flavio Giuseppe, Debelak, Caterina, Varricchione, Giuseppe, Budassi, Simone, Gatto, Laura, Romagnoli, Enrico, Di Pietro, Riccardo, Sammartini, Emanuele, Marco, Valeria, Paoletti, Giulia, Burzotta, Francesco, Ozaki, Yukio, Pastori, Daniele, Alfonso, Fernando, Arbustini, Eloisa, and Prati, Francesco

Published
2023
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4. Coronary Plaque Characteristics Associated With Major Adverse Cardiovascular Events in Atherosclerotic Patients and Lesions: A Systematic Review and Meta-Analysis

Author

Gallone, Guglielmo, Bellettini, Matteo, Gatti, Marco, Tore, Davide, Bruno, Francesco, Scudeler, Luca, Cusenza, Vincenzo, Lanfranchi, Antonio, Angelini, Andrea, De Filippo, Ovidio, Iannaccone, Mario, Baldetti, Luca, Audisio, Katia, Demetres, Michelle, Risi, Gaetano, Rizzello, Giulia, Porto, Italo, Fonio, Paolo, Prati, Francesco, Williams, Michelle C., Koo, Bon-Kwon, Pontone, Gianluca, Depaoli, Alessandro, Libby, Peter, Stone, Gregg W., Narula, Jagat, De Ferrari, Gaetano Maria, and D’Ascenzo, Fabrizio

Published
2023
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7. The Role of the Association Between Serum C-Reactive Protein Levels and Coronary Plaque Macrophage Accumulation in Predicting Clinical Events — Results from the CLIMA Registry

Author

Budassi, Simone, Biccirè, Flavio Giuseppe, Paoletti, Giulia, Marco, Valeria, Boi, Alberto, Romagnoli, Enrico, Fabbiocchi, Franco, Fineschi, Massimo, Di Pietro, Riccardo, Versaci, Francesco, Calligaris, Giuseppe, Gatto, Laura, Albertucci, Mario, Ramazzotti, Vito, Burzotta, Francesco, Ozaki, Yukio, Arbustini, Eloisa, Alfonso, Fernando, and Prati, Francesco

Published
2022
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8. Secondary prevention and follow-up of patients with ACS and not-at-target LDL: An Italian real-world retro-prospective analysis by the INERTIA group

Author

Del Pinto, Maurizio, Amico, Francesco, Brunetti, Natale, Caldarola, Pasquale, Carugo, Stefano, Cavallini, Claudio, D'Andrea, Antonello, Fedele, Francesco, Mauro, Ciro, Noussan, Patrizia, Paloscia, Leonardo, Prati, Francesco, Tarzia, Pierpaolo, Tespili, Maurizio, Barbieri, Lucia, Basso, Pierangelo, Buono, Andrea, D'Alleva, Alberto, Giubilato, Simona, Iannacone, Mario, Ferrante, Fabio, Granata, Giuseppina, Ieva, Riccardo, Madrid, Alfredo, Mallus, Maria Teresa, and Tagliamonte, Ercole

Published
2023
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9. Optical coherence tomography in coronary atherosclerosis assessment and intervention

Author

Araki, Makoto, Park, Seung-Jung, Dauerman, Harold L., Uemura, Shiro, Kim, Jung-Sun, Di Mario, Carlo, Johnson, Thomas W., Guagliumi, Giulio, Kastrati, Adnan, Joner, Michael, Holm, Niels Ramsing, Alfonso, Fernando, Wijns, William, Adriaenssens, Tom, Nef, Holger, Rioufol, Gilles, Amabile, Nicolas, Souteyrand, Geraud, Meneveau, Nicolas, Gerbaud, Edouard, Opolski, Maksymilian P., Gonzalo, Nieves, Tearney, Guillermo J., Bouma, Brett, Aguirre, Aaron D., Mintz, Gary S., Stone, Gregg W., Bourantas, Christos V., Räber, Lorenz, Gili, Sebastiano, Mizuno, Kyoichi, Kimura, Shigeki, Shinke, Toshiro, Hong, Myeong-Ki, Jang, Yangsoo, Cho, Jin Man, Yan, Bryan P., Porto, Italo, Niccoli, Giampaolo, Montone, Rocco A., Thondapu, Vikas, Papafaklis, Michail I., Michalis, Lampros K., Reynolds, Harmony, Saw, Jacqueline, Libby, Peter, Weisz, Giora, Iannaccone, Mario, Gori, Tommaso, Toutouzas, Konstantinos, Yonetsu, Taishi, Minami, Yoshiyasu, Takano, Masamichi, Raffel, O. Christopher, Kurihara, Osamu, Soeda, Tsunenari, Sugiyama, Tomoyo, Kim, Hyung Oh, Lee, Tetsumin, Higuma, Takumi, Nakajima, Akihiro, Yamamoto, Erika, Bryniarski, Krzysztof L., Di Vito, Luca, Vergallo, Rocco, Fracassi, Francesco, Russo, Michele, Seegers, Lena M., McNulty, Iris, Park, Sangjoon, Feldman, Marc, Escaned, Javier, Prati, Francesco, Arbustini, Eloisa, Pinto, Fausto J., Waksman, Ron, Garcia-Garcia, Hector M., Maehara, Akiko, Ali, Ziad, Finn, Aloke V., Virmani, Renu, Kini, Annapoorna S., Daemen, Joost, Kume, Teruyoshi, Hibi, Kiyoshi, Tanaka, Atsushi, Akasaka, Takashi, Kubo, Takashi, Yasuda, Satoshi, Croce, Kevin, Granada, Juan F., Lerman, Amir, Prasad, Abhiram, Regar, Evelyn, Saito, Yoshihiko, Sankardas, Mullasari Ajit, Subban, Vijayakumar, Weissman, Neil J., Chen, Yundai, Yu, Bo, Nicholls, Stephen J., Barlis, Peter, West, Nick E. J., Arbab-Zadeh, Armin, Ye, Jong Chul, Dijkstra, Jouke, Lee, Hang, Narula, Jagat, Crea, Filippo, Nakamura, Sunao, Kakuta, Tsunekazu, Fujimoto, James, Fuster, Valentin, and Jang, Ik-Kyung

Published
2022
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11. Clinical Impact of Intracoronary Imaging in the Management of Stent Thrombosis.

Author

Karamasis, Grigoris V., Katsikis, Athanasios, Konstantinou, Klio, Clesham, Gerald J., Kelly, Paul A., Jagathesan, Rohan, Prati, Francesco, Bourantas, Christos V., Davies, John R., and Keeble, Thomas R.

Subjects
ST elevation myocardial infarction, PERCUTANEOUS coronary intervention, OPTICAL coherence tomography, PROPENSITY score matching, THROMBOSIS
Abstract

Objectives: Use of intracoronary imaging (ICI) in cases of stent thrombosis (ST) is recommended and tailored treatment appears reasonable. Nevertheless, data supporting such a strategy are lacking. The aim of this study was to evaluate the clinical impact of ICI in the management of ST. Methods: The unadjusted study population was consecutive patients with definite ST presenting in a single tertiary cardiac centre and undergoing percutaneous coronary intervention (PCI). The presumed major mechanism of ST was assigned according to the real-time ICI interpretation by the PCI operator. Propensity score matching was performed with regard to ICI use to form the adjusted population and Kaplan–Meier analysis was applied to compare survival free of cardiac death (CD) or target lesion revascularization (TLR). Results: The unadjusted population included 130 ST patients, with the majority presenting with ST-elevation myocardial infarction (STEMI) (88%) and very late ST (86%). ICI was performed in 45 patients, of whom optical coherence tomography (OCT) was performed in 30 cases. When the individual ST mechanisms were viewed as groups, there was an interaction observed between type of treatment (stent vs. non-stent) and ST mechanism, with non-stent treatment being more prevalent in cases of underexpansion, malapposition, in-stent restenosis and mechanism uncertainty. After application of matching, two groups of 30 patients were formed. ICI-guided management resulted in better survival free of CD–TLR at 2 years (93% vs. 73%, p = 0.037). Conclusions: Intracoronary imaging guidance during PCI for ST had a direct impact on management (stent vs. non-stent) and resulted in a lower event rate at mid-term follow-up when propensity matched analysis was applied. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Adoption of a new automated optical coherence tomography software to obtain a lipid plaque spread-out plot

Author

Isidori, Francesco, Lella, Eugenio, Marco, Valeria, Albertucci, Mario, Ozaki, Yukio, La Manna, Alessio, Biccirè, Flavio Giuseppe, Romagnoli, Enrico, Bourantas, Christos V., Paoletti, Giulia, Fabbiocchi, Franco, Gatto, Laura, Budassi, Simone, Sticchi, Alessandro, Burzotta, Francesco, Taglieri, Nevio, Calligaris, Giuseppe, Arbustini, Eloisa, Alfonso, Fernando, and Prati, Francesco

Published
2021
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17. Association of Sex with Outcome in Elderly Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Author

De Rosa, Roberta, Morici, Nuccia, De Luca, Giuseppe, De Luca, Leonardo, Ferri, Luca A., Piatti, Luigi, Tortorella, Giovanni, Grosseto, Daniele, Franco, Nicoletta, Misuraca, Leonardo, Sganzerla, Paolo, Cacucci, Michele, Antonicelli, Roberto, Cavallini, Claudio, Lenatti, Laura, Leuzzi, Chiara, Murena, Ernesto, Ravera, Amelia, Ferrario, Maurizio, Corrada, Elena, Colombo, Delia, Prati, Francesco, Piscione, Federico, Petronio, A. Sonia, Galasso, Gennaro, De Servi, Stefano, and Savonitto, Stefano

Published
2021
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20. Prevalence and quantitative assessment of macrophages in coronary plaques

Author

Gatto, Laura, Paoletti, Giulia, Marco, Valeria, La Manna, Alessio, Fabbiocchi, Franco, Cortese, Bernardo, Vergallo, Rocco, Boi, Alberto, Fineschi, Massimo, Di Giorgio, Alessandro, Taglieri, Nevio, Calligaris, Giuseppe, Budassi, Simone, Burzotta, Francesco, Isidori, Francesco, Lella, Eugenio, Ruscica, Giovanni, Albertucci, Mario, Tamburino, Corrado, Ozaki, Yukio, Alfonso, Fernando, Arbustini, Eloisa, and Prati, Francesco

Published
2021
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28. TCT-684 Evaluation of the Performance of Deep Learning-Based Methods in Assessing Plaque Pathology in OCT and NIRS IVUS: A Head-to-Head Comparison With Histology

Author

Parasa, Ramya, primary, Bajaj, Retesh, additional, Broersen, Alexander, additional, Mohil, Garg, additional, Prati, Francesco, additional, Çap, Murat, additional, Lecaros Yap, Nathan Angelo, additional, Grainger, Stephanie, additional, White, Stephen, additional, Baumbach, Andreas, additional, Mathur, Anthony, additional, Garcia-Garcia, Hector Manel, additional, Dijkstra, Jouke, additional, Precht, Helle, additional, and Bourantas, Christos, additional

Published
2023
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34. Comparison between different approaches to evaluate fibrous cap thickness in sequential optical coherence tomography studies

Author

ROMAGNOLI, Enrico, primary, PAOLETTI, Giulia, additional, MARCO, Valeria, additional, GATTO, Laura, additional, CALLIGARIS, Giuseppe, additional, FABBIOCCHI, Franco, additional, FINESCHI, Massimo, additional, BOI, Alberto, additional, ALBERTUCCI, Mario, additional, NICHOLLS, Stephen J., additional, and PRATI, Francesco, additional

Published
2023
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36. Combined immunosuppressive treatment for giant cell myocarditis: a case report.

Author

Iebba, Filippo, Bottari, Vera Elena, Di Sora, Fiorella, Mallus, Maria Teresa, Manfredi, Rosa Maria, and Prati, Francesco

Abstract

Giant cell myocarditis (GCM) is a rare and often fulminant autoimmune disease. The immune-mediated pathogenesis of GCM is also supported by animal models, association with other immunological diseases and therapeutic efficacy of immunosuppressive drugs. The diagnosis of GCM is based on endomyocardial biopsy. GCM is an orphan disease. Heart transplantation is effective but up to 25% of transplanted patients experience disease recurrence. Immunosuppressive drugs have been shown to be potential therapeutic agents for GCM. In the present case report, the prescription of cyclosporine, azathioprine and prednisone resulted in a rapid and prolonged remission in support of the role of a combined immunosuppressive regimen in improving the long-term prognosis of this cardiac pathology. [ABSTRACT FROM AUTHOR]

Published
2024
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37. Clinical impact of OCT-derived suboptimal stent implantation parameters and definitions.

Author

Romagnoli, Enrico, Burzotta, Francesco, Vergallo, Rocco, Gatto, Laura, Biondi-Zoccai, Giuseppe, Ramazzotti, Vito, Biccirè, Flavio, Budassi, Simone, Trani, Carlo, Ali, Ziad, Stone, Gregg W, and Prati, Francesco

Subjects
PERCUTANEOUS coronary intervention, DRUG-eluting stents, MULTIVARIATE analysis, RETROSPECTIVE studies, TREATMENT effectiveness, COMPARATIVE studies, OPTICAL coherence tomography, RESEARCH funding, COMPLICATIONS of prosthesis, PROPORTIONAL hazards models
Abstract

Aims Despite growing evidence supporting the clinical utility of optical coherence tomography (OCT) guidance during percutaneous coronary interventions (PCIs), there is no common agreement as to the optimal stent implantation parameters that enhance clinical outcome. Methods and results We retrospectively examined the predictive accuracy of suboptimal stent implantation definitions proposed from the CLI-OPCI II, ILUMIEN-IV OPTIMAL PCI, and FORZA studies for the long-term risk of device-oriented cardiovascular events (DoCE) in the population of large all-comers CLI-OPCI project. A total of 1020 patients undergoing OCT-guided drug-eluting stent implantation in the CLI-OPCI registry with a median follow-up of 809 (quartiles 414–1376) days constituted the study population. According to CLI-OPCI II, ILUMIEN-IV OPTIMAL PCI, and FORZA criteria, the incidence of suboptimal stent implantation was 31.8%, 58.1%, and 57.8%, respectively. By multivariable Cox analysis, suboptimal stent implantation criteria from the CLI-OPCI II [hazard ratio 2.75 (95% confidence interval 1.88–4.02), P < 0.001] and ILUMIEN-IV OPTIMAL PCI [1.79 (1.18–2.71), P = 0.006] studies, but not FORZA trial [1.11 (0.75–1.63), P = 0.597], were predictive of DoCE. At long-term follow-up, stent edge disease with minimum lumen area <4.5 mm2 [8.17 (5.32–12.53), P < 0.001], stent edge dissection [2.38 (1.33–4.27), P = 0.004], and minimum stent area <4.5 mm2 [1.68 (1.13–2.51), P = 0.011] were the main OCT predictors of DoCE. Conclusion The clinical utility of OCT-guided PCI might depend on the metrics adopted to define suboptimal stent implantation. Uncovered disease at the stent border, stent edge dissection, and minimum stent area <4.5 mm2 were the strongest OCT associates of stent failure. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Spontaneous coronary artery dissection: an unpredictable event

Author

Smirnova, Alexandra, primary, Aliberti, Flaminia, additional, Cavaliere, Claudia, additional, Gatti, Ilaria, additional, Vilardo, Viviana, additional, Giorgianni, Carmelina, additional, Cassani, Chiara, additional, Repetto, Alessandra, additional, Narula, Nupoor, additional, Giuliani, Lorenzo, additional, Urtis, Mario, additional, Ozaki, Yukio, additional, Prati, Francesco, additional, Arbustini, Eloisa, additional, and Ferrari, Michela, additional

Published
2023
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46. Current Applications and New Perspectives in Optical Coherence Tomography (OCT) Coronary Atherosclerotic Plaque Assessment: From PCI Optimization to Pharmacological Treatment Guidance

Author

Viscusi, Michele Mattia, primary, La Porta, Ylenia, additional, Migliaro, Giuseppe, additional, Gargano, Gian Marco, additional, Nusca, Annunziata, additional, Gatto, Laura, additional, Budassi, Simone, additional, Paolucci, Luca, additional, Mangiacapra, Fabio, additional, Ricottini, Elisabetta, additional, Melfi, Rosetta, additional, Rinaldi, Raffaele, additional, Prati, Francesco, additional, Ussia, Gian Paolo, additional, and Grigioni, Francesco, additional

Published
2023
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47. OCT guided vs. COmplete pci in patieNts with sT segment elevation myocArdial infarCtion and mulTivessel disease: OCT-CONTACT RCT

Author

IANNACCONE, Mario, primary, DE FILIPPO, Ovidio, additional, MONTABONE, Andrea, additional, MARENGO, Giorgio, additional, MALTESE, Ludovica, additional, UGO, Fabrizio, additional, QUADRI, Giorgio, additional, MENNUNI, Maro, additional, SECCO, Gioel G., additional, TAGLIALATELA, Vittorio, additional, CINCONZE, Sebastian, additional, MORETTI, Claudio, additional, TRUFFA, Alessandra, additional, GAMBINO, Alfonso, additional, BOCCUZZI, Giacomo, additional, INFANTINO, Vincenzo, additional, CONROTTO, Federico, additional, LUPI, Alessandro, additional, VARBELLA, Ferdinando, additional, PATTI, Giuseppe, additional, ROGNONI, Andrea, additional, MUSUMECI, Giuseppe, additional, PRATI, Francesco, additional, DE FERRARI, Gaetano M., additional, and D’ASCENZO, Fabrizio, additional

Published
2023
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49. Clinical Impact of OCT-Derived Suboptimal Stent Implantation Parameters and Definitions

Author

Romagnoli, Enrico, Burzotta, Francesco, Vergallo, Rocco, Gatto, Laura, Biondi-Zoccai, Giuseppe, Ramazzotti, Vito, Biccirè, Flavio, Budassi, Simone, Trani, Carlo, Ali, Ziad, Stone, Gregg W, Prati, Francesco, Burzotta, Francesco (ORCID:0000-0002-6569-9401), Trani, Carlo (ORCID:0000-0001-9777-013X), Romagnoli, Enrico, Burzotta, Francesco, Vergallo, Rocco, Gatto, Laura, Biondi-Zoccai, Giuseppe, Ramazzotti, Vito, Biccirè, Flavio, Budassi, Simone, Trani, Carlo, Ali, Ziad, Stone, Gregg W, Prati, Francesco, Burzotta, Francesco (ORCID:0000-0002-6569-9401), and Trani, Carlo (ORCID:0000-0001-9777-013X)

Abstract

Aims: Despite growing evidence supporting the clinical utility of optical coherence tomography (OCT)-guidance during percutaneous coronary interventions (PCIs), there is no common agreement as to the optimal stent implantation parameters that enhance clinical outcome. Methods and results: We retrospectively examined the predictive accuracy of suboptimal stent implantation definitions proposed from the CLI-OPCI II, ILUMIEN-IV OPTIMAL PCI, and FORZA studies for the long-term risk of device oriented cardiovascular events (DoCE) in the population of large all-comers CLI-OPCI project.A total of 1020 patients undergoing OCT-guided drug-eluting stent implantation in the CLI-OPCI registry with a median follow-up of 809 (quartiles 414-1376) days constituted the study population. According to CLI-OPCI II, ILUMIEN-IV OPTIMAL PCI, and FORZA criteria, the incidence of suboptimal stent implantation was31.8%, 58.1%, and 57.8%, respectively. By multivariable Cox analysis, suboptimal stent implantation criteria from the CLI-OPCI II (hazard ratio 2.75 [95% confidence interval 1.88-4.02], p<0.001) and ILUMIEN-IV OPTIMAL PCI (1.79 [1.18-2.71], p=0.006) studies, but not FORZA trial (1.11 [0.75-1.63], p=0.597), were predictive of DoCE. At long-term follow-up, stent edge disease with minimum lumen area <4.5mm2 (8.17 [5.32-12.53], p<0.001), stent edge dissection (2.38 [1.33-4.27], p=0.004) and minimum stent area <4.5mm2 (1.68 [1.13-2.51], p=0.011) were the main OCT predictors of DoCE. Conclusion: The clinical utility of OCT-guided PCI might depend on the metrics adopted to define suboptimal stent implantation. Uncovered disease at the stent border, stent edge dissection, and minimum stent area <4.5mm2 were the strongest OCT associates of stent failure.

Published
2023

50. Optical Coherence Tomography-Guided versus Angiography-Guided PCI

Author

Ali A, Ziad, Landmesser, Ulf, Maehara, Akiko, Matsumura, Mitsuaki, Shlofmitz, Richard A, Guagliumi, Giulio, Price, Matthew J, Hill, Jonathan M, Akasaka, Takashi, Prati, Francesco, Bezerra, Hiram G, Wijns, William, Leistner, David, Canova, Paolo, Alfonso, Fernando, Fabbiocchi, Franco, Dogan, Ozgen, Mcgreevy, Robert J, Mcnutt, Robert W, Nie, Hong, Buccola, Jana, West, Nick E J, Stone, Gregg W, Trani, Carlo, ILUMIEN IV, Investigators, Trani, Carlo (ORCID:0000-0001-9777-013X), Ali A, Ziad, Landmesser, Ulf, Maehara, Akiko, Matsumura, Mitsuaki, Shlofmitz, Richard A, Guagliumi, Giulio, Price, Matthew J, Hill, Jonathan M, Akasaka, Takashi, Prati, Francesco, Bezerra, Hiram G, Wijns, William, Leistner, David, Canova, Paolo, Alfonso, Fernando, Fabbiocchi, Franco, Dogan, Ozgen, Mcgreevy, Robert J, Mcnutt, Robert W, Nie, Hong, Buccola, Jana, West, Nick E J, Stone, Gregg W, Trani, Carlo, ILUMIEN IV, Investigators, and Trani, Carlo (ORCID:0000-0001-9777-013X)

Abstract

BACKGROUND Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited.METHODS In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and targetvessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed.RESULTS The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72 +/- 2.04 mm(2) in the OCT group and 5.36 +/- 1.87 mm(2) in the angiography group (mean difference, 0.36 mm(2); 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group.CONCLUSIONS Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.)

Published
2023

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