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1. Antibacterial and Antifungal Efficacy of Medium and Low Weight Chitosan-Shelled Nanodroplets for the Treatment of Infected Chronic Wounds

Author

Mandras N, Argenziano M, Prato M, Roana J, Luganini A, Allizond V, Tullio V, Finesso N, Comini S, Bressan BE, Pecoraro F, Giribaldi G, Troia A, Cavalli R, Cuffini AM, and Banche G

Subjects
chitosan nanodroplets, methicillin-resistant staphylococcus aureus, streptococcus pyogenes, candida spp, chronic wounds, Medicine (General), R5-920
Abstract

Narcisa Mandras,1 Monica Argenziano,2 Mauro Prato,1 Janira Roana,1 Anna Luganini,3 Valeria Allizond,1 Vivian Tullio,1 Nicole Finesso,4 Sara Comini,1 Bruno Emilio Bressan,4 Francesca Pecoraro,4 Giuliana Giribaldi,4 Adriano Troia,5 Roberta Cavalli,2 Anna Maria Cuffini,1,* Giuliana Banche1,* 1Department of Public Health and Pediatric Sciences, University of Torino, Turin, 10126, Italy; 2Department of Drug Science and Technology, University of Torino, Turin, 10125, Italy; 3Department of Life Sciences and Systems Biology, University of Torino, Turin, 10123, Italy; 4Department of Oncology, University of Torino, Turin, 10126, Italy; 5Istituto Nazionale di Ricerca Metrologica, Turin, 10135, Italy*These authors contributed equally to this workCorrespondence: Valeria Allizond, Department of Public Health and Pediatric Sciences, University of Torino, Via Santena 9, Turin, 10126, Italy, Tel +390116705644, Fax +390112365644, Email valeria.allizond@unito.itPurpose: Medium versus low weight (MW vs LW) chitosan-shelled oxygen-loaded nanodroplets (cOLNDs) and oxygen-free nanodroplets (cOFNDs) were comparatively challenged for biocompatibility on human keratinocytes, for antimicrobial activity against four common infectious agents of chronic wounds (CWs) – methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus pyogenes, Candida albicans and C. glabrata – and for their physical interaction with cell walls/membranes.Methods: cNDs were characterized for morphology and physico-chemical properties by microscopy and dynamic light scattering. In vitro oxygen release from cOLNDs was measured through an oximeter. ND biocompatibility and ability to promote wound healing in human normoxic/hypoxic skin cells were challenged by LDH and MTT assays using keratinocytes. ND antimicrobial activity was investigated by monitoring upon incubation with/without MW or LW cOLNDs/cOFNDs either bacteria or yeast growth over time. The mechanical interaction between NDs and microorganisms was also assessed by confocal microscopy.Results: LW cNDs appeared less toxic to keratinocytes than MW cNDs. Based on cell counts, either MW or LW cOLNDs and cOFNDs displayed long-term antimicrobial efficacy against S. pyogenes, C. albicans, and C. glabrata (up to 24 h), whereas a short-term cytostatic effects against MRSA (up to 6 h) was revealed. The internalization of all ND formulations by all four microorganisms, already after 3 h of incubation, was showed, with the only exception to MW cOLNDs/cOFNDs that adhered to MRSA walls without being internalized even after 24 h.Conclusion: cNDs exerted bacteriostatic and fungistatic effects, due to the presence of chitosan in the outer shell and independently of oxygen addition in the inner core. The duration of such effects strictly depends on the characteristics of each microbial species, and not on the molecular weight of chitosan in ND shells. However, LW chitosan was better tolerated by human keratinocytes than MW. For these reasons, the use of LW NDs should be recommended in future research to assess cOLND efficacy for the treatment of infected CWs.Keywords: chitosan nanodroplets, methicillin-resistant Staphylococcus aureus, Streptococcus pyogenes, Candida spp, chronic wounds

Published
2022

2. New chitosan nanobubbles for ultrasound-mediated gene delivery: preparation and in vitro characterization

Author

Cavalli R, Bisazza A, Trotta M, Argenziano M, Civra A, Donalisio M, and Lembo D

Subjects
Medicine (General), R5-920
Abstract

Roberta Cavalli,1 Agnese Bisazza,1 Michele Trotta,1 Monica Argenziano,1 Andrea Civra,2 Manuela Donalisio,2 David Lembo21Department of Pharmaceutical Sciences and Technology; 2Department of Clinical and Biological Sciences University of Turin, Turin, ItalyBackground: The development of nonviral gene delivery systems is one of the most intriguing topics in nanomedicine. However, despite the advances made in recent years, several key issues remain unsettled. One of the main problems relates to the difficulty in designing nanodevices for targeted delivery of genes and other drugs to specific anatomic sites. In this study, we describe the development of a novel chitosan nanobubble-based gene delivery system for ultrasound-triggered release.Methods and results: Chitosan was selected for the nanobubble shell because of its low toxicity, low immunogenicity, and excellent biocompatibility, while the core consisted of perfluoropentane. DNA-loaded chitosan nanobubbles were formed with a mean diameter of less than 300 nm and a positive surface charge. Transmission electron microscopic analysis confirmed composition of the core-shell structure. The ability of the chitosan nanobubbles to complex with and protect DNA was confirmed by agarose gel assay. Chitosan nanobubbles were found to be stable following insonation (2.5 MHz) for up to 3 minutes at 37°C. DNA release was evaluated in vitro in both the presence and absence of ultrasound. The release of chitosan nanobubble-bound plasmid DNA occurred after just one minute of insonation. In vitro transfection experiments were performed by exposing adherent COS7 cells to ultrasound in the presence of different concentrations of plasmid DNA-loaded nanobubbles. In the absence of ultrasound, nanobubbles failed to trigger transfection at all concentrations tested. In contrast, 30 seconds of ultrasound promoted a moderate degree of transfection. Cell viability experiments demonstrated that neither ultrasound nor the nanobubbles affected cell viability under these experimental conditions.Conclusion: Based on these results, chitosan nanobubbles have the potential to be promising tools for ultrasound-mediated DNA delivery.Keywords: chitosan, nanobubbles, transfection, DNA, gene carrier, ultrasound

Published
2012

13. CRIS: A Novel Tool Described Using Only Three Self-Explanatory Words Performs Similarly To JNET Amongst Western Experts In The Detection Of Cancer And Determination Of Correct Treatment In Large Non-Pedunculated Colorectal Polyps

Author

Argenziano, M. E., additional, Debels, L., additional, Smeets, S., additional, Montori, M., additional, Poortmans, P. J., additional, Ridolfo, S., additional, Tornai, T., additional, Kaminski, M., additional, Lala, V., additional, Valori, R., additional, Anderson, J., additional, Bourke, M. J., additional, Desomer, L., additional, and Tate, D. J., additional

Published
2024
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15. Moving mass over a viscoelastic system: asymptotic behaviours and insights into nonlinear dynamics

Author

Argenziano M., Cutolo A., Babilio E., Carotenuto A. R., Fraldi M., Argenziano M., Cutolo A., Babilio E., Carotenuto A.R., and Fraldi M.

Subjects
Duffing model, Control and Systems Engineering, Applied Mathematics, Mechanical Engineering, 2-DOF system, Nonlinear dynamic, Non-smooth friction, Aerospace Engineering, Moving ma, Ocean Engineering, Electrical and Electronic Engineering
Abstract

Moving masses are of interest in many applications of structural dynamics, soliciting in the last decades a vast debate in the scientific literature. However, despite the attention devoted to the subject, to the best of the authors’ knowledge, there is a lack of analysis about the fate of a movable mass when it rolls or slips with friction on a structure. With the aim of elucidating the dynamics of the simplest paradigm of this system and to investigate its asymptotic response, we make reference to a two-degree-of-freedom model made of an elastically vibrating carriage surmounted by a spherical mass, facing the problem both theoretically and experimentally. In case of linear systems, the analytical solutions and the laboratory tests performed on ad hoc constructed prototypes highlighted a counterintuitive asymptotic dynamics, here called binary: in the absence of friction at the interface of the bodies’ system, the mass holds its initial position or, if nonzero damping acts, at the end of the motion it is in a position that exactly recovers the initial relative distance carriage–sphere. While the first result might be somewhat obvious, the second appears rather surprising. Such a binary behaviour is also confirmed for a Duffing-like system, equipped with cubic springs, while it can be lost when non-smooth friction phenomena occur, as well as in the case of elastic springs restraining the motion of the sphere. The obtained analytical results and the numerical findings, also confirmed by experimental evidences, contribute to the basic understanding of the role played by the damping parameters governing the systems’ dynamics with respect to its asymptotic behaviour and could pave the way for designing active or passive vibration controllers of interest in engineering.

Published
2023

17. Curriculum for training in endoscopic mucosal resection in the colon: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement

Author

Tate, D. J., Argenziano, M. E., Anderson, J., Bhandari, P., Boskoski, Ivo, Bugajski, M., Desomer, L., Heitman, S. J., Kashida, H., Kriazhov, V., Lee, R. R. T., Lyutakov, I., Pimentel-Nunes, P., Rivero-Sanchez, L., Thomas-Gibson, S., Thorlacius, H., Bourke, M. J., Tham, T. C., Bisschops, R., Boskoski I. (ORCID:0000-0001-8194-2670), Tate, D. J., Argenziano, M. E., Anderson, J., Bhandari, P., Boskoski, Ivo, Bugajski, M., Desomer, L., Heitman, S. J., Kashida, H., Kriazhov, V., Lee, R. R. T., Lyutakov, I., Pimentel-Nunes, P., Rivero-Sanchez, L., Thomas-Gibson, S., Thorlacius, H., Bourke, M. J., Tham, T. C., Bisschops, R., and Boskoski I. (ORCID:0000-0001-8194-2670)

Abstract

Main recommendationsEndoscopic mucosal resection (EMR) is the standard of care for the complete removal of large (≥ 10mm) nonpedunculated colorectal polyps (LNPCPs). Increased detection of LNPCPs owing to screening colonoscopy, plus high observed rates of incomplete resection and need for surgery call for a standardized approach to training in EMR. 1 Trainees in EMR should have achieved basic competence in diagnostic colonoscopy, < 10-mm polypectomy, pedunculated polypectomy, and common methods of gastrointestinal endoscopic hemostasis. The role of formal training courses is emphasized. Training may then commence in vivo under the direct supervision of a trainer. 2 Endoscopy units training endoscopists in EMR should have specific processes in place to support and facilitate training. 3 A trained EMR practitioner should have mastered theoretical knowledge including how to assess an LNPCP for risk of submucosal invasion, how to interpret the potential difficulty of a particular EMR procedure, how to decide whether to remove a particular LNPCP en bloc or piecemeal, whether the risks of electrosurgical energy can be avoided for a particular LNPCP, the different devices required for EMR, management of adverse events, and interpretation of reports provided by histopathologists. 4 Trained EMR practitioners should be familiar with the patient consent process for EMR. 5 The development of endoscopic non-technical skills (ENTS) and team interaction are important for trainees in EMR. 6 Differences in recommended technique exist between EMR performed with and without electrosurgical energy. Common to both is a standardized technique based upon dynamic injection, controlled and precise snare placement, safety checks prior to the application of tissue transection (cold snare) or electrosurgical energy (hot snare), and interpretation of the post-EMR resection defect. 7 A trained EMR practitioner must be able to manage adverse events associated with EMR including intraprocedural

Published
2023

21. Eltrombopag in paediatric immune thrombocytopenia: Iron metabolism modulation in mesenchymal stromal cells

Author

Di Paola, A., Palumbo, G., Tortora, C., Argenziano, M., Catanoso, M., Di Leva, C., Ceglie, G., Perrotta, S., Locatelli, Franco, Rossi, F., Locatelli F. (ORCID:0000-0002-7976-3654), Di Paola, A., Palumbo, G., Tortora, C., Argenziano, M., Catanoso, M., Di Leva, C., Ceglie, G., Perrotta, S., Locatelli, Franco, Rossi, F., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Immune thrombocytopenia (ITP) is an autoimmune disease caused by platelet destruction mediated by auto-antibody production. It is characterized by a compromised immune system and alteration of the inflammatory response. Mesenchymal stromal cells (MSCs) play an important role in modulating immune and inflammatory processes, exerting immune-suppressing and anti-inflammatory properties. In ITP-MSCs the activity and survival are strongly impaired. Eltrombopag (ELT) is a thrombopoietin receptor agonist approved in chronic ITP for stimulating platelet production. It has immunomodulating properties by stimulating T and B regulatory cell activity and by promoting a macrophage switch from the pro-inflammatory to the anti-inflammatory phenotype. ELT also exhibits iron-chelating properties. Iron is a crucial element involved in several physiologic processes, but its intracellular accumulation determines cell damages. Therefore, for the first time we analysed the effect of ELT on ITP-MSCs demonstrating its ability to restore survival and activity of MSCs directly and to promote their survival and proliferation indirectly, by iron metabolism modulation.

Published
2022

22. Antimicrobial oxygen-loaded nanobubbles as promising tools to promote wound healing in hypoxic human keratinocytes [*N. Mandras is the corresponding author, **A.M. Cuffini and M. Prato are co-last authors]

Author

Banche, G., Allizond, V., Mandras, N., Finesso, N., Luganini, A., Genova, T., Argenziano, M., Magnetto, C., Gulino, G. R., Roana, J., Tullio, V., Giribaldi, G., Cavalli, R., Spagnolo, R., Troia, A., Cuffini, A. M., and Prato, M.

Subjects
Keratinocytes, Chronic wounds (CWs), Candida albicans, Nanobubbles (NBs), Methicillin-resistant Staphylococcus aureus (MRSA)
Published
2022

23. Antibacterial and Antifungal Efficacy of Medium and Low Weight Chitosan-Shelled Nanodroplets for the Treatment of Infected Chronic Wounds [* V. Allizond is the corresponding author; **A.M. Cuffini and G. Banche are co-last authors]

Author

Mandras, N., Argenziano, M., Prato, M., Roana, J., Luganini, A., Allizond, V., Tullio, V., Finesso, N., Comini, S., Bressan, B. E., Pecoraro, F., Giribaldi, G., Troia, A., Cavalli, R., Cuffini, A. M., and Banche, G.

Subjects
Candida spp, Methicillin-Resistant Staphylococcus aureus, Chitosan, Antifungal Agents, Streptococcus pyogenes, Candida glabrata, chitosan nanodroplets, chronic wounds, methicillin-resistant Staphylococcus aureus, Anti-Bacterial Agents, Candida albicans, Humans, Microbial Sensitivity Tests, Oxygen, Anti-Infective Agents, Wound Infection
Published
2022

24. Iron Metabolism: From Inflammation to Cancer

Author

Di Paola A, Tortora C, Argenziano M, Di Leva C, Rossi Francesca, Di Paola A, Tortora C, Argenziano, M, Di Leva, C, and Rossi, Francesca

Subjects
iron, cancer, inflammation
Abstract

Iron is a trace element essential for several physiological cell functions and any alteration in its metabolism could be associated to the onset of several disorders. Cells normally avoid any dysregulation, activating fine molecular mechanisms to balance iron uptake, utilization, recycling, storage and export. The main “actors” in this event are hepcidin, ferroportin, ferritin and transferrin, both at cell and systemic level. Dysregulation in iron homeostasis is closely related to inflammation onset and perpetuation, osteoporosis and cancer progression. During inflammation, it has been observed a reduction in circulating iron as direct consequence of increase in ferritin levels, aimed to contain inflammatory processes and in many cases to restore the immune response. Iron overload directly promotes bone resorption and inhibits bone formation inducing osteoporosis. Moreover, iron cellular accumulation is responsible for ROS production with consequent DNA damage and neoplastic transformation of cells. In conclusion, even though many molecular mechanisms have to be clarified, targeting iron and also the mediators of its metabolism could be useful to manage a great variety of disorders, such inflammation, immune diseases, osteoporosis and cancer.

Published
2021

26. Can Denosumab be used in combination with Doxorubicin in Osteosarcoma?

Author

Punzo F. a, bEmail Author, Tortora C. a, Argenziano M. b, Di Pinto, D. a Pota, E. a, Di Martino, M. a, Di Paola, A. b, Rossi Francesca, Punzo, F. a., Bemail, Author, Tortora, C. a., Argenziano, M. b., Di, Pinto, Pota, D. a., E., A., Di, Martino, M., A., Di, Paola, A., B., and Rossi, Francesca

Abstract

Osteosarcoma is an aggressive bone tumor of the pediatric age. It is therefore important to improve conventional therapies (chemotherapy and surgery). Anticancer drugs often cause osteoporosis due to a misbalance of RANK/RANK-L/OPG pathway. Denosumab is a monoclonal antibody with high affinity and specificity to RANK-L, the ligand released by osteoblasts that enhances osteoclasts differentiation and bone resorption. It is used in osteoporosis and in other conditions characterized by bone mass loss. Doxorubicin is a chemotherapic drug used in several kinds of tumors, and also patients treated with it often develop osteoporosis. We investigated the effects of Denosumab alone and in combination with Doxorubicin, in two human osteosarcoma cell lines (MG63 and U-2 OS). We evaluated the effect of these treatments on apoptosis, cell cycle progression, invasion capacity and bone metabolism. We observed for the first time an anti-invasive effect of Denosumab in OS cells and confirmed its anti-osteoporotic activity also in Osteosarcoma. On the other hand, we demonstrate that Denosumab not only does not affect apoptosis and cell cycle progression, but when used in combination with Doxorubicin, it causes an unexpected reduction of its activity. These results indicate that the presence of Denosumab might inhibit the efficacy of the chemotherapic drug. In conclusion, while our results certainly support and confirm the efficacy of Denosumab in Osteoporosis, we discourage the use of Denosumab in addition to conventional chemotherapy in Osteosarcoma, even though, certainly further investigations are necessary to better clarify the clinical role of this monoclonal antibody in cancer.

Published
2020

33. Measurement and prediction of heat transfer distributions on an aft-loaded vane subjected to the influence of catalytic and dry low N[O.sub.x] combustor turbulence

Author

Ames, F.E., Argenziano, M., and Wang, C.

Subjects
Turbomachines -- Research, Science and technology
Abstract

Aft-loaded vane designs can have an impact on surface heat transfer distributions by accelerating boundary layers for a greater portion of the suction surface. New combustion systems developed for low emissions have produced substantial changes to the characteristics of inlet turbulence entering nozzle guide vanes. This paper documents heat transfer rates on an aft-loaded vane subject to turbulence generated by mock combustion configurations representative of recently developed catalytic and dry low N[O.sub.x] (DLN) combustors. Four different inlet turbulence conditions with levels ranging up to 21% are documented in this study and wine heat transfer rates are acquired at vane exit chord Reynolds numbers ranging from 500,000 to 2,000,000. Heat transfer distributions show the influence of the turbulence conditions on heat transfer augmentation and transition. Cascade aerodynamics are well documented and match pressure distributions predicted by a commercial computational fluid dynamics (CFD) code for this large-scale low-speed facility. The aft-loaded vane pressure distribution exhibits a minimum value at about 50% are on the suction surface. This comprehensive vane heat transfer data set is expected to represent an excellent test case for vane heat transfer predictive methods. Predictive comparisons are shown based on a two-dimensional boundary layer code using an algebraic turbulence model for augmentation as well as a transition model. [DOI: 10.1115/1.1645867]

Published
2004

37. Cb2 receptor stimulation and dexamethasone restore the anti-inflammatory and immune-regulatory properties of mesenchymal stromal cells of children with immune thrombocytopenia

Author

Rossi, F., Tortora, C., Palumbo, G., Punzo, F., Argenziano, M., Casale, M., Di Paola, A., Locatelli, Franco, Perrotta, S., Locatelli F. (ORCID:0000-0002-7976-3654), Rossi, F., Tortora, C., Palumbo, G., Punzo, F., Argenziano, M., Casale, M., Di Paola, A., Locatelli, Franco, Perrotta, S., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by antibody-mediated platelet destruction, with a complex and unclear pathogenesis. The impaired immunosuppressive capacity of mesenchymal stromal cells in ITP patients (ITP-MSCs) might play a role in the development of the disease. Correcting the MSC defects could represent an alternative therapeutic approach for ITP. High-dose dexamethasone (HD-Dexa) is the mainstay of the ITP therapeutic regimen, although it has several side effects. We previously demonstrated a role for cannabinoid receptor 2 (CB2 ) as a mediator of anti-inflammatory and immunoregulatory properties of human MSCs. We analyzed the effects of CB2 stimulation, with the selective agonist JWH-133, and of Dexa alone and in combination on ITP-MSC survival and immunosuppressive capacity. We provided new insights into the pathogenesis of ITP, suggesting CB2 receptor involvement in the impairment of ITP-MSC function and confirming MSCs as responsive cellular targets of Dexa. Moreover, we demonstrated that CB2 stimulation and Dexa attenuate apoptosis, via Bcl2 signaling, and restore the immune-modulatory properties of MSCs derived from ITP patients. These data suggest the possibility of using Dexa in combination with JWH-133 in ITP, reducing its dose and side effects but maintaining its therapeutic benefits.

Published
2019

41. ITRACONAZOLE-LOADED CHITOSAN-SHELLED NANODROPLETS AS NEW NONCONVENTIONAL ANTIFUNGAL STRATEGY AGAINST CANDIDA ALBICANS AND C.GLABRATA INFECTIONS IN HYPOXIC CHRONIC WOUNDS

Author

Mandras, N, Roana, J, Scalas, D, Argenziano, M, Finesso, N, Luganini, A, Giribaldi, G, Fumagalli, M, Sangiovanni, E, D’Alessandro, S, Basilico, N, Dell’Agli, M, Banche, G, Allizond, V, Cavalli, R, Prato, M, Cuffini, Am, and Tullio, V

Subjects
Itraconazole, nanodroplets, Candida albicans, Candida glabrata, hypoxic chronic wounds, Candida albicans, nanodroplets, Candida glabrata, Itraconazole, hypoxic chronic wounds
Published
2018

45. Everolimus-eluting stents or bypass surgery for left main coronary artery disease

Author

Stone, Gw, Sabik, Jf, Serruys, Pw, Simonton, Ca, Généreux, P, Puskas, J, Kandzari, De, Morice, Mc, Lembo, N, Brown WM 3rd, Taggart, Dp, Banning, A, Merkely, B, Horkay, F, Boonstra, Pw, van Boven AJ, Ungi, I, Bogáts, G, Mansour, S, Noiseux, N, Sabaté, M, Pomar, J, Hickey, M, Gershlick, A, Buszman, P, Bochenek, A, Schampaert, E, Pagé, P, Dressler, O, Kosmidou, I, Mehran, R, Pocock, Sj, Kappetein, Ap, van Es GA, Leon, Mb, Gersh, B, Chaturvedi, S, Kint, Pp, Valgimigli, M, Colombo, A, Costa, M, Di Mario, C, Ellis, S, Fajadet, J, Fearon, W, Kereiakes, D, Makkar, R, Mintz, Gs, Moses, Jw, Teirstein, P, Ruel, M, Sergeant, P, Mack, M, Fontana, G, Mohr, Fw, Nataf, P, Smith, C, Boden, B, Fox, K, Maron, D, Steg, G, Blackstone, E, Juni, P, Parise, H, Wallentin, L, Bertrand, M, Krucoff, M, Turina, M, Ståhle, E, Tijssen, J, Brill, D, Atkins, C, Applegate, B, Argenziano, M, Faly, Rc, Dauerman, H, Davidson, C, Griffith, B, Reisman, M, Rizik, D, Sakwa, M, Shemin, R, Romano, M, Hamm, C, Gummert, J, Tamburino, C, Alfieri, O, Savina, C, de Bruyne, B, Machado, Fp, Uva, S, Moccetti, T, Siclari, F, Hildick Smith, D, Szekely, L, Erglis, A, Stradins, P, Abizaid, A, Bento Sousa LC, Belardi, J, Navia, D, Park, Sj, Lee, Jw, Meredith, I, Smith, J, Yehuda, Ob, Schneijdenberg, R, Ronden, J, Jonk, J, Jonkman, A, van Remortel, E, de Zwart, I, Elshout, L, de Vries, T, Andreae, R, Tol van, J, Teurlings, E, Balachandran, S, Breazna, A, Jenkins, P, Mcandrew, T, Marx, So, Connolly, Mw, Hong, Mk, Weinberger, J, Wong, Sc, Dizon, J, Biviano, A, Morrow, J, Wang, D, Corral, M, Alfonso, M, Sanchez, R, Wright, D, Djurkovic, C, Lustre, M, Jankovic, I, Sanidas, E, Lasalle, L, Maehara, A, Matsumura, M, Sun, E, Iacono, S, Greenberg, T, Jacobson, J, Pullano, A, Gacki, M, Liu, S, Cohen, Dj, Magnuson, E, Baron, Sj, Wang, K, Traylor, K, Worthley, S, Stuklis, R, Barbato, E, Stockman, B, Dubois, C, Meuris, B, Vrolix, M, Dion, R, Bento de Souza LC, Costantini, C, Woitowicz, V, Hueb, W, Stolf, N, Beydoun, H, Baskett, R, Curtis, M, Kieser, T, Doucet, S, Pellerin, M, Hamburger, J, Cook, R, Kutryk, M, Peterson, M, Madan, M, Fremes, S, Mehta, S, Cybulsky, I, Prabhakar, M, Peniston, C, Welsh, R, Macarthur, R, Berland, J, Bessou, Jp, Carrié, D, Glock, Y, Darremont, O, Deville, C, Grimaud, Jp, Soula, P, Lefèvre, T, Maupas, E, Durrleman, N, Silvestri, M, Houel, R, Pratt, A, Francis, J, Van Belle, E, Vicentelli, A, Luchner, A, Hilker, M, Endemann, Dh, Felix, S, Wollert, Hg, Walther, T, Erbel, R, Jacob, H, Kahlert, P, Kupatt, C, Näbauer, M, Schmitz, C, Scholtz, W, Börgermann, J, Schuler, G, Borger, M, Davierwala, P, Fontos, G, Székely, L, Bedogni, F, Panisi, P, Berti, S, Glauber, M, Marzocchi, A, Di Bartolomeo, R, Merlo, M, Guagliumi, G, Fenili, F, Napodano, M, Gerosa, G, Ribichini, F, Faggian, Giuseppe, Saccà, S, Giacomin, A, Mignosa, C, Tumscitz, C, Savini, C, Van Mieghem, N, von Birgelen, C, Grandjean, J, Kubica, J, Anisimowicz, L, Zmudka, K, Sadowski, J, Hernández García, J, Such, M, Macaya, C, Rodríguez Hernández JE, Maroto, L, Serra, A, Padro, J, Tenas, Ms, De Souza, A, Egred, M, Clark, S, Trivedi, U, Jain, A, Uppal, R, Redwood, S, Young, C, Stables, Rh, Pullan, M, Uren, N, Pessotto, R, Abu Fadel, M, Peyton, M, Allaqaband, S, O’Hair, D, Bachinsky, W, Mumtaz, M, Blankenship, J, Casale, A, Brott, B, Davies, J, Brown, D, Cannon, L, Talbott, J, Chang, G, Macheers, S, Choi, J, Henry, C, Cutlip, D, Khabbaz, K, Das, G, Liao, K, Diver, D, Thayer, J, Dobies, D, Fliegner, K, Fischbein, M, Feldman, T, Pearson, P, Foster, M, Briggs, R, Giugliano, G, Engelman, D, Gordon, P, Ehsan, A, Grantham, J, Allen, K, Grodin, J, Jessen, M, Gruberg, L, Taylor JR Jr, Gupta, S, Hermiller J., Jr, Heimansohn, D, Iwaoka, R, Chan, B, Kander, Nh, Duff, S, Brown, W, Karmpaliotis, D, Kini, A, Filsoufi, F, Kong, D, Lin, S, Kutcher, M, Kincaid, E, Leya, F, Bakhos, M, Liberman, H, Halkos, M, Lips, D, Eales, F, Mahoney, P, Rich, J, Barreiro, C, Cheng, W, Metzger, C, Greenfield, T, Moses, J, Palacios, I, Macgillivray, T, Perin, E, Del Prete, J, Pompili, V, Kilic, A, Ragosta, M, Kron, I, Rashid, J, Mueller, D, Riley, R, Reimers, C, Patel, N, Resar, J, Shah, A, Schneider, J, Landvater, L, Reardon, M, Shavelle, D, Baker, C, Singh, J, Maniar, H, Wei, L, Strain, J, Zapolanski, A, Taheri, H, Ad, N, Tannenbaum, M, Prabhakar, G, Waksman, R, Corso, P, Wang, J, Fiocco, M, Wilson, Bh, Steigel, Rm, Chadwick, S, Zidar, F, Oswalt, J., Stone, Gregg W., Sabik, Joseph F., Serruys, Patrick W., Simonton, Charles A., Généreux, Philippe, Puskas, John, Kandzari, David E., Morice, Marie Claude, Lembo, Nichola, Brown, W. Morri, Taggart, David P., Banning, Adrian, Merkely, Béla, Horkay, Ferenc, Boonstra, Piet W., Van Boven, Ad J., Ungi, Imre, Bogáts, Gabor, Mansour, Samer, Noiseux, Nicola, Sabaté, Manel, Pomar, José, Hickey, Mark, Gershlick, Anthony, Buszman, Pawel, Bochenek, Andrzej, Schampaert, Erick, Pagé, Pierre, Dressler, Ovidiu, Kosmidou, Ioanna, Mehran, Roxana, Pocock, Stuart J., Kappetein, A. Pieter, for the EXCEL Trial Investigators:, [. . ., Antonio, Marzocchi, DI BARTOLOMEO, Roberto, ], . ., and Cardiothoracic Surgery

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Drug-Eluting Stent, Humans, Everolimus, 030212 general & internal medicine, cardiovascular diseases, Coronary Artery Bypass, Aged, Female, Middle Aged, Drug-Eluting Stents, business.industry, Coronary Artery Bypa, Medicine (all), Percutaneous coronary intervention, General Medicine, medicine.disease, Surgery, Cardiac surgery, Everolimu, surgical procedures, operative, Bypass surgery, Conventional PCI, Cardiology, business, medicine.drug, Human
Abstract

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P

Published
2017

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