43 results on '"Fontos, G."'
Search Results
2. Percutaneous paravalvular leak closure: a single-centre experience of 54 cases
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Vertesaljai, M, primary, Denes, M, additional, Temesvari, A, additional, Fontos, G, additional, and Andreka, P, additional
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- 2022
- Full Text
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3. Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial
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Hochman, JS, Reynolds, HR, Bangalore, S, O'Brien, SM, Alexander, KP, Senior, R, Boden, WE, Stone, GW, Goodman, SG, Lopes, RD, Lopez-Sendon, J, White, HD, Maggioni, AP, Shaw, LJ, Min, JK, Picard, MH, Berman, DS, Chaitman, BR, Mark, DB, Spertus, JA, Cyr, DD, Bhargava, B, Ruzyllo, W, Wander, GS, Chernyavskiy, AM, Rosenberg, YD, Maron, DJ, Mavromatis, K, Miller, T, Banerjee, S, Abdul-Nour, K, Stone, PH, Jang, JJ, Weitz, S, Arnold, S, Shapiro, MD, El-Hajjar, M, McFalls, EO, Khouri, MG, Goldberg, JL, Goldweit, R, Cohen, RA, Winchester, DE, Kronenberg, M, Heitner, JF, Dauber, IM, Cannan, C, Sudarshan, S, Mehta, PK, Hedgepeth, CM, Sahul, Z, Booth, D, Setty, S, Barua, RS, Hage, F, Dajani, K, Arif, I, Trejo (Gutierrez), JF, Gemignani, A, Meadows, JL, Call, JT, Hannan, J, Martin, ET, Vorobiof, G, Moorman, A, Kinlay, S, Rayos, G, Seedhom, A, Kumkumian, G, Sedlis, SP, Tamis-Holland, JE, Saba, S, Badami, U, Marzo, K, Robbins, IH, Hamroff, GS, Little, RW, Lui, CY, Hu, B, Labovitz, AJ, Rodriguez, F, Deedwania, P, Sweeny, J, Spizzieri, C, Hochberg, CP, Salerno, WD, Wyman, R, Zarka, A, Haldis, T, Kohn, JA, Girotra, S, Almousalli, O, Krishnam, MS, Coram, R, Thomas, S, El Shahawy, M, Stafford, J, Abernethy, WB, Zurick, A, Meyer, TM, Rutkin, B, Bokhari, S, Sokol, SI, Hamzeh, I, Turner, MC, Good, AP, Shammas, NW, Chilton, R, Nguyen, PK, Jezior, M, Gordon, PC, Stenberg, R, Pedalino, RP, Wiesel, J, Juang, GJ, Al-Amoodi, M, Wohns, D, Lader, EW, Mumma, M, Dharmarajan, L, McGarvey, JFX, Downes, TR, Cheong, B, Potluri, S, Mastouri, RA, Li, D, Giedd, K, Old, W, Burt, F, Sokhon, K, Gopal, D, Valeti, US, Kobashigawa, J, Govindan, SC, Manjunath, CN, Pandit, N, Dwivedi, SK, Mathew, A, Gadkari, MA, Satheesh, S, Mathur, A, Christopher, J, Oomman, A, Naik, S, Grant, P, Kachru, R, Kumar, A, Kaul, U, Gamma, RA, De Belder, MA, Nageh, T, Lindsay, SJ, Hoye, A, Donnelly, P, Chauhan, A, Barr, C, Alfakih, K, Henriksen, P, Okane, P, De Silva, R, Conway, DSG, Sirker, AA, Hoole, SP, Witherow, FN, Johnston, N, Luckie, M, Sobolewska, J, Jeetley, P, Travill, C, Braganza, D, Henderson, R, Berry, C, Moriarty, AJ, Glover, JD, Mikhail, G, Gosselin, G, Diaz, A, Phaneuf, DC, Garg, P, Chow, BJW, Bainey, KR, Cheema, AN, Cha, J, Howarth, AG, Wong, G, Uxa, A, Galiwango, P, Lam, A, Mehta, S, Udell, J, Genereux, P, Hameed, A, Daba, L, Hueb, W, Smanio, PEP, De Quadros, AS, Vitola, JV, Marin-Neto, JA, Polanczyk, CA, Carvalho, AC, Alves Junior, AR, Dracoulakis, MDA, Figueiredo, E, Caramori, PR, Tumelero, R, Dall'Orto, F, Mesquita, CT, Ribeiro da Silva, EE, Saraiva, JF, Costantini, C, Demkow, M, Mazurek, T, Drozdz, J, Szwed, H, Witkowski, A, Gajos, G, Pruszczyk, P, Loboz-Grudzien, K, Lesiak, M, Reczuch, KW, Kalarus, Z, Musial, WJ, Bockeria, L, Bershtein, LL, Demchenko, EA, Lopez-Sendon, JL, Peteiro, J, Gonzalez Juanatey, JR, Sionis, A, Miro, V, Ortuno, FM, Blancas, MG, Luena, JEC, Fernandez-Aviles, F, Chen, J, Wu, Y, Ma, Y, Ji, Z, Yang, X, Lin, W, Zeng, H, Fu, X, Yang, B, Wang, S, Cheng, G, Zhao, Y, Fang, X, Zeng, Q, Su, X, Li, Q, Nie, S-P, Yu, Q, Wang, J, Zhang, S, Perna, GP, Provasoli, S, Monti, L, Di Chiara, A, Mortara, A, Galvani, M, Sicuro, M, Calabro, P, Tarantini, G, Racca, E, Briguori, C, Amati, R, Russo, A, Poh, K-K, Foo, D, Chua, T, Doerr, R, Sechtem, U, Schulze, PC, Nickenig, G, Schuchlenz, H, Lang, IM, Huber, K, Vertes, A, Varga, A, Fontos, G, Merkely, B, Kerecsen, G, Hinic, S, Beleslin, BD, Cemerlic-Adjic, N, Davidovic, G, Dekleva, MN, Stankovic, G, Apostolovic, S, Escobedo, J, Rosas, EA, Selvanayagam, JB, Thambar, ST, Beltrame, JF, Hillis, GS, Thuaire, C, Steg, P-G, Slama, MS, El Mahmoud, R, Nicollet, E, Barone-Rochette, G, Furber, A, Laucevicius, A, Kedhi, E, Riezebos, RK, Suryapranata, H, Ramos, R, Pinto, FJ, Ferreira, N, Guzman, L, Figal, JC, Alvarez, C, Courtis, J, Schiavi, L, Rubio, M, Devlin, GP, Stewart, RAH, Kedev, S, Held, C, Aspberg, J, Sharir, T, Kerner, A, Fukuda, K, Yasuda, S, Nishimura, S, Goetschalckx, K, Hung, C-L, Ntsekhe, M, Moccetti, T, Abdelhamid, M, Pop, C, Popescu, BA, Al-Mallah, MH, Ramos, WEM, Kuanprasert, S, Yamwong, S, Khairuddin, A, Ferguson, B, Harrington, R, Williams, D, Berger, J, Newman, J, Sidhu, M, Dzavik, V, Jiang, L, Keltai, M, Kohsaka, S, Maggioni, A, Mancini, GBJ, Merz, CNB, Weintraub, W, Ballantyne, C, Calfas, KJ, Davidson, M, Friedrich, M, Hachamovitch, R, Kwong, R, Harrell, F, Kullo, I, McManus, B, Cohen, DJ, Bugiardini, R, Celutkiene, J, Lyubarova, R, Mattina, D, Nwosu, S, Broderick, S, Cyr, D, Rockhold, F, Anstrom, K, Jones, P, Phillips, L, Hayes, SW, Friedman, JD, Gerlach, RJ, Kwong, RY, Mongeon, FP, Hung, J, Scherrer-Crosbie, M, Zeng, X, Ali, Z, Arsanjani, R, Budoff, M, Leipsic, J, Nakanishi, R, Youn, T, Orso, F, Zhang, H, Zhang, L, Diaz, R, Van de Werf, F, Fleg, J, Kirby, R, Jeffries, N, and Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Alexander KP, Senior R, Boden WE, Stone GW, Goodman SG, Lopes RD, Lopez-Sendon J, White HD, Maggioni AP, Shaw LJ, Min JK, Picard MH, Berman DS, Chaitman BR, Mark DB, Spertus JA, Cyr DD, Bhargava B, Ruzyllo W, Wander GS, Chernyavskiy AM, Rosenberg YD, Maron DJ, Mavromatis K, Miller T, Banerjee S, Abdul-Nour K, Stone PH, Jang JJ, Weitz S, Arnold S, Shapiro MD, El-Hajjar M, McFalls EO, Khouri MG, Goldberg JL, Goldweit R, Cohen RA, Winchester DE, Kronenberg M, Heitner JF, Dauber IM, Cannan C, Sudarshan S, Mehta PK, Hedgepeth CM, Sahul Z, Booth D, Setty S, Barua RS, Hage F, Dajani K, El-Hajjar M, Arif I, Trejo JF, Gemignani A, Meadows JL, Call JT, Hannan J, Martin ET, Vorobiof G, Moorman A, Kinlay S, Rayos G, Seedhom A, Kumkumian G, Sedlis SP, Tamis-Holland JE, Saba S, Badami U, Marzo K, Robbins IH, Hamroff GS, Little RW, Lui CY, Booth D, Hu B, Labovitz AJ, Maron DJ, Rodriguez F, Deedwania P, Sweeny J, Spizzieri C, Hochberg CP, Salerno WD, Wyman R, Zarka A, Haldis T, Kohn JA, Girotra S, Almousalli O, Krishnam MS, Coram R, Thomas S, El Shahawy M, Stafford J, Abernethy WB, Zurick A, Meyer TM, Rutkin B, Bokhari S, Sokol SI, Hamzeh I, Turner MC, Good AP, Shammas NW, Chilton R, Nguyen PK, Jezior M, Gordon PC, Stenberg R, Pedalino RP, Wiesel J, Juang GJ, Al-Amoodi M, Wohns D, Lader EW, Mumma M, Dharmarajan L, McGarvey JFX, Downes TR, Cheong B, Potluri S, Mastouri RA, Li DY, Giedd K, Old W, Burt F, Sokhon K, Gopal D, Valeti US, Kobashigawa J, Govindan SC, Manjunath CN, Pandit N, Dwivedi SK, Wander G, Bhargava B, Mathew A, Gadkari MA, Satheesh S, Mathur A, Christopher J, Oomman A, Naik S, Christopher J, Grant P, Kachru R, Kumar A, Christopher J, Kaul U, Gamma RA, de Belder MA, Nageh T, Lindsay SJ, Hoye A, Donnelly P, Chauhan A Barr C, Alfakih K, Henriksen P, Okane P, de Silva R, Conway DSG, Sirker AA, Hoole SP, Witherow FN, Johnston N, Luckie M, Sobolewska J, Jeetley P, Travill C, Braganza D, Henderson R, Berry C, Moriarty AJ, Glover JD, Mikhail G, Gosselin G, Diaz A, Phaneuf DC, Garg P, Chow BJW, Bainey KR, Cheema AN, Cheema AN, Cha J, Howarth AG, Wong G, Uxa A, Galiwango P, Lam A, Mehta S, Udell J, Genereux P, Hameed A, Daba L, Hueb W, Smanio PEP, de Quadros AS, Vitola JV, Marin-Neto JA, Polanczyk CA, Carvalho AC, Alves AR, Dracoulakis MDA, Figueiredo E, Caramori PR, Tumelero R, Dall'Orto F, Mesquita CT, da Silva EER, Saraiva JF, Costantini C, Demkow M, Mazurek T, Drozdz J, Szwed H, Witkowski A, Gajos G, Pruszczyk P, Loboz-Grudzien K, Lesiak M, Reczuch KW, Kalarus Z, Musial WJ, Bockeria L, Chernyavskiy AM, Bershtein LL, Demchenko EA, Lopez-Sendon JL, Peteiro J, Juanatey JRG, Sionis A, Miro V, Ortuno FM, Blancas MG, Luena JEC, Fernandez-Aviles F, Chen JY, Wu YJ, Ma YT, Ji Z, Yang XC, Lin WH, Zeng HS, Fu, X, Yang B, Wang ST, Cheng G, Zhao YL, Fang XH, Zeng QT, Su X, Li QX, Nie SP, Yu Q, Wang JA, Zhang SY, Perna GP, Provasoli S, Monti L, Di Chiara A, Mortara A, Galvani M, Sicuro M, Calabro P, Tarantini G, Racca E , Briguori C, Amati R, Russo A, Poh KK, Foo D, Chua, Doerr R, Sechtem U, Schulze PC, Nickenig G, Schuchlenz H, Lang IM, Huber K, Vertes A, Varga A, Fontos G, Merkely B, Kerecsen G, Hinic S, Beleslin BD, Cemerlic-Adjic N, Davidovic G, Dekleva MN, Stankovic G, Apostolovic S, Escobedo J, Rosas EA, Selvanayagam JB, Thambar ST, Beltrame JF, Hillis GS, Thuaire C, Steg PG, Slama MS, El Mahmoud R, Nicollet E, Barone-Rochette G, Furber A, Laucevicius A, Kedhi E, Riezebos RK, Suryapranata H, Ramos R, Pinto FJ, Ferreira N, Guzman L, Figal JC, Alvarez C, Courtis J, Schiavi L, Rubio M, Devlin GP, Stewart RAH, Kedev S, Held C, Aspberg, J, Sharir T, Kerner A, Fukuda K, Yasuda S, Nishimura S , Goetschalckx K, Hung CL, Ntsekhe M, Moccetti T, Abdelhamid M, Pop C, Popescu BA, Al-Mallah MH, Ramos WEM, Kuanprasert S, Yamwong S, Khairuddin A, O'Brien SM, Boden WE, Ferguson B, Harrington R, Stone GW, Williams D, Berger J, Newman J, Sidhu M, Mark DB, Shaw LJ, Spertus JA, Berman DS, Chaitman BR, Doerr R, Dzavik V, Goodman SG, Gosselin G, Held C, Jiang LX, Keltai M, Kohsaka S, Lopes RD, Lopez-Sendon JL, Maggioni A, Mancini GBJ, Merz CNB, Min JK, Picard MH, Ruzyllo W, Selvanayagam JB, Senior R, Steg PG, Szwed H, Weintraub W, White HD, Ballantyne C, Calfas KJ, Davidson M, Stone PH, Friedrich M, Hachamovitch R, Kwong R, Harrell F, Kullo I, McManus B, Cohen DJ, Bugiardini R, Celutkiene J, Escobedo J , Hoye A, Lyubarova R, Mattina D, Peteiro J, Nwosu S, Broderick S, Cyr D, Rockhold F, Anstrom K, Jones P, Phillips L, Hayes SW, Friedman JD, Gerlach RJ, Kwong RY, Mongeon FP, Hung J, Scherrer-Crosbie M, Zeng X, Ali Z, Genereux P, Arsanjani R, Budoff M, Leipsic J, Nakanishi R, Youn T , Orso F, Carvalho AC, Zhang HB, Zhang LH, Diaz R, Van de Werf F, Goetschalckx K, Rosenberg YD, Fleg J, Kirby R, Jeffries N.
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medicine.medical_specialty ,Cardiac & Cardiovascular Systems ,IMPACT ,medicine.medical_treatment ,Population ,030204 cardiovascular system & hematology ,Revascularization ,law.invention ,MEDICAL THERAPY ,ISCHEMIA Research Group ,Angina ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Severity of illness ,SCORE ,medicine ,BENEFIT ,030212 general & internal medicine ,cardiovascular diseases ,education ,education.field_of_study ,OUTCOMES ,Science & Technology ,business.industry ,PCI ,medicine.disease ,Clinical trial ,PROGNOSTIC VALUE ,Stenosis ,Cardiology ,Cardiovascular System & Cardiology ,CORONARY-ARTERY-DISEASE ,REVASCULARIZATION ,Cardiology and Cardiovascular Medicine ,business ,ECHOCARDIOGRAPHY ,Life Sciences & Biomedicine - Abstract
Importance It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. Objective To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles. Design, Setting, and Participants The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (
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- 2019
4. The Natural History of Nonculprit Lesions in STEMI: An FFR Substudy of the Compare-Acute Trial
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Piróth, Zsolt, Boxma-de Klerk, Bianca M., Omerovic, Elmir, Andréka, P. ter, Fontos, G. za, Fülöp, G. bor, Abdel-Wahab, Mohamed, Neumann, Franz-Josef, Richardt, Gert, Abdelghani, Mohammad, Smits, Pieter C., Cardiology, ACS - Heart failure & arrhythmias, and ACS - Atherosclerosis & ischemic syndromes
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STEMI ,cardiovascular diseases ,nonculprit lesions ,FFR - Abstract
Objectives: The aim of this study was to determine the prognostic value of fractional flow reserve (FFR) in non-infarct-related arteries (IRAs) in ST-segment elevation myocardial infarction (MI). Background: Patients with ST-segment elevation MI often present with multivessel disease. The treatment of non-IRAs is debated. The applicability of FFR has not been widely proved. Methods: Outcomes were analyzed in all patients in the Compare-Acute (Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD) trial in whom, after successful primary percutaneous coronary intervention, non-IRAs were interrogated using FFR and treated medically. The treating cardiologist was blinded to the FFR value. The primary endpoint was the composite of cardiovascular mortality, target vessel–related (non-IRA with FFR measurement at primary percutaneous coronary intervention) nonfatal MI, and target vessel revascularization: major adverse cardiac events (MACE) at 24 months. Results: A total of 751 patients (963 vessels) were included. Target non-IRAs with MACE had lower FFR compared with those without (0.78 vs. 0.84, respectively; p < 0.001). The median FFR of non-IRAs with TVR was lower than that of those without (0.79 vs. 0.85, respectively; p < 0.001). The difference was significant in all vessels. The median FFR of target non-IRAs with MI was lower than that of those without (0.79 vs. 0.84, respectively; p = 0.016). The MACE rate was significantly (p < 0.001) higher in the lowest of FFR tertiles (
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- 2020
5. P1811 Prognostic impact of different subtypes of severe aortic stenosis undergoing transcatheter aortic valve implantation
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Pal, M, primary, Dekany, G, additional, Mandzak, A, additional, Piroth, Z S, additional, Fontos, G, additional, and Andreka, P, additional
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- 2020
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6. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial
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Tomaniak, M, Chichareon, P, Onuma, Y, Deliargyris, EN, Takahashi, K, Kogame, N, Modolo, R, Chang, CC, Rademaker-Havinga, T, Storey, RF, Dangas, GD, Bhatt, DL, Angiolillo, DJ, Hamm, C, Valgimigli, M, Windecker, S, Steg, PG, Vranckx, P, Serruys, PW, Bertrand, OF, Plante, S, Van Geuns, RJ, Hofma, SH, Royaards, KJ, Slagboom, T, Suryapranata, H, Umans, VAWM, Rensing, B, van der Harst, P, Magro, M, Barbato, E, Aminian, A, Benit, E, Janssens, L, Vrolix, M, Buysschaert, I, Carrie, D, Barraud, P, Teiger, E, Koning, R, Farzin, B, Morelle, JF, Isaaz, K, Maillard, L, Abdellaoui, M, Brunel, P, Angioi, M, Lantelme, P, Sabate, M, Gonzalez-Trevilla, AA, Cequier, A, Iiguez, A, Penaranda, AS, Miguel, CM, Diaz, JF, Antolin, RAH, Goicolea, J, Ribeiro, VG, da Silva, PC, Ferreira, RC, Almeida, M, Ungi, I, Merkely, B, Fontos, G, Horvath, I, Koszegi, Z, Jambrik, Z, Edes, I, Jozsef, F, Colombo, A, Bolognese, L, Ferrario, M, Tumscitz, C, Dominici, M, Curello, S, Roffi, M, Eeckhout, E, Moccetti, T, Moschovitis, A, Leibundgut, G, Huber, K, Frey, B, Delle Karth, G, Friedrich, G, Steinwender, C, Zweiker, R, Stables, R, Anderson, R, Chowdhary, S, Garg, S, Hildick-Smith, D, Fath-Ordoubadi, F, Oldroyd, KG, Galasko, G, Kukreja, N, Zaman, A, Subkovas, E, Curzen, N, Hoole, S, Talwar, S, Walsh, S, Adlam, D, Cotton, J, Holmvang, L, Ottesen, MM, Buszman, P, Zurakowski, A, Galuszka, G, Prokopczuk, J, Zmudka, K, Jasionowicz, P, Mlodziankowski, A, Liebetrau, C, Naber, CK, Neumann, FJ, Schchinger, V, Seidler, T, Ibrahim, K, Zrenner, B, Gori, T, Werner, N, Akin, I, Geisler, T, vom Dahl, J, Haude, M, Eitel, I, Krackhardt, F, Jung, W, Neto, PAL, Sousa, A, Quintella, EF, Leandro, S, Botelho, R, Raffel, C, Barlis, P, Hai, KT, Ong, P, Petrov, I, Konteva, M, Velchev, V, Gelev, V, Tonev, G, Valkov, V, Vassilev, D, and Trendafilova-Lazarova, D
- Abstract
Key PointsQuestionWhat are the benefits and risks of continuing aspirin in addition to P2Y12 receptor inhibition with ticagrelor among patients with acute coronary syndrome between 1 month and 12 months after percutaneous coronary intervention? FindingsIn this nonprespecified, post hoc analysis of the GLOBAL LEADERS randomized clinical trial, beyond 1 month after percutaneous coronary intervention in acute coronary syndrome, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. MeaningThe findings of this hypothesis-generating analysis pave the way for further trials evaluating aspirin-free antiplatelet strategies after percutaneous coronary intervention. ImportanceThe role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. ObjectiveTo evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and ParticipantsThis is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. InterventionsThe experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and MeasuresThe primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. ResultsOf 15968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P=.07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P=.004). Conclusions and RelevanceBetween 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. Trial RegistrationClinicalTrials.gov identifier: NCT01813435. This secondary analysis of the GLOBAL LEADERS randomized clinical trial evaluates the benefit and risks of aspirin in addition to ticagrelor among patients with acute coronary syndrome beyond 1 month after percutaneous coronary intervention.
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- 2019
7. 3331Impact of baseline hemoglobin level and white blood cell count in real-world patients undergoing contemporary percutaneous coronary intervention: insights from the GLOBAL LEADER study
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Chichareon, P, primary, Modolo, R, additional, Tomaniak, M, additional, Kogame, N, additional, Fontos, G, additional, Lantelme, P, additional, Barraud, P, additional, Hamm, C, additional, Steg, G, additional, Juni, P, additional, Vranckx, P, additional, Valgimigli, M, additional, Windecker, S, additional, Onuma, Y, additional, and Serruys, P W, additional
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- 2019
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8. Everolimus-eluting stents or bypass surgery for left main coronary artery disease
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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
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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
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- 2017
9. Cardiopoietic cell therapy for advanced ischemic heart failure : results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial
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Bartunek, Jozef, Terzic, Andre, Davison, Beth A, Filippatos, Gerasimos S, Radovanovic, Slavica, Beleslin, Branko, Merkely, Bela, Musialek, Piotr, Wojakowski, Wojciech, Andreka, Peter, Horvath, Ivan G, Katz, Amos, Dolatabadi, Dariouch, El Nakadi, Badih, Arandjelovic, Aleksandra, Edes, Istvan, Seferovic, Petar M, Obradovic, Slobodan, Vanderheyden, Marc, Jagic, Nikola, Petrov, Ivo, Atar, Shaul, Halabi, Majdi, Gelev, Valeri L, Shochat, Michael K, Kasprzak, Jaroslaw D, Sanz Ruiz, Ricardo, Heyndrickx, Guy R, Nyolczas, Noémi, Legrand, Victor, Guédès, Antoine, Heyse, Alex, Moccetti, Tiziano, Fernandez Aviles, Francisco, Jimenez Quevedo, Pilar, Bayes Genis, Antoni, Hernandez Garcia, Jose Maria, Ribichini, Flavio, Gruchala, Marcin, Waldman, Scott A, Teerlink, John R, Gersh, Bernard J, Povsic, Thomas J, Henry, Timothy D, Metra, Marco, Hajjar, Roger J, Tendera, Michal, Behfar, Atta, Alexandre, Bertrand, Seron, Aymeric, Stough, Wendy Gattis, Sherman, Warren, Cotter, Gad, Wijns, W. i. l. l. i. a. m. Collaborators Clinical investigators, Dens, sites Belgium: Ziekenhuis Oost Limburg: J., Dupont, M., Mullens, W., Janssens, M., Dolatabadi, Hoˆpital Civil de Charleroi: D., De Bruyne, Y., Lalmand, J., Dubois, P., El Nakadi, B., Aminian, A., De Vuyst, E., Gurnet, P., Gujic, M., Blankoff, I., Guedes, CHU Mont Godinne UCL: A., Gabriel, L., Seldrum, S., Doyen, C., Andre´, M., Heyse, AZ Glorieux: A., Van Durme, F., Verschuere, J., Legrand, Domaine Universitaire du Sart Tilman: V., Gach, O., D’Orio, V., Davin, L., Lancellotti, P., Baudoux, E., Ancion, A., Dulgheru, R., Vanderheyden, OLV Ziekenhuis Aalst – Cardiologie: M., Bartunek, J., Wijns, W., Verstreken, S., Penicka, . M., Gelev, P. Meeus Bulgaria: Tokuda Hospital Sofia: V., Zheleva Kichukova, I., Parapunova, R., Melamed, R., Sardovski, S., Radev, O., Yordanov, A., Radinov, A., Nenov, D., Amine, I., Petrov, City Hospital Clinic Cardiology Center: I., Kichukov, K., Nikitasov, L., Stankov, Z., Stoyanov, H., Tasheva Dimitrova, I., Angelova, M., Dimitrov, E., Minchev, M., Garvanski, I., Botev, C., Polomski, P., Alexandrovska University Hospital, Vassilev, Sofia: D., Karamfiloff, K., Tarnovska Kadreva, R., Vladimirova, L., Dimitrov, G., Hadzhiev, E., Tzvetkova, G., Andreka, . M. Atanasova Hungary: Gottsegen Gyo¨ rgy Orszagos Kardiologiai Inte´zet: P., Fontos, G., Fabian, J., Csepregi, A., Uzonyi, G., Gelei, A., Edes, Debreceni Egyetem Orvos e´s Ege´szse´gtudomanyi Centrum Altalanos Orvostudomanyi Kar Kardiologia Inte´zet: I., Balogh, L., Vajda, G., Darago, A., Gergely, S., Fulop, T., Jenei, C., Horvath, Pe´csi Tudomanyegyetem Klinikai Ko¨zpont Szıvgyogyaszati Klinika: I., Magyari, B., Nagy, A., Cziraki, A., Faludi, R., Kittka, B., Alizadeh, H., Merkely, Semmelweis Egyetem Varosmajori Szıv e´s Ergyogyaszati Klinika: B., Geller, L., Farkas, P., Szombath, G., Foldes, G., Skopal, J., Kovacs, A., Kosztin, A., Gara, E., Sydo, N., Nyolczas, MH Ege´szse´gu¨gyi Ko¨zpont Kardiologiai Osztaly: N., Kerecsen, G., Korda, A., Kiss, . M., Borsanyi, T., Polgar, B., Muk, B., Sharif, Z. Bari Ireland: HRB Clinical Research Facility: F., Atar, Y. M. Smyth Israel:Western Galilee Hospital: S., Shturman, A., Akria, L., Kilimnik, M., Brezins, M., Halabi, Ziv Medical Center: M., Dally, N., Goldberg, A., Aehab, K., Rosenfeld, I., Levinas, T., Saleem, D., Katz, Barzilai Medical Center: A., Plaev, T., Drogenikov, T., Nemetz, A., Barshay, Y., Jafari, J., Orlov, I., Nazareth Hospital EMMS: M. Omory, N. Kogan Nielsen, Shochat, Hillel Yaffe Medical Center: M., Shotan, A., Frimerman, A., Meisel, S., Asif, A., Sofer, O., Blondheim, D. S., Vazan, A., Metra, L. Arobov Italy: A. O. Spedali Civili di Brescia: M., Bonadei, I., Inama, L., Chiari, E., Lombardi, C., Magatelli, M., Russo, D., Lazzarini, V., Carubelli, V., Vassanelli, AOUI Verona – Borgo Trento Hospital: C., Ribichini, Flavio Luciano, Bergamini, C., Krampera, Mauro, Cicoria, M. A., Zanolla, L., Dalla Mura, D., Gambaro, A., Rossi, A., Pesarini Poland: Jagiellonian University Department of Cardiac, G., Musialek, Vascular Diseases at John Paul II Hospital in Krakow: P., Mazurek, A., Drabik, L., Ka˛dzielski, A., Walter, Z., Dzieciuch Rojek, M., Rubis, P., Plazak, . W., Tekieli, L., Podolec, J., Orczyk, W., Sutor, U., Zmudka, K., Olszowska, M., Podolec, P., Gruchala, Uniwersyteckie Centrum Kliniczne: M., Ciecwierz, D., Mielczarek, M., Burakowski, S., Chmielecki, M., Zielinska, M., Frankiewicz, A., Wdowczyk, J., Stopczynska, I., Bellwon, J., Mosakowska, K., Nadolna, R., Wroblewska, J., Rozmyslowska, M., Rynkiewicz, M., Marciniak, I., Raczak, G., Tarnawska, M., Taszner, M., Kasprzak, Bieganski Hospital: J., Plewka, M., Fiutowska, D., Rechcinski, T., Lipiec, P., Sobczak, M., Weijner Mik, P., Wraga, M., Krecki, R., Markiewicz, M., Haval Qawoq, D., Wojakowski, Gornosla˛skie Centrum Medyczne Sla˛skie j. Akademii Medycznej: W., Ciosek, J., Dworowy, S., Gaszewska Zurek, E., Ochala, A., Cybulski, W., Jadczyk, T., Wanha, W., Parma, Z., Kozlowski, M., Dzierzak, M., Markiewicz Serbia: Clinical Hospital Center Zvezdara, M., Arandjelovic, Cardiology Clinic: A., Sekularac, N., Boljevic, D., Bogdanovic, A., Zivkovic, S., Cvetinovic, N., Loncar, G., Clinical Centre of Serbia, Beleslin, Cardiology Clinic: B., Nedeljkovic, M., Trifunovic, D., Giga, V., Banovic, M., Nedeljkovic, I., Stepanovic, J., Vukcevic, V., Djordjevic Dikic, A., Dobric, M., Obrenovic Kircanski, B., Seferovic, Cardiology Clinic: P., Orlic, D., Tesic, M., Petrovic, O., Milinkovic, I., Simeunovic, D., Jagic, Clinical Center of Kragujevac: N., Tasic, M., Nikolic, D., Miloradovic, V., Djurdjevic, P., Sreckovic, M., Zornic, N., Clinical Hospital Center Bezanijska Kosa, Radovanovic, Cardiology Department: S., Saric, J., Hinic, S., Djokovic, A., Ðordevic, S., Bisenic, V., Markovic, O., Stamenkovic, S., Malenkovic, V., Tresnjak, J., Misic, G., Cotra, D., Tomovic, L., Vuckovic, V., Clinic of Emergency Internal Medicine, Obradovic, Military Medical Academy: S., Jovic, Z., Vukotic, S., Markovic, D., Djenic, N., Ristic Andjelkov, A., Bayes Genis, D. Ljubinka Spain: Hospital Universitario Germans Trias I. Pujol: A., Rodriguez Leor, O., Labata, C., Vallejo, N., Ferrer, E., Batlle, M., Fernandez Aviles, Hospital General Universitario Gregorio Mara~non: F., Sanz Ruiz, R., Casado, A., Loughlin, G., Zatarain, E., Anguita, J., Ferna ndez Santos, M. E., Pascual, C., Bermejo, J., Hernandez Garcia, Hospital Clinico Universitario Virgen de la Victoria: J. M., Jimenez Navarro, M., Dominguez, A., Carrasco, F., Mu~noz, A., Garcia Pinilla, J. M., Ruiz, J., Queipo de Llano, M. P., Hernandez, A., Fernandez, A., Jimenez Quevedo, Hospital Clinico San Carlos: P., Guerra, R., Biagioni, C., Gonzalez, R. A., Gomez deDiego, J. J., Mansson Broberg, L. Perez de Isla Sweden: Karolinska University Hospital: A., Sylve´n, C., Leblanc, K., Winter, R., Blomberg, P., Gunyeli, E., Ruck, A., Silva, C., Fo¨rstedt Switzerland: CardioCentro Ticino, J., Moccetti, Switzerland: T., Rossi, M., Pasotti, E., Petrova, I., Crljenica, C., Monti, C., Murzilli, R., Su¨rder, D., Moccetti, M., Turchetto, L., Locicero, V., Chiumiento, L., Maspoli, S., Mombelli, M., Anesini, A., Biggiogero, M., Ponti, G., Camporini, C., Polledri, S., Hill, G. Dolci United Kingdom: Kings College Hospital: J., Plymen, C., Amin Youssef, G., Mcdonagh, T., Drasar, E., Mijovic, A., Jouhra, F., Mcloman, D., Dworakowski, R., Webb, I., Byrne, J., and Potter, V.
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0301 basic medicine ,Male ,Cardiopoiesis ,Cardiovascular disease ,Disease severity ,Marker ,Precision medicine ,Regenerative medicine ,Stem cell ,Target population ,Adult ,Aged ,Double-Blind Method ,Female ,Heart Failure ,Humans ,Mesenchymal Stem Cell Transplantation ,Middle Aged ,Myocardial Ischemia ,Prospective Studies ,Treatment Outcome ,Young Adult ,Cardiology and Cardiovascular Medicine ,Cell- and Tissue-Based Therapy ,mesenchymal stem-cells ,030204 cardiovascular system & hematology ,Cardiorespiratory Medicine and Haematology ,outcomes ,Fast-Track Clinical Research ,Sudden cardiac death ,0302 clinical medicine ,Ischemia ,cardiovascular disease ,Clinical endpoint ,target population ,CHART Program ,Ejection fraction ,bone-marrow ,Heart Failure/Cardiomyopathy ,3. Good health ,Cohort ,Cardiology ,Fast Track ,disease severity ,delivery ,medicine.medical_specialty ,precision medicine ,Clinical Sciences ,regenerative medicine ,03 medical and health sciences ,cardiopoiesis ,Internal medicine ,medicine ,Adverse effect ,marker ,disease ,business.industry ,medicine.disease ,mortality ,Confidence interval ,Clinical trial ,stem cell ,Editor's Choice ,030104 developmental biology ,predictors ,Cardiovascular System & Hematology ,Heart failure ,business - Abstract
Altres ajuts: This work was supported by Celyad, SA (Mont-Saint-Guibert, Belgium). Celyad has received research grants from the Walloon Region (Belgium, DG06 funding). Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.
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- 2017
10. Poster Session 5The imaging examination and quality assessmentP1064The natural course of heart failure with preserved ejection fraction (HFpEF) - insights from an exploratory echocardiographic registryP1065Epicardial fat and effectiveness of catheter radiofrequency ablation in patients with atrial fibrillation and metabolic syndromeP1066Systematic disinfection of echocardiographic probe after each examination to reduce the persistence of pathogens as a potential source of nosocomial infectionsP1067Left atrial mechanical function assessed by two-dimensional echocardiography in hypertensive patientsP1068Real live applications of three-dimensional echocardiographic quantification of the left ventricular volumes and function using an automated adaptive analytics algorithmP10693D echocardiographic left ventricular dyssynchrony indices in end stage kidney disease: associations and outcomesP1070Relative contribution of right ventricular longitudinal shortening and radial displacement to global pump function in healthy volunteersP1071ECHO-parameters, associated with short-term mortality and long-term complications in patients with pulmonary embolism of high and intermediate riskP1072Increased epicardial fat is an independent marker of heart failure with preserved ejection fraction.P1073Influence of optimized beta-blocker therapy on diastolic dysfunction determined echocardiographically in heart failure patientsP1074Early diastolic mitral flow velocity/ annular velocity ratio is a sensitive marker of elevated filling pressure in left ventricular dyssynchronyP1075Left ventricular diastolic function in STEMI patients receiving early and late reperfusion by percutaneous coronary intervention P1076Could anatomical and functional features predict cerebrovascular events in patients with patent foramen ovale?P1077Efficacy of endarterectomy of the left anterior descending artery: evaluation by adenosine echocardiography?P1078Left ventricular diastolic dysfunction after acute myocardial infarction with preserved ejection fraction is related to lower exercise capacityP1079Potentially predictors of ventricular arrhythmia during six months follow up in STEMI patientsP1080Association between left atrial dilatation and invasive haemodynamics at rest and during exercise in asymptimatic aortic stenosisP1081Cardiac amyloidosis and aortic stenosis - the convergence of two aging processes and its association with outcomesP1082Prognostic impact of initial left ventricular dysfunction and mean gradient after transcatheter aortic valve implantationP1083Distribution and prognostic significance of left ventricular global longitudinal strain in asymptomatic significant aortic stenosis: an individual participant data meta-analysisP1084Discrepancies between echocardiographic and invasive assessment of aortic stenosis in multimorbid elderly patientsP1085Echocardiographic determinants and outcome of patients with low-gradient moderate and severe aortic valve stenosis: implications for aortic valve replacementP1086Atrial deformation correlated with functional capacity in mitral stenosisP1087Net atrioventricular compliance can predict reduction of pulmonary artery pressure after percutaneous mitral balloon commissurotomy
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Koschutnik, M., primary, Ionin, VA., primary, Boeckstaens, S., primary, Zakhama, L., primary, Hinojar, R., primary, Chiu, D Y Y, primary, Kovacs, A., primary, Kochmareva, EA., primary, Saliba, E., primary, Stanojevic, D., primary, Aalen, J., primary, Chen, XH., primary, Zito, C., primary, Demerouti, E., primary, Smarz, K., primary, Krljanac, G., primary, Christensen, NL., primary, Cavalcante, JL., primary, Pal, M., primary, Magne, J., primary, Giannakopoulos, G., primary, Liu, D., primary, Chien, CY., primary, Moustafa, TAMER, primary, Schwaiger, M., additional, Zotter-Tufaro, C., additional, Aschauer, S., additional, Duca, F., additional, Kammerlander, A., additional, Bonderman, D., additional, Mascherbauer, J., additional, Zaslavskaya, EL., additional, Soboleva, AV., additional, Listopad, OV., additional, Malikov, KN., additional, Baranova, EI., additional, Shlyakhto, EV., additional, Van Der Hoogstraete, M., additional, Coltel, N., additional, De Laet, N., additional, Beernaerts, C., additional, Desmet, K., additional, Gillis, K., additional, Droogmans, S., additional, Cosyns, B., additional, Antit, S., additional, Herbegue, B., additional, Slama, I., additional, Belaouer, A., additional, Chenik, S., additional, Boussabah, E., additional, Thameur, M., additional, Masmoudi, M., additional, Benyoussef, S., additional, Fernandez-Golfin, C., additional, Gonzalez-Gomez, A., additional, Casas, E., additional, Garcia Martin, A., additional, Pardo, A., additional, Del Val, D., additional, Ruiz, S., additional, Moya, JL., additional, Barrios, V., additional, Jimenez Nacher, JJ., additional, Zamorano, JL., additional, Kalra, PA., additional, Green, D., additional, Hughes, J., additional, Sinha, S., additional, Abidin, N., additional, Muraru, D., additional, Lakatos, BK., additional, Surkova, E., additional, Peluso, D., additional, Toser, Z., additional, Tokodi, M., additional, Merkely, B., additional, Badano, LP., additional, Volkova, AL., additional, Rusina, VA., additional, Kokorin, VA., additional, Gordeev, IG., additional, Baudet, M., additional, Chartrand Lefebvre, C., additional, Chen-Tournoux, A., additional, Hodzic, A., additional, Tournoux, F., additional, Apostolovic, S., additional, Jankovic-Tomasevic, R., additional, Djordjevic-Radojkovic, D., additional, Salinger-Martinovic, S., additional, Kostic, T., additional, Tahirovic, E., additional, Dungen, HD., additional, Andersen, OS., additional, Gude, E., additional, Andreassen, A., additional, Aalen, OO., additional, Larsen, CK., additional, Remme, EW., additional, Smiseth, OA., additional, Xu, HG., additional, Liu, FC., additional, Zha, DG., additional, Cui, K., additional, Zhang, AD., additional, Trio, O., additional, Soraci, E., additional, Cusma Piccione, M., additional, D'amico, G., additional, Ioppolo, A., additional, Alibani, L., additional, Falanga, G., additional, Todaro, MC., additional, Oreto, L., additional, Nucifora, G., additional, Vizzari, G., additional, Pizzino, F., additional, Di Bella, G., additional, Carerj, S., additional, Boutsikou, M., additional, Perreas, K., additional, Katselis, CH., additional, Samanidis, G., additional, Antoniou, TH., additional, Karatasakis, G., additional, Zaborska, B., additional, Jaxa-Chamiec, T., additional, Maciejewski, P., additional, Bartoszewicz, Z., additional, Budaj, A., additional, Trifunovic, D., additional, Asanin, M., additional, Savic, L., additional, Matovic, D., additional, Petrovic, M., additional, Zlatic, N., additional, Mrdovic, I., additional, Dahl, JS., additional, Carter-Storch, R., additional, Bakkestroem, R., additional, Soendergaard, E., additional, Videbaek, L., additional, Moeller, JE., additional, Rijal, S., additional, Abdelkarim, I., additional, Althouse, AD., additional, Sharbaugh, MS., additional, Fridman, Y., additional, Han, W., additional, Soman, P., additional, Forman, DE., additional, Schindler, JT., additional, Gleason, TG., additional, Lee, JE., additional, Schelbert, EB., additional, Dekany, G., additional, Mandzak, A., additional, Chaurasia, AK., additional, Gyovai, J., additional, Hegedus, N., additional, Piroth, ZS., additional, Szabo, GY., additional, Fontos, G., additional, Andreka, P., additional, Popescu, BA., additional, Carstensen, HG., additional, Dahl, J., additional, Desai, M., additional, Kearney, L., additional, Marwick, T., additional, Sato, K., additional, Takeuchi, M., additional, Zito, C., additional, Mohty, D., additional, Lancellotti, P., additional, Habib, G., additional, Noble, S., additional, Frei, A., additional, Mueller, H., additional, Hu, K., additional, Liebner, E., additional, Weidemann, F., additional, Herrmann, S., additional, Ertl, G., additional, Voelker, W., additional, Gorski, A., additional, Leyh, R., additional, Stoerk, S., additional, Nordbeck, P., additional, Tsai, WC., additional, Moustafa, TAMER, additional, and Aldydamony, MOHAMD, additional
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- 2016
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11. Remote ischaemic postconditioning protects the heart during acute myocardial infarction in pigs
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Andreka, G., primary, Vertesaljai, M., additional, Szantho, G., additional, Font, G., additional, Piroth, Z., additional, Fontos, G., additional, Juhasz, E. D, additional, Szekely, L., additional, Szelid, Z., additional, Turner, M. S, additional, Ashrafian, H., additional, Frenneaux, M. P, additional, and Andreka, P., additional
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- 2007
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12. Thallium-201 myocardial SPECT in left bundle branch block: Diagnosis of myocardial ischemia with a disease-specific reference database
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ZUPAN, K, primary, KARI, B, additional, FONTOS, G, additional, DEKANY, P, additional, and PARTOS, O, additional
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- 2006
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13. [Experiences with the first, Hungarian autologous bone marrow cell transplantation in acute myocardial infarction]
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Vértesaljai M, Piróth Z, Fontos G, Tóth A, Simor T, Lueff S, Péter Reményi, Réti M, Masszi T, and Andréka P
14. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events
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Sergio Leandro, Jan G.P. Tijssen, Norihiro Kogame, Masafumi Ono, Christian W. Hamm, Johan Verbeeck, Margit Niethammer, Hideyuki Kawashima, Rutao Wang, David van Klaveren, Rodrigo Modolo, Chao Gao, Marco Valgimigli, Mariusz Tomaniak, Emanuele Barbato, Peter Jüni, Yoshinobu Onuma, Vasco Gama Ribeiro, Kuniaki Takahashi, Hironori Hara, Stephan Windecker, Géza Fontos, Faisal Sharif, Patrick W. Serruys, Ply Chichareon, Philippe Gabriel Steg, Michael Angioi, Hara, H., Van Klaveren, D., Takahashi, K., Kogame, N., Chichareon, P., Modolo, R., Tomaniak, M., Ono, M., Kawashima, H., Wang, R., Gao, C., Niethammer, M., Fontos, G., Angioi, M., Ribeiro, V. G., Barbato, E., Leandro, S., Hamm, C., Valgimigli, M., Windecker, S., Juni, P., Steg, P. G., Verbeeck, J., Tijssen, J. G. P., Sharif, F., Onuma, Y., Serruys, P. W., University of Zurich, Serruys, Patrick W, Graduate School, Cardiology, ACS - Heart failure & arrhythmias, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and Public Health
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medicine.medical_specialty ,Time Factors ,Endpoint Determination ,aspirin ,medicine.medical_treatment ,Hemorrhage ,610 Medicine & health ,Equivalence Trials as Topic ,Revascularization ,Rate ratio ,Risk Assessment ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,ticagrelor ,Risk Factors ,Internal medicine ,medicine ,Humans ,Myocardial infarction ,Stroke ,Aspirin ,business.industry ,Dual Anti-Platelet Therapy ,Hazard ratio ,percutaneous coronary intervention ,Percutaneous coronary intervention ,medicine.disease ,mortality ,Treatment Outcome ,myocardial infarction ,Research Design ,Data Interpretation, Statistical ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,Ticagrelor ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Background: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. Methods and Results: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88–1.01]; log-rank P =0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97–1.13; P =0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85–0.99; P =0.020] and hazard ratio, 0.92 [95% CI, 0.85–0.99; P =0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84–1.04; log-rank P =0.22). Conclusions: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.
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- 2020
15. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial
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Pascal Vranckx, Marco Valgimigli, Peter Jüni, Christian Hamm, Philippe Gabriel Steg, Dik Heg, Gerrit Anne van Es, Eugene P McFadden, Yoshinobu Onuma, Cokky van Meijeren, Ply Chichareon, Edouard Benit, Helge Möllmann, Luc Janssens, Maurizio Ferrario, Aris Moschovitis, Aleksander Zurakowski, Marcello Dominici, Robert Jan Van Geuns, Kurt Huber, Ton Slagboom, Patrick W Serruys, Stephan Windecker, Mohamed Abdellaoui, David Adlam, Ibrahim Akin, Agustin Albarran Gonzalez-Trevilla, Manuel Almeida, Pedro Alves Lemos Neto, Adel Aminian, Richard Anderson, Rick Andreae, Michael Angioi, Taku Asano, Emanuele Barbato, Peter Barlis, Pascal Barraud, Olivier Bertrand, Farzin Beygui, Leonardo Bolognese, Roberto Botelho, Coby Bouwman, Marco Bressers, Philippe Brunel, Pawel Buszman, Ian Buysschaert, Pedro Canas da Silva, Didier Carrie, Angel Cequier, Chun Chin Chang, Saqib Chowdhary, Carlos Collet, Antonio Colombo, James Cotton, Rui Cruz Ferreira, Salvatore Curello, Nick Curzen, Judith de Bot, Tone de Vreede, Georg Delle Karth, Lynn Dijksma, István Édes, Eric Eeckhout, Ingo Eitel, József Faluközy, Farzin Fath-Ordoubadi, Geza Fontos, Jose Francisco Diaz, Edgard Freitas Quintella, Bernhard Frey, Guy Friedrich, Gavin Galasko, Grzegorz Galuszka, Vasco Gama Ribeiro, Scot Garg, Giuseppe Gargiulo, Tobias Geisler, Valeri Gelev, Art Ghandilyan, Javier Goicolea, Tommaso Gori, Felice Gragnano, Ana Guimarães, Michael Haude, Pieter Heijke, Rosa Ana Hernández Antolin, David Hildick-Smith, Dorien Hillen, Ina Hoekman, Sjoerd Hofma, Lene Holmvang, Stephen Hoole, Iván Horváth, Annemarie Hugense, Karim Ibrahim, Andres Iñiguez, Karl Isaaz, Zoltán Jambrik, Pawel Jasionowicz, Judith Jonk, Werner Jung, Yuki Katagiri, Norihiro Kogame, Tian Hai Koh, René Koning, Mariana Konteva, Zsolt Kőszegi, Florian Krackhardt, Yvonne Kreuger, Neville Kukreja, Boudijn Ladan, Pierre Lantelme, Sergio Leandro, Gregor Leibundgut, Christoph Liebetrau, Wietze Lindeboom, Carlos Macaya Miguel, François Mach, Michael Magro, Luc Maillard, Negar Manavifar, Laura Mauri, Eugene McFadden, Bela Merkely, Yosuke Miyazaki, Adam Młodziankowski, Tiziano Moccetti, Rodrigo Modolo, Helge Möllman, Jean-François Morelle, Michael Munndt Ottesen, Martin Muurling, Christoph Kurt Naber, Franz-Josef Neumann, Keith Oldroyd, Paul Ong, Sanne Palsrok, Ivo Petrov, Sylvain Plante, Janusz Prokopczuk, Tessa Rademaker-Havinga, Christopher Raffel, Benno Rensing, Marco Roffi, Kees-Jan Royaards, Manel Sabate, Volker Schächinger, Tim Seidler, Antonio Serra Peñaranda, Patrick Serruys, Lali Sikarulidze, Osama I Soliman, Amanda Sousa, Ernest Spitzer, Rod Stables, Gabriel Steg, Clemens Steinwender, Eduardas Subkovas, Harry Suryapranata, Kuniaki Takahashi, Suneel Talwar, Emmanuel Teiger, Addy ter Weele, Eva Teurlings, Attila Thury, Jan Tijssen, Gincho Tonev, Diana Trendafilova-Lazarova, Carlo Tumscitz, Victor Umans, Imre Ungi, Veselin Valkov, Pim van der Harst, Robert Jan van Geuns, Dobrin Vassilev, Vasil Velchev, Esther Velthuizen, Freek Verheugt, Natalia Vlcek, Jürgen vom Dahl, Mathias Vrolix, Simon Walsh, Nikos Werner, Maarten Witsenburg, Azfar Zaman, Krzysztof Żmudka, Bernhard Zrenner, Robert Zweiker, University of Zurich, Serruys, Patrick W, Cardiology, Vranckx, P., Valgimigli, M., Juni, P., Hamm, C., Steg, P. G., Heg, D., van Es, G. A., Mcfadden, E. P., Onuma, Y., van Meijeren, C., Chichareon, P., Benit, E., Mollmann, H., Janssens, L., Ferrario, M., Moschovitis, A., Zurakowski, A., Dominici, M., Van Geuns, R. J., Huber, K., Slagboom, T., Serruys, P. W., Windecker, S., Abdellaoui, M., Adlam, D., Akin, I., Albarran Gonzalez-Trevilla, A., Almeida, M., Alves Lemos Neto, P., Aminian, A., Anderson, R., Andreae, R., Angioi, M., Asano, T., Barbato, E., Barlis, P., Barraud, P., Bertrand, O., Beygui, F., Bolognese, L., Botelho, R., Bouwman, C., Bressers, M., Brunel, P., Buszman, P., Buysschaert, I., Canas da Silva, P., Carrie, D., Cequier, A., Chin Chang, C., Chowdhary, S., Collet, C., Colombo, A., Cotton, J., Cruz Ferreira, R., Curello, S., Curzen, N., de Bot, J., de Vreede, T., Delle Karth, G., Dijksma, L., Edes, I., Eeckhout, E., Eitel, I., Falukozy, J., Fath-Ordoubadi, F., Fontos, G., Francisco Diaz, J., Freitas Quintella, E., Frey, B., Friedrich, G., Galasko, G., Galuszka, G., Gama Ribeiro, V., Garg, S., Gargiulo, G., Geisler, T., Gelev, V., Ghandilyan, A., Goicolea, J., Gori, T., Gragnano, F., Guimaraes, A., Haude, M., Heijke, P., Hernandez Antolin, R. A., Hildick-Smith, D., Hillen, D., Hoekman, I., Hofma, S., Holmvang, L., Hoole, S., Horvath, I., Hugense, A., Ibrahim, K., Iniguez, A., Isaaz, K., Jambrik, Z., Jasionowicz, P., Jonk, J., Jung, W., Katagiri, Y., Kogame, N., Koh, T. H., Koning, R., Konteva, M., Koszegi, Z., Krackhardt, F., Kreuger, Y., Kukreja, N., Ladan, B., Lantelme, P., Leandro, S., Leibundgut, G., Liebetrau, C., Lindeboom, W., Macaya Miguel, C., Mach, F., Magro, M., Maillard, L., Manavifar, N., Mauri, L., Mcfadden, E., Merkely, B., Miyazaki, Y., Mlodziankowski, A., Moccetti, T., Modolo, R., Mollman, H., Morelle, J. -F., Munndt Ottesen, M., Muurling, M., Naber, C. K., Neumann, F. -J., Oldroyd, K., Ong, P., Palsrok, S., Petrov, I., Plante, S., Prokopczuk, J., Rademaker-Havinga, T., Raffel, C., Rensing, B., Roffi, M., Royaards, K. -J., Sabate, M., Schachinger, V., Seidler, T., Serra Penaranda, A., Serruys, P., Sikarulidze, L., Soliman, O. I., Sousa, A., Spitzer, E., Stables, R., Steg, G., Steinwender, C., Subkovas, E., Suryapranata, H., Takahashi, K., Talwar, S., Teiger, E., ter Weele, A., Teurlings, E., Thury, A., Tijssen, J., Tonev, G., Trendafilova-Lazarova, D., Tumscitz, C., Umans, V., Ungi, I., Valkov, V., van der Harst, P., van Geuns, R. J., Vassilev, D., Velchev, V., Velthuizen, E., Verheugt, F., Vlcek, N., vom Dahl, J., Vrolix, M., Walsh, S., Werner, N., Witsenburg, M., Zaman, A., Zmudka, K., Zrenner, B., Zweiker, R., ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Graduate School, ACS - Heart failure & arrhythmias, and ACS - Amsterdam Cardiovascular Sciences
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medicine.medical_specialty ,Aspirin ,Acute coronary syndrome ,business.industry ,medicine.medical_treatment ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,Percutaneous coronary intervention ,610 Medicine & health ,General Medicine ,2700 General Medicine ,030204 cardiovascular system & hematology ,medicine.disease ,Clopidogrel ,11171 Cardiocentro Ticino ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Drug-eluting stent ,Internal medicine ,medicine ,030212 general & internal medicine ,Myocardial infarction ,business ,Ticagrelor ,medicine.drug - Abstract
Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme
- Published
- 2018
16. First application of the distal radial approach for severe mechanical surgical aortic valve paravalvular leak transcatheter closure with a double vascular plug: a case report.
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Sasi V, Fontos G, Kormányos Á, Vértesaljai M, and Ruzsa Z
- Abstract
Background: Severe aortic paravalvular leaks (PVLs) after surgical mechanical aortic valve replacement (AVR) represent a high risk for congestive heart failure, haemolysis, and infective endocarditis. This is the first reported case of distal radial artery (DRA) access for severe mechanical aortic PVL closure with a sequential double vascular plug guided by computed tomography angiography (CTA), transoesophageal echocardiography (TOE), and 3D TOE in an acute setting., Case Summary: A 51-year-old male presented with significant mixed aortic valve disease. Aortic valve replacement was performed (Slimline Bicarbon A-25 mm) according to guidelines. Four and 16 days later, a re-exploration was carried out due to pericardial effusion. Four months after discharge from rehabilitation, the patient was readmitted due to worsening dyspnoea on exertion and then at rest. Transthoracic echocardiography, TOE, and consequently, CTA, revealed severe PVL, following which the procedure of transcatheter PVL closure was chosen, with a preference for DRA access. After a CTA scan analysis and angiographic, TOE, and 3D TOE visualization of the leak, a 14/5 mm and a 10/5 mm vascular plug (AVPIII) were deployed to achieve good results. A 9-month clinical, echocardiographic, and CTA follow-up revealed good long-term results., Discussion: For transcatheter PVL closure, CTA is helpful for not only vascular access planning, but also a visualization of the magnitude of the leak, location, and device planning. This case report demonstrates that the distal radial approach is feasible in patients with severe mechanical aortic valve PVL retrograde transcatheter closure. DRA access could possibly represent less bleeding and vascular access site complications when compared with femoral access and has some potential advantages over regular radial access., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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17. Short- and Medium-Term Outcomes Comparison of Native- and Valve-in-Valve TAVI Procedures.
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Bartos PV, Molnar B, Herold Z, Dekany G, Piroth Z, Horvath G, Ahres A, Heesch CM, Czobor NR, Satish S, Pinter T, Fontos G, and Andreka P
- Abstract
Background: In high-risk patients with degenerated aortic bioprostheses, valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a less invasive alternative to surgical valve replacement. To compare outcomes of ViV and native valve (NV) TAVI procedures., Methods: 34 aortic ViV-TAVI performed between 2012 and 2022 using self-expanding valves, were included in this retrospective analysis. Propensity score matching (1:2 ratio, 19 criteria) was used to select a comparison NV-TAVI group from a database of 1206 TAVI procedures. Clinical and echocardiographic endpoints, short- and long-term all-cause mortality (ACM) and cardiovascular mortality (CVM) data were obtained. Subgroup analyses were completed according to the true internal diameter, dividing patients into a small ( ≤ 19 mm) valve group (SVG) and a large ( > 19 mm) valve group (LVG)., Results: Clinical outcomes of ViV- and NV-TAVI were comparable, including device success [88.2% vs. 91.1%, p = 0.727], major adverse cardiovascular and cerebrovascular events [5.8% vs. 5.8%, p = 1.000], hemodialysis need [5.8% vs. 2.9%, p = 0.599], pacemaker need [2.9% vs. 11.7%, p = 0.265], major vascular complications [2.9% vs. 1.4%, p = 1.000], life-threatening or major bleeding [2.9% vs. 1.4%, p = 1.000] and in-hospital mortality [8.8% vs. 5.9%, p = 0.556]. There was a significant difference in the immediate post-intervention mean residual aortic valve gradient (MAVG) [14.6 ± 8.5 mm Hg vs. 6.4 ± 4.5 mm Hg, p < 0.0001], which persisted at 1 year [ p = 0.0002]. There were no differences in 12- or 30-month ACM [11.8% vs. 8.8%, p = 0.588; 23.5% vs. 27.9%, p = 0.948], and CVM [11.8% vs. 7.3%, p = 0.441; 23.5% vs. 16.2%, p = 0.239]. Lastly, there was no difference in CVM at 1 year and 30 months [11.1% vs. 12.5%, p = 0.889; 22.2% vs. 25.0%, p = 0.742]., Conclusions: Analyzing a limited group (n = 34) of ViV-TAVI procedures out of 1206 TAVIs done at a single institution, ViV-TAVI appeared to be an acceptable approach in patients not deemed appropriate candidates for redo valve replacement surgery. Clinical outcomes of ViV-TAVI were comparable to TAVI for native valve stenosis., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 The Author(s). Published by IMR Press.)
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- 2023
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18. Long-Term Efficacy and Safety of Left Atrial Appendage Closure Procedures.
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Zadori A, Kis Z, Toth T, Szigeti M, Temesvari A, Fontos G, Nyolczas N, and Andreka P
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- Aged, Aged, 80 and over, Humans, Middle Aged, Hemorrhage complications, Retrospective Studies, Treatment Outcome, Atrial Appendage surgery, Atrial Fibrillation complications, Atrial Fibrillation surgery, Stroke epidemiology, Stroke etiology, Stroke prevention & control
- Abstract
The aim of the present single-center, nonrandomized, retrospective study was to assess the safety and long-term efficacy of percutaneous left atrial appendage closure (LAAC) procedures and to compare the different LAAC devices and therapeutic regimes in this respect.Medical data of 136 patients (pts) (mean age, 72.5 ± 7.6 years; score for atrial fibrillation stroke risk estimation [CHA
2 DS2 -VASc], 4.6 ± 1.6; and score for estimation of major bleeding risk for patients on anticoagulant therapy [HAS-BLED], 2.6 ± 0.9) who underwent percutaneous LAAC procedures in Gottsegen National Cardiovascular Center from January 2010 to January 2020 were analyzed.The rates of outpatient cardiac mortality, ischemic brain event, and major bleeding were 3.8, 1, and 1.9/100 pt years, respectively. The rate of successful device deployment was 96.4%. There was one case of procedural mortality (0.7%), one case of device dislocation (0.7%), one case of ischemic stroke (0.7%), and one case of myocardial infarction (0.7%). Two cases of pericardial tamponades (1.5%) and four cases of major femoral complications (3%) occurred. Although the implantation success of different occluder types was similar, significant differences were found concerning procedural characteristics. Patients on single antiplatelet therapy (SAPT) in the first 3 months after the LAAC procedure did not suffer from stroke or embolic events.The present study confirmed the safety and effectivity of percutaneous LAAC. Robust relative stroke risk reduction and less pronounced but significant bleeding risk reduction were observed. Device implantation success was high. The perioperative complication rate was relatively low. The results of long-term observations regarding ischemic events confirmed the safety of using a simplified antithrombotic regime after LAAC in pts with high bleeding risk.- Published
- 2023
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19. Elevated Fasting Glucose and C-Reactive Protein Levels Predict Increased All-Cause Mortality after Elective Transcatheter Aortic Valve Implantation.
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Dekany G, Keresztes K, Bartos VP, Csenteri O, Gharehdaghi S, Horvath G, Ahres A, Heesch CM, Pinter T, Fontos G, Satish S, and Andreka P
- Abstract
Surgical aortic valve replacement in the elderly is now being supplanted by transcatheter aortic valve implantation (TAVI). Scoring systems to predict survival after catheter-based procedures are understudied. Both diabetes (DM) and underlying inflammatory conditions are common in patients undergoing TAVI, but their impact remains understudied in this patient group. We examined 560 consecutive TAVI procedures and identified eight pre-procedural factors: age, body mass index (BMI), DM, fasting blood glucose (BG), left-ventricular ejection fraction (EF), aortic valve (AV) mean gradient, C-reactive protein levels, and serum creatinine levels and studied their impact on survival. The overall mortality rate at 30 days, 1 year and 2 years were 5.2%, 16.6%, and 34.3%, respectively. All-cause mortality was higher in patients with DM (at 30 days: 8.9% vs. 3.1%, p = 0.008; at 1 year: 19.7% vs. 14.9%, p = 0.323; at 2 years: 37.9% vs. 32.2%, p = 0.304). The presence of DM was independently associated with increased 30-day mortality (hazard ratio [HR] 5.38, 95% confidence interval [CI], 1.24-23.25, p = 0.024). BG levels within 7-11, 1 mmol/L portended an increased risk for 30-day and 2-year mortality compared to normal BG ( p = 0.001 and p = 0.027). For each 1 mmol/L increase in BG 30-day mortality increased (HR 1.21, 95% CI, 1.04-1.41, p = 0.015). Reduced EF and elevated CRP were each associated with increased 2-year mortality ( p = 0.042 and p = 0.003). DM, elevated BG, reduced EF, and elevated baseline CRP levels each are independent predictors of short- and long-term mortality following TAVI. These easily accessible screening parameters should be integrated into risk-assessment tools for catheter-based aortic valve replacement candidates.
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- 2022
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20. Treatment of three-vessel disease in light of the results of the FAME-3 study
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Piróth Z, Fülöp G, Csanádi B, Fontos G, Andréka P, Nyolczas N, and Szolnoky J
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- Coronary Artery Bypass methods, Humans, Treatment Outcome, Coronary Artery Disease surgery, Drug-Eluting Stents, Fractional Flow Reserve, Myocardial, Myocardial Infarction, Percutaneous Coronary Intervention methods
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Previous randomized clinical studies have shown the superiority of coronary artery bypass grafting over percutaneous coronary intervention in the treatment of severe multivessel disease mainly because of a reduced need for repeat revascularization but, in some, a mortality benefit and reduced rate of myocardial infarction were shown among those undergoing surgery. The late breaker multicentric, randomized FAME (Fractional Flow Reserve Versus Angiography in Multivessel Evaluation)-3 study, involving 1500 patients, sought to determine whether fractional flow reserve guided percutaneous coronary intervention with implantation of new-generation drug-eluting stents was non -inferior to present-day coronary bypass surgery with respect to the composite of all-cause death, myocardial infarction, stroke and repeat revascularization at one year. The authors who were particularly active in the FAME-3 trial describe the study setting, the characteristics of the patient population, the procedures, and the results. The FAME-3 study failed to show the non-inferiority of percutaneous coronary intervention to bypass surgery in the treatment of three vessel disease using the predetermined margin. The authors present a detailed analysis of the possible reasons and some important secondary results. These include a lack of significant difference between the two arms with respect to `hard end points' and the significantly higher perioperative morbidity of the surgical group. Albeit our clinical practice should be based on the analysis of the primary end point, informing patients and shared decision making must include these secondary results when individual revascularization strategies are planned.
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- 2022
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21. Transcatheter aortic valve replacement – 10 years experience at Gottsegen György National Cardiovascular Center in Hungary
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Mandzák A, Dékány G, Vértesaljai M, Pál M, Piróth Z, Pintér T, Kovács A, Agócs G, Sai S, Fontos G, and Andréka P
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- Aged, Femoral Artery, Humans, Hungary, Incidence, Transcatheter Aortic Valve Replacement
- Abstract
Összefoglaló. Bevezetés: A transzkatéteres aortaműbillentyű-beültetés (TAVI) az idős, súlyos aortastenosisban szenvedő, multimorbid, magas műtéti kockázattal rendelkező betegek esetében javasolt a szívsebészeti aortaműbillentyű-beültetés alternatívájaként. Célkitűzés: Jelen munkánkban az intézetünkben elindult TAVI-program első 10 éve alatt elvégzett 463, TAVI-n átesett beteg rövid és hosszú távú eredményeit tekintjük át és értékeljük. Külön vizsgáljuk az első 200 beteg és az utánuk következő 263 beteg eredményeit. Módszer: 2008. november 11. és 2018. december 31. között 463 betegnél végeztünk TAVI-t. Betegeink átlagéletkora 79,6 év, átlagos logisztikus EuroSCORE-értékük 19,0%, átlagos STS-score-értékük pedig 5,2% volt. A beavatkozás előtt az esetek 72%-ában NYHA III-as vagy IV-es funkcionális stádiumban voltak. A beavatkozások 92,8%-át transfemoralis behatolásból végeztük. Az aortabillentyűn mért átlagos gradiens 50 Hgmm, a billentyűarea 0,55 cm2 volt. Az esetek mintegy 2%-ában az aortabillentyű-bioprotézis restenosisa miatt "valve-in-valve" beavatkozást végeztünk. Eredmények: A TAVI után a 30 napos halálozás 5,2%, az 1 éves pedig 16,4% volt. A TAVI-t követően kialakult szövődményeket a VARC-2 kritériumrendszere alapján értékeltük. A beavatkozás után 2,2%-ban fordult elő major stroke. A leggyakoribb szövődmény, a posztoperatív pacemakerimplantáció (19,9%) aránya szignifikánsan csökkent a később TAVI-n átesett 263 beteg esetében (26,5% vs. 14,8% [p = 0,002]). A vérzéses szövődmények aránya a percutan beavatkozások bevezetésével szignifikánsan emelkedett ugyan (10% vs. 20,2% [p = 0,016]), de ez nem járt a mortalitás emelkedésével. Következtetés: Az eredmények alapján elmondhatjuk, hogy a TAVI intézetünkben is biztonságos alternatívát jelent a magas műtéti rizikóval rendelkező, súlyos, tünetes aortastenosisban szenvedő betegek esetében. Orv Hetil. 2022; 163(6): 229-235., Introduction: Transcatheter aortic valve implantation (TAVI) is an alternative treatment to surgical aortic valve replacement for elderly, high surgical risk patients., Objective: The aim of this study was to evaluate the short- and long-term outcomes of those 463 patients who underwent TAVI during the first 10 years in our TAVI program. We compare the first 200 patients' results with the further 263 patients' results., Method: Between 11th November 2008 and 31st December 2018, 463 patients underwent TAVI. The average age of the patients was 79.6 years, the average logistic EuroSCORE was 19.0%, the average STS score was 5.2%. 72% of the patients were in NYHA III or IV stage before TAVI. 92% of TAVIs were performed from femoral arteries. Average mean gradient was 50.0 mmHg and aortic valve area was 0.55 cm2, respectively. In 2% of the cases, "valve-in-valve" intervention was performed because of the restenosis of former aortic valve prosthesis., Results: 30-day mortality was 5.2% and the 1-year mortality was 16.4% after TAVI. Post-TAVI complications were evaluated according to the VARC-2 definitions. Major stroke occurred in 2.2% after TAVI. The most common complication was pacemaker implantation (19.9%), but their incidence was significantly reduced between the 2 groups (26.5% vs. 14.8% [p = 0.002]). The incidence of vascular access site complications was significantly higher between the 2 groups (10% vs. 20.2% [p = 0.016]), but it did not affect the mortality., Conclusion: Based on our results, TAVI is a safe alternative treatment for patients with severe, symptomatic aortic stenosis in our institute as well. Orv Hetil. 2022; 163(6): 229-235.
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- 2022
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22. Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment-Elevation Myocardial Infarction.
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Piróth Z, Fülöp G, Boxma-de Klerk BM, Abdelghani M, Omerovic E, Andréka P, Fontos G, Neumann FJ, Richardt G, and Smits PC
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- Coronary Angiography, Coronary Vessels diagnostic imaging, Humans, Predictive Value of Tests, Prognosis, Treatment Outcome, Coronary Stenosis diagnosis, Fractional Flow Reserve, Myocardial, Myocardial Infarction diagnosis, Myocardial Infarction therapy, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction therapy
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Background: The applicability of resting indices to guide noninfarct-related artery revascularization in ST-elevation myocardial infarction is unknown., Methods: We analyzed the correlation and prognostic value of fractional flow reserve (FFR) and resting distal coronary to aortic pressure ratio (Pd/Pa) in all patients of the Compare-Acute trial in whom, after successful primary percutaneous coronary intervention, the noninfarct-related artery was interrogated by both and treated medically. The treating cardiologist was blinded to these values. The primary end point was the composite of target vessel (interrogated noninfarct-related artery) related nonfatal target vessel myocardial infarction and target vessel repeat revascularization at 36 months., Results: Five hundred seventeen patients (665 vessels) were included. On receiver-operating characteristic analysis, the optimal Pd/Pa cut off for FFR≤0.80 was 0.905 ( C statistic: 0.894). The diagnostic accuracy of Pd/Pa was 80.15% (95% CI, 76.91%-83.12%) with respect to FFR. During the 36-month follow-up, 130 target vessel revascularization and 14 target vessel myocardial infarction occurred. FFR and Pd/Pa had a diagnostic accuracy to predict these events of 62.86% (95% CI, 59.06%-66.54%) and 56.84% (95% CI, 52.98%-60.64%), respectively ( P =0.20). When they were discrepant, FFR was significantly better than Pd/Pa in identifying which vessels could be safely deferred ( P =0.048)., Conclusions: Immediately after successful primary percutaneous coronary intervention, resting Pd/Pa has a diagnostic accuracy of 80% with respect to FFR measured in the noninfarct-related artery. FFR is not significantly superior in predicting target vessel myocardial infarction and target vessel revascularization during 36 months of follow-up but, in case FFR and Pd/Pa are discrepant, FFR is superior in identifying which nonculprit vessels can be safely deferred. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01399736.
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- 2022
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23. The prognostic value of immediate post-TAVI hemodynamic evaluation is superior to aortography and transoesophageal echocardiography in predicting patient survival.
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Dekany G, Fontos G, Satish S, Szabo G, Pinter T, Piroth Z, Vertesaljai M, Pal M, Mandzak A, Gulyas Z, Gharehdaghi S, Ferenci T, and Andreka P
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- Aortic Valve diagnostic imaging, Aortic Valve surgery, Aortography, Cardiac Catheterization, Echocardiography, Transesophageal, Hemodynamics, Humans, Prognosis, Severity of Illness Index, Treatment Outcome, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Transcatheter Aortic Valve Replacement
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Background: Although post-TAVI PAR is commonly seen, its exact evaluation, grading and the true impact on patients' survival are still debated. This single center study aimed to evaluate the effect of post transcatheter aortic valve implantation (TAVI) paravalvular aortic regurgitation (PAR) on patients' survival. The outcome was evaluated by the three most commonly used techniques just after TAVI in the interventional arena., Methods: 201 high risk patients with severe symptomatic aortic stenosis underwent TAVI with the self-expandable system. The severity of post-TAVI PAR was prospectively evaluated by aortography and transesophageal echocardiography (TEE) using a four-class scheme and hemodynamic evaluation by calculation of the regurgitation index (RI). Median follow up time was 763 days., Results: Post-TAVI PAR results of the three different modalities were concordant with each other (all p < 0.001). Patients with grade 0-I PAR by aortography had better long term outcomes compared to those who had grade II-III PAR (unadjusted HR 1.77 [95% CI, 1.04-3.01], p = 0.03). Although in multivariate analysis neither aortography nor TEE were shown to be significant predictors of survival, hemodynamic assessment using the exact RI result was a significant predictor of survival and its effect was found to be linear (adjusted HR 0.72 [95% CI, 0.52-0.98] for 10% point increase in RI, p = 0.03595)., Conclusions: Among the three modalities that are frequently used to evaluate the outcome, post-TAVI RI showed the highest added predictive value for survival., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)
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- 2021
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24. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events.
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Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Jüni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, and Serruys PW
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- Aspirin adverse effects, Data Interpretation, Statistical, Hemorrhage chemically induced, Humans, Myocardial Infarction etiology, Myocardial Infarction mortality, Myocardial Infarction prevention & control, Platelet Aggregation Inhibitors adverse effects, Risk Assessment, Risk Factors, Stroke etiology, Stroke mortality, Stroke prevention & control, Ticagrelor adverse effects, Time Factors, Treatment Outcome, Aspirin therapeutic use, Dual Anti-Platelet Therapy adverse effects, Endpoint Determination, Equivalence Trials as Topic, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Platelet Aggregation Inhibitors therapeutic use, Research Design, Ticagrelor therapeutic use
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Background: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study., Methods and Results: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P =0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P =0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P =0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P =0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P =0.22)., Conclusions: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.
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- 2020
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25. The Natural History of Nonculprit Lesions in STEMI: An FFR Substudy of the Compare-Acute Trial.
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Piróth Z, Boxma-de Klerk BM, Omerovic E, Andréka P, Fontos G, Fülöp G, Abdel-Wahab M, Neumann FJ, Richardt G, Abdelghani M, and Smits PC
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- Aged, Coronary Artery Disease mortality, Coronary Artery Disease physiopathology, Female, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Risk Assessment, Risk Factors, ST Elevation Myocardial Infarction mortality, ST Elevation Myocardial Infarction physiopathology, Time Factors, Treatment Outcome, Cardiac Catheterization, Coronary Artery Disease diagnosis, Coronary Artery Disease therapy, Coronary Vessels physiopathology, Fractional Flow Reserve, Myocardial, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction therapy
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Objectives: The aim of this study was to determine the prognostic value of fractional flow reserve (FFR) in non-infarct-related arteries (IRAs) in ST-segment elevation myocardial infarction (MI)., Background: Patients with ST-segment elevation MI often present with multivessel disease. The treatment of non-IRAs is debated. The applicability of FFR has not been widely proved., Methods: Outcomes were analyzed in all patients in the Compare-Acute (Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD) trial in whom, after successful primary percutaneous coronary intervention, non-IRAs were interrogated using FFR and treated medically. The treating cardiologist was blinded to the FFR value. The primary endpoint was the composite of cardiovascular mortality, target vessel-related (non-IRA with FFR measurement at primary percutaneous coronary intervention) nonfatal MI, and target vessel revascularization: major adverse cardiac events (MACE) at 24 months., Results: A total of 751 patients (963 vessels) were included. Target non-IRAs with MACE had lower FFR compared with those without (0.78 vs. 0.84, respectively; p < 0.001). The median FFR of non-IRAs with TVR was lower than that of those without (0.79 vs. 0.85, respectively; p < 0.001). The difference was significant in all vessels. The median FFR of target non-IRAs with MI was lower than that of those without (0.79 vs. 0.84, respectively; p = 0.016). The MACE rate was significantly (p < 0.001) higher in the lowest of FFR tertiles (<0.80) compared with the others (0.80 to 0.87 and ≥0.88)., Conclusions: In patients with ST-segment elevation MI with multivessel disease, FFR measured in the medically treated non-IRA immediately after successful primary percutaneous coronary intervention shows a nonlinear and inverse risk continuum of MACE. Importantly, worsening prognosis is demonstrated around the cutoff of 0.80., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2020
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26. [Emergency care of patients with myocardial infarction: from the onset of symptoms until opening the vessel].
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Jánosi A, Csató G, Pach FP, Guti S, Pápai G, Erdős G, Fontos G, and Andréka P
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- Humans, Hungary, Myocardial Infarction diagnosis, Time Factors, Treatment Outcome, Emergency Medical Services statistics & numerical data, Myocardial Infarction surgery, Patient Transfer methods, Percutaneous Coronary Intervention, Time-to-Treatment statistics & numerical data
- Abstract
Introduction and aim: The authors analyse emergency care data for 6878 patients treated for acute myocardial infarction (AMI) using data from the Hungarian Myocardial Infarction Registry (HUMIR) and the National Ambulance Service (NAS). Method: Patients received treatment between 01/01/2017 and 31/12/2018, and all patients underwent percutaneous coronary intervention (PCI): 47.5% of patients had ST-elevation myocardial infarction (STEMI) and 3614 patients (52.5%) had non-ST-elevation myocardial infarction. The time between the beginning of the complaint and notification of NAS was regarded as the patient delay (PD). The time from the notification of NAS until arrival on the scene (M1), that of the on-site care (M2) and of the transport from the scene to the hospital (M3) were recorded. In-hospital care was evaluated from admission until opening the vessel ("door to balloon time"). The results were also broken down by counties. The median values and the quartiles (Q1, Q3) were given when the time was reported. Results: Patient delay in both types of infarction was unfavourably long: 101 minutes for STEMI and 687 minutes for NSTEMI. Immediate ambulance action was recorded in 58.7% for STEMI patients and 43.7% for NSTEMI patients. In both types of myocardial infarction, the median M1 time was 13 minutes, on-site care (M2) was 23 minutes, and M3 time was 30 minutes. In patients treated for STEMI, the time from hospital admission until opening the infarct-related artery was 37 minutes, and the total ischemic time was 243 minutes. In 9.5% of STEMI patients, the infarct-related artery was opened within 2 hours, in 49.1% within 4 hours, and in 88.1% within 12 hours. Significant differences were found between the counties for each of the periods examined. Conclusions: The PD is currently the biggest problem in providing optimal care timely for myocardial infarction patients. There are significant regional differences in rescue times, and further analysis is needed to investigate the causes. Orv Hetil. 2020; 161(12): 458-467.
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- 2020
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27. Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.
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Konigstein M, Srdanovic I, Gore AK, Rahim HM, Généreux P, Ben-Yehuda O, Kumsars I, Lesiak M, Kini A, Fontos G, Slagboom T, Ungi I, Christopher Metzger D, Crowley A, Leon MB, and Ali ZA
- Subjects
- Aged, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Restenosis etiology, Equivalence Trials as Topic, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Prosthesis Design, Risk Factors, Time Factors, Treatment Outcome, Coronary Artery Disease therapy, Percutaneous Coronary Intervention instrumentation, Stents
- Abstract
Objectives: We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs., Background: Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions., Methods: We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year., Results: Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (p
non-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052)., Conclusions: In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes., (© 2018 Wiley Periodicals, Inc.)- Published
- 2019
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28. [The first 200 transcatheter aortic valve implantations in the Gottsegen Gyorgy Institute of Cardiology, Hungary].
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Fontos G, Dékány G, Hegedüs N, Piróth Z, Amit Kumar C, Pál M, Mandzák A, Takács V, Varga A, Kovács A, Szabó G, and Andréka P
- Subjects
- Aged, Aged, 80 and over, Aortic Valve Stenosis diagnosis, Female, Humans, Hungary, Male, Middle Aged, Minimally Invasive Surgical Procedures statistics & numerical data, Treatment Outcome, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis statistics & numerical data, Heart Valve Prosthesis Implantation statistics & numerical data
- Abstract
Introduction: Transcatheter aortic valve implantation is a therapeutic alternative for contraindicated and high surgical risk patients with severe symptomatic aortic stenosis. This intervention is part of daily routine in the Institute of the authors., Aim: In the present work the results of the first 200 patients are discussed., Method: Until January, 2016, 200 patients (female 55%, mean age 79.9 years, average EuroSCORE 19.3%, left ventricular ejection fraction 54%, peak gradient 81.2 mmHg, mean aortic gradient 50.9 mmHg) underwent transcatheter aortic valve implantation., Results: The procedure was performed with 99% success rate. Complications were evaluated according to VARC 2 definitions. Mortality was 5% at one month and 17.4% at one year. Cardiac mortality was 13.6 at one year. Cerebrovascular complications were 5% within one year, and 95% of patients were in NYHA I or II functional classes at one year., Conclusion: These findings are consistent with worldwide results. Orv. Hetil., 2016, 157(45), 1786-1792.
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- 2016
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29. Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.
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Généreux P, Kini A, Lesiak M, Kumsars I, Fontos G, Slagboom T, Ungi I, Metzger DC, Wykrzykowska JJ, Stella PR, Bartorelli AL, Fearon WF, Lefèvre T, Feldman RL, Tarantini G, Bettinger N, Minalu Ayele G, LaSalle L, Francese DP, Onuma Y, Grundeken MJ, Garcia-Garcia HM, Laak LL, Cutlip DE, Kaplan AV, Serruys PW, and Leon MB
- Subjects
- Aged, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary mortality, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Stenosis diagnostic imaging, Coronary Stenosis mortality, Coronary Thrombosis etiology, Female, Humans, Male, Middle Aged, Myocardial Infarction etiology, Prospective Studies, Prosthesis Design, Risk Factors, Severity of Illness Index, Single-Blind Method, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary instrumentation, Coronary Artery Disease therapy, Coronary Stenosis therapy, Stents
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Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs., Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs)., Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA., Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004)., Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)
- Published
- 2016
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30. Five-year outcome of consecutive unprotected left main percutaneous coronary interventions.
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Piroth Z, Ferenci T, Fontos G, Szonyi T, Nemeth J, Szoke S, Chaurasia AK, and Andreka P
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- Aged, Female, Humans, Male, Middle Aged, Time Factors, Treatment Outcome, Coronary Stenosis surgery, Percutaneous Coronary Intervention methods
- Published
- 2016
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31. A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions.
- Author
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Généreux P, Kumsars I, Lesiak M, Kini A, Fontos G, Slagboom T, Ungi I, Metzger DC, Wykrzykowska JJ, Stella PR, Bartorelli AL, Fearon WF, Lefèvre T, Feldman RL, LaSalle L, Francese DP, Onuma Y, Grundeken MJ, Garcia-Garcia HM, Laak LL, Cutlip DE, Kaplan AV, Serruys PW, and Leon MB
- Subjects
- Coronary Angiography, Coronary Stenosis diagnostic imaging, Europe, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Single-Blind Method, Time Factors, Treatment Outcome, United States, Angioplasty, Balloon, Coronary methods, Coronary Stenosis surgery, Coronary Vessels surgery, Drug-Eluting Stents
- Abstract
Background: Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB)., Objectives: The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty., Methods: We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months., Results: We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p=0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p=0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p=0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p=0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis≥50%) at 9 months follow-up (22.6% vs. 26.8%, p=0.44)., Conclusions: Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2015
- Full Text
- View/download PDF
32. Left circumflex coronary artery occlusion due to a left atrial appendage closure device.
- Author
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Katona A, Temesvári A, Szatmári A, Nemes A, Forster T, and Fontos G
- Abstract
Nowadays, percutaneous left atrial appendage (LAA) closure is spreading, and a large number of patients with this procedure have concomitant coronary artery disease. With the presented case it could be concluded that coronary angiography is recommended before LAA closure.
- Published
- 2015
- Full Text
- View/download PDF
33. [Percutaneous left atrial appendage closure after resolution of left atrial appendage thrombi with dabigatran].
- Author
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Kis Z, Földesi C, Pál M, Som Z, Csillik A, Abrahám P, Temesvári A, Fontos G, Szatmári A, Andréka P, and Kardos A
- Subjects
- Anticoagulants administration & dosage, Atrial Fibrillation diagnostic imaging, Comorbidity, Dabigatran, Echocardiography, Transesophageal, Female, Heparin, Low-Molecular-Weight administration & dosage, Humans, Middle Aged, Obesity, Morbid complications, Risk Factors, Stroke prevention & control, Thrombosis diagnostic imaging, Treatment Outcome, beta-Alanine therapeutic use, Antithrombins therapeutic use, Atherectomy, Atrial Appendage diagnostic imaging, Atrial Appendage pathology, Atrial Fibrillation therapy, Benzimidazoles therapeutic use, Thrombosis drug therapy, beta-Alanine analogs & derivatives
- Abstract
The "gold standard" of the prevention of atrial fibrillation related thromboembolic events is anticoagulation therapy with oral vitamin K antagonists. A certain proportion of high-risk patients with atrial fibrillation are not receiving effective antithrombotic therapy because of problems associated with its use. Resolution of subsequent left atrial appendage thrombi is quite a great challenge in patients who are not tolerating "standard" antithrombotic drugs. According to the knowledge of the authors, this is the first report of a patient with non-valvular persistent atrial fibrillation and high stroke risk, who was intolerant to "standard" anticoagulant therapy and had persistent left atrial appendage thrombi following the use of a wide variety of "standard" anticoagulants. Successful resolution of left atrial appendage thrombi with dabigatran and successful percutaneous left atrial appendage closure were performed in this case.
- Published
- 2013
- Full Text
- View/download PDF
34. Ventricular septal rupture caused by myocardial bridge, solved by interventional closure device.
- Author
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Zóka A, Andréka P, Becker D, Fontos G, Merkely B, Szabó G, Szatmári A, and Bárczi G
- Subjects
- Aged, 80 and over, Echocardiography, Electrocardiography, Female, Heart Ventricles diagnostic imaging, Humans, Magnetic Resonance Imaging, Myocardium, Radiography, Septal Occluder Device, Myocardial Bridging complications, Ventricular Septal Rupture etiology, Ventricular Septal Rupture therapy
- Abstract
Myocardial bridging is a common coronary anomaly, which is generally described as a benign phenomenon. However, a growing number of studies consider this anomaly a relevant pathophysiological phenomenon with serious pathological consequences. Here we report on the case of an 88-year-old woman suffering from myocardial infarction and ventricular septal rupture, lacking any recognizable coronary disease except for a myocardial bridge causing the systolic compression of the left anterior descending coronary artery. A wide range of diagnostic procedures, including coronarography, echocardiography, and magnetic resonance imaging were used. The septal rupture was finally closed by using a percutaneous closure device. This event indicates that myocardial bridges - at least in some cases - may have notable clinical relevance.
- Published
- 2012
- Full Text
- View/download PDF
35. Acute coronary syndrome with unexpected background: rupture of left valsalva sinus aneurysm.
- Author
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Toth G, Fontos G, and Andreka P
- Subjects
- Aortic Rupture diagnosis, Aortic Rupture diagnostic imaging, Aortic Rupture surgery, Echocardiography, Transesophageal, Humans, Radiography, Acute Coronary Syndrome complications, Aortic Rupture complications, Sinus of Valsalva diagnostic imaging
- Published
- 2011
- Full Text
- View/download PDF
36. [Percutaneous closure of left atrial appendage in non-valvular atrial fibrillation--international and Hungarian experiences].
- Author
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Fontos G, Andréka P, Temesvári A, Wéber D, and Szatmári A
- Subjects
- Administration, Oral, Aged, Alloys, Anticoagulants administration & dosage, Atrial Appendage diagnostic imaging, Atrial Fibrillation complications, Atrial Fibrillation diagnostic imaging, Clinical Trials as Topic, Contraindications, Echocardiography, Transesophageal, Female, Heart Diseases prevention & control, Humans, Hungary, Male, Middle Aged, Prosthesis Design, Radiography, Risk Assessment, Risk Factors, Septal Occluder Device, Stents, Stroke etiology, Thoracoscopy, Thrombosis complications, Thrombosis etiology, Treatment Outcome, Atrial Appendage surgery, Atrial Fibrillation surgery, Cardiac Surgical Procedures instrumentation, Cardiac Surgical Procedures methods, Stroke prevention & control, Thrombosis prevention & control
- Abstract
In patients with non-valvular atrial fibrillation, efficacy of stroke prevention with oral anticoagulant therapy has been proved. Despite their high risk for thromboembolic events, there are substantial numbers of patients who are not candidates for long-term oral anticoagulant therapy, therefore the interest in alternative treatment strategies are in focus these days. The most common place within the heart for thrombus formation in patients with non-valvular atrial fibrillation is the left atrial appendage. Two devices specifically designed for percutaneous left atrial appendage closure are currently available in Europe: the WATCHMAN LAA system (Atritech, Inc) and the AMPLATZER Cardiac Plug (AGA Medical Corporation). Although present trial results (PLAATO, PROTECT AF) suggest that LAA closure may be performed at acceptable safety and it may reduce the long-term stroke risk, available data are still very limited. At present these procedures may be an acceptable alternative in selected high-risk patients with non-valvular atrial fibrillation who are not or suboptimal candidates for oral anticoagulant therapy. On 28. January, 2010 we performed the first three successful percutaneous left atrial appendage closure procedures in Gottsegen György Hungarian Institute of Cardiology in Hungary.
- Published
- 2010
- Full Text
- View/download PDF
37. [The first percutaneous aortic valve implantation in Hungary].
- Author
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Fontos G, Piróth Z, Szoke S, Tóth G, Vincze D, Szegedi M, Szüts K, Temesvári A, Hódi G, Székely L, Olev L, and Andréka P
- Subjects
- Aged, 80 and over, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis physiopathology, Humans, Hungary, Minimally Invasive Surgical Procedures methods, Patient Selection, Severity of Illness Index, Treatment Outcome, Aortic Valve surgery, Aortic Valve Stenosis surgery, Catheterization, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods
- Abstract
Aortic valve replacement can produce dramatic benefit in the setting of symptomatic aortic stenosis. The potential for morbidity and mortality associated with thoracotomy, cardiopulmonary bypass, and aortotomy has fostered a search for alternatives. Early experience with transcatheter endovascular aortic valve implantation demonstrated feasibility and efficacy, but the procedure was difficult to reproduce. However, equipment, techniques, and experience have evolved rapidly. Balloon-expandable and self-expanding prostheses and percutaneous femoral artery and open left ventricular apical access have found favor, each with potential advantages and disadvantages. Procedural success rates and clinical outcomes continue to improve. Current studies suggest that morbidity and mortality rates of percutaneous aortic valve implantations are much better in comparison to conventional surgery in selected high-risk patients. On November 11, 2008, in the Gottsegen György Hungarian Institute of Cardiology we performed the first two successful percutaneous aortic valve implantations in Central and Eastern Europe, following a more than one-year preparation period. After seven days the patients were discharged in very good conditions.
- Published
- 2009
- Full Text
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38. Drugs, gene transfer, signaling factors: a bench to bedside approach to myocardial stem cell therapy.
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Vertesaljai M, Piroth Z, Fontos G, Andreka G, Font G, Szantho G, Lueff S, Reti M, Masszi T, Ablonczy L, Juhasz ED, Simor T, Turner MS, and Andreka P
- Subjects
- Animals, Humans, Treatment Outcome, Cardiovascular Agents therapeutic use, Gene Transfer Techniques, Heart Failure therapy, Myocardial Infarction therapy, Point-of-Care Systems, Stem Cell Transplantation methods
- Abstract
In the past few years, the dogma that the heart is a terminally differentiated organ has been challenged. Evidence from preclinical investigations emerged that there are cells, even in the heart itself, that may be able to restore impaired cardiac function after myocardial infarction. Although the exact mechanisms by which the infarcted heart can be repaired by stem cells are not yet fully defined, there is a new optimism among cardiologists that this treatment will prove successful in addressing the cause of heart failure after myocardial infarction-myocyte loss. Despite the promising preliminary data of human myocardial stem cell trials, scientists have also focused on the possibility of enhancing the underlying mechanisms of stem cell repair to gain healthier myocardial tissue. Attempts to induce neo-angiogenesis by transfecting stem cells with signaling factors (such as VEGF), to raise the number of endothelial progenitor cells with medical treatments (such as statins), to transfect stem cells with heat shock protein 70 (as a cardioprotective agent against ischemia) and to enhance the healing process after myocardial infarction with the use of various forms of stimulating factors (G-CSF, SCF, GM-CSF) have been made with notable results. In this article, we summarize the evidence from preclinical and clinical myocardial stem cell studies that have addressed the possibility of enhancing the regenerative capacity of cells used after myocardial infarction.
- Published
- 2008
- Full Text
- View/download PDF
39. [Transient left ventricular apical akinesis with systolic dysfunction after physical exercise: a form of tako-tsubo syndrome].
- Author
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Vértesaljai M, Szoke S, Szonyi T, Piróth Z, Fontos G, Szüts K, Szegedi M, Böhm T, and Andréka P
- Subjects
- Adult, Coronary Angiography, Echocardiography, Electrocardiography, Female, Humans, Exercise, Takotsubo Cardiomyopathy diagnostic imaging, Takotsubo Cardiomyopathy etiology, Takotsubo Cardiomyopathy physiopathology, Ventricular Dysfunction, Left diagnostic imaging, Ventricular Dysfunction, Left etiology, Ventricular Dysfunction, Left physiopathology
- Abstract
A 43-year-old woman with mild hypertension and type-2 diabetes mellitus was presented to the coronary care unit because of ongoing chest pain and associated dyspnea after physical exercise. On arrival, her ECG disclosed ST-segment elevations in the precordial leads. The emergent cardiac catheterization failed to demonstrate coronary artery disease. The prompt performed transthoracic echocardiogram demonstrated systolic dysfunction with apical ballooning. Akinetic segments were irrespective of coronary artery anatomy. Laboratory tests revealed only slightly elevated cardiac enzymes: we observed a significant discrepancy between the extent of akinesis and the minimal increase in cardiac necroenzymes. The patient was medically managed and discharged in stable condition, with follow-up at 4 weeks demonstrating nearly total recovery of cardiac function and total resolution of wall motion disorder. Her clinical presentation is consistent with that of tako-tsubo cardiomyopathy, a syndrome that is characterized by transient apical regional wall motion abnormalities in the absence of epicardial coronary artery disease. Main precipitating factor is thought to be the cathecolamin excess due to emotional or physical stress, subarachnoid hemorrhage, phaeochromocytoma or cocaine use. The authors report the first physical exercise induced tako-tsubo syndrome in the Hungarian medical literature.
- Published
- 2008
- Full Text
- View/download PDF
40. [Drug-eluting coronary stents].
- Author
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Fontos G
- Subjects
- Cell Cycle drug effects, Cell Proliferation drug effects, Coronary Artery Disease drug therapy, Coronary Restenosis etiology, Coronary Restenosis metabolism, Cost-Benefit Analysis, Delayed-Action Preparations therapeutic use, Humans, Hungary, Muscle, Smooth, Vascular drug effects, Muscle, Smooth, Vascular pathology, Protein Kinases drug effects, TOR Serine-Threonine Kinases, Treatment Outcome, Tubulin Modulators therapeutic use, United States, Coronary Artery Disease metabolism, Coronary Artery Disease therapy, Coronary Restenosis prevention & control, Paclitaxel therapeutic use, Sirolimus therapeutic use, Stents economics, Stents standards
- Abstract
The first method of percutaneously treating a diseased vessel was developed by Dotter and Judkins in 1964. Andreas Grüntzig performed the first coronary angioplasty in 1977. In 1985 Palmaz et al. implanted the first balloon-mounted stent in a peripheral artery. Puel and Sigwart implanted the first human coronary stent in March 1986; it was a self-expanding mesh-like device. Schatz et al. applied some small modifications to the original Palmaz stent, which resulted in the first coronary stent available on the market, called Palmaz-Schatz stent. In 1987 Sigwart was the first to suggest the use of coronary stents in acute vessel occlusions during unsuccessful PTCA. Using the device it became possible to cover the intimal flap and to prevent elastic recoil. Because of the high incidence of subacute stent thromboses and the bleeding complications (aggressive anticoagulation regimens) these times the coronary stents were implanted only in order to avoid emergency CABG surgery. In 1993 BENESTENT and STRESS trials have proved that elective stent implantation can significantly reduce the incidence of restenosis. The dual antiplatelet therapy and the high pressure stent implantation technique dramatically reduced the incidence of subacute stent thrombosis. The treatment of coronary artery disease has undergone revolutionary changes in the past decade but remained the leading cause of mortality in the developed world. The most important limitation of PCI has been in-stent restenosis, which occurs in 20-40% of stent implantations. Clinically it results in recurrent ischemic episodes most often requiring repeat revascularisation (rePCI or CABG). With the use of drug-eluting stents the incidence of in-stent restenosis can be reduced dramatically, based on the currently available clinical trials it remains below 10%.
- Published
- 2006
41. [Experiences with the first, Hungarian autologous bone marrow cell transplantation in acute myocardial infarction].
- Author
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Vértesaljai M, Piróth Z, Fontos G, Tóth A, Simor T, Lueff S, Reményi P, Réti M, Masszi T, and Andréka P
- Subjects
- Angina Pectoris etiology, Coronary Angiography, Electrocardiography, Humans, Hungary, Magnetic Resonance Imaging, Myocardial Infarction complications, Myocardial Infarction pathology, Myocardial Infarction physiopathology, Retrospective Studies, Stroke Volume, Time Factors, Transplantation, Autologous, Treatment Outcome, Bone Marrow Transplantation, Myocardial Infarction surgery
- Abstract
Intracoronary transfer of autologous bone marrow cells promotes recovery of left ventricular systolic function in patients with acute myocardial infarction. Although the exact mechanisms of stem cell therapy are still intensely debated, the concept of stem cell therapy has already been introduced into the clinical practice--at least as an adjunctive therapy in clinical trials. In this article the authors report their experiences about the first Hungarian phase I. trial in bone marrow stem cell transplantation after acute myocardial infarction. So far, four patients with acute ST elevation myocardial infarction were eligible and recruited into the trial. All patients received purified, autologous bone marrow stem cells into the re-opened infarct related artery via a second catheterisation. The primary end point of the study is ejection fraction, which is measured by cardiac MRI at the beginning and 6 months after recruitment. So far, cell transfer did not increase the risk of adverse clinical events or proarrhythmic effects.
- Published
- 2006
42. [Stem cell therapy in cardiovascular diseases].
- Author
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Vértesaljai M, Piróth Z, Fontos G, Andréka G, Font G, Szánthó G, Réti M, Masszi T, and Andréka P
- Subjects
- Cardiovascular Diseases surgery, Clinical Trials, Phase I as Topic, Feasibility Studies, Heart Failure etiology, Heart Failure surgery, Humans, Myocardial Infarction pathology, Myocardial Infarction physiopathology, Ventricular Remodeling, Heart Failure prevention & control, Myocardial Infarction complications, Myocardial Infarction surgery, Myocytes, Cardiac pathology, Pluripotent Stem Cells transplantation, Stem Cell Transplantation
- Abstract
Myocardial infarction is the leading cause of congestive heart failure in the industrialized world. Current treatments fail to address the underlying scarring and cell loss, which are the causes of ischaemic heart failure. Recent interest has focused on stem cells, which are undifferentiated and pluripotent cells that can proliferate, potentially self-renew, and differentiate into cardiomyocytes and endothelial cells. Myocardial regeneration is the most widely studied and debated example of stem cell plasticity. Early reports from animal and clinical investigations disagree on the extent of myocardial renewal in adults, but evidence indicates that cardiomyocytes were generated in what was previously considered a postmitotic organ. So far, candidates for cardiac stem cell therapy have been limited to patients with acute myocardial infarction and chronic ischaemic heart failure. Currently, bone marrow stem cells seem to be the most attractive cell type for these patients. The cells may be delivered by means of direct surgical injection, intracoronary infusion, retrograde venous infusion, and transendocardial infusion. Stem cells may directly increase cardiac contractility or passively limit infarct expansion and remodeling. Early phase I clinical studies indicate that stem cell transplantation is feasible and may have beneficial effects on ventricular remodeling after myocardial infarction. Future randomized clinical trials will establish the magnitude of benefit and the effect on mortality after stem cell therapy.
- Published
- 2005
43. Treatment of patients suffering from dermatomycoses with nizoral tablet.
- Author
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Vánkos J, Fontos G, and Vajda Z
- Subjects
- Humans, Dermatomycoses drug therapy, Ketoconazole therapeutic use
- Published
- 1985
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