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1. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Author

Siqueira, Dimytri, Pinto, Ibraim, Cervone, Alberto, Assef, Jorge, Vilela, Andrea, Paladino, Antonio, Ramos, Auristela, Rezende, Mariana, Ghorayeb, Samira, Braga Silva, Tacianne Rolemberg, Gjorgjievska, Savica, Hadzibegovic, Irzal, Jurin, Ivana, Sipic, Tomislav, Pavlovic, Nikola, Rudez, Igor, Manola, Sime, GALLET DE SAINT-AURIN, Romain, BOUKANTAR, Madjid, NICOLAS, Eroan, ENNEZAT, Pierre Valdimir, URIEN, Jean Marie, Vincent, Flavien, Delhaye, Cedric, Denimal, Tom, Cosenza, Alessandro, Pamart, Thibault, Porouchani, Sina, Pontana, Francois, Montaigne, David, Balmette, Vincent, Bechiri, Mohamed, Chen, Elisabeth, Janah, Dany, Renker, Matthias, Westermann, Dirk, Valina, Christian, Ferenc, Miroslaw, Löffelhardt, Nikolaus, Rahimi, Faridun, Breitbart, Philipp, Franke, Kilian, Czerny, Martin, Diab, Nawras, Sick, Peter, Adeishvili, Medea, Mangner, Norman, Haussig, Stephan, Sveric, Krunuslav, Crusius, Lisa, Roehlig, Marie, Koliastasis, Leonidas, Drakopoulou, Maria, Katsaros, Odysseas, Ktenopoulos, Nikolaos, Ioanniadis, Andreas, Evangelou, Sotirios, Ninios, Ilias, Molnar, Levente, Papp, Roland, Arnold-Béla, Ferencz, Demeterné Kiss, Orsolya, Nagy, Andrea, Czimbalmos, Csilla, Pellegrinni, Dario, Montonati, Carolina, Pellicano, Mariano, Guagliumi, Giulio, Tespili, Maurizio, Barbara, Bellini, Filippo, Russo, Marco, Ancona, Ciro, Vella, Luca, Ferri, Eustachio, Agricola, Giacomo, Ingallina, Cannone, Gaspare, Brambilla, Nedy, Testa, Luca, Avondo, Stefano, Valvo, Roberto, Clarke, Robin, Fish, Mandy, Kosowski, Michal, Krawczyk, Magdalena, Kubler, Piotr, Kotwica, Tomasz, Teles, Rui, Gonçalves, Pedro, Raposo, Luis, Brito, Joã, Leal, Silvio, Freitas, Pedro, Ribeiras, Regina, Poliacikova, Petra, Mihailovic, Peter Marko, Terseglav, Simon, Steblovnik, Klemen, Cercek, Miha, Vitez, Luka, Sustersic, Miha, Kovac, Ana, Kogoj, Polonca, Dimitrovska, Ljupka, Arana, J.Raul Delgado, Martinez, Sandra Santos, Dieguez, Alfredo Redondo, Barrero, Alejandro, Gonzalez-Bartol, Esther, Aristizabal, Cristhian, Frutos, Ana Serrador, Luna, Juan Pablo Sanchez, Gomez, Mario Garcia, Gabella, Tania Rodriguez, Nelson, Verónica Quevedo, Medina, Jose Novoa, Ojeda, Soledad, de Lezo, Javier Suarez, Romero, Miguel, Gonzalez-Manzanares, Rafael, Alvarado, Marco, Mesa, Dolores, Perea, Jorge, Petursson, Petur, Alchay, Monér, Andréen, Sofie, Gameren, Menno Van, Heijer, Peter den, Meuwissen, Martijn, CHENG, JIN M., Vos, Jeroen, Schölzel, B.E., Simsek, C, Hubbers, S, Van den Branden, Ben J.L., Stens, NA, Versteeg, GAA, Rooijakkers, MJP, Gehlmann, HR, Verkroost, MWA, Geuzebroek, GSC, Van Wely, MH, Van Geuns, RJ, van Nunen, LX, van Garsse, LAFM, Timmers, L, ten Berg, Jurrien, Kraaijeveld, A.O., Dickinson, M.G., Dessing, T.C., Mokhles, M.M., Baumbach, Andreas, van Royen, Niels, Amat-Santos, Ignacio J, Hudec, Martin, Bunc, Matjaz, Ijsselmuiden, Alexander, Laanmets, Peep, Unic, Daniel, Merkely, Bela, Hermanides, Renicus S, Ninios, Vlasis, Protasiewicz, Marcin, Rensing, Benno J W M, Martin, Pedro L, Feres, Fausto, De Sousa Almeida, Manuel, van Belle, Eric, Linke, Axel, Ielasi, Alfonso, Montorfano, Matteo, Webster, Mark, Toutouzas, Konstantinos, Teiger, Emmanuel, Bedogni, Francesco, Voskuil, Michiel, Pan, Manuel, Angerås, Oskar, Kim, Won-Keun, Rothe, Jürgen, Kristić, Ivica, Peral, Vicente, Garg, Scot, Elzomor, Hesham, Tobe, Akihiro, Morice, Marie-Claude, Onuma, Yoshinobu, Soliman, Osama, and Serruys, Patrick W

Published
2024
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2. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Author

Baumbach, Andreas, primary, van Royen, Niels, additional, Amat-Santos, Ignacio J, additional, Hudec, Martin, additional, Bunc, Matjaz, additional, Ijsselmuiden, Alexander, additional, Laanmets, Peep, additional, Unic, Daniel, additional, Merkely, Bela, additional, Hermanides, Renicus S, additional, Ninios, Vlasis, additional, Protasiewicz, Marcin, additional, Rensing, Benno J W M, additional, Martin, Pedro L, additional, Feres, Fausto, additional, De Sousa Almeida, Manuel, additional, van Belle, Eric, additional, Linke, Axel, additional, Ielasi, Alfonso, additional, Montorfano, Matteo, additional, Webster, Mark, additional, Toutouzas, Konstantinos, additional, Teiger, Emmanuel, additional, Bedogni, Francesco, additional, Voskuil, Michiel, additional, Pan, Manuel, additional, Angerås, Oskar, additional, Kim, Won-Keun, additional, Rothe, Jürgen, additional, Kristić, Ivica, additional, Peral, Vicente, additional, Garg, Scot, additional, Elzomor, Hesham, additional, Tobe, Akihiro, additional, Morice, Marie-Claude, additional, Onuma, Yoshinobu, additional, Soliman, Osama, additional, Serruys, Patrick W, additional, Siqueira, Dimytri, additional, Pinto, Ibraim, additional, Cervone, Alberto, additional, Assef, Jorge, additional, Vilela, Andrea, additional, Paladino, Antonio, additional, Ramos, Auristela, additional, Rezende, Mariana, additional, Ghorayeb, Samira, additional, Braga Silva, Tacianne Rolemberg, additional, Gjorgjievska, Savica, additional, Hadzibegovic, Irzal, additional, Jurin, Ivana, additional, Sipic, Tomislav, additional, Pavlovic, Nikola, additional, Rudez, Igor, additional, Manola, Sime, additional, GALLET DE SAINT-AURIN, Romain, additional, BOUKANTAR, Madjid, additional, NICOLAS, Eroan, additional, ENNEZAT, Pierre Valdimir, additional, URIEN, Jean Marie, additional, Vincent, Flavien, additional, Delhaye, Cedric, additional, Denimal, Tom, additional, Cosenza, Alessandro, additional, Pamart, Thibault, additional, Porouchani, Sina, additional, Pontana, Francois, additional, Montaigne, David, additional, Balmette, Vincent, additional, Bechiri, Mohamed, additional, Chen, Elisabeth, additional, Janah, Dany, additional, Matthias, Renker, additional, Westermann, Dirk, additional, Valina, Christian, additional, Ferenc, Miroslaw, additional, Löffelhardt, Nikolaus, additional, Rahimi, Faridun, additional, Breitbart, Philipp, additional, Franke, Kilian, additional, Czerny, Martin, additional, Diab, Nawras, additional, Sick, Peter, additional, Adeishvili, Medea, additional, Mangner, Norman, additional, Haussig, Stephan, additional, Sveric, Krunuslav, additional, Crusius, Lisa, additional, Roehlig, Marie, additional, Koliastasis, Leonidas, additional, Drakopoulou, Maria, additional, Katsaros, Odysseas, additional, Ktenopoulos, Nikolaos, additional, Ioanniadis, Andreas, additional, Evangelou, Sotirios, additional, Ninios, Ilias, additional, Molnar, Levente, additional, Papp, Roland, additional, Arnold-Béla, Ferencz, additional, Demeterné Kiss, Orsolya, additional, Nagy, Andrea, additional, Czimbalmos, Csilla, additional, Pellegrinni, Dario, additional, Montonati, Carolina, additional, Pellicano, Mariano, additional, Guagliumi, Giulio, additional, Tespili, Maurizio, additional, Barbara, Bellini, additional, Filippo, Russo, additional, Marco, Ancona, additional, Ciro, Vella, additional, Luca, Ferri, additional, Eustachio, Agricola, additional, Giacomo, Ingallina, additional, Cannone, Gaspare, additional, Brambilla, Nedy, additional, Testa, Luca, additional, Avondo, Stefano, additional, Valvo, Roberto, additional, Clarke, Robin, additional, Fish, Mandy, additional, Kosowski, Michal, additional, Krawczyk, Magdalena, additional, Kubler, Piotr, additional, Kotwica, Tomasz, additional, Teles, Rui, additional, Gonçalves, Pedro, additional, Raposo, Luis, additional, Brito, João, additional, Leal, Silvio, additional, Freitas, Pedro, additional, Ribeiras, Regina, additional, Poliacikova, Petra, additional, Mihaolovic, Peter Marko, additional, Terseglav, Simon, additional, Steblovnik, Klemen, additional, Cercek, Miha, additional, Vitez, Luka, additional, Sustersic, Miha, additional, Kovac, Ana, additional, Kogoj, Polonca, additional, Dimitrovska, Ljupka, additional, Arana, J.Raul Delgado, additional, Martinez, Sandra Santos, additional, Dieguez, Alfredo Redondo, additional, Barrero, Alejandro, additional, Gonzalez-Bartol, Esther, additional, Aristizabal, Cristhian, additional, Frutos, Ana Serrador, additional, Luna, Juan Pablo Sanchez, additional, Gomez, Mario Garcia, additional, Gabella, Tania Rodriguez, additional, Nelson, Verónica Quevedo, additional, Medina, Jose Novoa, additional, Ojeda, Soledad, additional, de Lezo, Javier Suarez, additional, Romero, Miguel, additional, Gonzalez-Manzanares, Rafael, additional, Alvarado, Marco, additional, Mesa, Dolores, additional, Perea, Jorge, additional, Petursson, Petur, additional, Alchay, Monér, additional, Andréen, Sofie, additional, Van Gameren, Menno, additional, den Heijer, Peter, additional, Meuwissen, Martijn, additional, CHENG, JIN M., additional, Vos, Jeroen, additional, Schölzel, B.E., additional, Simsek, C, additional, Hubbers, S, additional, Stens, NA, additional, Versteeg, GAA, additional, Rooijakkers, MJP, additional, Gehlmann, HR, additional, Verkroost, MWA, additional, Geuzebroek, GSC, additional, Van Wely, MH, additional, Van Geuns, RJ, additional, van Nunen, LX, additional, van Garsse, LAFM, additional, Timmers, L, additional, ten Berg, Jurrien, additional, Kraaijeveld, A.O., additional, Dickinson, M.G., additional, Dessing, T.C., additional, and Mokhles, M.M., additional

Published
2024
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3. Long-term outcomes following paclitaxel-coated balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis in chronic coronary syndrome (CCS Dragon-Registry).

Author

Wańha, Wojciech, D'Ascenzo, Fabrizio, Kuźma, Łukasz, Januszek, Rafał, Iwańczyk, Sylwia, Tomasiewicz, Brunon, Brzozowski, Piotr, Niezgoda, Piotr, Kowalewski, Mariusz, Jaguszewski, Miłosz, Wybraniec, Maciej, Tomaniak, Mariusz, Pindlowski, Patryk, Kochman, Janusz, Kubler, Piotr, Dobrzycki, Sławomir, Bartuś, Stanisław, Lesiak, Maciej, Gąsior, Mariusz, and Witkowski, Adam

Published
2024
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4. Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

Author

Wańha W, Iwańczyk S, Januszek R, Wolny R, Tomasiewicz B, Kuliczkowski W, Reczuch K, Pawlus P, Pawłowski TZ, Kuźma Ł, Kubler P, Niezgoda P, Kubica J, Gil RJ, Pawłowski TF, Gąsior M, Jaguszewski M, Wybraniec M, Witkowski A, Kowalewski M, D'Ascenzo F, Greco A, Bartuś S, Lesiak M, Grygier M, Wojakowski W, and Cortese B

Subjects
Humans, Male, Female, Aged, Middle Aged, Treatment Outcome, Time Factors, Risk Factors, Angioplasty, Balloon, Coronary instrumentation, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary mortality, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention mortality, Prosthesis Design, Europe, Myocardial Infarction mortality, Myocardial Infarction etiology, Cardiac Catheters, Coronary Artery Disease therapy, Coronary Artery Disease mortality, Coronary Artery Disease diagnostic imaging, Sirolimus administration & dosage, Sirolimus adverse effects, Drug-Eluting Stents, Registries, Coronary Restenosis etiology, Coronary Restenosis diagnostic imaging, Coronary Restenosis mortality, Coronary Restenosis therapy, Coated Materials, Biocompatible, Cardiovascular Agents administration & dosage, Cardiovascular Agents adverse effects
Abstract

Background: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting., Methods: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up., Results: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P =0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P =0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P =0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P =0.329), target vessel revascularization (14.0% versus 13.1%; P =0.822), myocardial infarction (7.2% versus 4.5%; P =0.186), all-cause death (5.7% versus 4.2%; P =0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P =0.242) between DES and SCB treatment., Conclusions: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years., Competing Interests: None.

Published
2024
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5. Long-term outcomes following paclitaxel-coated balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis in chronic coronary syndrome (CCS Dragon-Registry).

Author

Wańha W, D'Ascenzo F, Kuźma Ł, Januszek R, Iwańczyk S, Tomasiewicz B, Brzozowski P, Niezgoda P, Kowalewski M, Jaguszewski M, Wybraniec M, Tomaniak M, Pindlowski P, Kochman J, Kubler P, Dobrzycki S, Bartuś S, Lesiak M, Gąsior M, Witkowski A, Kubica J, Gil RJ, Cortese B, Wojakowski W, and Wolny R

Subjects
Humans, Male, Female, Middle Aged, Aged, Treatment Outcome, Percutaneous Coronary Intervention, Angioplasty, Balloon, Coronary, Drug-Eluting Stents, Paclitaxel administration & dosage, Paclitaxel therapeutic use, Coronary Restenosis etiology, Registries
Abstract

Background: The long-term outcomes for patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied., Aims: We aimed to investigate the outcomes for patients with drug-eluting stents (DES)-ISR and CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES., Methods: A total of 846 consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin (strut thickness <100 μm) strut-DES (381 [45%]) or paclitaxel-DCB (465 [55%]) for DES-ISR were enrolled between February 2008 and October 2021. The median follow-up was 1006 (IQR 426-1770) days. The primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint (DOCE: cardiac death, TLR, or target vessel myocardial infarction [TV-MI])., Results: Patients who received DES, compared with those who received DCB, had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74]; P <0.001), TVR (HR, 0.56 [95% CI, 0.39-0.86]; P <0.001), and DOCE (HR, 0.63 [95% CI, 0.45-0.88]; P = 0.007). The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33-0.88]; P = 0.013), TVR (HR, 0.57 [95% CI, 0.41-0.80]; P = 0.009) and DOCE (HR, 0.65 [95% CI, 0.42-0.99]; P = 0.046) between the DES and DCB groups, respectively., Conclusions: In long-term follow-up of CCS patients undergoing PCI of ISR, the use of DES was associated with reduced rates of TLR, TVR, and DOCE compared with patients treated with DCB.

Published
2024
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