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23 results on '"Vlachojannis G"'

2. Direct stenting versus stenting after predilatation in STEMI patients with high thrombus burden: a subanalysis from the randomized COMPARE CRUSH trial

Author

Vogel, R F, primary, Delewi, R, additional, Wilschut, J M, additional, Lemmert, M E, additional, Diletti, R, additional, Nuis, R J, additional, Paradies, V, additional, Alexopoulos, D, additional, Zijlstra, F, additional, Montalescot, G, additional, Angiolillo, D J, additional, Krucoff, M W, additional, Van Mieghem, N M, additional, Smits, P C, additional, and Vlachojannis, G J, additional

Published
2022
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3. COMPARE LAAO: Rationale and design of the randomized controlled trial 'COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy'

Author

Huijboom, M., Maarse, M., Aarnink, E., Dijk, V. van, Swaans, M., Heijden, J. van der, Ijsselmuiden, S., Folkeringa, R., Blaauw, Y., Elvan, A., Stevenhagen, J., Vlachojannis, G., Voort, P. van der, Westra, S.W., Chaldoupi, M., Khan, M., Groot, J., Kley, F. van der, Mieghem, N. van, Dijk, E.J. van, Dijkgraaf, M., Tijssen, J., Boersma, L., Huijboom, M., Maarse, M., Aarnink, E., Dijk, V. van, Swaans, M., Heijden, J. van der, Ijsselmuiden, S., Folkeringa, R., Blaauw, Y., Elvan, A., Stevenhagen, J., Vlachojannis, G., Voort, P. van der, Westra, S.W., Chaldoupi, M., Khan, M., Groot, J., Kley, F. van der, Mieghem, N. van, Dijk, E.J. van, Dijkgraaf, M., Tijssen, J., and Boersma, L.

Abstract

Contains fulltext : 252137.pdf (Publisher’s version ) (Open Access), BACKGROUND: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. STUDY OBJECTIVES: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. STUDY DESIGN: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. SUMMARY: The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use. NCT TRIAL NUMBER: NCT04676880.

Published
2022

4. Platelet reactivity and bleeding outcomes in female patients presenting with ST-segment elevation myocardial infarction: a COMPARE CRUSH substudy

Author

Vogel, R F, primary, Vlachojannis, G J, additional, Wilschut, J M, additional, Lemmert, M E, additional, Diletti, R, additional, Nuis, R J, additional, Paradies, V, additional, Alexopoulos, D, additional, Zijlstra, F, additional, Montalescot, G, additional, Angiolillo, D J, additional, Krucoff, M W, additional, Van Mieghem, N M, additional, Smits, P C, additional, and Delewi, R, additional

Published
2021
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5. Ischemic signs on the post-resuscitation ECG in absence of STEMI is associated with lower survival. A COACT trial's sub-study

Author

Team Medisch, Circulatory Health, Spoormans, E., Lemkes, J. S., Janssens, G. N., Van der Hoeven, N. W., Soultana, O., Jewbali, L. S. D., Dubois, E. A., Meuwissen, M., Bosker, H. A., Bleeker, G. B., Vlachojannis, G. J., Van der Harst, P., Voskuil, M., Van De Ven, P., Van Royen, N., Team Medisch, Circulatory Health, Spoormans, E., Lemkes, J. S., Janssens, G. N., Van der Hoeven, N. W., Soultana, O., Jewbali, L. S. D., Dubois, E. A., Meuwissen, M., Bosker, H. A., Bleeker, G. B., Vlachojannis, G. J., Van der Harst, P., Voskuil, M., Van De Ven, P., and Van Royen, N.

Published
2021

6. Assessing the cardiology community position on transradial intervention and the use of bivalirudin in patients with acute coronary syndrome undergoing invasive management: results of an EAPCI survey

Author

Adamo, Marianna, Byrne, Robert A., Baumbach, Andreas, Haude, Michael, Windecker, Stephan, Valgimigli, Marco, Aaroe, J., Abdeltawab, A. A., Accardi, R., Addad, F., Agostoni, P., Alajab, A., Alcázar, E., Alhabil, B., Altug Cakmak, H., Amico, F., Amoroso, G., Anderson, R., Andò, G., Andreou, A. Y., Antoniadis, D., Aquilina, M., Aramberry, L., Auer, J., Auffret, V., Ausiello, A., Austin, D., Avram, A., Ayman, E., Babunashvili, V., Bagur, R., Bakotic, Z., Balducelli, M., Ballesteros, S. M., Baptista, S., Baranauskas, A., Barbeau, G., Bax, M., Benchimol, C., Berroth, R., Biasco, L., Bilal, A., Binias, K., Blanco Mata, R., Boccuzzi, G., Bolognese, L., Boskovic, S., Bourboulis, N., Briguori, C., Bunc, M., Buysschaert, I., Calabro’, P., Campo, G., Candiello, A., Caprotta, U. F., Cardenas, M., Carrilho-Ferreira, P., Carrizo, S., Caruso, M., Cassar, A., Cernigliaro, C., Chacko, G., Chamie, D., Clapp, B., Coceani, M., Colangelo, S., Colombo, A., Comeglio, M., Connaughton, M., Conway, D., Cortese, B., Cosgrave, J., Costa, F., Couvoussis, E., Crimi, G., Crook, R., Cruz-Alvarado, J. E., Curello, S., D’Ascenzo, F., D’Urbano, M., Dana, A., De Backer, O., De Carlo, M., De Cesare, N., De Iaco, G., De La Torre, H. J. M., De Oliveira Netoj, B., Devlin, G. P., Di Lorenzo, E., Díaz, A., Dina, C., Dorsel, T. H., Eberli, F. R., Echeverría, R., Eftychiou, C., Elguindy, A., Ercilla, J., Ernst, A., Esposito, G., Ettori, F., Eufracino, Null, Ezquerra Aguilera, W., Falcone, C., Falu, R. M., Feres, F., Ferlini, M., Fernández, G., Fernández-Rodríguez, D., Fileti, L., Fischetti, D., Florescu, N., Formigli, D., Fouladvand, F., Franco, N., Fresco, C., Frigoli, E., Furmaniuk, J., Gabaldo, K., Galli, M., Galli, S., Garbo, R., Garducci, S., Garg, S., Gavrielatos, G., Gensch, J., Giacchi, G., Giunio, L., Giustino, G., Goldberg, L., Goldsmit, R., Gommeaux, A., González Godínez, H., Gosselin, G., Govorov, A., Grimfjard, P., Gross, E., Grosz, C., Guagliumi, G., Hadad, W., Hadadi, L., Hansen, P. R., Harb, S., Hatrick, R., Hayrapetyan, H. G., Hernández-Enríquez, M., Ho Heo, J., Horvath, I. G., Huan Loh, P., Ibrahim, A. M., Ierna, S., Ilic, I., Imperadore, F., Ionescu-Silva, E., Jacksch, R., James, S., Janiak, B., Jensen, S. E., Jeroen, S., Jugessur, R. K., Kala, P., Kambis, M., Kanakakis, J., Karamasis, G., Karchevsky, D., Karpovskiy, A., Kayaert, P., Kedev, S., Kemala, E., Ketteler, T., Khan, S. Q., Kharlamov, A., Kiernan, T., Kiviniem, T., Koltowski, L., Koskinas, K. C., Kouloumpinis, A., Kraaijeveld, A. O., Krizanic, F., Krötz, B., Kuczmik, W., Kukreja, N., Kuksa, D., Yav, K., Kyriakos, D., Labrunie, A., Laine, M., Lapin, O., Larosa, C., Latib, A., Lattuca, B., Lauer, B., Lefèvre, T., Legrand, V., Lehto, P., Leiva-Pons, J. L., Leone, A. M., Lev, G., Lim, R., Limbruno, U., Linares Vicente, J. A., Lindsay, S., Linnartz, C., Liso, A., Lluberas, R., Locuratolo, N., Lokshyn, S., Lunde, K., Lupi, A., Magnavacchi, P., Maia, F., Mainar, V., Mancone, M., Manolios, M. G., Mansour, S., Mariano, E., Marques, K., Martins, H., Mckenzie, D., Meco, S., Meemook, K., Mehmed, K., Melikyan, A., Mellwig, K. P., Mendiz, O. A., Merkulov, E., Mesquita, H. G., Mezzapelle, G., Miloradovic, V., Mohamed, S., Mohammed, B., Mohammed, F., Mohammed, K., Mohanad, A., Morawiec, B., More, R., Moreno-Martínez, F. L., Mrevlje, B., Muhammad, F., Näveri, H., Nazzaro, M. S., Neary, P., Negus, B. H., Nelson Durval, F. G., Nick, H., Nilva, E., Oldroyd, K. G., Olivares Asencio, C., Omerovic, E., Ortiz, M. A., Ota, H., Otasevic, P., Otieno, H. A., Paizis, I., Papp, E., Pasquetto, G., Patsourakos, N. G., Peels, J., Pelliccia, F., Pennacchi, M., Penzo, C., Perez, P., Perkan, A., Petrou, E., Phipathananunth, W., Pierri, A., Pinheiro, L. F., Pipa, J. L., Piva, T., Polad, J., Porto, I., Poveda, J., Predescu, L., Prog, R., Puri, R., Raco, D. L., Ramazan, O., Ramazzotti, V., Rao, S. V., Raungaard, B., Reczuch, K., Rekik, S., Rhouati, A., Rigattieri, S., Rodríguez-Olivares, R., Roik, M., Romagnoli, E., Román, A. J., Routledge, H., Rubartelli, P., Rubboli, A., Ruiz-García, J., Russo, F., Ruzsa, Z., Ryding, A., Saad, Aly, Sabate, M., Sabouret, P., Sadowski, M., Saia, F., Sanchez Perez, I., Santoro, G. M., Sarenac, D., Saririan, M., Sarma, J., Schuetz, T., Sciahbasi, A., Sebastian, M., Sebik, R., Sesana, M., Hur, Seung-Ho, Sganzerla, P., Shalva, R., Sharma, S., Sheiban, I., Shein, K. K., Shiekh, I. A., Sinha, M., Slhessarenko, J., Smith, D., Smyth, D. W., Sönmez, K., Sood, N., Sourgounis, A., Srdanovic, I., Stables, R. H., Stefanini, G. G., Stewart, J., Stoyanov, N., Suliman, A. A., Suryadevara, R., Suwannasom, P., Tange Veien, K., Tauchert, S., Tebet, M., Testa, L., Thury, A., Tilsted, H. H., Tiroch, K., Torres, A., Tosi, P., Traboulsi, M., Trani, C., Tresoldi, S., Tsigkas, G., Tueller, D., Turri, M., Udovichenko, A. E., Uretsky, B., Van Der Harst, P., Van Houwelingen, K. G., Vandoni, P., Vandormael, M., Varbella, F., Venkitachalam, C. G., Vercellino, M., Vidal-Perez, R., Vigna, C., Vignali, L., Vogt, F., Voudris, V., Vranckx, P., Vrolix, M., Vydt, T., Webster, M., Wijns, W., Woody, W., Wykrzykowska, J., Yazdani, S., Yildiz, A., Yurlevich, D., Zauith, R., Zekanovic, D., Zhao, M., Zimarino, M., Zingarelli, A., Abdelsamad, A. Y., Abo Shaera, E. S., Afshar, M. S., Agatiello, C., Aguiar, P., Ahmad, A. M., Akin, I., Alameda, M., Alegría-Barrero, E., Alejos, R., Alkhashab, K., Alkutshan, R. S. A., Almorraweh, A., Altnji, I., Alvarez Iorio, C., Anchidin, O., Angel, J., Antonopoulos, A., Apshilava, G., Arana, C., Ashikaga, T., Assomull, R., Atef, S. Z., Azmus, A. D., Azzalini, L., Azzouz, A., Baglioni, P., Bampas, G., Basil, M. P., Baumbach, A., Besh, D., Bhushan Sharm, A., Bien Hsien, H., Bihui, L., Bing-Chen, L., Biryukov, S., Blatt, A., Bocchi, E., Boghdady, A., Bonarjee, V. V. S., Bosnjak, I., Bravo Baptista, S., Brinckman, S. L., Buchter, B., Burzotta, F., Cacucci, M., Cagliyan, C. E., Calabrò, P., Cernetti, C., Chávez Mizraym, R., Choo, W. S., Choudhury, R., Cicco, N., Cisneros Clavijo, P., Çitaku, H., Collet, J. P., Consuegra-Sánchez, L., Conte, M., Corral, J. M., Damonte, A., Dangoisse, V., Dastani, M., Della Rosa, F., Deora, S., Devadathan, S., Dharma, S., Di Giorgio, A., Diez, J. L., Dinesha, B., Duplančić, D., El Behwashi, M. F., Elghawaby, H., Elshahawy, O., Eskola, M. J., Etman, A., Eun Gyu, L., Fabiano, L., Facta, A., Fan, Y., Fang-Yang, H., Farag, E., Fathi, Y., Fazeli, N., Federico, P., Fereidoun, M. Z., Fernandez-Nofrerias, E., Flensted Lassen, J., Flessas, D., Fouad, H., Franco-Pelaez, J. A., Fu, Q., Furtado, R., Gadepalli, R., Gallino, R., Gasparetto, V., Gentiletti, A., Gholoobi, A., Ghosh, A. K., Gkizas, S., Golchha, S. K., Goncharov, A., Gössl, M., Götberg, M., Greco, F., Grundeken, M. J., Gupta, D., Gupta, S., Guray, U., Hahalis, G., Hakim Vista, J., Hamid, M. A., Hammoudeh, A., Hasan, A. R. I., Hatsumura, F. E., Heintzen, M. P., Helal, T., Hetherington, S., Hewarathna, U. I., Hioki, H., Hissein, F., Ho-Ping, Y., Homs, S., Huber, K., Ibarra, F. M., Ielasi, A., Ipek, E., Jambunathan, R., Jamshidi, P., Jarrad, I., Javier, W., Jensen, J., Jimenez-Quevedo, P., Kalpak, O., Kan, J., Kanaan, T., Kao, D. H. M., Karamfiloff, K., Karegren, A., Karjalainen, P. P., Kasabov, R., Katsimagklis, G. D., Kaul, U., Khan, A., Kiemeneij, E., Kiviniemi, T., Kleiban, A., Komiyama, N., Konteva, M., Koshy, G., Krepsky, A. M., Kuljit, S., Kulkarni, P., Kumar, V., Kuznetsov, I., Lai, G., Lateef, M. A., Lawand, S., Le Hong, T., Lettieri, C., Levy, G., Lindvall, P., Maitra, A., Makowski, M., Mamas, M. A., Mandal, S. C., Mangalanandan, P., Marin, R., Mashhadi, M., Matsukage, T., Meier, B., Milosavljevic, B., Miro, S. S., Mitov, A., Moeriel, M., Moguel, R., Mohanty, A., Montalescot, G., Mörsdorf, W., Moscato, F., Muniz, A., Muraglia, S., Myć, J., Nada, A., Nair, P., Namazi, M. H., Naraghipour, F., Nguyen, Q. N., Nicosia, A., Nikas, D., Ober, M., Ocaranza-Sánchez, R., Olivecrona, G., Pahlajani, D., Pandey, B. P., Parma, A., Parma, R., Patsilinakos, S. P., Pattam, J., Peddi, S., Perez, P. R., Peruga, J. Z., Pescoller, F., Petrov, I., Piatti, L., Pico-Aracil, F., Pina, J., Piroth, Z., Popa, V., Pourbehi, M. R., Pradhan, A. K., Prida, X. E., Purohit, B. V., Pyun, W. B., Quang Hung, D., Rada, I., Rafizadeh, O., Rahman, M. A., Rai, L., Ramsewak, A., Ravindran, R., Rodriguez De Leiras, O. S., Rodríguez Esteban, M., Roque Figueira, H., Saket, A., Sakhov, O., Saktheeswaran, M. K., Salachas, A., Sallam, A., Sampaolesi, A., Samy, A., Sanchis, J., Santaera, O., Santarelli, A., Santharaj, W. S., Sarango, B., Satheesh, S., Schmitz, T., Schühlen, H., Seewoosagur, R., Segev, A., Seisembekov, V., Semitko, S., Sengottuvelu, G., Sepulveda Varela, P., Sethi, A., Sharma, A., Sharma, R. K., Shi, Hy., Şimşek, M. A., Siqueira, B., Skalidis, E., Slawin, J., Sorokhtey, L., Spaulding, C., Srinivas, B., Srinivasan, M., Stakos, D., Stefanini, G., Stojkovic, S., Tacoy, G., Tawade, M., Tiecco, F., Tondi, S., Torresani, E. M., Tousek, P., Tran, T., Trantalis, G., Triantafyllou, K., Trivedi, R., Trivisonno, A., Tsui, K. L., Türkoğlu, C., Tzung-Dau, W., Ueno, H., Urban, U., Uretsky, B. F., Uscumlic, A., Venugopal, V., Verney, R., Vilar, J. V., Villacorta, V. G., Vishwanath, R., Vlachojannis, G. J., Vlachojannis, M., Vlad, V., Von Birgelen, C., Vukcevic, V., Wahab, A., Waksman, R., Wei-Wen, L., Weisz, G., Whittaker, A., Yadav, A., Yokoi, Y., Zacharoulis, A., Zahran, M., Zamani, J., Ziakas, A., Zimmermann, J. P., Adamo, M., Byrne, R. A., Baumbach, A., Haude, M., Windecker, S., Valgimigli, M., Aaroe, J., Abdeltawab, A. A., Accardi, R., Addad, F., Agostoni, P., Alajab, A., Alcazar, E., Alhabil, B., Altug Cakmak, H., Amico, F., Amoroso, G., Anderson, R., Ando, G., Andreou, A. Y., Antoniadis, D., Aquilina, M., Aramberry, L., Auer, J., Auffret, V., Ausiello, A., Austin, D., Avram, A., Ayman, E., Babunashvili, V., Bagur, R., Bakotic, Z., Balducelli, M., Ballesteros, S. M., Baptista, S., Baranauskas, A., Barbeau, G., Bax, M., Benchimol, C., Berroth, R., Biasco, L., Bilal, A., Binias, K., Blanco Mata, R., Boccuzzi, G., Bolognese, L., Boskovic, S., Bourboulis, N., Briguori, C., Bunc, M., Buysschaert, I., Calabro', P., Campo, G., Candiello, A., Caprotta, U. F., Cardenas, M., Carrilho-Ferreira, P., Carrizo, S., Caruso, M., Cassar, A., Cernigliaro, C., Chacko, G., Chamie, D., Clapp, B., Coceani, M., Colangelo, S., Colombo, A., Comeglio, M., Connaughton, M., Conway, D., Cortese, B., Cosgrave, J., Costa, F., Couvoussis, E., Crimi, G., Crook, R., Cruz-Alvarado, J. E., Curello, S., D'Ascenzo, F., D'Urbano, M., Dana, A., De Backer, O., De Carlo, M., De Cesare, N., De Iaco, G., De La Torre, H. J. M., De Oliveira Netoj, B., Devlin, G. P., Di Lorenzo, E., Diaz, A., Dina, C., Dorsel, T. H., Eberli, F. R., Echeverria, R., Eftychiou, C., Elguindy, A., Ercilla, J., Ernst, A., Esposito, G., Ettori, F., Eufracino, Ezquerra Aguilera, W., Falcone, C., Falu, R. M., Feres, F., Ferlini, M., Fernandez, G., Fernandez-Rodriguez, D., Fileti, L., Fischetti, D., Florescu, N., Formigli, D., Fouladvand, F., Franco, N., Fresco, C., Frigoli, E., Furmaniuk, J., Gabaldo, K., Galli, M., Galli, S., Garbo, R., Garducci, S., Garg, S., Gavrielatos, G., Gensch, J., Giacchi, G., Giunio, L., Giustino, G., Goldberg, L., Goldsmit, R., Gommeaux, A., Gosselin, G., Govorov, A., Gonzalez Godinez, H., Gross, E., Grosz, C., Guagliumi, G., Hadad, W., Hadadi, L., Hansen, P. R., Harb, S., Hatrick, R., Hayrapetyan, H. G., Hernandez-Enriquez, M., Ho Heo, J., Horvath, I. G., Huan Loh, P., Ibrahim, A. M., Ierna, S., Ilic, I., Imperadore, F., Ionescu-Silva, E., Jacksch, R., James, S., Janiak, B., Jensen, S. E., Jeroen, S., Jugessur, R. K., Kala, P., Kambis, M., Kanakakis, J., Karamasis, G., Karchevsky, D., Karpovskiy, A., Kayaert, P., Kedev, S., Kemala, E., Ketteler, T., Khan, S. Q., Kharlamov, A., Kiernan, T., Kiviniem, T., Koltowski, L., Koskinas, K. C., Kouloumpinis, A., Kraaijeveld, A. O., Krizanic, F., Krotz, B., Kuczmik, W., Kukreja, N., Kuksa, D., Yav, K., Kyriakos, D., Labrunie, A., Laine, M., Lapin, O., Larosa, C., Latib, A., Lattuca, B., Lauer, B., Lefevre, T., Legrand, V., Lehto, P., Leiva-Pons, J. L., Leone, A. M., Lev, G., Lim, R., Limbruno, U., Linares Vicente, J. A., Lindsay, S., Linnartz, C., Liso, A., Lluberas, R., Locuratolo, N., Lokshyn, S., Lunde, K., Lupi, A., Magnavacchi, P., Maia, F., Mainar, V., Mancone, M., Manolios, M. G., Mansour, S., Mariano, E., Marques, K., Martins, H., Mckenzie, D., Meco, S., Meemook, K., Mehmed, K., Melikyan, A., Mellwig, K. P., Mendiz, O. A., Merkulov, E., Mesquita, H. G., Mezzapelle, G., Miloradovic, V., Mohamed, S., Mohammed, B., Mohammed, F., Mohammed, K., Mohanad, A., Morawiec, B., More, R., Moreno-Martinez, F. L., Mrevlje, B., Muhammad, F., Naveri, H., Nazzaro, M. S., Neary, P., Negus, B. H., Nelson Durval, F. G., Nick, H., Nilva, E., Oldroyd, K. G., Olivares Asencio, C., Omerovic, E., Ortiz, M. A., Ota, H., Otasevic, P., Otieno, H. A., Paizis, I., Papp, E., Pasquetto, G., Patsourakos, N. G., Peels, J., Pelliccia, F., Pennacchi, M., Penzo, C., Perez, P., Perkan, A., Petrou, E., Phipathananunth, W., Pierri, A., Pinheiro, L. F., Pipa, J. L., Piva, T., Polad, J., Porto, I., Poveda, J., Predescu, L., Prog, R., Puri, R., Raco, D. L., Ramazan, O., Ramazzotti, V., Rao, S. V., Raungaard, B., Reczuch, K., Rekik, S., Rhouati, A., Rigattieri, S., Rodriguez-Olivares, R., Roik, M., Romagnoli, E., Roman, A. J., Routledge, H., Rubartelli, P., Rubboli, A., Ruiz-Garcia, J., Russo, F., Ruzsa, Z., Ryding, A., Saad, A., Sabate, M., Sabouret, P., Sadowski, M., Saia, F., Sanchez Perez, I., Santoro, G. M., Sarenac, D., Saririan, M., Sarma, J., Schuetz, T., Sciahbasi, A., Sebastian, M., Sebik, R., Sesana, M., Hur, S. -H., Sganzerla, P., Shalva, R., Sharma, S., Sheiban, I., Shein, K. K., Shiekh, I. A., Sinha, M., Slhessarenko, J., Smith, D., Smyth, D. W., Sonmez, K., Sood, N., Sourgounis, A., Srdanovic, I., Stables, R. H., Stefanini, G. G., Stewart, J., Stoyanov, N., Suliman, A. A., Suryadevara, R., Suwannasom, P., Tange Veien, K., Tauchert, S., Tebet, M., Testa, L., Thury, A., Tilsted, H. H., Tiroch, K., Torres, A., Tosi, P., Traboulsi, M., Trani, C., Tresoldi, S., Tsigkas, G., Tueller, D., Turri, M., Udovichenko, A. E., Uretsky, B., Van Der Harst, P., Van Houwelingen, K. G., Vandoni, P., Vandormael, M., Varbella, F., Venkitachalam, C. G., Vercellino, M., Vidal-Perez, R., Vigna, C., Vignali, L., Vogt, F., Voudris, V., Vranckx, P., Vrolix, M., Vydt, T., Webster, M., Wijns, W., Woody, W., Wykrzykowska, J., Yazdani, S., Yildiz, A., Yurlevich, D., Zauith, R., Zekanovic, D., Zhao, M., Zimarino, M., Zingarelli, A., Abdelsamad, A. Y., Abo Shaera, E. S., Afshar, M. S., Agatiello, C., Aguiar, P., Ahmad, A. M., Akin, I., Alameda, M., Alegria-Barrero, E., Alejos, R., Alkhashab, K., Alkutshan, R. S. A., Almorraweh, A., Altnji, I., Alvarez Iorio, C., Anchidin, O., Angel, J., Antonopoulos, A., Apshilava, G., Arana, C., Ashikaga, T., Assomull, R., Atef, S. Z., Azmus, A. D., Azzalini, L., Azzouz, A., Baglioni, P., Bampas, G., Basil, M. P., Besh, D., Bhushan Sharm, A., Bien Hsien, H., Bihui, L., Bing-Chen, L., Biryukov, S., Blatt, A., Bocchi, E., Boghdady, A., Bonarjee, V. V. S., Bosnjak, I., Bravo Baptista, S., Brinckman, S. L., Buchter, B., Burzotta, F., Cacucci, M., Cagliyan, C. E., Cernetti, C., Chavez Mizraym, R., Choo, W. S., Choudhury, R., Cicco, N., Cisneros Clavijo, P., Citaku, H., Collet, J. P., Consuegra-Sanchez, L., Conte, M., Corral, J. M., Damonte, A., Dangoisse, V., Dastani, M., Della Rosa, F., Deora, S., Devadathan, S., Dharma, S., Di Giorgio, A., Diez, J. L., Dinesha, B., Duplancic, D., El Behwashi, M. F., Elghawaby, H., Elshahawy, O., Eskola, M. J., Etman, A., Eun Gyu, L., Fabiano, L., Facta, A., Fan, Y., Fang-Yang, H., Farag, E., Fathi, Y., Fazeli, N., Federico, P., Fereidoun, M. Z., Fernandez-Nofrerias, E., Flensted Lassen, J., Flessas, D., Fouad, H., Franco-Pelaez, J. A., Fu, Q., Furtado, R., Gadepalli, R., Gallino, R., Gasparetto, V., Gentiletti, A., Gholoobi, A., Ghosh, A. K., Gkizas, S., Golchha, S. K., Goncharov, A., Gossl, M., Gotberg, M., Greco, F., Grundeken, M. J., Gupta, D., Gupta, S., Guray, U., Hahalis, G., Hakim Vista, J., Hamid, M. A., Hammoudeh, A., Hasan, A. R. I., Hatsumura, F. E., Heintzen, M. P., Helal, T., Hetherington, S., Hewarathna, U. I., Hioki, H., Hissein, F., Ho-Ping, Y., Homs, S., Huber, K., Ibarra, F. M., Ielasi, A., Ipek, E., Jambunathan, R., Jamshidi, P., Jarrad, I., Javier, W., Jensen, J., Jimenez-Quevedo, P., Kalpak, O., Kan, J., Kanaan, T., Kao, D. H. M., Karamfiloff, K., Karegren, A., Karjalainen, P. P., Kasabov, R., Katsimagklis, G. D., Kaul, U., Khan, A., Kiemeneij, E., Kiviniemi, T., Kleiban, A., Komiyama, N., Konteva, M., Koshy, G., Krepsky, A. M., Kuljit, S., Kulkarni, P., Kumar, V., Kuznetsov, I., Lai, G., Lateef, M. A., Lawand, S., Le Hong, T., Lettieri, C., Levy, G., Lindvall, P., Maitra, A., Makowski, M., Mamas, M. A., Mandal, S. C., Mangalanandan, P., Marin, R., Mashhadi, M., Matsukage, T., Meier, B., Milosavljevic, B., Miro, S. S., Mitov, A., Moeriel, M., Moguel, R., Mohanty, A., Montalescot, G., Morsdorf, W., Moscato, F., Muniz, A., Muraglia, S., Myc, J., Nada, A., Nair, P., Namazi, M. H., Naraghipour, F., Nguyen, Q. N., Nicosia, A., Nikas, D., Ober, M., Ocaranza-Sanchez, R., Olivecrona, G., Pahlajani, D., Pandey, B. P., Parma, A., Parma, R., Patsilinakos, S. P., Pattam, J., Peddi, S., Perez, P. R., Peruga, J. Z., Pescoller, F., Petrov, I., Piatti, L., Pico-Aracil, F., Pina, J., Piroth, Z., Popa, V., Pourbehi, M. R., Pradhan, A. K., Prida, X. E., Purohit, B. V., Pyun, W. B., Quang Hung, D., Rada, I., Rafizadeh, O., Rahman, M. A., Rai, L., Ramsewak, A., Ravindran, R., Rodriguez De Leiras, O. S., Rodriguez Esteban, M., Roque Figueira, H., Saket, A., Sakhov, O., Saktheeswaran, M. K., Salachas, A., Sallam, A., Sampaolesi, A., Samy, A., Sanchis, J., Santaera, O., Santarelli, A., Santharaj, W. S., Sarango, B., Satheesh, S., Schmitz, T., Schuhlen, H., Seewoosagur, R., Segev, A., Seisembekov, V., Semitko, S., Sengottuvelu, G., Sepulveda Varela, P., Sethi, A., Sharma, A., Sharma, R. K., Shi, Hy., Simsek, M. A., Siqueira, B., Skalidis, E., Slawin, J., Sorokhtey, L., Spaulding, C., Srinivas, B., Srinivasan, M., Stakos, D., Stojkovic, S., Tacoy, G., Tawade, M., Tiecco, F., Tondi, S., Torresani, E. M., Tousek, P., Tran, T., Trantalis, G., Triantafyllou, K., Trivedi, R., Trivisonno, A., Tsui, K. L., Turkoglu, C., Tzung-Dau, W., Ueno, H., Urban, U., Uretsky, B. F., Uscumlic, A., Venugopal, V., Verney, R., Vilar, J. V., Villacorta, V. G., Vishwanath, R., Vlachojannis, G. J., Vlachojannis, M., Vlad, V., Von Birgelen, C., Vukcevic, V., Wahab, A., Waksman, R., Wei-Wen, L., Weisz, G., Whittaker, A., Yadav, A., Yokoi, Y., Zacharoulis, A., Zahran, M., Zamani, J., Ziakas, A., Zimmermann, J. P., and Cardiology

Subjects
Hirudin, Percutaneous, Antithrombin, medicine.medical_treatment, Psychological intervention, 030204 cardiovascular system & hematology, medical, 0302 clinical medicine, Peptide Fragment, Surveys and Questionnaires, Surveys and Questionnaire, Medicine, Bivalirudin, 030212 general & internal medicine, Societies, Medical, Transradial, Anticoagulant, Hirudins, Middle Aged, Recombinant Protein, Recombinant Proteins, Femoral Artery, Radial Artery, Cardiology, acute coronary syndrome, bivalirudin, transradial, adult, antithrombins, cardiology, femoral artery, hirudins, humans, middle aged, peptide fragments, percutaneous coronary intervention, recombinant proteins, societies, medical, surveys and questionnaires, attitude of health personnel, radial artery, Acute coronary syndrome, Cardiology and Cardiovascular Medicine, Human, medicine.drug, Adult, medicine.medical_specialty, Attitude of Health Personnel, medicine.drug_class, MEDLINE, Antithrombins, 03 medical and health sciences, societies, Percutaneous Coronary Intervention, Internal medicine, Humans, Acute Coronary Syndrome, Peptide Fragments, Management of acute coronary syndrome, business.industry, Percutaneous coronary intervention, medicine.disease, business
Abstract

AIMS Our aim was to report on a survey initiated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) collecting the opinion of the cardiology community on the invasive management of acute coronary syndrome (ACS), before and after the MATRIX trial presentation at the American College of Cardiology (ACC) 2015 Scientific Sessions. METHODS AND RESULTS A web-based survey was distributed to all individuals registered on the EuroIntervention mailing list (n=15,200). A total of 572 and 763 physicians responded to the pre- and post-ACC survey, respectively. The radial approach emerged as the preferable access site for ACS patients undergoing invasive management with roughly every other responder interpreting the evidence for mortality benefit as definitive and calling for a guidelines upgrade to class I. The most frequently preferred anticoagulant in ACS patients remains unfractionated heparin (UFH), due to higher costs and greater perceived thrombotic risks associated with bivalirudin. However, more than a quarter of participants declared the use of bivalirudin would increase after MATRIX. CONCLUSIONS The MATRIX trial reinforced the evidence for a causal association between bleeding and mortality and triggered consensus on the superiority of the radial versus femoral approach. The belief that bivalirudin mitigates bleeding risk is common, but UFH still remains the preferred anticoagulant based on lower costs and thrombotic risks.

Published
2016
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8. 2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent

Author

Xu, B., Saito, Y., Baumbach, A., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., Lansky, A., Wijns, W., Xu, B., Saito, Y., Baumbach, A., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., Lansky, A., and Wijns, W.

Abstract

Item does not contain fulltext, OBJECTIVES: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. BACKGROUND: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. METHODS: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). CONCLUSIONS: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Published
2019

10. Rationale for catheter-based therapies in acute pulmonary embolism

Author

MS Interne Geneeskunde, Team Medisch, Longziekten, de Winter, M A, Vlachojannis, G J, Ruigrok, D, Nijkeuter, M, Kraaijeveld, A O, MS Interne Geneeskunde, Team Medisch, Longziekten, de Winter, M A, Vlachojannis, G J, Ruigrok, D, Nijkeuter, M, and Kraaijeveld, A O

Published
2019

11. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial

Author

Lansky, A., Wijns, W., Xu, B., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., Baumbach, A., Lansky, A., Wijns, W., Xu, B., Kelbaek, H., Royen, N. van, Zheng, M., Morel, M.A., Knaapen, P., Slagboom, T., Johnson, T.W., Vlachojannis, G., Arkenbout, K.E., Holmvang, L., Janssens, L., Ochala, A., Brugaletta, S., Naber, C.K., Anderson, R., Rittger, H., Berti, S., Barbato, E., Toth, G.G., Maillard, L., Valina, C., Buszman, P., Thiele, H., Schachinger, V., and Baumbach, A.

Abstract

Item does not contain fulltext, BACKGROUND: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population. METHODS: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180. FINDINGS: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6.1%)

Published
2018

12. Optical coherence tomography substudy of a prospective multicentre randomised post-market trial to assess the safety and effectiveness of the Firehawk cobalt-chromium coronary stent (rapamycin target-eluting) system for the treatment of atherosclerotic lesions: TARGET All Comers

Author

Baumbach, A., Lansky, A.J., Onuma, Y., Asano, T., Johnson, T., Anderson, R., Kiemeneij, F., Zheng, M., Royen, N. van, Slagboom, T., Vlachojannis, G., Xu, B., Serruys, P.W., Wijns, W., Baumbach, A., Lansky, A.J., Onuma, Y., Asano, T., Johnson, T., Anderson, R., Kiemeneij, F., Zheng, M., Royen, N. van, Slagboom, T., Vlachojannis, G., Xu, B., Serruys, P.W., and Wijns, W.

Abstract

Item does not contain fulltext, AIMS: Durable polymer drug-eluting stents (DP-DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this optical coherence tomography (OCT) substudy was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (Firehawk(R)) (BP-DES) versus the DP-DES (XIENCE) at 90 days in an all-comers patient population. METHODS AND RESULTS: The TARGET All Comers study is a prospective multicentre randomised post-market trial of 1,656 patients randomised 1:1 to Firehawk or XIENCE at 21 centres in 10 European countries. The TARGET OCT substudy enrolled 36 consecutive patients with 52 lesions at six centres proficient in OCT. Follow-up OCT was performed at three months or prior to revascularisation when occurring before the three-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions: Firehawk, n=24; XIENCE, n=28), was not significantly different between groups (Firehawk 75.5 mum vs. XIENCE V 82.3 mum) meeting the primary endpoint of non-inferiority (pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9+/-0.3% vs. 100+/-0.1%, p=0.26), and the proportion of malapposed struts (1.0+/-1.6% vs. 1.2+/-2.0%, p=0.51) was low in both groups. CONCLUSIONS: Based on OCT, the Firehawk BP-DES has a similar healing response three months after implantation compared to the DP-DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

Published
2018

14. Phosphorus control in peritoneal dialysis patients.

Author

Yavuz, A., Ersoy, F. F., Passadakis, P. S., Tam, P., Evaggelos, D. M., Katopodis, K. P., Özener, Ç., Akçiçek, F., Çamsari, T., Ateş, K., Ataman, R., Vlachojannis, G. J., Dombros, N. A., Utaş, C., Akpolat, T., Bozfakiogğlu, S., Wu, G., Karayaylali, I., Arinsoy, T., and Stathakis, C. P.

Subjects
*PERITONEAL dialysis, *PHOSPHORUS, *SERUM, *BLOOD plasma, *ALKALINE phosphatase
Abstract

Hyperphosphatemia is independently associated with an increased risk of death among dialysis patients. In this study, we have assessed the status of phosphate control and its clinical and laboratory associations in a large international group of patients on chronic peritoneal dialysis (PD) treatment. This cross-sectional multicenter study was carried out in 24 centers in three different countries (Canada, Greece, and Turkey) among 530 PD patients (235 women, 295 men) with a mean±s.d. age of 55±16 years and mean duration of PD of 33±25 months. Serum calcium (Ca2+), ionized Ca2+, phosphate, intact parathyroid hormone (iPTH), 25-hydroxy vitamin D3, 1,25-dihydroxy vitamin D3, total alkaline phosphatase, and bone alkaline phosphatase concentrations were investigated, along with adequacy parameters such as Kt/V, weekly creatinine clearance, and daily urine output. Mean Kt/V was 2.3±0.65, weekly creatinine clearance 78.5±76.6 l, and daily urine output 550±603 ml day−1. Fifty-five percent of patients had a urine volume of <400 ml day−1. Mean serum phosphorus level was 4.9±1.3 mg per 100 ml, serum Ca2+ 9.4±1.07 mg per 100 ml, iPTH 267±356 pg ml−1, ionized Ca2+ 1.08±0.32 mg per 100 ml, calcium phosphorus (Ca × P) product 39±19 mg2dl−2, 25(OH)D3 8.3±9.3 ng ml−1, 1,25(OH)2D3 9.7±6.7 pg ml−1, total alkaline phosphatase 170±178 U l−1, and bone alkaline phosphatase 71±108 U l−1. While 14% of patients were hypophosphatemic, with a serum phosphorus level lower than 3.5 mg per 100 ml, most patients (307 patients, 58%) had a serum phosphate level between 3.5 and 5.5 mg per 100 ml. Serum phosphorus level was 5.5 mg per 100 ml or greater in 28% (149) of patients. Serum Ca2+ level was 9.5 mg per 100 ml in 250 patients (49%), between 8.5 and 9.5 mg per 100 ml in 214 patients (40%), and lower than 8.5 mg per 100 ml in 66 patients (12%). Ca × P product was >55 mg2dl−2 in 136 patients (26%) and lower than 55 mg2dl−2 in 394 patients (74%). Serum phosphorus levels were positively correlated with serum albumin (P<0.027) and iPTH (P=0.001), and negatively correlated with age (P<0.033). Serum phosphorus was also statistically different (P = 0.013) in the older age group (>65 years) compared to younger patients; mean levels were 5.1±1.4 and 4.5±1.1 mg per 100 ml, respectively, in the two groups. In our study, among 530 PD patients, accepted uremic-normal limits of serum phosphorus control was achieved in 58%, Ca × P in 73%, serum Ca2+ in 53%, and iPTH levels in 24% of subjects. Our results show that chronic PD, when combined with dietary measures and use of phosphate binders, is associated with satisfactory serum phosporus control in the majority of patients.Kidney International (2008) 73, S152–S158; doi:10.1038/sj.ki.5002617 [ABSTRACT FROM AUTHOR]

Published
2008
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15. The value of computed tomography for head trauma in patients presenting with out-of-hospital cardiac arrest before emergency percutaneous coronary intervention.

Author

Bosch L, Rittersma SZH, van der Worp BH, Kraaijeveld AO, Vlachojannis G, van der Harst P, and Voskuil M

Abstract

Introduction: Out-of-hospital cardiac arrest (OHCA) caused by an ST-elevation myocardial infarction (STEMI) is often accompanied by a sudden loss of consciousness that may cause the patient to collapse with resulting head trauma, leading to a suspicion of possible intracranial haemorrhage. To rule out intracranial haemorrhage before emergency percutaneous coronary intervention (PCI), emergency computed tomography (CT) of the head might be useful but also causes a delay in percutaneous STEMI treatment., Methods: The medical records of all adult patients that presented with OHCA to the emergency department (ED) of the University Medical Centre Utrecht (UMCU), the Netherlands between 16 February 2020 and 16 February 2022 were reviewed., Results: A total of 263 patients presented to the ED with an OHCA; 50 presented with a STEMI requiring emergency PCI. Thirty-nine (78%) patients with a STEMI were immediately referred to the catheterisation laboratory and 11 (22%) STEMI patients underwent a CT scan prior to emergency angiography; in no case was PCI deferred on the basis of the CT findings. The dominant indication for CT of the head was collapse, reported by 10 patients and resulting in a visible traumatic head injury in 7 patients. In none of the patients was intracranial haemorrhage detected. However, there was a delay between presentation to the ED and arrival at the catheterisation laboratory in patients who underwent CT of the head (mean 63 ± 25 min) before emergency PCI compared to patients without a CT scan (mean 37 ± 21 min)., Conclusion: CT of the head did not result in a diagnosis of intracranial haemorrhage or deferral of PCI but did delay PCI treatment for STEMI in patients presenting with OHCA., (© 2023. The Author(s).)

Published
2024
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17. COMPARE LAAO: Rationale and design of the randomized controlled trial "COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy".

Author

Huijboom M, Maarse M, Aarnink E, van Dijk V, Swaans M, van der Heijden J, IJsselmuiden S, Folkeringa R, Blaauw Y, Elvan A, Stevenhagen J, Vlachojannis G, van der Voort P, Westra S, Chaldoupi M, Khan M, de Groot J, van der Kley F, van Mieghem N, van Dijk E, Dijkgraaf M, Tijssen J, and Boersma L

Subjects
Anticoagulants, Female, Humans, Male, Standard of Care, Treatment Outcome, Atrial Appendage surgery, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Stroke complications, Stroke prevention & control, Thromboembolism etiology, Thromboembolism prevention & control
Abstract

Background: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking., Study Objectives: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications., Study Design: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands., Summary: The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use., Nct Trial Number: NCT04676880., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2022
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18. 2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent.

Author

Xu B, Saito Y, Baumbach A, Kelbæk H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, Lansky A, and Wijns W

Subjects
Aged, Cardiovascular Agents adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Thrombosis etiology, Dual Anti-Platelet Therapy, Europe, Everolimus adverse effects, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Prospective Studies, Prosthesis Design, Risk Factors, Sirolimus adverse effects, Time Factors, Treatment Outcome, Absorbable Implants, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Drug-Eluting Stents, Everolimus administration & dosage, Percutaneous Coronary Intervention instrumentation, Polymers chemistry, Sirolimus administration & dosage
Abstract

Objectives: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent., Background: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial., Methods: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization., Results: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34)., Conclusions: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Published
2019
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19. Optical coherence tomography substudy of a prospective multicentre randomised post-market trial to assess the safety and effectiveness of the Firehawk cobalt-chromium coronary stent (rapamycin target-eluting) system for the treatment of atherosclerotic lesions: TARGET All Comers.

Author

Baumbach A, Lansky AJ, Onuma Y, Asano T, Johnson T, Anderson R, Kiemeneij F, Zheng M, Van Royen N, Slagboom T, Vlachojannis G, Xu B, Serruys PW, and Wijns W

Subjects
Chromium, Cobalt, Coronary Vessels, Europe, Humans, Neointima, Prospective Studies, Prosthesis Design, Sirolimus, Stents, Tomography, Optical Coherence, Treatment Outcome, Atherosclerosis, Coronary Artery Disease, Drug-Eluting Stents
Abstract

Aims: Durable polymer drug-eluting stents (DP-DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this optical coherence tomography (OCT) substudy was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (Firehawk®) (BP-DES) versus the DP-DES (XIENCE) at 90 days in an all-comers patient population., Methods and Results: The TARGET All Comers study is a prospective multicentre randomised post-market trial of 1,656 patients randomised 1:1 to Firehawk or XIENCE at 21 centres in 10 European countries. The TARGET OCT substudy enrolled 36 consecutive patients with 52 lesions at six centres proficient in OCT. Follow-up OCT was performed at three months or prior to revascularisation when occurring before the three-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions: Firehawk, n=24; XIENCE, n=28), was not significantly different between groups (Firehawk 75.5 μm vs. XIENCE V 82.3 μm) meeting the primary endpoint of non-inferiority (pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9±0.3% vs. 100±0.1%, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups., Conclusions: Based on OCT, the Firehawk BP-DES has a similar healing response three months after implantation compared to the DP-DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

Published
2018
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20. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial.

Author

Lansky A, Wijns W, Xu B, Kelbæk H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, and Baumbach A

Subjects
Aged, Equivalence Trials as Topic, Everolimus administration & dosage, Female, Humans, Intention to Treat Analysis, Male, Middle Aged, Prospective Studies, Prosthesis Design, Treatment Outcome, Absorbable Implants, Drug-Eluting Stents, Immunosuppressive Agents administration & dosage, Myocardial Ischemia surgery, Sirolimus administration & dosage
Abstract

Background: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population., Methods: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180., Findings: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6·1%) of 758 patients in the FIREHAWK group and in 45 (5·9%) of 764 patients in the XIENCE group (difference 0·2%, 90% CI -1·9 to 2·2, p non-inferiority =0·004, 95% CI -2·2 to 2·6, p superiority =0·88). There were no differences in ischaemia-driven revascularisation or stent thrombosis rates at 12 months. 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0·17 mm (SD 0·48) in the FIREHAWK group and 0·11 mm (0·52) in the XIENCE group (p=0·48), with an absolute difference of 0·05 mm (95% CI -0·09 to 0·18, p non-inferiority =0·024)., Interpretation: In a broad all-comers population of patients requiring stent implantation for myocardial ischaemia, the FIREHAWK was non-inferior to the XIENCE as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months. The FIREHAWK is a safe and effective alternative stent to treat patients with ischaemic coronary artery disease in clinical practice., Funding: Shanghai Microport Medical., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Published
2018
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21. Absorb bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD-ABSORB studies.

Author

Tarantini G, Masiero G, Barioli A, Paradies V, Vlachojannis G, Tellaroli P, Cortese B, di Palma G, Varricchio A, Ielasi A, Loi B, Steffenino G, Ueshima D, Mojoli M, and Smits P

Subjects
Aged, Cardiovascular Agents adverse effects, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease epidemiology, Coronary Thrombosis epidemiology, Everolimus adverse effects, Female, Humans, Incidence, Male, Middle Aged, Percutaneous Coronary Intervention adverse effects, Propensity Score, Prosthesis Design, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Absorbable Implants, Cardiovascular Agents administration & dosage, Coronary Artery Disease surgery, Drug-Eluting Stents, Everolimus administration & dosage, Metals, Percutaneous Coronary Intervention instrumentation
Abstract

Background: Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern., Objective: We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies., Methods: Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific., Results: Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04)., Conclusion: In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group., (© 2018 Wiley Periodicals, Inc.)

Published
2018
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22. Enhanced expression of group IIA secreted phospholipase A2 by elevated glucose levels in cytokine-stimulated rat mesangial cells and in kidneys of diabetic rats.

Author

Vlachojannis GJ, Scholz-Pedretti K, Fierlbeck W, Geiger H, Pfeilschifter J, and Kaszkin M

Subjects
Analysis of Variance, Animals, Blotting, Northern, Cells, Cultured, Diabetes Mellitus, Experimental physiopathology, Diabetic Nephropathies physiopathology, Disease Models, Animal, Enzyme Induction, Enzyme-Linked Immunosorbent Assay, Female, Gene Expression Regulation, Glomerular Mesangium drug effects, Hyperglycemia diagnosis, Kidney metabolism, Kidney physiopathology, Male, Phospholipases A genetics, Phospholipases A2, Probability, Promoter Regions, Genetic, RNA, Messenger analysis, Rats, Rats, Sprague-Dawley, Sensitivity and Specificity, Streptozocin, Cytokines pharmacology, Diabetic Nephropathies enzymology, Glomerular Mesangium cytology, Glomerular Mesangium enzymology, Hyperglycemia enzymology, Phospholipases A metabolism
Abstract

Background: Group IIA secreted phospholipase A2 (sPLA2-IIA) has been implicated in various inflammatory processes including the kidney. Previously it has been shown that potent proinflammatory cytokines such as interleukin 1beta (IL-1beta) increase sPLA2-IIA expression and secretion in rat mesangial cells., Aim: The present study examines the effects of glucose on sPLA2-IIA regulation in interleukin-1beta (IL-1beta) treated mesangial cell cultures and in diabetic kidneys of Sprague-Dawley rats., Materials and Methods: Rat mesangial cells were grown either in low glucose (5.55 mM D-Glucose) or high glucose (25 mM) conditions followed by assessment of sPLA2-IIA transcription, expression and secretion after 24 h. The model of streptozotocin induced diabetes mellitus in Sprague-Dawley rats was used for the in vivo experiments. Diabetic kidneys where examined for sPLA2-IIA-mRNA and -protein expression as well as IL-1beta-levels at 2, 4 and 6 weeks after induction of diabetes mellitus., Results: Increased concentration of glucose had a weak, but significant stimulatory effect on sPLA2-IIA expression, which was markedly up-regulated (2-3-fold) in IL-1beta treated mesangial cells compared to the levels obtained in low glucose medium. Concerning the underlying mechanism, we found that high concentration of glucose increased the activity of the rat sPLA2-IIA-promoter, whereas mRNA stability was not affected. Furthermore, the in vivo experiments revealed a marked up-regulation of sPLA2-IIA mRNA and protein in the diabetic rat kidneys 2 - 4 weeks after induction. Since the strong up-regulation of sPLA2-IIA in vitro under high glucose conditions occurred mainly in presence of cytokine, we measured the levels of IL-1beta in diabetic kidneys by ELISA. We detected rat IL-1beta only in diabetic, but not in control rat kidneys., Conclusions: The changes of sPLA2-IIA expression under increased glucose concentrations as well as in diabetic rat kidneys suggest a function of this enzyme as an acute phase protein providing lipid autacoids that may contribute to early changes in the course of diabetic nephropathy.

Published
2005
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23. Modulation of cytokine-induced expression of secretory phospholipase A2-type IIA by protein kinase C in rat renal mesangial cells.

Author

Scholz K, Vlachojannis GJ, Spitzer S, Schini-Kerth V, Van Den Bosch H, Kaszkin M, and Pfeilschifter J

Subjects
Animals, Cells, Cultured, Down-Regulation, Drug Interactions, Enzyme Induction, Enzyme Inhibitors pharmacology, Glomerular Mesangium cytology, Glomerular Mesangium drug effects, Glomerular Mesangium metabolism, Group II Phospholipases A2, Naphthalenes pharmacology, Phorbol Esters pharmacology, Phospholipases A antagonists & inhibitors, Phospholipases A genetics, Phospholipases A2, Protein Kinase C antagonists & inhibitors, RNA, Messenger metabolism, Rats, Thrombin pharmacology, Glomerular Mesangium enzymology, Interleukin-1 metabolism, Phospholipases A biosynthesis, Protein Kinase C metabolism
Abstract

Renal mesangial cells express the 14 kDa secretory phospholipase A2-type IIA (sPLA2-IIA) in response to interleukin-1beta (IL-1beta). In order to understand the regulation of cytokine-induced sPLA2-IIA induction in more detail, we investigated whether phorbol ester-activated protein kinase C (PKC) has an influence on the IL-1beta-induced expression of sPLA2-IIA. We found that treatment of mesangial cells with the biologically active phorbol 12-myristate 13-acetate (PMA) and phorbol 12,13-dibutyrate inhibited IL-1beta induction of sPLA2-IIA mRNA, protein, and activity, whereas the inactive compound 4alpha-phorbol 12,13-didecanoate was without effect. An 8-hr pretreatment with PMA, which led to down-regulation of PKC-alpha and -delta isoenzymes, still inhibited sPLA2-IIA induction. Only after down-regulation of PKC-epsilon isoenzyme by 24-hr preincubation with PMA were we able to reconstitute the IL-1beta-induced sPLA2-IIA expression. Thrombin as a physiological activator of PKC in mesangial cells exerted similar effects as PMA and inhibited sPLA2-IIA expression. The selective PKC inhibitor calphostin C potentiated IL-1beta induction of sPLA2-IIA mRNA levels and partially reconstituted the thrombin-induced inhibition of sPLA2-IIA mRNA and activity. These data show that IL-1beta induction of sPLA2-IIA can be modulated by PKC and that the epsilon-isoenzyme of the PKC family is the most likely candidate mediating the suppression of cytokine-induced sPLA2-IIA expression in mesangial cells.

Published
1999
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