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1. Use of cardiovascular registries in regulatory pathways:perspectives from the EU-MDR Cardiovascular Collaboratory

Author

Spitzer, E, Hernandez, JMD, Guomundsdottir, IJ, Mcfadden, E, Held, C, Hanet, C, Boersma, E, Ren, CB, Delgado, V, Erlinge, D, Prado, APD, Bax, JJ, Tijssen, JGP, Spitzer, E, Hernandez, JMD, Guomundsdottir, IJ, Mcfadden, E, Held, C, Hanet, C, Boersma, E, Ren, CB, Delgado, V, Erlinge, D, Prado, APD, Bax, JJ, and Tijssen, JGP

Abstract

On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.

Published
2024

2. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type

Author

Camenzind, Edoardo, Boersma, Eric, Wijns, William, Mauri, Laura, Rademaker-Havinga, Tessa, Ordoubadi, Farzin Fath, Suttorp, Maarten J., Al Kurdi, Mohammad, Steg, Ph Gabriel, Camenzind, E, Mauri, L, OʼNeill, W, Serruys, P W, Steg, PhG, Wijns, W, Verheugt, FWA, Bertrand, ME, Califf, R, DeMets, D, Wallentin, L, Bocksch, W, Bosmans, J, Garcia, H, Garg, S, Hanet, C, Herrman, J-PR, Kelbaek, H, Mc Fadden, E, Radke, PW, Rutsch, W, Tilsted, HH, Wykrzykowska, J, Alvarez, C, Rodriguez, A, Meredith, I, Muller, D, Whitbourn, R, Worthley, S, Whelan, A, Walters, D, Shetty, S, New, G, Cox, S, Batra, R, van Gaal, W, Bellamy, G, Mayr, H, Heigert, M, Huber, K, Leisch, F, Wijns, W, Desmet, W, Boland, J, Schroeder, E, Chenu, P, Legrand, V, Labinaz, M, Teefy, P, Bertrand, O, Gao, R, Ge, J, Kala, P, Cervinka, P, Ureña, P, Hartikainen, J, Steg, G, Fajadet, J, Carrie, D, Gilard, M, Barragan, P, Lablanche, J-M, Koning, R, Eltchaninoff, H, Darremont, O, Leroy, F, Bertrand, B, Robert, G, Schiele, F, Chassaing, S, Bressollette, E, Brunel, P, Quilliet, L, Brunet, J, Pansieri, M, Sideris, G, Stratiev, V, Teiger, E, Lebreton, H, Bonnet, J-L, Karsenty, B, Delarche, N, Lusson, J-R, Cassagnes, J, Brachmann, J, Kurowski, V, Buerke, M, Schieffer, B, Scholtz, W, Wiemer, M, Fichtlscherer, S, Schächinger, V, Kupatt, C, Boekstegers, P, Genth-Zotz, S, Bode, C, Frey, N, Neumann, F-J, Witzenbichler, B, Pels, K, Strasser, R, Kuck, K-H, Hauptmann, K-E, Baldus, S, Heitzer, T, Haude, M, Hoffmann, E, Jung, W, Hoffmann, S, Schmitt, C, Dissmann, M, Pauschinger, M, Werner, G, Braun-Delleus, R, Burkhardt, D, Manz, M, Voudris, V, Sionis, D, Kang-Yin, M-L, Tse, T-S, Merkely, B, Mehta, A, Parikh, K, Kumar, V, Chandra, P, Rath, P, Hiremath, S, Crean, P, Daly, K, Kornowski, R, Kerner, A, Mosseri, M, Jafari, G, Giudice, P, Trani, C, Manari, A, Prati, F, Pangrazi, A, Bolognese, L, Jeong, M-H, Kim, M-Y, Kim, H-S, Park, S-J, Erglis, A, Kalnins, A, Wagner, D, Zambahari, R, Ong, T-K, Sim, K, den Heijer, P, Appelman, Y, Suttorp, M-J, de Smet, B, Koolen, J, Stella, P, Harding, S, Warwick, J, Maslowski, A, Abernethy, M, Devlin, G, Rotevatn, S, Myreng, Y, Ciecwierz, D, Peruga, J, Reczuch, K, Campante Teles, R, Farto, P, Abreu, E, Leitão-Marques, A, Pereira, H, Vinereanu, D, Alkasab, S, Mhish, H, Al Kurdi, M, Al Turki, F, Wong, P, Teo, S-G, Goicolea Ruigomez, F-J, Valdés Chávarri, M, Bethencourt Gonzalez, A, Iñiguez Romo, A, López Minguez, J, Hernández García, J-M, Diaz Fernández, J, Ruiz Salmeron, R, Martinez Elbal, L, Zueco, J, López-Palop, RF, Melgares, R, Diderholm, E, Kåregren, A, Herterich, O, Olivencrona, G, Fröbert, O, Roffi, M, Verin, V, Girod, G, Vuilliomenet, A, Hsieh, I-C, Wu, C-J, Gershlick, A, Densem, C, Doshi, S, Manoharan, G, McCarthy, P, De Belder, M, Mills, J, Fath-Ordoubadi, F, Simpson, I, Greenwood, J, Chamberlain-Webber, R, Khan, Z, Cotton, J, Gunning, M, Smith, D, Talwar, S, Holmberg, S, Purcell, I, Anderson, R, Alamgir, F, Beatt, K, Kelly, P, Moussavian, M, Aji, J, Prashad, R, Zankar, A, Banerjee, S, Lewis, S, McLaurin, B, Douglas, J, Brener, S, Gupta, A, Walters, L, Driesman, M, Aycock, R, Mego, C, Fisher, D, Frankel, R, and Satler, L

Published
2014
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4. Determinants of extrahospital delays in case of management of STEMI

Author

Schröder, E., primary, Bihin, B., additional, Gorani, A., additional, Dangoisse, V., additional, Guedes, A., additional, Hanet, C., additional, De Canniere, L., additional, Dive, A., additional, Feye, F., additional, Foret, F., additional, Vasile, M., additional, Darii, D., additional, and Morandini, E., additional

Published
2020
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5. Evaluation of antiplatelet agent (AP) prescribing in patients on direct oral anticoagulant (DOAC)

Author

UCL - (MGD) Département de pharmacie, UCL - SSS/LDRI - Louvain Drug Research Institute, UCL - (MGD) Service de chirurgie cardio-vasculaire et thoracique, UCL - (MGD) Service de cardiologie, Larock, Anne-Sophie, Spinewine, Anne, Laloux, P, Eucher, P, Hanet, C, UCL - (MGD) Département de pharmacie, UCL - SSS/LDRI - Louvain Drug Research Institute, UCL - (MGD) Service de chirurgie cardio-vasculaire et thoracique, UCL - (MGD) Service de cardiologie, Larock, Anne-Sophie, Spinewine, Anne, Laloux, P, Eucher, P, and Hanet, C

Published
2019

9. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type

Author

Camenzind, Edoardo, Boersma, Eric, Wijns, William, Mauri, Laura, Rademaker-Havinga, Tessa, Ordoubadi, Farzin Fath, Suttorp, Maarten J., Al Kurdi, Mohammad, Steg, Ph Gabriel, Camenzind, E., Mauri, L., O'Neill, W., Serruys, P W., Steg, PhG, Wijns, W., Verheugt, FWA, Bertrand, ME, Califf, R., DeMets, D., Wallentin, L., Bocksch, W., Bosmans, J., Garcia, H., Garg, S., Hanet, C., Herrman, J-PR, Kelbaek, H., Mc Fadden, E., Radke, PW, Rutsch, W., Tilsted, HH, Wykrzykowska, J., Alvarez, C., Rodriguez, A., Meredith, I., Muller, D., Whitbourn, R., Worthley, S., Whelan, A., Walters, D., Shetty, S., New, G., Cox, S., Batra, R., van Gaal, W., Bellamy, G., Mayr, H., Heigert, M., Huber, K., Leisch, F., Desmet, W., Boland, J., Schroeder, E., Chenu, P., Legrand, V., Labinaz, M., Teefy, P., Bertrand, O., Gao, R., Ge, J., Kala, P., Cervinka, P., Ureña, P., Hartikainen, J., Steg, G., Fajadet, J., Carrie, D., Gilard, M., Barragan, P., Lablanche, J-M, Koning, R., Eltchaninoff, H., Darremont, O., Leroy, F., Bertrand, B., Robert, G., Schiele, F., Chassaing, S., Bressollette, E., Brunel, P., Quilliet, L., Brunet, J., Pansieri, M., Sideris, G., Stratiev, V., Teiger, E., Lebreton, H., Bonnet, J-L, Karsenty, B., Delarche, N., Lusson, J-R, Cassagnes, J., Brachmann, J., Kurowski, V., Buerke, M., Schieffer, B., Scholtz, W., Wiemer, M., Fichtlscherer, S., Schächinger, V., Kupatt, C., Boekstegers, P., Genth-Zotz, S., Bode, C., Frey, N., Neumann, F-J, Witzenbichler, B., Pels, K., Strasser, R., Kuck, K-H, Hauptmann, K-E, Baldus, S., Heitzer, T., Haude, M., Hoffmann, E., Jung, W., Hoffmann, S., Schmitt, C., Dissmann, M., Pauschinger, M., Werner, G., Braun-Delleus, R., Burkhardt, D., Manz, M., Voudris, V., Sionis, D., Kang-Yin, M-L, Tse, T-S, Merkely, B., Mehta, A., Parikh, K., Kumar, V., Chandra, P., Rath, P., Hiremath, S., Crean, P., Daly, K., Kornowski, R., Kerner, A., Mosseri, M., Jafari, G., Giudice, P., Trani, C., Manari, A., Prati, F., Pangrazi, A., Bolognese, L., Jeong, M-H, Kim, M-Y, Kim, H-S, Park, S-J, Erglis, A., Kalnins, A., Wagner, D., Zambahari, R., Ong, T-K, Sim, K., den Heijer, P., Appelman, Y., Suttorp, M-J, de Smet, B., Koolen, J., Stella, P., Harding, S., Warwick, J., Maslowski, A., Abernethy, M., Devlin, G., Rotevatn, S., Myreng, Y., Ciecwierz, D., Peruga, J., Reczuch, K., Campante Teles, R., Farto, P., Abreu, E., Leitão-Marques, A., Pereira, H., Vinereanu, D., Alkasab, S., Mhish, H., Al Kurdi, M., Al Turki, F., Wong, P., Teo, S-G, Goicolea Ruigomez, F-J, Valdés Chávarri, M., Bethencourt Gonzalez, A., Iñiguez Romo, A., López Minguez, J., Hernández García, J-M, Diaz Fernández, J., Ruiz Salmeron, R., Martinez Elbal, L., Zueco, J., López-Palop, RF, Melgares, R., Diderholm, E., Kåregren, A., Herterich, O., Olivencrona, G., Fröbert, O., Roffi, M., Verin, V., Girod, G., Vuilliomenet, A., Hsieh, I-C, Wu, C-J, Gershlick, A., Densem, C., Doshi, S., Manoharan, G., McCarthy, P., De Belder, M., Mills, J., Fath-Ordoubadi, F., Simpson, I., Greenwood, J., Chamberlain-Webber, R., Khan, Z., Cotton, J., Gunning, M., Smith, D., Talwar, S., Holmberg, S., Purcell, I., Anderson, R., Alamgir, F., Beatt, K., Kelly, P., Moussavian, M., Aji, J., Prashad, R., Zankar, A., Banerjee, S., Lewis, S., McLaurin, B., Douglas, J., Brener, S., Gupta, A., Walters, L., Driesman, M., Aycock, R., Mego, C., Fisher, D., Frankel, R., and Satler, L.

Subjects
animal structures, cardiovascular diseases, equipment and supplies
Abstract

Aim To investigate the putative modifying effect of dual antiplatelet therapy (DAPT) use on the incidence of stent thrombosis at 3 years in patients randomized to Endeavor zotarolimus-eluting stent (E-ZES) or Cypher sirolimus-eluting stent (C-SES). Methods and results Of 8709 patients in PROTECT, 4357 were randomized to E-ZES and 4352 to C-SES. Aspirin was to be given indefinitely, and clopidogrel/ticlopidine for ≥3 months or up to 12 months after implantation. Main outcome measures were definite or probable stent thrombosis at 3 years. Multivariable Cox regression analysis was applied, with stent type, DAPT, and their interaction as the main outcome determinants. Dual antiplatelet therapy adherence remained the same in the E-ZES and C-SES groups (79.6% at 1 year, 32.8% at 2 years, and 21.6% at 3 years). We observed a statistically significant (P = 0.0052) heterogeneity in treatment effect of stent type in relation to DAPT. In the absence of DAPT, stent thrombosis was lower with E-ZES vs. C-SES (adjusted hazard ratio 0.38, 95% confidence interval 0.19, 0.75; P = 0.0056). In the presence of DAPT, no difference was found (1.18; 0.79, 1.77; P = 0.43). Conclusion A strong interaction was observed between drug-eluting stent type and DAPT use, most likely prompted by the vascular healing response induced by the implanted DES system. These results suggest that the incidence of stent thrombosis in DES trials should not be evaluated independently of DAPT use, and the optimal duration of DAPT will likely depend upon stent type (Clinicaltrials.gov number NCT00476957)

Published
2017

17. Quality control assessment in cardiac surgery: single center experience in aortic valve replacement by mechanical prosthesis

Author

Guillaume, L., primary, Schröder, E., additional, Bihin, B., additional, Michaux, I., additional, Dive, A., additional, Hanet, C., additional, Guédès, A., additional, Dangoisse, V., additional, Gabriel, L., additional, Seldrum, S., additional, Gérard, M., additional, Eucher, P.H., additional, Louagie, Y., additional, and Buche, M., additional

Published
2017
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18. Prediction of 30-day outcome for out of hospital cardiac arrest survivers (OHCAS)

Author

Higny, J., primary, Jamart, J., additional, De Cannière, L., additional, Boulouffe, C., additional, Muschart, X., additional, Gérard, V., additional, Vanpee, D., additional, Dive, A., additional, Evrard, P., additional, Feye, F., additional, Foret, F., additional, Darii, D., additional, Hanet, C., additional, Gabriel, L., additional, Dangoisse, V., additional, Guédès, A., additional, and Schröder, E., additional

Published
2017
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19. The influence of stent length on clinical and angiographic outcome in patients undergoing elective stenting for native coronary artery lesions; final results of the Magic 5L Study

Author

Foley, DP, Pieper, M, Wijns, W, Suryapranata, H (Harry), Grollier, G, Legrand, V, De Scheerder, I, Hanet, C, Puel, J, Mudra, H, Bonnier, JJRM, Colombo, A, Thomas, M, Probst, P, Morice, MC, Kleijne, J, Serruys, PWJC (Patrick), MAGIC 5L Investigators,, and Cardiology

Subjects
Male, medicine.medical_specialty, Percutaneous, medicine.medical_treatment, Coronary Disease, Coronary Angiography, Restenosis, Occlusion, medicine, Myocardial Revascularization, Humans, Cumulative incidence, Prospective Studies, Prospective cohort study, Aged, medicine.diagnostic_test, Unstable angina, business.industry, Stent, Middle Aged, medicine.disease, Survival Analysis, Surgery, Elective Surgical Procedures, Angiography, Female, Stents, Radiology, Cardiology and Cardiovascular Medicine, business
Abstract

Aims To prospectively evaluate the influence of stent length on 6 month clinical and angiographic outcome, in patients with native coronary lesions up to 45mm in length, undergoing elective Magic Wallstent implantation. Methods and Results On the basis of pre-procedural angiography, 276 patients (aged 61·3±10·2 years; 78·6% male; 41·7% unstable angina) with a total of 302 lesions were prospectively assigned to one of five different length categories of Magic Wallstent. Angiography in multiple matched projections before and after implantation and at 6 months follow-up was analysed at the core laboratory. Primary end-points for the efficacy analysis were cumulative incidence of major adverse cardiac events and quantitative coronary angiography analysis 6 months after stent implantation. Magic Wallstent implantation was successful in 301 of 302 lesions and in 98·6% a residual stenosis

Published
2001

20. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes

Author

Tricoci, P, Huang, Z, Held, C, Moliterno, Dj, Armstrong, Pw, Van de Werf, F, White, Hd, Aylward, Pe, Wallentin, L, Chen, E, Lokhnygina, Y, Pei, J, Leonardi, S, Rorick, Tl, Kilian, Am, Jennings, Lh, Ambrosio, G, Bode, C, Cequier, A, Cornel, Jh, Diaz, R, Erkan, A, Huber, K, Hudson, Mp, Jiang, L, Jukema, Jw, Lewis, Bs, Lincoff, Am, Montalescot, G, Nicolau, Jc, Ogawa, H, Pfisterer, M, Prieto, Jc, Ruzyllo, W, Sinnaeve, Pr, Storey, Rf, Valgimigli, M, Whellan, Dj, Widimsky, P, Strony, J, Harrington, Ra, Mahaffey, Kw, Huo, Y, Lixin, J, Isaza, D, Grande, P, Laine, M, Wong, L, Ofner, P, Yamaguchi, T, Park, Sj, Nordrehaug, Je, Providencia, L, Cheem, Th, Dalby, A, Betriu, A, Chen, Mf, Verheugt, F, Frye, Rl, Hochman, J, Steg, Pg, Bailey, Kr, Easton, Jd, Lincoff, A, Underwood, Fd, Wrestler, J, Larson, D, Vandyne, B, Kilian, A, Harmelin-Kadouri, R, Layton, L, Lipka, L, Petrauskas, S, Qidwai, M, Sorochuck, C, Temple, T, Mason, D, Sydlowski, D, Gallagher, B, Villasin, A, Beernaert, A, Douglas, S, Garrett, J, Wiering, J, Adriaenssens, T, Ganame, J, Hulselmans, M, Katz, Jn, Kayaert, P, La Gerche, A, Onsea, K, Zalewski, J, Johnson, A, O'Briant, J, Smith, M, Akerblom, A, Armaganijan, L, Bertolami, A, Brennan, M, da Ponte Nacif SA, de Campos Gonzaga, C, Dequadros, A, Déry, Jp, Dev, S, Ducrocq, G, Eapen, Zp, Echenique, L, Eggers, K, Garcia, H, Guimaraes, Hp, Hagstrom, E, Hanet, C, James, S, Jonelid, B, Kolls, Bj, Leiria, T, Leite, R, Lombardi, C, Lopes, Rd, Malagutti, P, Mathews, R, Mehta, Rh, Melloni, C, Piccini, Jp, Rodriques Soares, P, Roe, Mt, Shah, Br, Stashenko, G, Szczech, La, Truffa, A, Varenhorst, C, Vranckx, P, Williams, J, Kilaru, R, White, Ja, Binkowitz, B, He, W, Ramos, Ms, Hasbani, E, Farras, Ha, Luz del Valle, L, Zapata, G, Centeno, Ep, Hominal, M, Beloscar, J, Panno, M, Berli, M, Carlevaro, O, Wasserman, T, Lembo, L, Diez, F, Bettinotti, M, Allall, O, Macin, S, Hii, C, Bett, N, Aroney, C, Roberts-Thomson, P, Arstall, M, Horowitz, J, Prasan, A, Farshid, A, Rankin, J, Duffy, S, Sinhal, A, Hendricks, R, Waites, J, Hill, A, French, J, Adams, M, Soward, A, Dick, R, Jepson, N, Nelson, G, Thompson, P, Neunteufl, T, Pachinger, O, Leisch, F, Siostrzonek, P, Roithinger, F, Pieske, B, Weber, H, Eber, B, Zenker, G, Sinnaeve, P, Roosen, J, Vervoort, G, Coussement, P, Striekwold, H, Boland, J, Van Dorpe, A, Dujardin, K, Mertens, D, Vanneste, L, Celen, H, Lesseliers, H, Vrolix, M, Leone, A, De Maeseneire, S, Hellemans, S, Silva, Fa, Franken, M, Moraes JB Jr, Mora, R, Michalaros, Y, Perin, M, Guimaraes, Ae, da Silva DG, Mattos, Ma, Alves AR Jr, Hernandes, Me, Golin, V, da Silva SA, Ardito, W, Dery, Jp, Mukherjee, A, Tanguay, Jf, Kornder, J, Lutchmedial, S, Degrace, M, Klinke, P, Constance, C, Nogareda, G, Wong, G, Macdonald, P, Senaratne, M, Rupka, D, Halperin, F, Ramanathan, K, Natarajan, M, Lai, C, Brossoit, R, Tymchak, W, Rose, B, Dupuis, R, Mansour, S, Bata, I, Zadra, R, Turek, M, Madan, M, Le May, M, Leon, L, Perez, L, Yovaniniz, P, Pedemonte, O, Campos, P, Pincetti, C, Sepulveda, P, Li, W, Zhao, R, Li, Z, Yang, Y, Chen, J, Li, H, Jiang, Y, Li, D, Qu, P, Sun, Y, Zheng, Y, Zhou, C, Zhang, F, Wei, M, Wang, D, Lemus, J, Fernandez, Rl, Jaramillo, C, Ochoa, J, Velez, S, Cano, N, Lutz, J, Botero, R, Jaramillo, M, Saaib, J, Sanchez, G, Hernandez, H, Mendoza, F, Rizcala, A, Urina, M, Polasek, R, Motovska, Z, Zemanek, D, Ostransky, J, Kettner, J, Spinar, J, Groch, L, Ramik, C, Stumar, J, Linhart, A, Pleva, L, Niedobova, E, Macha, J, Vojacek, J, Stipal, R, Galatius, S, Eggert, S, Mickley, H, Egstrup, K, Pedersen, O, Hvilsted, L, Sykulski, R, Skagen, K, Dodt, K, Klarlund, K, Husted, S, Jensen, G, Melchior, T, Sjoel, A, Steffensen, Fh, Airaksinen, Ke, Laukkanen, Ja, Syvanne, Ms, Kotila, Mj, Mikael, K, Naveri, Hk, Hekkala, Am, Mustonen, Jn, Halkosaari, M, Ohlmann, P, Khalife, K, Dibon, O, Hirsch, Jl, Furber, A, Nguyen-Khac, Jo, Delarche, N, Probst, V, Lim, P, Bayet, G, Dauphin, R, Levai, L, Galinier, M, Belhassane, A, Wiedemann, Jy, Fouche, R, Coisne, D, Henry, P, Schiele, F, Boueri, Z, Vaquette, B, Davy, Jm, Cottin, Y, D'Houdain, F, Danchin, N, Cassat, C, Messner, P, Elbaz, M, Coste, P, Zemour, G, Maupas, E, Feldman, L, Soto, Fx, Ferrari, E, Haltern, G, Heuer, H, Genth-Zotz, S, Loges, C, Stellbrink, C, Terres, W, Ferrar, M, Zeymer, U, Brachmann, J, Mudra, H, Vohringer, Hf, vom Dah, J, Kreuzer, J, Hill, S, Kleinertz, K, Kadel, C, Appel, Kf, Nienabe, C, Behrens, S, Frantz, S, Mehrhof, F, Krings, P, Hengstenberg, C, Lueders, S, Hanefel, C, Krulls-Munch, J, Dorse, T, Leschke, M, Nogai, K, Butter, C, Darius, H, Fichtlscherer, Hp, Schmitt, C, Kasisk, Hp, Dorr, M, Fran, N, Jereczek, M, Wiemer, M, Nickenig, G, Boudriot, E, Werner, G, Altila, T, Strasser, R, Baldus, S, Desaga, M, Buerke, M, Land, S, Schunkert, H, Schulze, Ho, Holmer, S, Sohn, Hy, Burkhardt, W, Lauer, B, Schwimmbeck, P, Schoeller, R, Lapp, H, Gross, M, Kindermann, I, Schuster, P, Yu, Cm, Lee, S, Merkely, B, Apro, D, Lupkovics, G, Edes, I, Ungi, I, Piroth, Z, Csapo, K, Dezsi, Ca, Herczeg, B, Sereg, M, Butnaru, A, Lewis, B, Rosenschein, U, Mosseri, M, Turgeman, Y, Pollak, A, Shotan, A, Hammerman, H, Rozenman, Y, Gottlieb, S, Atar, S, Weiss, A, Marmor, A, Iakobishvili, Z, Mascia, F, De Cesare, N, Piovaccari, G, Ceravolo, R, Fiscella, A, Salvioni, A, Silvestri, O, Moretti, L, Severi, S, Carmina, Mg, De Caterina, R, Fattore, L, Terrosu, P, Trimarco, B, Ardissino, D, Uguccioni, L, Auguadro, C, Gregorio, G, De Ferrari, G, Testa, R, Evola, R, De Servi, S, Sganzerla, P, Vassanelli, C, Brunelli, C, Scherillo, M, Tamburino, C, Limido, A, Luzza, F, Percoco, Gf, Sinagra, G, Volpe, M, Crea, F, Fedele, F, Rasetti, G, Cinelli, F, Merlini, P, Sisto, F, Biancoli, S, Fresco, C, Corrada, E, Casolo, G, Santini, M, D'Alessandro, B, Antoniucci, D, Tuccillo, B, Assennato, P, Puccioni, E, Pasquetto, G, Perna, Gp, Morgagni, G, Takizawa, K, Kato, K, Oshima, S, Yagi, M, Asai, T, Kamiya, H, Hirokami, M, Sakota, S, Sueyoshi, A, Shimomura, H, Hashimoto, T, Miyahara, M, Matsumura, T, Nakao, K, Kakuta, T, Nakamura, S, Nishi, Y, Kawajiri, K, Nagai, Y, Takahashi, A, Ikari, Y, Hara, K, Koga, T, Fujii, K, Tobaru, T, Tsunoda, R, Uchiyama, T, Hirayama, H, Fujimoto, K, Sakurai, S, Tanigawa, T, Ohno, M, Yamamoto, E, Ikuta, S, Kato, A, Kikuta, K, Takami, A, Chong, Wp, Ong, Tk, Yusof, A, Maskon, O, Kahar, A, Breedveld, Rw, Bendermacher, Pe, Hamer, Bj, Oude Ophuis AJ, Nierop, Pr, Westendorp, Ic, Beijerbacht, Hp, Herrman, Jp, van 't Hof AW, Troquay, Rp, van der Meer, P, Peters, Rh, van Rossum, P, Liem, A, Pieterse, Mg, van Eck JW, van der Zwaan, C, Pasupati, S, Elliott, J, Tisch, J, Hart, H, Luke, R, Scott, D, Ternouth, I, White, H, Hamer, A, Harding, S, Wilkins, G, O'Meeghan, T, Harrison, N, Nilsen, D, Thalamus, J, Aaberge, L, Brunvand, H, Lutterbey, G, Omland, Tm, Eritsland, J, Wiseth, R, Aase, O, Campos, C, Horna, M, Toce, L, Salazar, M, Przewlocki, T, Ponikowski, P, Kasprzak, J, Kopaczewski, J, Musial, W, Mazurek, W, Kawecka-Jaszcz, K, Pluta, W, Dobrzycki, S, Loboz-Grudzien, K, Lewczuk, J, Karwowski, D, Grajek, S, Dudek, D, Trusz-Gluza, M, Kornacewicz-Jach, Z, Gil, R, Ferreira, J, Gavina, C, Ferreira, R, Martins, D, Garcia-Rinaldi, R, Ufret, R, Vazquez-Tanus, J, Banchs, H, Wong, A, Tan, Hc, Guerra, M, Ebrahim, I, Roux, J, Blomerus, P, Saaiman, A, Corbett, C, Pillay, T, Freeman, V, Horak, A, Zambakides, C, Burgess, L, Yoon, Jh, Ahn, Th, Gwon, Hc, Seong, Iw, Kim, Hs, Jeong, Mh, Kim, Yd, Chae, Sc, Hernandez, Jm, Pique, M, Fernandez Portales, J, Paz, Ma, Lopez Palop, R, Iniguez, A, Diaz Fernandez, J, Alvarez, P, Sanz, E, Heras, M, Sala, J, Goicolea, J, Cruz Fernandez, J, Serra, A, Fernandez Ortiz, A, Calle, G, Barriales, V, Albarran, A, Curos, A, Molano Casimiro FJ, Suarez, Ma, Franco, Sn, Bayon, J, Suarez, J, Belchi, J, Moreu, J, San Martin, M, Melgares Moreno, R, Aguirre Salcedo, J, Gonzalez Juanatey JR, Martinez Romero, P, Galache Osuna JG, Albertsson, P, Diderholm, E, Lycksell, M, Rasmanis, G, Swahn, E, Cherfan, P, Christensen, K, Lundman, P, Larson, Le, Vasko, P, Pripp, Cm, Johansson, A, Moccetti, T, Corti, R, Pieper, M, Mach, F, Eberli, F, Jeger, R, Rickli, H, Vogt, P, Windecker, S, Wu, Cj, Kao, Hl, Charng, Mj, Chang, Kc, Chen, Zc, Tsa, Cd, Shyu, Kg, Lai, Wt, Hsieh, Ic, Hou, Jy, Yeh, Hi, Ueng, Kc, Yin, Wh, Timurkaynak, T, Yigit, Z, Yilmaz, M, Boyaci, A, Sahin, M, Goktekin, O, Bozkurt, E, Ercan, E, Yildirir, A, Muthusamy, R, Keeling, P, Levy, T, Zaman, A, Cohen, A, Gorog, D, Baumbach, A, Oldroyd, K, Kadr, H, Tait, G, Bellenger, N, Davis, G, Shakespeare, C, Senior, R, Bruce, D, Uren, N, Trouton, T, Ahsan, A, Hamed, A, Malik, I, Sarma, J, Millar-Craig, M, Robson, H, Kennon, S, Sprigings, D, Brodie, B, Kang, Gs, Thomas, G, Cheng, Sc, Espinoza, A, Kassas, S, Jafar, Z, Kumar, P, Izzo, M, Wiseman, A, Chandna, H, Felten, W, D'Urso, M, Gudipati, Cr, Coram, R, Gill, S, Bengtson, J, Chang, M, Raisinghani, A, Blankenship, J, Harbor, Wf, Kraft, P, Ashraf, R, Chambers, J, Albirini, A, Malik, A, Ziada, K, Slepian, M, Taussig, A, Vernon, H, Jetty, P, Islam, Ma, Canaday, D, Martin, T, Burchenal, Jj, Gencheff, N, Nygaard, T, Panchal, V, Merritt, R, Abrahams, L, Lambert, C, Reyes, P, Leimbach, W, Chhabra, A, Caputo, R, Imburgia, M, Erickson, B, Kleiman, N, Hunter, J, Dehning, M, Graham, B, Strain, J, White, Jk, Mcgarvey, J Jr, Henderson, D, Treasure, C 2nd, Mirro, M, Pancholy, S, Helmy, T, Westerhausen, D, Dib, N, Penny, W, Kim, H, Degregorio, M, Jay, D, Kmonicek, J, Berlowitz, M, Starling, M, Langevin, E, Nelson, R, Singer, A, Siachos, A, Gibson, G, Parrott, C, Held, J, Puleo, P, Wolford, T, Omar, B, Brilakis, E, Lewis, S, Heller, L, Brener, S, Addo, T, Lieberman, S, Eisenberg, D, Feldman, R, Waksman, R, Waltman, J, Schulman, S, Bounds, C, Voyce, S, Batchelor, W, Dobies, D, Pasnoori, V, Chandrashekhar, Y, Vetrovec, G, Azrin, M, Spriggs, D, Hirsch, C, Smucker, M, Chetcuti, S, Stella, R, Levite, H, Shoukfeh, M, Vidovich, M, Saucedo, J, Fintel, D, Low, R, Gellman, J, Ahsan, C, Unks, Dm, Tolleson, T, Ceccoli, H, Aggarwal, K, Bhaktaram, V, Olson, C, Decaro, M, Kaluski, E, Mehta, V, Puma, J, Singh, V, Fulmer, J, Lewis, D, Khadra, S, Staniloae, C, East, M, Sundram, Ps, Anderson, J, Wasserman, H, Guy, D, Brill, D, Kruse, K, Ebrahimi, R, Nguyen, T, Keating, F, Srivastava, R, Wassmer, P, Todd, J 3rd, Stein, M, Hamzeh, I, Laxson, D, Hodson, R, Puri, S, Vijayaraghavan, K, Gazmuri, R, Chu, A, Vijay, N, Rabinowitz, A, Block, T, Agarwal, H, Martin, J, Zetterlund, P, Fortuin, D, Macdonell, A 3rd, Zouzoulas, S, Chepuri, V, Schmalfuss, C, Karve, M, Aviles, R, Lieberman, E, Amlani, M, Murphy, S, Shapiro, T, Herzog, E, Ariani, K, Bhagwat, R, Hockstad, E, Kai, W, Saririan, M, Roth, R, Weiland, F, Atassi, K, Harjai, K, Muhlestein, J, Marsh, R, Shokooh, S, Nahhas, A, Labroo, A, Mayor, M, Koshy, S, Tariq, M, Rayos, G, Jones, S, Klugherz, B, Dewey, R, Rashid, Hu, Wohns, D, Feiring, A, Bowles, M, Rohrbeck, S, Monroe, Vs, De Gottlieb, A, Gumm, D, Brown, C 3rd, Chang, D, Kalaria, V, Minisi, A, Joumaa, M, Josephson, R, Kleczka, J, Silver, K, Coleman, P, Brachfeld, C, Saltiel, F, Reiner, J, Carell, E, Hanovich, G, Rosenberg, M, Das, G, Blick, D, and Universitat de Barcelona

Subjects
Male, Pyridines, medicine.medical_treatment, Kaplan-Meier Estimate, law.invention, Lactones, Randomized controlled trial, law, Thrombin receptor antagonist, clopidogrel, placebo, thienopyridine derivative, vorapaxar, antithrombocytic agent, lactone, proteinase activated receptor 1, pyridine derivative, Coronary Artery Bypass, Vorapaxar, Cardiovascular diseases [NCEBP 14], Drugs, General Medicine, Middle Aged, Combined Modality Therapy, Cardiovascular diseases, Cardiovascular Diseases, Cardiology, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, Plaquetes sanguínies, Intracranial Hemorrhages, Major bleeding, Medicaments, medicine.drug, medicine.medical_specialty, Acute coronary syndrome, Bypass cardiopulmonary, Hemorrhage, Pharmacotherapy, Blood platelets, Double-Blind Method, Angioplasty, Internal medicine, medicine, Humans, Receptor, PAR-1, Acute Coronary Syndrome, Aged, business.industry, Malalties cardiovasculars, medicine.disease, Surgery, Bypass cardiopulmonar, business, Platelet Aggregation Inhibitors, Follow-Up Studies
Abstract

Item does not contain fulltext BACKGROUND: Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation. METHODS: In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization. RESULTS: Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P=0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P=0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P

Published
2012

21. Chronic competitive flow from a patent arterial or venous graft to the circumflex system does not impair the long-term patency of internal thoracic artery to left anterior descending grafts in patients with isolated predivisional left main disease: Long-term angiographic results of 2 different revascularization strategies

Author

Gaudino, Mario Fulvio Luigi, Massetti, Massimo, Farina, Piero, Hanet, C, Etienne, Py, Mazza, Andrea, Glineur, D., Gaudino, Mario Fulvio Luigi (ORCID:0000-0001-7529-438X), Massetti, Massimo (ORCID:0000-0002-7100-8478), Gaudino, Mario Fulvio Luigi, Massetti, Massimo, Farina, Piero, Hanet, C, Etienne, Py, Mazza, Andrea, Glineur, D., Gaudino, Mario Fulvio Luigi (ORCID:0000-0001-7529-438X), and Massetti, Massimo (ORCID:0000-0002-7100-8478)

Abstract

OBJECTIVE: To compare 2 different surgical approaches to treatment of patients with isolated predivisional stenosis of the left main coronary artery (IOSLM) and to evaluate the effect of chronic competitive flow from a patent arterial or venous graft to the circumflex system on the long-term patency of internal thoracic artery (ITA) to left anterior descending grafts. METHODS: Thirty-two patients with IOSLM were treated at our institutions during a 9-year period: 14 patients received double ITA grafts, whereas 18 underwent ITA graft plus saphenous vein (SV) bypass. All patients were reviewed clinically and angiographically at long-term follow-up. RESULTS: No patient died during hospitalization. At a mean follow-up of 96 ± 9 months 7 patients had died (6 from noncardiac causes) and 5 had experienced angina/ischemia recurrence, without differences between the 2 revascularization strategies. At control reangiography all ITA and SV grafts were found to be fully patent, without evidence of caliber reduction or string sign in the ITA. CONCLUSIONS: In patients with IOSLM, long-term ITA to left anterior descending artery patency is not jeopardized by chronic flow competition from a concomitant arterial or venous graft to the circumflex system. Notably, the addition of a second ITA graft or of a SV to the first ITA does not lead to differences in long-term angiographic patency. Our results minimize the role of flow competition in this setting and should be kept in mind when choosing the appropriate graft configuration.

Published
2014

23. The immediate and long-term effect of optimal balloon angioplasty on the absolute coronary blood flow velocity reserve. A subanalysis of the DEBATE study. Doppler Endpoints Balloon Angioplasty Trial Europe

Author

Piek, J. J., Boersma, E., Voskuil, M., di Mario, C., Schroeder, E., Vrints, C., Probst, P., de Bruyne, B., Hanet, C., Fleck, E., Haude, M., Verna, E., Voudris, V., Geschwind, H., Emanuelsson, H., Mühlberger, V., Peels, H. O., Serruys, P. W., and Other departments

Abstract

There are limited data regarding the immediate and long-term effect of balloon angioplasty on the coronary flow reserve evaluated in a multicentre setting. A total of 86 patients with one-vessel disease and normal left ventricular function were analysed before and after optimal balloon angioplasty (diameter stenosis 2.5 (46% vs 23% and 36% vs 16%, respectively; P 2.5. This patient group consists of patients prone to develop restenosis, while other patients are characterized by a persistently low coronary flow reserve, probably secondary to disturbed autoregulation and/or diffuse mild coronary atherosclerosis. Coronary flow reserve alterations in patients without restenosis were related to changes in hyperaemic blood flow velocity, suggesting that this phenomenon relates to epicardial remodelling

Published
2001

24. Angiographical and Doppler flow-derived parameters for assessment of coronary lesion severity and its relation to the result of exercise electrocardiography

Author

Piek, JJ, Boersma, E, di Mario, C, Schroeder, E, Vrints, C, Probst, P, de Bruyne, B, Hanet, C, Fleck, E, Haude, M, Verna, E, Voudris, [No Value], Geschwind, H, Emanuelsson, H, Muhlberger, [No Value], Serruys, PW, and Faculteit Medische Wetenschappen/UMCG

Subjects
coronary stenosis, BALLOON ANGIOPLASTY, MYOCARDIAL BLOOD-FLOW, ARTERY STENOSES, HUMANS, PRESSURE, VELOCITY RESERVE, GUIDE-WIRE, VALIDATION, DISEASE, exercise electrocardiography, intracoronary Doppler, DISTAL, angiography
Abstract

Aims Evaluation of angiographical and intracoronary Doppler-derived parameters of coronary stenosis severity. Methods and Results A total of 225 patients with one-vessel disease were studied before PTCA and at 6 months follow-up. Exercise electrocardiography was performed to document presence (n=157) or absence (n=138) of an ST segment shift (greater than or equal to 0.1 mV). Intracoronary blood flow velocity analysis was performed to determine the proximal/distal flow velocity ratio, the distal diastolic/systolic flow velocity ratio and coronary flow velocity reserve. Receiver operator characteristic curves were calculated to assess the predictive value of these variables compared with the exercise test. The distal coronary flow velocity reserve demonstrated the best linear correlation for both percentage diameter stenosis and minimum lumen diameter (r=0.67 and r=0.66; P Conclusions The distal coronary flow velocity reserve is the best intracoronary Doppler parameter for evaluation of coronary narrowings. Angiographical estimates of coronary lesion severity and distal coronary flow velocity reserve are good and independent predictors for the assessment of functional severity of coronary stenosis, emphasizing the complementary role of these parameters for clinical decision making. (C) 2000 The European Society of Cardiology.

Published
2000

28. Prognostic value of intracoronary flow velocity and diameter stenosis in assessing the short- and long-term outcomes of coronary balloon angioplasty - The DEBATE study (Doppler Endpoints Balloon Angioplasty Trial Europe)

Author

Serruys, PW, diMario, C, Piek, J, Schroeder, E, Vrints, C, Probst, P, deBruyne, B, Hanet, C, Fleck, E, Haude, M, Verna, E, Voudris, [No Value], Geschwind, H, Emanuelsson, H, Muhlberger, [No Value], Danzi, G, Ford, AJ, Boersma, E, and Faculteit Medische Wetenschappen/UMCG

Subjects
RESERVE, ARTERY DISEASE, stenosis, angioplasty, balloon, prognosis, RESTENOSIS, PRESSURE, STENT IMPLANTATION, GUIDE, VALIDATION
Abstract

Background The aim of this prospective, multicenter study was the identification of Doppler flow velocity measurements predictive of clinical outcome of patients undergoing single-vessel balloon angioplasty with no previous Q-wave myocardial infarction. Methods and Results In 297 patients, a Doppler guidewire was used to measure basal and maximal hyperemic flow velocities proximal and distal to the stenosis before and after angioplasty. In 225 patients with an angiographically successful percutaneous transluminal coronary angioplasty (PTCA), post-procedural distal coronary flow reserve (CFR) and percent diameter stenosis (DS%) were correlated with symptoms and/or ischemia at 1 and 6 months, with the need for target lesion revascularization, and with angiographic restenosis (defined as DS greater than or equal to 50% at follow-up). Logistic regression and receiver operator characteristic curve analyses were applied to determine the prognostic cutoff value of CFR and DS separately and in combination. Optimal cutoff criteria for predictors of these clinical events were DS, 35%; CFR, 2.5. A distal CFR after angioplasty >2.5 with a residual DS less than or equal to 35% identified lesions with a low incidence of recurrence of symptoms at 1 month (10% versus 19%, P=.149) and at 6 months (23% versus 47%, P=.005), a low need for reintervention (16% versus 34%, P=.024), and a low restenosis rate (16% versus 41%, P=.002) compared with patients who did nor meet these criteria. Conclusions Measurements of distal CFR after PTCA, in combination with DS%, have a predictive value, albeit modest for the short-and long-term outcomes after PTCA, and thus may be used to identify patients who will or will not benefit from additional therapy such as stent implantation.

Published
1997

31. Vasomotor response to ergometrine and nitrates of saphenous vein grafts, internal mammary artery grafts, and grafted coronary arteries late after bypass surgery

Author

Hanet C, Robert A, and William Wijns

Subjects
Male, Cardiac Catheterization, Time Factors, Isosorbide Dinitrate, Middle Aged, Coronary Angiography, Coronary Vessels, Vasomotor System, Methylergonovine, Image Processing, Computer-Assisted, Humans, Female, Saphenous Vein, Postoperative Period, Coronary Artery Bypass, Mammary Arteries, Internal Mammary-Coronary Artery Anastomosis
Abstract

In vitro studies have shown that the vasomotor response of internal mammary artery to vasoactive agents differs from that of saphenous vein.To assess whether the response in vivo to methylergometrine and to nitrates differs in saphenous vein grafts, internal mammary artery grafts, and coronary arteries, 25 patients were studied more than 6 months (range, 6-96 months) after surgery. Angiograms of saphenous vein grafts (n = 11) or mammary artery grafts (n = 14) were obtained in basal conditions, after intravenous infusion of 0.4 mg methylergometrine, and after intragraft infusion of 1 mg isosorbide dinitrate. Computerized quantitative angiography was used to assess the changes in luminal diameter of the bypass graft and of the grafted coronary artery (n = 11). Methylergometrine reduced the diameter of saphenous vein grafts by 6.9 +/- 7.4%, from 3.26 +/- 0.71 to 3.05 +/- 0.76 mm (p0.01), and that of grafted coronary arteries by 9.3 +/- 7.2% (NS compared with saphenous vein grafts), from 2.08 +/- 0.49 to 1.89 +/- 0.49 mm (p0.005). The diameter of internal mammary artery grafts did not change significantly, from 3.27 +/- 0.42 to 3.25 +/- 0.44 mm (-0.3 +/- 5.1%, p0.02 compared with saphenous vein grafts and p0.002 compared with coronary arteries). After isosorbide dinitrate, the diameter of both grafted coronary arteries and mammary artery grafts increased significantly (respectively to 2.46 +/- 0.62 mm and 3.44 +/- 0.43 mm), the vasodilatation being greater (p0.002) in coronary arteries (+17.8 +/- 9.8% in proportion to basal diameter, p0.001) than in mammary grafts (+5.5 +/- 3.3%, p0.001). The diameter of saphenous vein grafts returned to control values (3.28 +/- 0.70 mm, NS compared with basal); the changes in luminal diameter after nitrates (+0.7 +/- 3.1%, NS) were significantly smaller than for mammary artery grafts (p0.01) and for grafted coronary arteries (p0.001).Unlike internal mammary artery grafts, saphenous vein grafts constrict in response to methylergometrine and do not dilate in response to nitrates. These differences in vasomotor response could reflect heterogeneity in the sensitivity of vascular smooth muscle to these agents or differences in the basal level of vasomotor tone.

Published
1992

33. Flow-induced vasomotor response to tachycardia of the human internal mammary artery and saphenous vein grafts late following bypass surgery

Author

Hanet C, Schroeder E, Michel X, Cosyns J, Dion R, Verhelst R, and William Wijns

Subjects
Male, Time Factors, Cardiac Pacing, Artificial, Isosorbide Dinitrate, Middle Aged, Coronary Angiography, Adaptation, Physiological, Vasomotor System, Coronary Circulation, Tachycardia, Humans, Female, Saphenous Vein, Endothelium, Vascular, Postoperative Period, Coronary Artery Bypass, Internal Mammary-Coronary Artery Anastomosis
Abstract

Increasing blood flow results in endothelium-dependent vasodilation of angiographically normal epicardial coronary arteries in humans. To compare the ability of internal mammary artery (IMA) and saphenous vein (SV) used as coronary artery bypass grafts to adapt their vasomotor tone to an increase in myocardial blood flow demand induced by tachycardia, 10 IMA and seven SV grafts were studied by quantitative angiography more than 6 months (range, 6-82 months) after surgery in 17 patients. All grafts were angiographically smooth and implanted to large nonakinetic perfusion zones. Angiograms were obtained in basal sinus rhythm (71 +/- 10 beats/min), during atrial pacing (129 +/- 9 beats/min), and after intragraft infusion of 1 mg isosorbide dinitrate (ISDN). In basal sinus rhythm, the cross-sectional area of SV was superior to that of IMA (10.7 +/- 3.6 versus 5.4 +/- 1.7 mm2; p less than 0.01). All IMA dilated during pacing (+14.8 +/- 11.5%; p less than 0.005) and a further increase in IMA cross-sectional area occurred after ISDN (+27.4 +/- 20.1% versus basal; p less than 0.005). In contrast, SV failed to dilate during pacing (+0.3 +/- 5.4%; p = NS) and after ISDN (+0.7 +/- 6.0% versus basal; p = NS). Thus, an increase in myocardial blood flow demand induced by tachycardia results in dilation of IMA but not of SV grafted on coronary vessels. The ability of the endothelium to modulate the vasomotor tone of IMA grafts in response to changes in blood flow could contribute to their excellent long-term functional results after coronary artery bypass surgery.

Published
1991

34. An open multicenter registry to evaluate local heparin delivery following balloon angioplasty for the prevention of restenosis: preliminary results

Author

Camenzind, E., Legrand, V., Vrolix, M., Hanet, C., Wijns, W., Bauters, C., Aengevaeren, W.R.M., Heijer, P. den, Gershlick, T., Montauban van Swijndrecht, E., Meer, P..M. van der, Melkert, R., Serruys, P.W., Camenzind, E., Legrand, V., Vrolix, M., Hanet, C., Wijns, W., Bauters, C., Aengevaeren, W.R.M., Heijer, P. den, Gershlick, T., Montauban van Swijndrecht, E., Meer, P..M. van der, Melkert, R., and Serruys, P.W.

Abstract

Contains fulltext : 22774___.PDF (publisher's version ) (Open Access)

Published
1996

35. Multicenter evaluation of the phosphorylcholinecoated biodivYsio stent in short de novo coronary lesions: The SOPHOS study

Author

Boland, JL, primary, Corbeij, HAM, additional, Giessen, W Van Der, additional, Seabra-Gomes, R, additional, Suryapranata, H, additional, Wijns, W, additional, Hanet, C, additional, Suttorp, MJ, additional, Buller, C, additional, Bonnier, JJRM, additional, Colombo, A, additional, Birgelen, C Van, additional, Pieper, M, additional, Mangioni, JA, additional, Londero, H, additional, Carere, RG, additional, Hamm, CW, additional, Bonan, R, additional, Bartorelli, A, additional, and Kyriakides, ZS, additional

Published
2000
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36. Usefulness of quantitative and qualitative angiographic lesion morphology, and clinical characteristics in predicting major adverse cardiac events during and after native coronary balloon angioplasty

Author

Hermans, W.R.M. (Walter), Rensing, B.J.W.M. (Benno), Rutsch, W.R. (Wolfgang), Heyndrickx, G.R. (Guy), Danchin, N. (Nicolas), Mast, E.G. (Gijs), Hanet, C. (Claude), Lablanche, J.M. (Jean Marc), Rafflenbeul, W., Uebis, R., Balcon, R. (Rafael), Feyter, P.J. (Pim) de, Serruys, P.W.J.C. (Patrick), Foley, D.P. (David), Hermans, W.R.M. (Walter), Rensing, B.J.W.M. (Benno), Rutsch, W.R. (Wolfgang), Heyndrickx, G.R. (Guy), Danchin, N. (Nicolas), Mast, E.G. (Gijs), Hanet, C. (Claude), Lablanche, J.M. (Jean Marc), Rafflenbeul, W., Uebis, R., Balcon, R. (Rafael), Feyter, P.J. (Pim) de, Serruys, P.W.J.C. (Patrick), and Foley, D.P. (David)

Abstract

Major, adverse cardiac events (death, myocardial infarction, bypass surgery and reintervention) occur in 4 to 7% of all patients undergoing coronary balloon angioplasty. Prospectively collected clinical data, and angiographic quantitative and qualitative lesion morphologic assessment and procedural factors were examined to determine whether the occurrence of these events could be predicted. Of 1,442 patients undergoing balloon angioplasty for native primary coronary disease in 2 European multicenter trials, 69 had major, adverse cardiac procedural or in-hospital complications after ≥1 balloon inflation and were randomly matched with patients who completed an uncomplicated in-hospital course after successful angioplasty. No quantitative angiographic variable was associated with major adverse cardiac events in univariate and multivariate analyses. Univariate analysis showed that major adverse cardiac events were associated with the following preprocedural variables: (1) unstable angina (odds ratio [OR] 3.11; p < 0.0001), (2) type C lesion (OR 2.53; p < 0.004), (3) lesion location at a bend >45 ° (OR 2.34; p < 0.004), and (4) stenosis located in the middle segment of the artery dilated (OR 1.88; p < 0.03); and with the following postprocedural variable: angiographically visible dissection (OR 5.39; p < 0.0001). Muttivariate logistic analysis was performed to identify variables independently correlated with the occurrence of major adverse cardiac events. The preprocedural multivariate model entered unstable angina (OR 3.77; p < 0.0003), lesions located at a bend >45 ° (OR 2.87; p < 0.0005), and stenosis located in the middle portion of the artery dilated (OR 1.95; p < 0.04). If all variables were included, then angiographically visible dissection (OR 6.58; p < 0.0001), unstable angina (OR 3.46; p < 0.002) and lesions located at a bend >45 ° (OR 2.54; p < 0.006) were independent predictors of major adverse cardiac events.

Published
1993
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42. Focus on diastolic dysfunction: a new approach to heart failure therapy.

Author

Pouleur, H, Hanet, C, Gurne, O, and Rousseau, MF

Abstract

1. Although heart failure is commonly associated with depressed systolic function, there is increasing evidence that impaired diastolic performance is also universally present and might be a key determinant of symptoms, physical capacity and even survival in some subsets of patients. 2. Reduced diastolic distensibility increases cardiac filling pressure not only at rest, but even more during exercise when diastolic filling time is reduced. The increases in filling pressure and diastolic wall stress lead to pulmonary congestion and subendocardial ischaemia, it also triggers myocardial hypertrophy and a detrimental remodelling of the ventricular cavity. Perhaps even more importantly, impaired ventricular distensibility limits the use of the Frank- Starling mechanism, impairing systolic pump function and cardiac output adaptation during exercise. Therapies able to improve the distensibility of the ventricle are, therefore, desirable in heart failure. 3. Nitrates, angiotensin converting enzyme (ACE) inhibitors and diuretics may indirectly increase left ventricular chamber compliance by their effects on the right side of the heart. Cardiac glycosides do not improve myocardial relaxation and may even cause diastolic contracture at toxic doses. The new beta 1-adrenoceptor partial agonist, xamoterol, on the other hand, consistently lowers left ventricular filling pressure at rest and during exercise, and produces an increase in left ventricular dynamic compliance through the direct lusitropic effect of beta 1-adrenoceptor stimulation. These beneficial effects are maintained during prolonged therapy and also appear sufficient to slow the remodelling of the ventricular cavity. The improvement in symptoms and in exercise tolerance observed during xamoterol (Corwin, Carwin, Corwil, Xamtol, ICI 118,587) therapy might, therefore, be related to the improvement in left ventricular diastolic distensibility induced by this drug. [ABSTRACT FROM AUTHOR]

Published
1989
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43. Effects of nicardipine on myocardial metabolism and coronary haemodynamics: A review.

Author

HANET, C., ROUSSEAU, M. F., VINCENT, MARIE-FRANCOISE, and POULEUR, H.

Abstract

Nicardipine is a dilator of the coronary vasculature and has a membrane-stabilising effect in ischaemia. In animal models of infarction, it preserved ventricular pump function, and infarct size, wall thinning and left ventricular dilatation were lessened. Pre-treatment before coronary ligation in baboons reduced infarct size., Nicardipine protected myocytes from irreversible contracture when exposed to veratrine and calcium, unlike diltiazem and nifedipine., Intravenous nicardipine increases resting heart rate and mean arterial pressure, and reduces coronary vascular resistance. The coronary vasodilator effects are not affected by β-adrenoceptor blockade., During a cold-pressor test at constant heart rate, arterio-coronary sinus difference in oxygen and the myocardial lactate uptake were improved, along with better indices of left ventricular function. In pacing-stress tests, lactate extraction fraction reduction was improved., An atrial pacing study using MUGA scanning showed improvement or normalisation of ventricular wall motion., In pacing-induced angina, nicardipine reduced lactate production, glucose extraction and glutamate uptake from control levels, reflecting a faster recovery of aerobic metabolism., After PTCA, lactate production was less after intracoronary injection of nicardipine and lactate extraction returned earlier than in controls, indicating a protective effect on the ischaemic myocardium., In a long-term angina study, nicardipine increased exercise duration and reduced ST segment depression at peak exercise. Lactate uptake was increased, the extent being related to plasma levels of nicardipine. Alanine and glutamine production fell, transcardiac release of thromboxane B2 was reduced, and that of 6-keto-PGF1α increased., Nicardipine improves myocardial metabolism in ischaemia, by increasing oxygen delivery in such areas. No negative inotropic effects were noted, rather, left ventricular function improved at rest and during exercise. Afterload reduction is also seen, favouring blood flow redistribution to underperfused areas. Nicardipine may also help maintain the integrity of myocyte membrane in ischaemia. [ABSTRACT FROM AUTHOR]

Published
1986
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46. Effects of intracoronary infusion of nicardipine during silent ischaemia on myocardial metabolism and function.

Author

Hanet, C., Gurné, O., Hue, L., Caucheteux, D., Rousseau, M. F., and Pouleur, H.

Abstract

The effects of an intracoronary infusion of nicardipine (0.2 mg over 10 min) on myocardial substrate uptake and function were studied in 16 patients with coronary artery disease and angina pecloris. Silent ischaemia, demonstrated by myocardial lactate production, was induced twice by pacing below anginal threshold. Nicardipine or saline was randomly infused during the first or second pacing. During pacing with nicardipine, no systemic effect was noted but coronary sinus flow increased (+ 18%; P<0.015) and myocardial oxygen uptake decreased by 12% (P<0.025). Transcardiac lactate production did not improve (– 8 to – 10 μmol min−1; NS) but net lactate uptake, estimated from radiolabelled lactate uptake, tended to rise and the glutamine uptake increased from 1.8 to 5.5 μmol min−1 (P<0.04). During recovery after pacing, lactate production decreased faster and LV peak (+) dP/dt and relaxation rate were significantly better after nicardipine infusion than after saline. Thus, during silent ischaemia induced by an increased oxygen demand, intracoronary nicardipine did not prevent lactate release but allowed a faster metabolic and functional recovery. These beneficial effects of nicardipine could be explained by an improved myocardial perfusion or by an effect on intracelluiar calcium homeostasis. [ABSTRACT FROM PUBLISHER]

Published
1988
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47. Multicenter evaluation of the phosphorylcholinecoated biodivYsio stent in short de novo coronary lesions: The SOPHOS study

Author

Boland, JL, Corbeij, HAM, Van Der Giessen, W., Seabra-Gomes, R., Suryapranata, H., Wijns, W., Hanet, C., Suttorp, MJ, Buller, C., Bonnier, JJRM, Colombo, A., Van Birgelen, C., Pieper, M., Mangioni, JA, Londero, H., Carere, RG, Hamm, CW, Bonan, R., Bartorelli, A., and Kyriakides, ZS

Abstract

AIMS: The BiodivYsio™ stent (Biocompatibles Ltd, Farnham, UK) is coated with a phosphorylcholine (PC)-containin copolymer to confer biocompatibility. The SOPHOS (Study Of PHosphorylcholine coating On Stents) study was designed to assess the safety and efficacy of this novel coronary stent and by indirect comparison to indicate equivalence with other formal stent studies. METHODS AND RESULTS: Patients with angina and a single short ( R12 mm) de novo lesion in a native coronary artery of ≥2.75 mm diameter were included. A total of 425 patients were allocated in 24 centers. Clinical data were collected at one-, six- and nine-month follow-up. Angiography was performed before and after the stent implantation. In addition, in the first 200 patients (SOPHOS A) angiography was routinely performed at six months. The following 225 patients (SOPHOS B) were merely followed up clinically. The primary end-point of the study, the six-month MACE-rate (MACE = Major Adverse Cardiac Events) was 13.4% (two cardiac death; five Q-wave/nine non-Qwave myocardial infarctions (MI); nine CABG and 32 target lesion revascularization (TLR), which is similar to the calculated 15% MACE-rate in comparable reference studies. Secondary end-points included among others restenosis at six months in the SOPHOS A population. The target vessel diameter was 2.98 ±0.48 mm. Minimal lumen diameter pre/post procedure and at follow-up was 1.00 ±0.32, 2.69 ±0.37, 1.91 ±0.71mm, respectively. The binary restenosis rate ( ≥50% diameter stenosis at follow-up) was 17.7%. CONCLUSION: The coronary BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with stable or unstable angina pectoris. Clinical and angiographic results are in the statistical range of equivalence with comparable studies with other current stents. (Int J Cardiovasc Intervent 2000; 3: 215-225)

Published
2000
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48. Long-term clinical and angiographic follow-up of sequential internal thoracic artery grafting.

Author

Dion, R, Glineur, D, Derouck, D, Verhelst, R, Noirhomme, P, El Khoury, G, Degrave, E, and Hanet, C

Abstract

Sequential internal thoracic artery (ITA) grafting allows a more complete arterial revascularization of the myocardium. We wanted to verify whether the excellent clinical and angiographic short term results reported by us before where maintained over 10 years and more.

Published
2000
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49. Surgical angioplasty of the left main coronary artery.

Author

Dion, R, Elias, B, El Khoury, G, Noirhomme, P, Verhelst, R, and Hanet, C

Abstract

The conventional surgical treatment of isolated critical stenosis of the left main coronary artery (LMCA) leads to the definitive occlusion of LMCA, restores only a retrograde perfusion to a rather extensive myocardial area and consumes bypass material. Direct surgical angioplasty avoids these inconveniences.

Published
1997
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50. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type

Author

Camenzind, Edoardo, Boersma, Eric, Wijns, William, Mauri, Laura, Rademaker-Havinga, Tessa, Ordoubadi, Farzin Fath, Suttorp, Maarten J., Al Kurdi, Mohammad, Steg, Ph Gabriel, Camenzind, E., Mauri, L., O'Neill, W., Serruys, P W., Steg, PhG, Wijns, W., Verheugt, FWA, Bertrand, ME, Califf, R., DeMets, D., Wallentin, L., Bocksch, W., Bosmans, J., Garcia, H., Garg, S., Hanet, C., Herrman, J-PR, Kelbaek, H., Mc Fadden, E., Radke, PW, Rutsch, W., Tilsted, HH, Wykrzykowska, J., Alvarez, C., Rodriguez, A., Meredith, I., Muller, D., Whitbourn, R., Worthley, S., Whelan, A., Walters, D., Shetty, S., New, G., Cox, S., Batra, R., van Gaal, W., Bellamy, G., Mayr, H., Heigert, M., Huber, K., Leisch, F., Desmet, W., Boland, J., Schroeder, E., Chenu, P., Legrand, V., Labinaz, M., Teefy, P., Bertrand, O., Gao, R., Ge, J., Kala, P., Cervinka, P., Ureña, P., Hartikainen, J., Steg, G., Fajadet, J., Carrie, D., Gilard, M., Barragan, P., Lablanche, J-M, Koning, R., Eltchaninoff, H., Darremont, O., Leroy, F., Bertrand, B., Robert, G., Schiele, F., Chassaing, S., Bressollette, E., Brunel, P., Quilliet, L., Brunet, J., Pansieri, M., Sideris, G., Stratiev, V., Teiger, E., Lebreton, H., Bonnet, J-L, Karsenty, B., Delarche, N., Lusson, J-R, Cassagnes, J., Brachmann, J., Kurowski, V., Buerke, M., Schieffer, B., Scholtz, W., Wiemer, M., Fichtlscherer, S., Schächinger, V., Kupatt, C., Boekstegers, P., Genth-Zotz, S., Bode, C., Frey, N., Neumann, F-J, Witzenbichler, B., Pels, K., Strasser, R., Kuck, K-H, Hauptmann, K-E, Baldus, S., Heitzer, T., Haude, M., Hoffmann, E., Jung, W., Hoffmann, S., Schmitt, C., Dissmann, M., Pauschinger, M., Werner, G., Braun-Delleus, R., Burkhardt, D., Manz, M., Voudris, V., Sionis, D., Kang-Yin, M-L, Tse, T-S, Merkely, B., Mehta, A., Parikh, K., Kumar, V., Chandra, P., Rath, P., Hiremath, S., Crean, P., Daly, K., Kornowski, R., Kerner, A., Mosseri, M., Jafari, G., Giudice, P., Trani, C., Manari, A., Prati, F., Pangrazi, A., Bolognese, L., Jeong, M-H, Kim, M-Y, Kim, H-S, Park, S-J, Erglis, A., Kalnins, A., Wagner, D., Zambahari, R., Ong, T-K, Sim, K., den Heijer, P., Appelman, Y., Suttorp, M-J, de Smet, B., Koolen, J., Stella, P., Harding, S., Warwick, J., Maslowski, A., Abernethy, M., Devlin, G., Rotevatn, S., Myreng, Y., Ciecwierz, D., Peruga, J., Reczuch, K., Campante Teles, R., Farto, P., Abreu, E., Leitão-Marques, A., Pereira, H., Vinereanu, D., Alkasab, S., Mhish, H., Al Kurdi, M., Al Turki, F., Wong, P., Teo, S-G, Goicolea Ruigomez, F-J, Valdés Chávarri, M., Bethencourt Gonzalez, A., Iñiguez Romo, A., López Minguez, J., Hernández García, J-M, Diaz Fernández, J., Ruiz Salmeron, R., Martinez Elbal, L., Zueco, J., López-Palop, RF, Melgares, R., Diderholm, E., Kåregren, A., Herterich, O., Olivencrona, G., Fröbert, O., Roffi, M., Verin, V., Girod, G., Vuilliomenet, A., Hsieh, I-C, Wu, C-J, Gershlick, A., Densem, C., Doshi, S., Manoharan, G., McCarthy, P., De Belder, M., Mills, J., Fath-Ordoubadi, F., Simpson, I., Greenwood, J., Chamberlain-Webber, R., Khan, Z., Cotton, J., Gunning, M., Smith, D., Talwar, S., Holmberg, S., Purcell, I., Anderson, R., Alamgir, F., Beatt, K., Kelly, P., Moussavian, M., Aji, J., Prashad, R., Zankar, A., Banerjee, S., Lewis, S., McLaurin, B., Douglas, J., Brener, S., Gupta, A., Walters, L., Driesman, M., Aycock, R., Mego, C., Fisher, D., Frankel, R., Satler, L., Camenzind, Edoardo, Boersma, Eric, Wijns, William, Mauri, Laura, Rademaker-Havinga, Tessa, Ordoubadi, Farzin Fath, Suttorp, Maarten J., Al Kurdi, Mohammad, Steg, Ph Gabriel, Camenzind, E., Mauri, L., O'Neill, W., Serruys, P W., Steg, PhG, Wijns, W., Verheugt, FWA, Bertrand, ME, Califf, R., DeMets, D., Wallentin, L., Bocksch, W., Bosmans, J., Garcia, H., Garg, S., Hanet, C., Herrman, J-PR, Kelbaek, H., Mc Fadden, E., Radke, PW, Rutsch, W., Tilsted, HH, Wykrzykowska, J., Alvarez, C., Rodriguez, A., Meredith, I., Muller, D., Whitbourn, R., Worthley, S., Whelan, A., Walters, D., Shetty, S., New, G., Cox, S., Batra, R., van Gaal, W., Bellamy, G., Mayr, H., Heigert, M., Huber, K., Leisch, F., Desmet, W., Boland, J., Schroeder, E., Chenu, P., Legrand, V., Labinaz, M., Teefy, P., Bertrand, O., Gao, R., Ge, J., Kala, P., Cervinka, P., Ureña, P., Hartikainen, J., Steg, G., Fajadet, J., Carrie, D., Gilard, M., Barragan, P., Lablanche, J-M, Koning, R., Eltchaninoff, H., Darremont, O., Leroy, F., Bertrand, B., Robert, G., Schiele, F., Chassaing, S., Bressollette, E., Brunel, P., Quilliet, L., Brunet, J., Pansieri, M., Sideris, G., Stratiev, V., Teiger, E., Lebreton, H., Bonnet, J-L, Karsenty, B., Delarche, N., Lusson, J-R, Cassagnes, J., Brachmann, J., Kurowski, V., Buerke, M., Schieffer, B., Scholtz, W., Wiemer, M., Fichtlscherer, S., Schächinger, V., Kupatt, C., Boekstegers, P., Genth-Zotz, S., Bode, C., Frey, N., Neumann, F-J, Witzenbichler, B., Pels, K., Strasser, R., Kuck, K-H, Hauptmann, K-E, Baldus, S., Heitzer, T., Haude, M., Hoffmann, E., Jung, W., Hoffmann, S., Schmitt, C., Dissmann, M., Pauschinger, M., Werner, G., Braun-Delleus, R., Burkhardt, D., Manz, M., Voudris, V., Sionis, D., Kang-Yin, M-L, Tse, T-S, Merkely, B., Mehta, A., Parikh, K., Kumar, V., Chandra, P., Rath, P., Hiremath, S., Crean, P., Daly, K., Kornowski, R., Kerner, A., Mosseri, M., Jafari, G., Giudice, P., Trani, C., Manari, A., Prati, F., Pangrazi, A., Bolognese, L., Jeong, M-H, Kim, M-Y, Kim, H-S, Park, S-J, Erglis, A., Kalnins, A., Wagner, D., Zambahari, R., Ong, T-K, Sim, K., den Heijer, P., Appelman, Y., Suttorp, M-J, de Smet, B., Koolen, J., Stella, P., Harding, S., Warwick, J., Maslowski, A., Abernethy, M., Devlin, G., Rotevatn, S., Myreng, Y., Ciecwierz, D., Peruga, J., Reczuch, K., Campante Teles, R., Farto, P., Abreu, E., Leitão-Marques, A., Pereira, H., Vinereanu, D., Alkasab, S., Mhish, H., Al Kurdi, M., Al Turki, F., Wong, P., Teo, S-G, Goicolea Ruigomez, F-J, Valdés Chávarri, M., Bethencourt Gonzalez, A., Iñiguez Romo, A., López Minguez, J., Hernández García, J-M, Diaz Fernández, J., Ruiz Salmeron, R., Martinez Elbal, L., Zueco, J., López-Palop, RF, Melgares, R., Diderholm, E., Kåregren, A., Herterich, O., Olivencrona, G., Fröbert, O., Roffi, M., Verin, V., Girod, G., Vuilliomenet, A., Hsieh, I-C, Wu, C-J, Gershlick, A., Densem, C., Doshi, S., Manoharan, G., McCarthy, P., De Belder, M., Mills, J., Fath-Ordoubadi, F., Simpson, I., Greenwood, J., Chamberlain-Webber, R., Khan, Z., Cotton, J., Gunning, M., Smith, D., Talwar, S., Holmberg, S., Purcell, I., Anderson, R., Alamgir, F., Beatt, K., Kelly, P., Moussavian, M., Aji, J., Prashad, R., Zankar, A., Banerjee, S., Lewis, S., McLaurin, B., Douglas, J., Brener, S., Gupta, A., Walters, L., Driesman, M., Aycock, R., Mego, C., Fisher, D., Frankel, R., and Satler, L.

Abstract

Aim To investigate the putative modifying effect of dual antiplatelet therapy (DAPT) use on the incidence of stent thrombosis at 3 years in patients randomized to Endeavor zotarolimus-eluting stent (E-ZES) or Cypher sirolimus-eluting stent (C-SES). Methods and results Of 8709 patients in PROTECT, 4357 were randomized to E-ZES and 4352 to C-SES. Aspirin was to be given indefinitely, and clopidogrel/ticlopidine for ≥3 months or up to 12 months after implantation. Main outcome measures were definite or probable stent thrombosis at 3 years. Multivariable Cox regression analysis was applied, with stent type, DAPT, and their interaction as the main outcome determinants. Dual antiplatelet therapy adherence remained the same in the E-ZES and C-SES groups (79.6% at 1 year, 32.8% at 2 years, and 21.6% at 3 years). We observed a statistically significant (P = 0.0052) heterogeneity in treatment effect of stent type in relation to DAPT. In the absence of DAPT, stent thrombosis was lower with E-ZES vs. C-SES (adjusted hazard ratio 0.38, 95% confidence interval 0.19, 0.75; P = 0.0056). In the presence of DAPT, no difference was found (1.18; 0.79, 1.77; P = 0.43). Conclusion A strong interaction was observed between drug-eluting stent type and DAPT use, most likely prompted by the vascular healing response induced by the implanted DES system. These results suggest that the incidence of stent thrombosis in DES trials should not be evaluated independently of DAPT use, and the optimal duration of DAPT will likely depend upon stent type (Clinicaltrials.gov number NCT00476957)

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