Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: Results from the Euro Heart Survey on Coronary Revascularization

Marjo Hordijk-Trion, Mattie Lenzen, William Wijns, Peter De Jaegere, Maarten L. Simoons, Wilma J.M. Scholte Op Reimer, Michel E. Bertrand, Nestor Mercado, Eric Boersma*, W. Maier, B. Meier, Cesar Moris, Federico Piscione, Udo Sechtem, P. Sergeant, E. Stahle, Jeroen Vos, Petr Widimsky, F. Unger, Malika ManiniClaire Bramley, Vale´rie Laforest, Charles Taylor, Susan Del Gaiso, Kurt Huber, Guy De Backer, Vera Sirakova, Roman Cerbak, Per Thayssen, Seppo Lehto, Jean Jacques Blanc, Franc¸ois Delahaye, Bondo Kobulia, Uwe Zeymer, Dennis Cokkinos, Kristof Karlocai, Ian Graham, Emer Shelley, Shlomo Behar, Aldo Maggioni, Virginija Grabauskiene, Jaap Deckers, Inger Asmussen, Janina Stepinska, Lino Gonc¸alves, Vyacheslav Mareev, Igor Riecansky, Miran F. Kenda, Angeles Alonso, Jose´ Luis Lopez-Sendon, Annika Rosengren, Peter Buser, Tugrul Okay, Oleg Sychov, Kevin Fox, David Wood, Harry Crijns, Kim Fox, Keith McGregor, Barbara Mulder, Sylvia Priori, Lars Ryde´n, Luigi Tavazzi, Alec Vahanian, Panos Vardas, Karine Sarkisyan, H. D. Glogar, Matthias Frick, O. Pachinger, Ralf Zwick, Christiaan Vrints, Els Van Hertbruggen, Marc Vercammen, Tineke Sysmans, E. Schroeder, Juliette Domange, Hilde De Pril, Johan De Vriese, Tonny Van Hecke, V. Legrand, Marie France Gillon, Michel Richardy, P. Doneux, Ivo Petrov, J. Jorgova, Boris Starcevic, Eric Eeckhout, Alexandre Berger, Veronique Prudent, E. Camenzind, Nicolas Masson, Costas Zambartas, Helen Kleanthous, Blanka Stellova, Michael Aschermann, Stanislav Simek, J. Kautzner, Vladimir Karmazin, P. Svab, Jan Indrak, M. Branny, Kveta Hladilova, P. Kala, Helle Cappelen, Lisette Okkels Jensen, A. Gitt, Konstanze Gehrke, Ludwigshafen am Rhein, R. Erbel, Achim Gutersohn, Holger Eggebrecht, Murad Al Khani, Antje Rosenberger, Holger Vogelsberg, H. Klepzig, Arnold Schmidt, Sigmund Silber, Birgit Mau, Christian Leuner, Karen Czyborra, Christina Reuschling, Eva Muno, Bad Nauheim, F. Kleber, Sascha Rux, Aly Saad, Maged Elabady, A. Castro Beiras, Jorge Salgado Fernandez, Felipe Navarro del Arno, A. Iniguez Romo, J. M.Cruz Fernandez, Alejandro Recio Mayoreal, Franciso Javier Rivero Rebanal, Mariano Garcia de la Borbolla, Marinela Chaparro, C. Brotons, C. Permanyer Miralda, Srta Irma Vila i Perez, F. Fernandez Aviles, Luis de la Fuente Galan, Paula Tejedor Vinuela, F. Malpartida de Torres, Javier Mora, Ignacio Santos Rodriguez, Itziar Piedra Bustamante, Pedro L.Sanchez Fernandez, J. L.Diago Torrent, Jose L.Diez Gil, Javier Perpinan, V. Palacios Motilla, M. Soledad Alcasena Juango, Jesus Berjon-Reyero, R. Melgares Moreno, Juan Carlos Fernandez Guerrero, Kirsti Savolainen, Mikko Syvanne, A. Cohen-Solal, Antoine Sylvain Oboa, J. P. Bassand, Denis Pales Espinosa, Veronique Jouet, Besancon Cedex, G. Montalescot, Vanessa Gallois, J. C. Daubert, Jean Michel Clerc, Jacques Machecourt, Y. Cottin, D. Walker, Fhiona Holland, Jenni Prosser, Lis Muir, Kate Barber, J. G.F. Cleland, Jocelyn Cook, Zaza Chapichadze, Ioannis Skoularigisn Athanasiou Christos, Nastasia Tsiavou, Christina Chrysohoou, Athanassios Manginas, John Terrovitis, John Kanakakis, Manolis Vavuranakis, Stavros Drakos, Thomas Farmakis, C. Samara, Christina Papakosta, Christos Bourantas, L. K. Michalis, Mpourantas Christos, Stefanos Foussas, Evdokia Adamopoulou, Mary Marketou, N. Alotti, Anna Maria Basa, Andras Vigh, Istvan Preda, Eva Csoti, M. Keltai, G. Kerkovits, Alberto Hendler, Alex Blatt, Beer Yakov, R. Beyar, Arie Shefer, David Halon, Margalait Bentzvi, Naomi Avramovitch, Avinoam Bakst, Kfar Saba, Carlos Cafri, Aviva Grosbard, Beer Sheva, Bella Margolis, Khalid Suleiman, Shmuel Banai, David Meerkin, Morris Mosseri, Pnina Guita, Rifat Jabara, Jamal Jafari, Debi Ben Shitrit, Dr Ghasan, Dr Salameh, Marc Brezins, Lily van den Akker-Berman, Victor Guetta, Tel Hashomer, Yoseph Rozenman, A. Biagini, Sergio Berti, Massimo Ferrero, A. Colombo, R. Roccaforte, Caterina Milici, L. Scarpino, A. Salvi, Alessandro Desideri, Daniela Sabbadin, Castelfranco Veneto, Alfredo Galassi, Giuseppe Giuffrida, Andrea Rognoni, Corrado Vassanelli, Paola Paffoni, Angelo Cioppa, Paolo Rubino, Marco de Carlo, Anna Sonia Petronio, F. Naccarella, Francesco Saia, Antonio Marzocchi, Stefano Sdringola Maranga, P. Presbitero, Fazya Valsecchi, Giovanni Esposito, Napoli M. Santini, Marco Tubaro, A. Erglis, Inga Narbute, Ausra Kavoliuniene, R. Zaliunas, Ramunas Navickas, Davia Luckute, Eduardas Subkovas, Daniel Wagner, F. Vermeer, Aimee Lousberg, Heidi Fransen, Arno Breeman, Henriette Tebbe, M. J. De Boer, Metske van der Wal, C. M. Leenders, M. J. Veerhoek, Chris Jansen, M. Bijl, Colinda Koppelaar, Van den Linden, R. Brons, J. W.M.G. Widdershofen, Herman Broers, F. Kontny, Marianne Jonzon, Jan Wodniecki, Andrzej Tomasik, M. Trusz-Gluza, Seweryn Nowak, Witold Ruzyllo, Tomasz Deptuch, Jorge Marques, F. Matias, H. Madeira, Joaquim Oliveira, Luis Sargento, Adina Ionac, Iosif Stefan Dragulescu, Bogdan Mut-Vitcu, Daniela Maximov, M. Dorobantu, E. Apetrei, Rodica Niculescu, Virgil Petrescu, Adrian Bucsa, Dan Deleanu, Bucharest, I. S. Benedek, Theodora Hintea, D. Aronov, Elena Tikhomirova, I. Kranjec, Katja Prokselj, Vojko Kanic, Ahmet Sepetoglu, S. Aytekin, V. Aytekin, Alp Burak Catakoglu, Hayri Parlar, Suavi Tufekcioglu, Zeki Ozyedek, Mehmet Baltali, Kiziltan, Milan Vukovic, A. N. Neskovic

*Corresponding author for this work

    Research output: Contribution to journalArticleResearchpeer-review

    108 Citations (Scopus)

    Abstract

    Aims: Revascularization in patients with coronary artery disease changed over the last two decades, favouring the number of patients treated by means of percutaneous coronary interventions (PCI) when compared with coronary artery bypass grafting (CABG). Many randomized controlled trials (RCTs) have been performed to compare these two competing revascularization techniques. Because of the strict enrolment criteria of RCTs in which highly selected patients are recruited, the applicability of the results may be limited in clinical practice. The current study evaluates to what extent patients in clinical practice were similar to those who participated in RCTs comparing PCI with CABG. Methods and results: Clinical characteristics and 1-year outcome of 4713 patients enrolled in the Euro Heart Survey on Coronary Revascularization were compared with 8647 patients who participated in 14 major RCTs, comparing PCI with CABG. In addition, we analysed which proportion of survey patients would have disqualified for trial participation (n = 3033, 64%), aiming at identifying differences between trial-eligible and trial-ineligible survey patients. In general, important differences were observed between trial participants and survey patients. Patients in clinical practice were older, more often had comorbid conditions, single-vessel disease, and left main stem stenosis when compared with trial participants. Almost identical differences were observed between trial-eligible and trial-ineligible survey patients. In clinical practice, PCI was the treatment of choice, even in patients who were trial-ineligible (46% PCI, 26% CABG, 28% medical). PCI remained the preferred treatment option in patients with multi-vessel disease (57% in trial-eligible and 40% in trial-ineligible patients, respectively, P < 0.001); yet, the risk profile of patients treated by PCI was better than that for patients treated either by CABG or by medical therapy. In the RCTs, there was no mortality difference between PCI and CABG. In clinical practice, however, we observed 1-year unadjusted survival benefit for PCI vs. CABG (2.9 vs. 5.4%, P < 0.001). Survival benefit was only observed in trial-ineligible patients (3.3 vs. 6.2%, P < 0.001). Conclusion: Many patients in clinical practice were not represented in RCTs. Moreover, only 36% of these patients were considered eligible for participating in a trial comparing PCI with CABG. We demonstrated that RCTs included younger patients with a better cardiovascular risk profile when compared with patients in everyday clinical practice. This study highlights the disparity between patients in clinical practice and patients in whom the studies that provide the evidence for treatment guidelines are performed.

    Original languageEnglish
    Pages (from-to)671-678
    Number of pages8
    JournalEuropean Heart Journal
    Volume27
    Issue number6
    DOIs
    Publication statusPublished - 1 Mar 2006

    Keywords

    • CABG
    • Euro Heart Survey
    • PCI
    • Randomized controlled trials

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