1Department of Cardiology, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands
2Division of Cardiology, Lille University Heart Institute, Lille, France
3Department of Cardiology, University Hospital Zurich, Zurich, Switzerland
4Cardiology Service, Hospital Central de Asturias, Asturias, Spain
5Division of Cardiology, Federico II University, Naples, Italy
6Department of Cardiology, Robert-Bosch-Krankenhaus, Stuttgart, Germany
7Thoracic and Cardiovascular Surgery, University Hospital, Uppsala, Sweden
8University Hospital Vinohrady, Prague, Czech Republic
9Cardiovascular Centre, OLV Hospital, 164 Moorselbaan, B 9300 Aalst, Belgium
Received 6 December 2004; revised 10 February 2005; accepted 23 February 2005; online publish-ahead-of-print 31 March 2005.
* Corresponding author. Tel: +32 53724439; fax: +32 53724185.E-mail address: william.wijns{at}olvz-aalst.be
See page 1147 for the editorial comment on this article (doi:10.1093/eurheartj/ehi247)
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Abstract |
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Methods and results Between November 2001 and March 2002, 7769 consecutive patients undergoing invasive evaluation at 130 hospitals (31 countries) were screened for the presence of one or more coronary stenosis >50% in diameter. Patient demographics and comorbidity, clinical presentation, invasive parameters, treatment options, and procedural techniques were prospectively entered in an electronic database (550 variables+29 per diseased coronary segment). Major adverse cardiac events (MACE) were evaluated at 30 days and 1 year. Out of 5619 patients with angiographically proven coronary stenosis (72% of screened population), 53% presented with stable angina while ST elevation myocardial infarction (STEMI) was the indication for coronary angiography in 16% and non-ST segment elevation myocardial infarction or unstable angina in 30%. Only medical therapy was continued in 21%, whereas mechanical revascularization was performed in the remainder [percutaneous coronary intervention (PCI) in 58% and coronary artery bypass grafting (CABG) in 21%]. Patients referred for PCI were younger, were more active, had a lower risk profile, and had less comorbid conditions. CABG was performed mostly in patients with left main lesions (21%), two- (25%), or three-vessel disease (67%) with 4.1 diseased segments, on average. Single-vessel PCI was performed in 82% of patients with either single- (45%), two- (33%), or three-vessel disease (21%). Stents were used in 75% of attempted lesions, with a large variation between sites. Direct PCI for STEMI was performed in 410 cases, representing 7% of the entire workload in the participating catheterization laboratories. Time delay was within 90 min in 76% of direct PCI cases. In keeping with the recommendations of practice guidelines, the survey identified under-use of adjunctive medication (GP IIb/IIIa receptor blockers, statins, and angiotensin-converting enzyme-inhibitors). Mortality rates at 30 days and 1 year were low in all subgroups. MACE primarily consisted of repeat PCI (12%).
Conclusion The current Euro Heart Survey on coronary revascularization was performed in the era of bare metal stenting and provides a global European picture of the invasive approach to patients with CAD. These data will serve as a benchmark for the future evaluation of the impact of drug-eluting stents on the practice of interventional cardiology and bypass surgery.
Key Words: Coronary artery disease Coronary angiography CABG PCI Practice survey
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Introduction |
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Practice guidelines for diagnostic procedures and patient management are established to help cardiologists in every-day clinical decision making. The scientific foundation for these guidelines is provided by randomized clinical trials, although non-randomized trials, retrospective studies, or consensus opinion of experts are also used.79
The European Society of Cardiology (ESC) is dedicated to improve health by reducing the impact of cardiovascular disease by various means. The Euro Heart Survey programme is meant to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe.10
The current survey focuses on patients with at least one >50% diameter stenosis, visualized during coronary angiography, who are potential candidates for coronary revascularization.
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Methods |
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The survey on coronary revascularization was conducted between November 2001 and March 2002. One year follow-up was made by personal or telephone contact and available in 4770 patients (83%). Fourteen hospitals (11%) were not able to provide follow-up information. Median (quartiles) follow-up period was 12 months (1113 months). Statistical analyses were carried out with SPSS statistical software (version 12.0 for Windows), using mostly descriptive statistics between subsets of patients defined by treatment preference. Results are presented as mean and median with corresponding values (SD and inter-quartile ranges, respectively) and as per cent. Given the large sample size, P-value of 0.001 was considered statistically significant.
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Results |
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Of all diseased segments at coronary angiography (15 856), 51% was considered suitable for PCI and 69% for CABG, whereas 24% of the lesions (1597 patients) were judged as only suitable for CABG, not for PCI. Most of the lesions unsuitable for PCI were totally occluded (70%) or located in the left main (20%). PCI was predominantly performed in patients with single-vessel disease and preserved ventricular function (Table 2). Nonetheless, two- and three-vessel disease was present in 33 and 21%, respectively, suggesting incomplete revascularization by anatomy. Single-PCI was performed in 82% of all cases and the attempted lesions were of type A in 15%, B in 50%, and C in 12%. Bypass surgery was mainly performed in patients with three-vessel disease (67%), left main stem stenosis, (21%) or extensive disease as reflected by the mean number of diseased segments (4.1). The left anterior descending coronary artery (LAD) was diseased in 90% of all patients undergoing CABG and extracorporeal circulation was used in 81% of all operations.
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Of the 5619 participating patients, 1.9% (104 patients) died within 30 days. The overall 1 year mortality was 4.7% (263 patients). The mortality differed between diagnosis and treatment groups (Table 4). One-year mortality was lowest in patients with stable angina who underwent PCI (1.9%) and highest in STEMI patients not undergoing mechanical revascularization (8.4%). However, a significantly reduced 1 year mortality between the three treatment groups was observed only in patients with stable angina, reflecting the large proportion of low-risk patients undergoing PCI.
After 1 year, 13% of the PCI patients required repeat revascularization (10% at least one repeat PCI, 3% were operated), whereas only 1% of patients initially treated with CABG needed repeat revascularization. A small proportion of patients who were initially treated medically underwent mechanical revascularization eventually (4%). Rehospitalization for cardiac reasons was more frequent in PCI and medical patients (28 and 25%, respectively), when compared with those undergoing CABG (15%).
At discharge, most patients (>90%) were prescribed at least one anti-thrombotic drug (either aspirin, thienopyridine, or anticoagulants), irrespective of treatment allocation (Table 5). When coronary stenting was performed, 94% were discharged on clopidogrel or ticlopidine. Other prophylactic drug classes such as beta-blockers, angiotensin-converting enzyme-inhibitors (ACE-inhibitors), and statins were used less frequently. Except for beta-blockers, comparison between the three treatment groups revealed significant differences in prescription profile. At 1 year follow-up, pharmacological treatment remained unchanged and below the target. Only the use of statins increased from discharge (54%) to 1 year in patients undergoing CABG (69%), but remained below the target.
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Discussion |
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In accordance with the guidelines, patients selected for CABG were sicker and had more extensive CAD; however, a sizable proportion of patients with multi-vessel or left main disease, impaired left ventricular function or diabetes did not undergo bypass surgery.
Patient and/or physician preference as well as the shorter time delay between angiography and PCI (compared with time delay between angiography and CABG) may have contributed to this choice. In patients with multi-vessel disease, recent meta-analyses show no difference in the rate of major irreversible adverse events between PCI and CABG.17,18 However, after 1 year follow-up, repeat PCI was performed in 10 and 3% eventually required CABG, indicative of the lower durability of the result after PCI. Coronary stenting using bare metal devices was applied in 72% of all segments and PCI was limited to a single-vessel in 82% of cases. Use of stents varied widely from 0% in two hospitals to 100% in 17 hospitals, a wide range that probably relates to differences in local reimbursement policies. It should be remembered that all data from the current survey have been acquired prior to the clinical availability of drug-eluting stents. Increased availability of these more durable devices will likely increase the confidence of interventional cardiologists in treating more complex patient and/or lesion subsets by means of PCI.19
Another proportion of patients who were at high risk did not undergo revascularization. This probably results from the limitations of currently available mechanical revascularization procedures in treating diffuse disease or from the poor general condition of some patients unable to undergo an invasive treatment or from the estimated unacceptably high procedural risks.
Despite their proven beneficial effects in high-risk patients (e.g. diabetes) and/or procedures,20,21 overall a sizable proportion of patients fulfiling these criteria did not receive GP IIb/IIIa receptor blockers. In addition, major variations across European hospitals in the use of GP IIb/IIIa receptor blockers were observed. Most surprising was the low use of these drugs in diabetic patients undergoing PCI for stable angina (15%). Also of concern was the failure to measure post-procedural necrosis markers in 39% of all PCI procedures. Increased levels of cardiac enzymes are indeed an independent predictor of cardiac mortality and subsequent myocardial infarction.22,23 Similarly, in patients undergoing CABG, necrosis markers were measured in only one-third, most likely reflecting the disputable value of these markers following surgery.24
As to the treatment of STEMI, this survey concurs with previous studies in showing that reperfusion treatment remains underused,25 even in this selected subgroup of patients referred for angiography. By design, we cannot analyse the factors that contribute to this sobering observation. In accordance with the guidelines, primary PCI is the preferred treatment for STEMI, provided this procedure can be performed by an experienced team within 90 min after first medical contact.9 It was encouraging to observe that the majority of patients undergoing primary PCI was treated within the advocated timeframe of 90 min. However, due to missing admission or procedure times, the in-hospital delay was unknown in a sizeable proportion of patients. The current prospective survey clearly shows that in clinical practice, reporting of all relevant time intervals was not optimal. This failure stresses the importance of a thorough registration as well as the need for implementing in each institution appropriate procedures and pathways that will permit to select the optimal treatment for an individual patient.26,27
The overall mortality figures were low (1.9% at 30 days and 4.7% at 1 year) in all patient groups and treatment modalities, even after risk-adjustment using for instance the EuroSCORE. As expected, 1 year mortality rate was larger in STEMI (7%) and in NSTEMI/UA (5%) compared with stable angina patients (3%).
Patients with established CAD enrolled in this survey should benefit from secondary prevention measures.28 Changing the patient risk behaviour (unhealthy diet, smoking, and sedentary lifestyle) and prescribing drugs with proven prophylactic effects are essential aspects of current treatment, even after mechanical revascularization.2933 Furthermore, effective secondary prevention in clinical practice, using evidence-based treatment, has been proven effective in reducing the composite of death, myocardial infarction, and stroke.34,35 Although the majority of patients used anti-thrombotics and beta-blockers, as recommended, ACE-inhibitors were underused in all subgroups and statins were particularly underused after CABG. Overall, prescription of these prophylactic drugs was increased when compared with EuroAspire II,36 indicating that time is required before guidelines are progressively endorsed. In any case, the moment that patients are admitted in the hospital to undergo an invasive procedure should be taken as an opportunity to further optimize their pharmacological treatment.
The limitations of this study are those inherent to observational surveys involving voluntarily participating hospitals. Although we have attempted to include a wide spectrum of hospitals in different countries, almost certainly the results are biased towards better than average practices. The sample size only represents a small fraction of all patients admitted in catheterization laboratories throughout Europe during the study period. Nevertheless, because patient inclusion was consecutive at the participating sites, we trust that the survey depicts the ongoing clinical practice. Data on the 1 year follow-up were not obtainable in 14 hospitals (from 10 countries) because of management problems unrelated to individual patient characteristics. Presumably, this did not introduce significant selection bias. Data quality was checked through queries for missing or contradictory entries. However, no site visits or source data verification was performed. However, since many participating sites are part of other Euro Heart Surveys, their performance is regularly evaluated.
To summarize, the current Euro Heart Survey on coronary revascularization provides a global European picture of the invasive approach to patients with CAD, as they present with either stable angina, STEMI or NSTEMI/UA. Although the recommendations of guidelines are mostly endorsed, the main area for improvement pertains to the underuse of adjunctive pharmacology (GP IIb/IIIa inhibitors, statins, and ACE-inhibitors). These data on the indications for revascularization, the choice between PCI or CABG and their outcome in the era of bare metal stenting will serve as a benchmark for the future evaluation of the impact of drug-eluting stents on the practice of coronary revascularization.
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Appendix: Organization of the survey |
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Euro Heart Survey Team (European Heart House, France): Malika Manini (Operations Manager); Claire Bramley (Data Monitor); Valérie Laforest (Data Monitor); Charles Taylor (Database Administrator); Susan Del Gaiso (Administrator).
National Coordinators: Austria, Kurt Huber; Belgium, Guy De Backer; Bulgaria, Vera Sirakova; Czech Republic, Roman Cerbak; Denmark, Per Thayssen; Finland, Seppo Lehto; France, Jean-Jacques Blanc, François Delahaye; Georgia, Bondo Kobulia; Germany, Uwe Zeymer; Greece, Dennis Cokkinos; Hungary, Kristof Karlocai; Ireland, Ian Graham, Emer Shelley; Israel, Shlomo Behar; Italy, Aldo Maggioni; Lithuania, Virginija Grabauskiene; The Netherlands, Jaap Deckers; Norway, Inger Asmussen; Poland, Janina Stepinska; Portugal, Lino Gonçalves; Russia, Vyacheslav Mareev; Slovakia, Igor Riecansky; Slovenia, Miran F. Kenda; Spain, Angeles Alonso, José Luis Lopez-Sendon; Sweden, Annika Rosengren; Switzerland, Peter Buser; Turkey, Tugrul Okay; Ukraine, Oleg Sychov; United Kingdom, Kevin Fox.
Euro Heart Survey Board Committee: David Wood (Chairman), United Kingdom; Angeles Alonso, Spain; Shlomo Behar, Israel; Eric Boersma, The Netherlands; Harry Crijns, The Netherlands; Kim Fox, United Kingdom; Malika Manini, France; Keith McGregor, France; Barbara Mulder, The Netherlands; Sylvia Priori, Italy; Lars Rydén, Sweden; Luigi Tavazzi, Italy; Alec Vahanian, France; Panos Vardas, Greece; William Wijns, Belgium; Uwe Zeymer, Germany.
Industry Sponsor: Eucomed.
List of Sponsoring Institutions: French Federation of Cardiology, Hellenic Cardiological Society, Netherland Heart Foundation, Swedish Heart and Lung Foundation, and individual hospitals.
Participating Centres, Investigators, and Data Collection Officers: Armenia: Karine Sarkisyan, Yerevan. Austria: H.D. Glogar, Michael Derntl, Vienna; Matthias Frick, O. Pachinger, Ralf Zwick, Innsbruck. Belgium: Christiaan Vrints, Els Van Hertbruggen, Marc Vercammen, Tineke Sysmans, Edegem; E. Schroeder, Juliette Domange, Yvoir; William Wijns, Hilde De Pril, Aalst; Johan De Vriese, Tonny Van Hecke, Gent; V. Legrand, Marie-France Gillon, Michel Richardy, P. Doneux, Liege. Bulgaria: Ivo Petrov, J. Jorgova, Sofia; Vera Sirakova, Varna. Croatia: Boris Starcevic, Zagreb. Switzerland: Eric Eeckhout, Alexandre Berger, Veronique Prudent, Lausanne; E. Camenzind, Nicolas Masson, Geneve. Cyprus: Costas Zambartas, Helen Kleanthous, Nicosia. Czech Republic: Petr Widimsky, Blanka Stellova, Michael Aschermann, Stanislav Simek, J. Kautzner, Vladimir Karmazin, P. Svab, Prague; Jan Indrak, M. Branny, Trinec; Kveta Hladilova, P. Kala, Brno. Denmark: P. Thayssen, Helle Cappelen, Lisette Okkels Jensen, Odense. Germany: A. Gitt, Konstanze Gehrke, Ludwigshafen am Rhein; R. Erbel, Achim Gutersohn, Holger Eggebrecht, Murad Al Khani, Essen; Udo Sechtem, Antje Rosenberger, Holger Vogelsberg, Stuttgart; H. Klepzig, Arnold Schmidt, Offenbach; Sigmund Silber, Birgit Mau, Munich; Christian Leuner, Karen Czyborra, Bielefeld; Christina Reuschling, Eva Muno, Bad Nauheim; F. Kleber, Sascha Rux, Berlin; U. Zeymer, Kassel. Egypt: Aly Saad, Zagazig; BSS. Ibrahim, Maged Elabady, Cairo. Spain: A. Castro Beiras, Jorge Salgado Fernandez, La Coruna; Felipe Navarro del Arno, A. Iniguez Romo, Madrid; J.M. Cruz Fernandez, Alejandro Recio Mayoreal, Franciso Javier Rivero Rebanal, Mariano Garcia de la Borbolla, Marinela Chaparro, Sevilla; C. Brotons, C. Permanyer Miralda, Srta Irma Vila i Perez, Barcelona; Cesar Moris, Oviedo; F. Fernandez Aviles, Luis de la Fuente Galan, Paula Tejedor Vinuela, Valladolid; F. Malpartida de Torres, Javier Mora, Malaga; Ignacio Santos Rodriguez, Itziar Piedra Bustamante, Pedro L. Sanchez Fernandez, Salamanca; J.L. Diago Torrent, Jose L. Diez Gil, Castellon; Javier Perpinan, V. Palacios Motilla, Alzira, Valencia; M. Soledad Alcasena Juango, Jesus Berjon-Reyero, Pamplona; R. Melgares Moreno, Juan Carlos Fernandez Guerrero, Granada. Finland: S. Lehto, Kirsti Savolainen, Kuopio; MS. Nieminen, Mikko Syvanne, Helsinki. France: A. Cohen-Solal, Antoine-Sylvain Oboa, Clichy; J.P. Bassand, Denis Pales Espinosa, Veronique Jouet, Besancon Cedex; G. Montalescot, Vanessa Gallois, Paris; J.C. Daubert, Jean Michel Clerc, Rennes; Jacques Machecourt, Grenoble; Y. Cottin, Dijon. United Kingdom: D. Walker, Fhiona Holland, St Leonards-on-Sea; D. Wood, Jenni Prosser, Lis Muir, Kate Barber, London; J.G.F. Cleland, Jocelyn Cook, Kingston upon Hull. Georgia: Bondo Kobulia, Zaza Chapichadze, Tbilisi. Greece: Ioannis Skoularigisn Athanasiou Christos, Larisa; Dennis Cokkinos, Nastasia Tsiavou, Christina Chrysohoou, Athanassios Manginas, John Terrovitis, John Kanakakis, Manolis Vavuranakis, Stavros Drakos, Athens; Thomas Farmakis, C. Samara, Thessaloniki; Christina Papakosta, Christos Bourantas, L.K. Michalis, Mpourantas Christos, Ioannina; Stefanos Foussas, Evdokia Adamopoulou, Pireus; P.E. Vardas, Mary Marketou, Heraklion, Crete. Hungary: N. Alotti, Anna Maria Basa, Andras Vigh, Zalaegerszeg; Istvan Preda, Eva Csoti, M. Keltai, G. Kerkovits, Budapest. Israel: Alberto Hendler, Alex Blatt, Beer Yakov; R. Beyar, Arie Shefer, David Halon, Margalait Bentzvi, Naomi Avramovitch, Haifa; Avinoam Bakst, Kfar Saba; Carlos Cafri, Aviva Grosbard, Beer Sheva; Bella Margolis, Khalid Suleiman, Afula; Shmuel Banai, David Meerkin, Morris Mosseri, Pnina Guita, Rifat Jabara, Jerusalem; Jamal Jafari, Debi Ben Shitrit, Ashkelon; Dr Ghasan, Dr Salameh, Tiberias; Marc Brezins, Lily van den Akker-Berman, Nahariya; Victor Guetta, Tel Hashomer; Yoseph Rozenman, Holon. Italy: A. Biagini, Sergio Berti, Massa; Massimo Ferrero, A. Colombo, R. Roccaforte, Caterina Milici, Milano; L. Scarpino, A. Salvi, Gorizia; Alessandro Desideri, Daniela Sabbadin, Castelfranco Veneto; Alfredo Galassi, Giuseppe Giuffrida, Catania; Andrea Rognoni, Corrado Vassanelli, Paola Paffoni, Novara; Angelo Cioppa, Paolo Rubino, Mercogliano (Avellino); Marco de Carlo, Anna Sonia Petronio, Pisa; F. Naccarella, Francesco Saia, Antonio Marzocchi, Stefano Sdringola Maranga, Bologna; P. Presbitero, Fazya Valsecchi, Rozzano-Milan; Federico Piscione, Giovanni Esposito, Napoli M. Santini, Marco Tubaro, Rome. Lithuania: A. Erglis, Inga Narbute, Riga; Ausra Kavoliuniene, R. Zaliunas, Ramunas Navickas, Kaunas; V. Grabauskiene, Davia Luckute, Eduardas Subkovas, Vilnius. Luxembourg: Daniel Wagner. The Netherlands: F. Vermeer, Aimee Lousberg, Heidi Fransen, Maastricht; Arno Breeman, Henriette Tebbe, M.J. De Boer, Metske van der Wal, Zwolle; J. Deckers, Jeroen Vos, C.M. Leenders, M.J. Veerhoek, Chris Jansen, Rotterdam; M. Bijl, Colinda Koppelaar, Dordrecht; Dr Van den Linden, Colinda Koppelaar, Vlaardingen; R. Brons, Henriette Tebbe, Meppel; J.W.M.G. Widdershofen, Herman Broers, Tilburg. Norway: F. Kontny, Marianne Jonzon, Oslo. Poland: Jan Wodniecki, Andrzej Tomasik, Zabrze; M. Trusz-Gluza, Seweryn Nowak, Katowice; Witold Ruzyllo, Tomasz Deptuch, Warsaw. Portugal: Jorge Marques, F. Matias, Almada; H. Madeira, Joaquim Oliveira, Luis Sargento, Lisbon. Romania: Adina Ionac, Iosif Stefan Dragulescu, Bogdan Mut-Vitcu, Daniela Maximov, Timisoara; M. Dorobantu, E. Apetrei, Rodica Niculescu, Virgil Petrescu, Adrian Bucsa, Dan Deleanu, Bucharest; I.S. Benedek, Theodora Hintea, Targu-Mures. Russian Federation: D. Aronov, Elena Tikhomirova, Moscow. Slovenia: I. Kranjec, Katja Prokselj, Ljubljana; Vojko Kanic, Maribor. Turkey: Tugrul Okay, Ahmet Sepetoglu, Istanbul; S. Aytekin, V. Aytekin, Alp Burak Catakoglu, Hayri Parlar, Suavi Tufekcioglu, Zeki Ozyedek, Sisli; Mehmet Baltali, Dr Kiziltan, Adana. Serbia & Montenegro: Milan Vukovic, A.N. Neskovic, Belgrade.
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