A Comparison of Balloon-Expandable-Stent Implantation with Balloon Angioplasty in Patients with Coronary Artery Disease
Patrick W. Serruys, Peter de Jaegere, Ferdinand Kiemeneij, Carlos Macaya, Wolfgang Rutsch, Guy Heyndrickx, Hakan Emanuelsson, Jean Marco, Victor Legrand, Pierre Materne, Jorge Belardi, Ulrich Sigwart, Antonio Colombo, Jean Jacques Goy, Paul van den Heuvel, Juan Delcan, Marie-angele Morel, for The Benestent Study Group
Background Balloon-expandable coronary-artery stents were developedto prevent coronary restenosis after coronary angioplasty. Thesedevices hold coronary vessels open at sites that have been dilated.However, it is unknown whether stenting improves long-term angiographicand clinical outcomes as compared with standard balloon angioplasty.
Methods A total of 520 patients with stable angina and a singlecoronary-artery lesion were randomly assigned to either stentimplantation (262 patients) or standard balloon angioplasty(258 patients). The primary clinical end points were death,the occurrence of a cerebrovascular accident, myocardial infarction,the need for coronary-artery bypass surgery, or a second percutaneousintervention involving the previously treated lesion, eitherat the time of the initial procedure or during the subsequentseven months. The primary angiographic end point was the minimalluminal diameter at follow-up, as determined by quantitativecoronary angiography.
Results After exclusions, 52 patients in the stent group (20percent) and 76 patients in the angioplasty group (30 percent)reached a primary clinical end point (relative risk, 0.68; 95percent confidence interval, 0.50 to 0.92; P = 0.02). The differencein clinical-event rates was explained mainly by a reduced needfor a second coronary angioplasty in the stent group (relativerisk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P= 0.005). The mean (±SD) minimal luminal diameters immediatelyafter the procedure were 2.48 ±0.39 mm in the stent groupand 2.05 ±0.33 mm in the angioplasty group; at follow-up,the diameters were 1.82 ±0.64 mm in the stent group and1.73 ±0.55 mm in the angioplasty group (P = 0.09), whichcorrespond to rates of restenosis (diameter of stenosis, 50percent) of 22 and 32 percent, respectively (P = 0.02). Peripheralvascular complications necessitating surgery, blood transfusion,or both were more frequent after stenting than after balloonangioplasty (13.5 vs. 3.1 percent, P<0.001). The mean hospitalstay was significantly longer in the stent group than in theangioplasty group (8.5 vs. 3.1 days, P<0.001).
Conclusions Over seven months of follow-up, the clinical andangiographic outcomes were better in patients who received astent than in those who received standard coronary angioplasty.However, this benefit was achieved at the cost of a significantlyhigher risk of vascular complications at the access site anda longer hospital stay.
Implantation of an intracoronary stent in conjunction with balloonangioplasty is not only highly effective in treating acute vesselclosure due to balloon-induced dissection, but it may also reducethe rate of restenosis1,2,3,4. Unfortunately, all stents currentlyavailable are metallic and thus thrombogenic, a problem thatnecessitates anticoagulation therapy5,6. This therapy exposesthe patient to an increased risk of major bleeding and vascularcomplications, which may prolong the hospital stay7. Despitethese drawbacks and although the superiority of stent implantationover standard balloon angioplasty has not yet been proved, stentinghas been used increasingly. Therefore, we conducted a multicenter,randomized study comparing stent implantation and balloon angioplastywith respect to their safety and efficacy in patients with stableangina pectoris and a single new lesion in a coronary artery.
Methods
Selection of Patients
Patients scheduled to undergo coronary angioplasty because ofstable angina due to a single new lesion in a coronary arterywere eligible for the study if they had no contraindicationto anticoagulant or antiplatelet therapy and if they were alsosuitable candidates for coronary bypass surgery. The targetlesion needed to be less than 15 mm long and to be located ina vessel more than 3 mm in diameter that supplied normally functioningmyocardium. Patients with an ostial lesion, a lesion at a bifurcation,or a lesion in a previously grafted vessel were excluded fromthe study, as were patients in whom an intracoronary thrombuswas suspected.
The study was carried out according to the principles of theDeclaration of Helsinki. Oral or written informed consent accordingto local practice was obtained for every patient.
Randomization
Patients were randomly assigned by telephone from a centraloffice to either implantation of a Palmaz-Schatz stent or balloonangioplasty. To ensure an equal distribution of treatments ineach center, we developed the randomization sequence on a sitebasis in blocks of six treatment assignments.
Balloon Angioplasty and Stent Implantation
Balloon angioplasty and stent implantation were performed accordingto standard clinical practice by the femoral approach. The stentwas deployed by inflating a balloon over which the collapsedstent was fitted. Inflation of the balloon expanded the stent.After the implantation of the stent, the stented area was oftendilated further by standard balloon angioplasty. All patientsreceived 250 to 500 mg of aspirin daily and 75 mg of dipyridamolethree times a day; this treatment was started the day beforethe procedure and was continued for six months. During the procedure,patients receiving a stent were treated with a continuous infusionof dextran (1000 ml) and a bolus dose of 10,000 U of heparin,repeated if necessary, followed by a combination of heparinand oral anticoagulation therapy (with warfarin) after the removalof the sheath and titrated by measuring the prothrombin timeand either the activated partial-thromboplastin time or theactivated clotting time. The dose of heparin was decreased progressivelyafter the prothrombin time had been in the therapeutic range(international normalized ratio, 2.5 to 3.5) for at least 36hours. Warfarin therapy was continued for three months. Thepatients who underwent balloon angioplasty received only 10,000U of heparin during that procedure, followed by an additionalbolus dose or a continuous infusion if deemed necessary. Inaddition, both treatment groups received calcium antagonistsuntil discharge from the hospital.
Clinical and Angiographic Follow-up
Patients were seen in the outpatient clinic after one, three,and six months for an interview, physical examination, and electrocardiogram.Exercise testing was performed before the second cardiac catheterizationand coronary angiography at six months. If a revascularizationprocedure involving the treated segment had been performed beforethe six-month angiography, the most recent angiogram obtainedbefore this intervention, if available, was used as the follow-upangiogram, regardless of the timing of the second intervention.If the time to follow-up angiography was less than three monthsand no second intervention was performed, the patient was askedto undergo angiography again at six months. In the absence ofa second angiogram at six months, the angiogram obtained mostrecently within the previous three months was used, if available,provided that no end point had occurred.
Three angiograms were obtained for each patient -- one justbefore the intervention, one immediately after, and one at follow-up.All the angiograms were analyzed by the Cardiovascular AngiographyAnalysis System and sent to the core laboratory (Cardialysis,Rotterdam, the Netherlands). To standardize the method of dataacquisition and to ensure the exact reproducibility of the angiogramsperformed after the intervention and at follow-up, measurementswere made as described earlier8.
End Points
The primary clinical end points were whichever of the followingoccurred first: death, a cerebrovascular accident, myocardialinfarction, bypass surgery, or a second percutaneous interventioninvolving the previously treated lesion between the time ofthe initial procedure and the angiography performed at 6 months(±4 weeks) (or at 7 months if no angiography was performedat 6 months). The indication for a second intervention or forbypass surgery had to be substantiated by symptoms or by electrocardiographicor scintigraphic evidence of myocardial ischemia at rest orduring exercise. All events were reviewed by the critical-eventcommittee, which was unaware of the treatment assignments.
Death was defined to include all deaths, regardless of cause.Cerebrovascular accidents occurring in patients receiving anticoagulanttherapy were considered to be intracranial hemorrhages unlessunequivocally demonstrated otherwise. Myocardial infarctionwas diagnosed if there were new pathologic Q waves accordingto the Minnesota Code9 or if there was an increase in serumcreatine kinase to more than twice the normal value, togetherwith a pathologic increase in myocardial isoenzymes. Bypasssurgery was defined to include emergency or elective bypasssurgery involving the previously treated segment. Emergencybypass surgery was defined as involving an immediate transferfrom the angioplasty suite to the operating room during theinitial phase of treatment. "Bailout" stent implantation wasdefined as the placement of a stent in the event of Thrombolysisin Myocardial Infarction (TIMI) grade 0 or 1 flow after angioplastyor in the case of worsening of the base-line TIMI flow by onegrade10. In all instances, prolonged balloon angioplasty hadto be attempted before bailout stenting was considered. By design,stent implantation as a bailout procedure was considered equivalentto emergency bypass surgery but was removed retroactively fromthe analysis of primary end points, since it is currently perceivedas an integral part of an angioplasty strategy. Only the untowardclinical events associated with such stenting were counted asend points. Second interventions were those involving a previouslytreated lesion that followed the initial procedure, which wasconsidered complete when the guiding catheter was removed fromthe arterial sheath. Revascularization (surgical or percutaneous)involving other coronary arteries did not constitute an endpoint.
The primary angiographic end point was the minimal luminal diameterat follow-up. For each treated segment, this value was calculatedfrom the mean values obtained in multiple matched projections.
Secondary end points included (1) the angiographic success rate,defined as the rate of achievement of less than 50 percent stenosison visual assessment; (2) the procedural success rate, definedas the rate of achievement of less than 50 percent stenosison quantitative assessment, without the occurrence of clinicalevents during the hospital stay; (3) the functional class accordingto the classification of the Canadian Cardiovascular Societyat six months or at the time of intercurrent angiography andsecond intervention; (4) the results of exercise testing atsix months or earlier, if clinically indicated; (5) the rateof restenosis (stenosis 50 percent at follow-up) at six months.
Power Calculations and Statistical Analysis
At the outset of the study, the size of the required sample(428 patients) was based on an assumed rate of clinical eventsof 30 percent in the angioplasty group and a reduction of thatrate by 40 percent in the stent group (by a two-sided test withan alpha error of 0.05 and a power of 0.80). To compensate forunsuccessful interventions and losses to follow-up, the samplewas enlarged by 10 percent (to 470 patients). In addition, toadjust for a loss of power due to a planned interim analysis,the sample was increased by another 10 percent, reaching a finalsize of 520 patients11.
The main clinical analysis consisted of a single comparisonbetween the two study groups with respect to the primary clinicalend point, regardless of its time of occurrence; this analysisinvolved all randomized patients with the exceptions of threepatients found after randomization not to be eligible and ofone patient who withdrew informed consent for further treatmentand follow-up according to the intention-to-treat principle.The clinical events were ranked according to the highest categoryof severity on the following scale: death, cerebrovascular accident,myocardial infarction, emergency bypass surgery, elective bypasssurgery, and repeat percutaneous intervention.
The main angiographic analysis consisted of a single comparisonbetween the two study groups with respect to minimal luminaldiameter and was performed according to the intention-to-treatprinciple.
Continuous variables are expressed as means ±SD and werecompared by the unpaired Student's t-test. The chi-square testwith Yates' correction was used to compare proportions. Discretevariables are expressed as counts and percentages and are comparedin terms of relative risks (for stenting as compared with angioplasty),with 95 percent confidence intervals calculated by the formulaof Greenland and Robins12. All statistical tests were two-tailed.
Results
Characteristics of the Patients
Between June 1991 and March 1993, 520 patients were randomlyassigned to stent implantation (262 patients) or balloon angioplasty(258 patients) at 28 participating centers. Of these 520 patients,4 were excluded from further analysis, 3 in the stent groupand 1 in the angioplasty group. One patient withdrew his informedconsent and left the hospital without receiving treatment, twoother patients did not undergo coronary revascularization becausetheir lesions proved to be unimportant during on-line quantitativecoronary angiography at the time of the intended intervention,and one patient participated in another study with an investigationaldrug. There were no differences in base-line characteristicsbetween the two study groups (Table 1 and Table 2).
Table 2. Angiographic Characteristics of the 516 Patients Included in the Intention-to-Treat Analysis and Characteristics of the Procedures They Underwent.
In-Hospital Clinical Outcomes
Of the remaining 259 patients randomly assigned to receive stents,14 (5.4 percent) did not receive a stent but were treated successfullywith balloon angioplasty. The reasons for this crossover werethe withdrawal of informed consent in five, the physician'spreference because of the patient's unfavorable anatomy (e.g.,small vessel size) or angiographic evidence of thrombus in three,and failure to cross the lesion with the stent in six. In addition,stent implantation was unsuccessful in 10 patients: 6 becausethe lesion was not dilated beforehand and 4 because the stentcould not be deployed. Of these 10 patients, 8 underwent bypasssurgery that was urgent in 3 and elective in 5. The remainingtwo patients, who unexpectedly had totally occluded coronaryarteries that could not be recanalized, were treated medically.
Of the 257 remaining patients randomly assigned to balloon angioplasty,13 (5.1 percent) received stents for the following reasons:acute vessel closure in 1, flow-limiting dissection in 11, anda suboptimal angiographic result in 1. Of these 13 patients,2 were referred for urgent bypass surgery and 1 had a non-Q-wavemyocardial infarction. In addition, three other patients whohad complicated balloon angioplasty and in whom no bailout stentimplantation was attempted underwent urgent bypass surgery.Therefore, the angiographic success rate was 96.9 percent inthe stent group and 98.1 percent in the angioplasty group, whereasthe procedural success rates were 92.7 and 91.1 percent, respectively.
The ranking and the total number of clinical events occurringin the hospital are shown in Table 3. The composite rate forall in-hospital events was similar in both groups (16 eventsor 6.2 percent in the angioplasty group vs. 18 events or 6.9percent in the stent group; relative risk, 1.12; 95 percentconfidence interval, 0.58 to 2.14). There were no in-hospitaldeaths in either group; one patient treated with balloon angioplastyhad an intracranial hemorrhage. There was no difference betweengroups in the incidence of Q-wave and non-Q-wave infarction(3.1 percent in the angioplasty group vs. 3.4 percent in thestent group; relative risk, 1.12; 95 percent confidence interval,0.44 to 2.85) or in the need for urgent or elective cardiacsurgery or second angioplasty during the hospital stay (2.7percent in the angioplasty group vs. 3.5 percent in the stentgroup; relative risk, 1.28; 95 percent confidence interval,0.48 to 3.37).
Table 3. Frequency of Primary Clinical End Points in the Hospital and at Seven Months in Descending Order of Severity, Total Number of Events, and Quantitative Comparison of Immediate and Long-Term Angiographic Results.
Angiographically documented stent thrombosis during the hospitalstay occurred in 3.5 percent of patients, an incidence similarto that of subacute vessel closure after balloon angioplasty(2.7 percent). It is noteworthy that no stent thrombosis occurredin the 13 patients treated with a bailout stent. However, theincidence of bleeding and vascular complications was significantlyhigher after stent implantation than after balloon angioplasty(13.5 vs. 3.1 percent; relative risk, 4.34; 95 percent confidenceinterval, 2.05 to 9.18; P<0.001).
The mean hospital stay was 8.5 days in the stent group and 3.1days in the angioplasty group (P<0.001).
Clinical Outcomes at Seven Months
The numbers of various types of clinical events at seven monthsamong all 516 patients are shown in Table 3. A primary clinicalend point was reached by 76 of the 257 patients randomly assignedto balloon angioplasty (30 percent), as compared with 52 ofthe 259 patients randomly assigned to stent implantation (20percent) (relative risk, 0.68; 95 percent confidence interval,0.50 to 0.92; P = 0.02). This difference in long-term clinicaloutcome is shown in the cumulative distribution curves for theprimary clinical end point in both treatment groups (Figure 1D).The favorable long-term outcome in the stent group wasalso partly reflected in the difference between the two groupsin functional class at the time of the second angiography (Table 4).The most striking difference in clinical outcomes was thesignificantly reduced need for an elective second revascularizationby means of percutaneous intervention involving the target lesion.There was a 42 percent reduction favoring stent implantation.
Figure 1. Cumulative Frequency Distribution Curves for the Two Study Groups, Showing Minimal Luminal Diameters Measured before and after Intervention and at Follow-up, the Percentage of Stenosis at Follow-up, and the Percentage of Patients with Clinical End Points.
Significant differences were apparent that consistently favored the stent group over the angioplasty group with respect to the increased minimal luminal diameter at intervention (Panel A) and follow-up (Panel B), the percentage of stenosis at follow-up (Panel C), and the incidence of major clinical events (Panel D). The vertical dashed line in Panel D indicates the end of the study.
Table 4. Functional Class at Seven Months of Follow-up or at the Time of the Intercurrent Intervention for the 516 Patients Included in the Intention-to-Treat Analysis.
During the study, three patients died, one in the angioplastygroup and two in the stent group. One patient treated with balloonangioplasty committed suicide four months after the intervention.Two other patients died two and three weeks after successfulstent implantations. In the first of these patients, death waspreceded by chest pain associated with ST-segment elevationand was therefore thought to be related to a subacute occlusion.In the second patient, the cause of death was hypovolemic shockduring surgical repair of an arteriovenous fistula. Althoughthe stent was patent at the time of the pathological examination,the death was considered to be related to the stent.
Angiographic Analysis
Angiographic follow-up data were obtained for 93 percent ofthe eligible patients (Table 3). The minimal luminal diameterat follow-up was greater after stent implantation than afterballoon angioplasty (1.82 ±0.64 vs. 1.73 ±0.55mm, P = 0.09; median difference, 0.17 mm). The cumulative distributionof the minimal luminal diameter and percentage of stenosis areshown in Figure 1A, Figure B, and Figure C. The incidence ofrestenosis (the criterion for which was 50 percent stenosis)was 22 percent after stent implantation as compared with 32percent after balloon angioplasty (P = 0.02).
Discussion
We found that implantation of coronary stents in patients withstable angina and a single new coronary-artery lesion was associatedwith a rate of immediate clinical success similar to that ofstandard balloon angioplasty, but a significantly lower rateof restenosis. This translated into a superior long-term clinicaloutcome, mainly due to a reduced need for additional percutaneousintervention, at least according to the composite analysis ofclinical end points. The advantage of this combined clinicalend point is that it leads to a simple estimate of the effectof treatment. However, this analysis ignores the relative effectof various events (i.e., it considers death, a cerebrovascularaccident, myocardial infarction, and the like to be equallyharmful to the patient) and does not reflect the multiplicityof events that may occur (e.g., in a patient undergoing secondangioplasty and surgery and ultimately dying). To address thisshortcoming, a count of all events is included in Table 3.
One of the major drawbacks of studies on the prevention of coronaryrestenosis is that at follow-up the angiographic knowledge ofcoronary anatomy may influence the physician's therapeutic decisionand artificially increase the number of second interventions.This is especially true when the investigator is not kept unawareof the treatment assignments, as when a new device is tested.To circumvent this possible source of bias, a second interventionwas considered an end point in this study only when it was substantiatedon the basis of anginal symptoms or objective evidence of ischemia(Table 5). Only two second interventions in the angioplastygroup and one in the stent group might not have been justified.Moreover, the fact that the cumulative curves for the compositeclinical end points (Figure 1D) diverged between day 75 andday 150 indicates that the difference in clinical outcome wasnot artificially driven by the angiographic findings at thetime of the second catheterization.
Table 5. Presence of Clinical Symptoms, Ischemic Signs, and Degree of Stenosis in Patients Who Underwent a Second Intervention at Follow-up.
Not unexpectedly, the incidence of major bleeding complicationswas significantly higher in the stent group (13.5 percent) thanin the angioplasty group (3.1 percent). The overall incidencereported in the literature, expressed as a weighted averageof groin hematomas and pseudoaneurysms, was 7.5 percent (range,2.7 to 26 percent) and 4.2 percent (range, 0 to 10.8 percent),respectively17.
Another significant difference between the two treatment groupswas in the duration of hospitalization. However, Cohen et al.recently showed that length of stay, consumption of resources,and total costs were still substantially greater for bypasssurgery than for stenting and that the initially higher in-hospitalcosts of stent implantation as compared with balloon angioplastyare compensated for by the reduction in subsequent interventionsduring follow-up18,19. The practitioner and the patient must,however, weigh a long hospital stay and a 13.5 percent riskof bleeding and vascular complications against the potentialbenefit of a reduction in the likelihood of clinical eventsfrom 30 percent to 20 percent.
It may be argued that the difference in drug therapy betweenthe two study groups accounts for the observed differences inangiographic outcome and rate of restenosis. However, a numberof clinical studies collectively rule out any beneficial effectof anticoagulant therapy on restenosis in humans20,21,22,23,24,25.Moreover, the degree of angiographically documented luminalloss was significantly higher after stent implantation thanafter balloon angioplasty (Table 3). Therefore, the beneficialangiographic and clinical effects of stent implantation areexplained by the propensity of the stent to achieve a consistentlygreater increase in luminal diameter immediately after the procedurethan is the case with balloon angioplasty, which is inherentlylimited by the well-described phenomenon of elastic recoil3,26.
It should be emphasized that in interpreting the favorable resultsobserved in this trial, the restrictive nature of the criteriafor inclusion and exclusion must be kept in mind, and thus theresults may not be generalizable to other patients, indications,and types of stents. Finally, bleeding and vascular complicationsand the prolonged hospitalization remain major drawbacks ofstent implantation and continue to hamper its acceptance inclinical practice.
Supported in part by a grant from Johnson and Johnson InterventionalSystems, Warren, N.J.; Schneider and Co., Bulach, Switzerland;and Lorex Pharmaceutica BV, Maarssen, the Netherlands.
Source Information
From the University Hospital Rotterdam Dijkzigt, Thorax Center, Rotterdam, the Netherlands (P.W.S., P.J., M.A.M.); Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (F.K.); University Hospital San Carlos, Madrid, Spain (C.M.); Universitatsklinikum Rudolf Virchow, Charlottenburg, Berlin, Germany (W.R.); Onze Lieve Vrouwe Kliniek, Aalst, Belgium (G.H.); Sahlgrenska Hospital, Goteborg, Sweden (H.E.); Clinique Pasteur, Toulouse, France (J.M.); Sart-Tilman Centre Hospitalier Universitaire, Liege, Belgium (V.L.); Hopital de la Citadelle, Liege, Belgium (P.M.); Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina (J.B.); Royal Brompton National Heart and Lung Institute, London (U.S.); Centro Cuore Columbus, Milan, Italy (A.C.); Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (J.J.G.); Middelheim Ziekenhuis, Antwerp, Belgium (P.H.); and Gregorio Maranon, Madrid, Spain (J.D.). The remaining investigators in the Benestent Study Group are listed in the Appendix.
Address reprint requests to Dr. Serruys at the Catheterization Laboratory, Thorax Center, Erasmus University Rotterdam, P.O. Box 1738, 3000 DR Rotterdam, the Netherlands.
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Appendix
The following institutions and investigators participated inthe Benestent study. The number of patients enrolled at eachcenter is given in parentheses.
University Hospital San Carlos, Madrid, Spain (76): F. Alfonso,J. Goicolea, R. Hernandez, and A. Iniguez; University HospitalRotterdam Dijkzigt, Thorax Center, Rotterdam, the Netherlands(57): P.J. de Feyter and M. van den Brand; Onze Lieve VrouweGasthuis, Amsterdam, the Netherlands (50): G.J. Laarman andR. vander Wieken; Universitatsklinikum Rudolf Virchow, Charlottenburg,Berlin, Germany (39): W. Rutsch; Onze Lieve Vrouwe Ziekenhuis,Aalst, Belgium (38): B. de Bruyne; Sahlgrenska Hospital, Goteborg,Sweden (36): P. Albertsson; Clinique Pasteur, Toulouse, France(32): J. Fajadet, S. Doucet, and O. Bar; Sart-Tilman CentreHospitalier Universitaire, Liege, Belgium (32): V. Legrand;Hopital de la Citadelle, Liege, Belgium (19): J. Boland; InstitutoCardiovascular de Buenos Aires, Buenos Aires, Argentina (19):J. Berrocal and R. Piraino; Royal Brompton National Heart andLung Institute, London (12): N. Buller and K. Priestley; CentroCuore Columbus, Milan, Italy (11): L. Maiello; Centre HospitalierUniversitaire Vaudois, Lausanne, Switzerland (11): E. Eeckhout;Middelheim Ziekenhuis, Antwerp, Belgium (10): F. van den Brande;Gregorio Maranon, Madrid, Spain (10): E. Garcia; Ziekenhuisde Weezenlanden, Zwolle, the Netherlands (8): H. Suryapranataand J. Hoorntje; St. Antonius Ziekenhuis, Nieuwegein, the Netherlands(8): T. Plokker and G. Mast; Hospital Maggiore, Trieste, Italy(8): S. Klugmann, E. Della Grazia, and A. Salvi; Hopital CantonalUniversitaire, Geneva, Switzerland (7): P. Urban and E. Camenzind;Academisch Ziekenhuis Groningen, Groningen, the Netherlands(6): P. den Heijer and R. van Dijk; Academic Medical Center,Amsterdam, the Netherlands (6): J. Piek and K. Koch; ChristianAlbrechts University, Kiel, Germany (6): R. Simon and G. Herrmann;Centre Cardiologique du Nord, Paris (5): M.C. Morice and T.Royer; St. James Hospital, Dublin, Ireland (5): P. Crean; CatharinaZiekenhuis, Eindhoven, the Netherlands (3): H. Bonnier, J. Koolen,and F. Bracke; Cliniques Universitaires St. Luc, UniversiteCatholique de Louvain, Brussels, Belgium (2): W. Wijns; CentreHospitalier Regional et Universitaire, Nancy, France (2): N.Danchin and Y. Juilliere; and the Polyclinique Volney, Rennes,France (2): C. Bourdonnec.
Ethics and Safety Committee: F. Verheugt, Free University Amsterdam,Amsterdam, the Netherlands; J. Tijssen, Academic Medical Center,Amsterdam, the Netherlands; and G. de Backer, State UniversityGhent, Ghent, Belgium.
Steering Committee: P.W. Serruys (chairman), H. Emanuelsson,G.R. Heyndrickx, P.P.T. de Jaegere, F. Kiemeneij (co-chairman),C. Macaya, J. Marco, and P. Materne.
Critical Event Committee: F. Kiemeneij (chairman), P.W. Serruys,P.P.T. de Jaegere, P.J. de Feyter, and P. van den Heuvel.
Angiographic Assessment Committee: P.P.T. de Jaegere (chairman),P.W. Serruys, W. Rutsch, B. de Bruyne, and V. Legrand.
Exercise Testing Committee: V. Legrand (chairman), G. Laarman,and N. Danchin.
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