Original Article
Effects of the Early Administration of Enalapril on Mortality in Patients with Acute Myocardial Infarction — Results of the Cooperative New Scandinavian Enalapril Survival Study II (Consensus II)
N Engl J Med 1992; 327:678-684September 3, 1992
- Abstract
- Abstract
Background.
Long-term administration of angiotensin-converting—enzyme (ACE) inhibitors has been shown to improve survival in patients with symptomatic left ventricular failure and to attenuate left ventricular dilatation in patients with myocardial infarction. We studied whether mortality could be reduced during the 6 months after an acute myocardial infarction with use of the ACE inhibitor enalapril.
Methods.
At 103 Scandinavian centers patients with acute myocardial infarctions and blood pressure above 100/60 mm Hg were randomly assigned to treatment with either enalapril or placebo, in addition to conventional therapy. Therapy was initiated with an intravenous infusion of enalapril (enalaprilat) within 24 hours after the onset of chest pain, followed by administration of oral enalapril.
Results.
Of the 6090 patients enrolled, 3046 were assigned to placebo and 3044 to enalapril. The life-table mortality rates in the two groups at one and six months were not significantly different (6.3 and 10.2 percent in the placebo group vs. 7.2 and 11.0 percent in the enalapril group, P = 0.26). The relative risk of death in the enalapril group was 1.10 (95 percent confidence interval, 0.93 to 1.29). Death due to progressive heart failure occurred in 104 patients (3.4 percent) in the placebo group and 132 (4.3 percent) in the enalapril group (P = 0.06). Therapy had to be changed because of worsening heart failure in 30 percent of the placebo group and 27 percent of the enalapril group (P<0.006). Early hypotension (systolic pressure <90 mm Hg or diastolic pressure <50 mm Hg) occurred in 12 percent of the enalapril group and 3 percent of the placebo group (P<0.001).
Conclusions.
Enalapril therapy started within 24 hours of the onset of acute myocardial infarction does not improve survival during the 180 days after infarction. (N Engl J Med 1992; 327:678–84.)
Media in This Article
Figure 1
Kaplan–Meier Life-Table Mortality Curves for the Placebo and Enalapril Groups.Table 1
Comparability of the Study Groups at Base Line.Article Activity
- Article
BOTH the short-term and the long-term prognosis for patients with acute myocardial infarction has improved in recent years with the use of beta-adrenergic blockers, thrombolytic agents, and aspirin.1 Mortality not prevented by these treatments is related to the extent of myocardial injury. Global left ventricular dilatation, determined by measurement of end-systolic and end-diastolic volume, has been identified as an important marker of prognosis after infarction.2 , 3 Recent studies show that progressive left ventricular dilatation occurs in many patients after myocardial infarction, a process known as "remodeling."4 5 6
The renin—angiotensin system may be activated in the course of acute myocardial infarction7 and is believed to be instrumental in the remodeling process. Treatment with an angiotensin-converting—enzyme (ACE) inhibitor would be expected to reduce plasma levels of angiotensin II and decrease the tension (or "stress") within the wall of the left ventricle by reducing afterload, preload, or both. Administration of the ACE inhibitor captopril between 48 hours and 14 days after a myocardial infarction has been shown to limit left ventricular dilatation during 3 months to 1 year of follow-up.8 9 10 It is unknown whether the initiation of ACE inhibition even earlier after an acute myocardial infarction may improve survival and prevent the development of congestive heart failure.
The Cooperative New Scandinavian Enalapril Survival Study II (CONSENSUS II) was designed to examine the effect on mortality of the ACE inhibitor enalapril when combined with conventional therapy and initiated within 24 hours after the onset of an acute myocardial infarction. We report here on survival, other major outcomes, and side effects.
Methods
The study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in patients with acute myocardial infarction. Patients were enrolled at 103 Scandinavian centers (18 in Denmark, 18 in Finland, 1 in Iceland, 20 in Norway, and 46 in Sweden) and randomly assigned to the study groups (enalapril and placebo) between March 1990 and March 1991. Patients were eligible for enrollment if they presented within 24 hours of the onset of chest pain considered to be the initial symptom of acute myocardial infarction, and if the pain was associated with at least one of the following features: elevation of the ST segment in two or more contiguous electrocardiographic leads; new, pathologic Q-waves; or elevated plasma levels of enzymes indicating myocardial damage. Patients were excluded if their blood pressure measured while they were supine was less than 100/60 mm Hg, a value later changed to 105/65 mm Hg on the recommendation of the safety committee (see below).
Patients were also excluded from study if they had any of the following: a need for vasopressor agents for blood-pressure support; hemodynamically severe valvular stenosis; untreated third-degree atrioventricular block; a history of angioedema or sensitivity to ACE inhibitors or the use of such drugs within one week before the infarction; clinically severe renal, hepatic, or hematologic disorders; a history of cerebral transient ischemic attacks related to a reduction in blood pressure within the preceding six months; a clear indication for treatment with ACE inhibitors; or life-threatening conditions other than myocardial infarction. They were also excluded if they were expected to comply poorly with treatment.
All potentially eligible patients received standard therapy, including analgesic agents, nitrates, beta-blockers, calcium-channel blockers, thrombolytic agents, aspirin, diuretic agents, and anticoagulants, as indicated. It was recommended that any treatment with thrombolytic agents or intravenous beta-blockers be completed before administration of enalapril or placebo. Patients who presented with conditions that would exclude them but that might be reversed could be reevaluated and enrolled up to 24 hours after the onset of chest pain. A log of all eligible patients was kept at each center.
The patients were stratified in blocks of 2 to 10 according to whether they had had a previous myocardial infarction and according to study center. Packages of the study drug (enalaprilat and enalapril; Merck Sharp and Dohme, Rahway, N.J.) and placebo were labeled only with numbers assigned to the patients. Enalaprilat (enalapril modified for parenteral use) was supplied in 2.5-ml vials (1 mg per milliliter of infusate), and enalapril in 2.5-mg and 10-mg tablets. Treatment was started with an intravenous infusion of 1 mg of enalaprilat diluted in 100 ml of 0.9 percent saline or an infusion of placebo; it was administered over a two-hour period. The infusion was stopped if the systolic blood pressure fell below 90 mm Hg or the diastolic pressure fell below 60 mm Hg, but it could be restarted after stabilization of the blood pressure at the discretion of the responsible physician. Six hours after the infusion was completed, therapy was continued with oral enalapril or placebo. The recommended doses were 2.5 mg twice a day on the second day, 5 mg twice a day on the third day, 10 mg daily on the fourth day, and 20 mg daily on the fifth day and thereafter. The oral dose was increased if the systolic blood pressure was ≥100 mm Hg or if the diastolic pressure was ≥60 mm Hg. The investigator could give a lower dose if clinically indicated.
On November 1, 1990, the study protocol was modified for reasons of safety. A nonsignificant trend indicating an increase in mortality among patients with early hypotensive reactions prompted the safety committee to recommend that the minimal blood-pressure limit for enrollment be increased to 105/65 mm Hg and that the duration of infusion be increased to three hours. The infusion was stopped and could not be restarted if the systolic pressure fell below 100 mm Hg or the diastolic pressure fell below 60 mm Hg, or if systolic pressure fell by more than 30 mm Hg.
The recommended treatment for patients in whom heart failure developed was conventional therapy with digitalis, diuretics, and nitrates. If the heart failure was so severe that treatment with an ACE inhibitor was considered necessary, the patients were withdrawn from the study.
The primary objective of the trial was to evaluate the effect of enalapril on death due to any cause that occurred within six months. Secondary end points were the effect of treatment on death within one month, the cause of death, reinfarction, and worsening heart failure as indicated by a change in treatment or hospitalization because of heart failure. The cause of death was classified by the responsible investigator and reviewed by an end-point committee. Progressive heart failure was indicated by pump failure and cardiogenic shock. Sudden unexpected death was defined as death that was presumed due to arrhythmogenic factors and that occurred within 1 hour of the onset of new symptoms, and rapid death as death that occurred between 1 and 24 hours after new symptoms developed. Subgroups of patients identified in the study protocol that were of particular interest were patients with previous myocardial infarction, those 70 years of age or older, those with an anterior myocardial infarction, those with a history of hypertension, those with diabetes, and those treated with beta-blockers or thrombolytic agents (or both).
Outcomes and adverse reactions were monitored by an independent safety committee. The steering committee had on-line access to blinded data. Informed consent was obtained from each patient, and the study was approved by the ethics committee at each center.
Statistical Analysis
The study population was to consist of 9000 patients; this number was calculated on the basis of an expected mortality at six months of 12 percent in the placebo group and 9.6 percent in the enalapril group, a 20 percent difference (significance level, two-sided P = 0.05; power, 95 percent). To control for Type I error, the safety-monitoring committee used a conditional-probability sequential-analysis procedure11 as a guideline. With this procedure the trial could be stopped early, with the conclusion that enalapril was better than placebo, if the probability of a statistically significant difference at the end of the trial was predicted to be 95 percent or greater. Similarly, the conclusion that enalapril was no better than placebo could be reached if the probability of a positive outcome at the end of the trial was predicted to be less than 10 percent.
The results were analyzed on an intention-to-treat basis by the study sponsor (Merck Sharp and Dohme). The main findings were confirmed by the steering committee in a separate analysis. Unadjusted survival curves were compared by a Cox regression model in which the treatment group (enalapril or placebo) served as the only covariate.
Results
The first patient was enrolled on March 22, 1990. On March 3, 1991, the safety committee recommended that recruitment be stopped but follow-up of patients receiving blinded therapy be continued. This recommendation was put into effect March 26. On April 12, 1991, the safety committee recommended stopping the trial. This recommendation was based on a very high probability that the null hypothesis (that enalapril was no better than placebo) would apply and on concern about a possible adverse effect among elderly patients with early hypotensive reactions. The follow-up period ended May 5, 1991, and blinded therapy was stopped as soon as possible after this date. The predetermined criteria for ending the study had been met before blinded therapy had ended.
When recruitment was stopped, 10,387 patients had been screened, of whom 4297 (41 percent) were excluded. Accordingly, the remaining 6090 patients were randomly assigned to one of the treatment groups, 3046 to the placebo group and 3044 to the enalapril group. The medical history and clinical characteristics of the two groups were similar at base line (Table 1Table 1
Comparability of the Study Groups at Base Line.). The mean age was 66 years, and 73 percent of the patients were men. A previous myocardial infarction had led to hospitalization in 24 percent of the patients. According to the responsible physician, heart failure had occurred before the index infarction in 6 percent, and heart failure was associated with the index infarction in 18 percent. Thrombolytic therapy had been administered to 57 percent.Because the trial was stopped early, the observation period in patients receiving blinded therapy ranged from 41 to 180 days; 2952 patients were followed for 180 days. All 6090 patients enrolled were included in the study analysis (on an intention-to-treat basis). No patient was lost to follow-up.
By the end of the trial 598 patients had died — 286 in the placebo group and 312 in the enalapril group (9.4 percent vs. 10.2 percent, P = 0.26). The cumulative mortality rates are shown in Figure 1Figure 1
Kaplan–Meier Life-Table Mortality Curves for the Placebo and Enalapril Groups.. The mortality rates according to life-table analysis at 10 days and at 1, 3, and 6 months were 4.3, 6.3, 8.2, and 10.2 percent, respectively, in the placebo group and 4.6, 7.2, 9.1, and 11.0 percent, respectively, in the enalapril group (P = 0.26). The relative risk associated with enalapril treatment and based on the mortality curves was 1.10, with a 95 percent confidence interval of 0.93 to 1.29. The causes of death are summarized in Table 2Table 2
Causes of Death..The effects of treatment on secondary end points are shown in Table 3Table 3
Secondary End Points.. Treatment was changed because of worsened heart failure in 30 percent of the placebo group and 27 percent of the enalapril group (P<0.006).Subgroup Analysis
The outcomes among patients in prespecified subgroups are shown in Table 4Table 4
Mortality in Predefined Subgroups.. Among the older patients (≥70 years), mortality was somewhat higher in the group given enalapril (placebo vs. enalapril, 15 percent vs. 17 percent; P = 0.07). Among patients with a previous infarction and patients with anterior infarction, mortality was not significantly different in the treatment groups.Mortality was essentially the same in the subgroups with a history of congestive heart failure, acute pulmonary edema, or heart failure after hospital admission, although the proportion of patients in each of these subgroups was small (6, 2, and 18 percent, respectively). Table 5Table 5
Mortality According to Concomitant Therapy at Base Line. shows mortality rates according to the use of concomitant medication. There was no evidence of a significant interaction between enalapril and other drugs.Adverse Effects
The total dose of intravenous study agent administered was less than the permitted maximum (1 mg) in 4 percent of the placebo group and 15 percent of the enalapril group (P<0.001). The target dose— 20 mg of oral study agent on day 10 — was achieved in 89 percent of the placebo group and 82 percent of the enalapril group.
On average, the lowest blood pressure within six hours after the start of blinded therapy was 117/72 mm Hg in the placebo group and 109/66 mm Hg in the enalapril group; symptomatic hypotension occurred after the first dose of drug in 2 percent and 7 percent, respectively. More patients in the enalapril group had a systolic blood pressure below 90 mm Hg or a diastolic blood pressure below 50 mm Hg than did the patients in the placebo group (12 percent vs. 3 percent; P<0.001). The incidence of hypotension after the first dose of drug was similar in both age subgroups (<70 vs. ≥70 years). Long-term mortality was higher among patients given enalapril who had hypotension after the first dose (17 percent) than among the other patients given this agent (9.3 percent) or among patients given placebo who had hypotension (12 percent). This difference was of concern to the safety committee during their periodic review of the unblinded data and was the reason for changing the guidelines for infusion (the protocol amendment of November 1, 1990).
More patients were reported to have had adverse effects in the enalapril group than in the placebo group (74 percent vs. 70 percent; P<0.001) (Table 6Table 6
Adverse Effects of Therapy.). The numbers of patients in whom blinded therapy was discontinued are shown in Table 7Table 7
Patients Withdrawn from Blinded Therapy (≥7 Days before Death), According to Reason for Withdrawal. (placebo vs. enalapril, 12 percent vs. 17 percent; P<0.001).Discussion
The hypothesis that early administration of an ACE inhibitor for acute myocardial infarction (i.e., treatment beginning within 24 hours) may reduce mortality at six months was not supported by this trial. The lack of effect was consistent across a number of prespecified subgroups. We could not demonstrate any beneficial effect among patients with previous infarctions, Q-wave infarctions, or anterior infarctions, nor among patients with pulmonary edema or heart failure complicating the index infarction. During the first week of treatment, the mortality curves for the two treatment groups were nearly identical. After one month, mortality was slightly but not significantly higher in the enalapril group.
Both enalapril and captopril have been shown to improve survival in rats with induced myocardial infarction.12 , 13 Both drugs limit the extent of ischemia and infarction in animal models.14 15 16 17 In humans, two studies have shown that patients given captopril after a Q-wave myocardial infarction without overt heart failure have a smaller increase in left ventricular volume than patients given placebo.8 , 9 Patients included in these studies had left ventricular ejection fractions of 45 percent or less, and treatment was started one to four weeks after myocardial infarction and continued for one year.8 , 9 Recently captopril was demonstrated to have a beneficial effect on left ventricular volume when the drug was started 24 to 48 hours after myocardial infarction and continued for three months10 or started within 24 hours after infarction.18 When captopril was administered early after thrombolytic therapy, it was well tolerated and lowered plasma levels of norepinephrine and angiotensin II.19 The hemodynamic result of these effects may be a reduction in stress on the myocardial wall and in the oxygen requirement, which might be expected to translate into clinical benefit.
The lack of a beneficial effect of enalapril on mortality in the present study therefore contrasts with previous, promising results in animals and humans. Our findings may have several explanations. One possibility is that the reported effects of ACE inhibitors on left ventricular dilatation (remodeling) may not translate into improvement in survival. If so, our primary hypothesis is invalid. Another possibility is that the dose of enalapril was inadequate. Enalapril was administered intravenously to produce a rapid onset of action. In a pilot trial for CONSENSUS II,20 a rapid and pronounced reduction in serum levels of ACE activity was achieved with the same dose and route of administration used in the present trial. The hypotensive reactions that we observed reflected a hemodynamic effect. The target oral dose of enalapril — 20 mg, reached in 82 percent of the patients after 10 days — is similar to the dose given for heart failure in trials that have demonstrated a reduction in mortality.21 , 22
The lack of an effect of enalapril on mortality could also be the result of a balance between beneficial and adverse effects of the drug during different periods after myocardial infarction. Early after infarction, myocardial protein synthesis stimulated by angiotensin II may be important in the healing process.23 This process might be suppressed by ACE inhibitors. An inhibitory effect of the ACE inhibitor cilazapril on the proliferation of smooth-muscle cells after vascular injury has been reported by Powell et al.24 Schoemaker and coworkers found that administering captopril to rats very soon after acute myocardial infarction did not improve cardiac output during follow-up.25 In contrast, when captopril was started 14 days later, cardiac output increased. Early administration of enalapril, as in our study, might inhibit beneficial compensatory cellular proliferation during the early healing of some infarctions.
Myocardial infarction is a dynamic process with considerable variability.26 Areas of "hibernating" myocardium may be present during the very early phase.27 Myocardial perfusion pressure during this phase is an important determinant of the subsequent extent of myocardial damage.28 A hypotensive reaction caused by the infusion of enalaprilat may thus produce larger subendocardial areas threatened by ischemia. Our results suggest that the hypotension occurring in some patients given enalapril may have led to increased mortality. Caution should be exercised in the interpretation of these results, however, because it is not certain that the hypotension was actually the cause of increased mortality.
In the recent Studies of Left Ventricular Dysfunction (SOLVD) trial22 in patients with symptomatic left ventricular dysfunction (ejection fraction <35 percent), 66 percent of the patients had previously had a myocardial infarction. In that trial, long-term therapy with enalapril, started more than one month after infarction, reduced mortality significantly over a four-year period.22 These findings were observed among patients dying of progressive heart failure. In the present trial, we observed a small but significant beneficial effect of enalapril on the progression of congestive heart failure, expressed as a change in therapy because of worsening heart failure and as the number of patients reported to have worsening of heart failure. However, there were slightly more deaths due to heart failure in the enalapril group than in the placebo group (132 vs. 104 [4.3 percent vs. 3.4 percent]; P = 0.062). A treatment period longer than six months may be necessary to demonstrate whether enalapril benefits patients who have had a myocardial infarction. This idea is supported by data from two large trials in patients with a previous infarction who had depressed left ventricular ejection fractions.29 , 30 The results indicate that nearly one year of treatment must be given to patients without heart failure before a benefit of ACE-inhibitor therapy is detected. This observation points to differences between the treatment of established heart failure, in which survival benefit has been observed much earlier, and the prevention of evolving left ventricular dysfunction. Whether longer treatment with enalapril in our study would eventually have resulted in improved survival cannot be determined.
Address reprint requests to Dr. Swedberg at the Department of Medicine, University of Göteborg, Östra Hospital, S-416 85 Göteborg, Sweden.
Supported by a grant from Merck Sharp and Dohme Research Laboratories.
*The participants in the CONSENSUS II trial are listed in the Appendix.
Appendix
The following persons and institutions participated in the CONSENSUS II study (asterisks denote principal investigators, and the numbers in parentheses denote the numbers of patients).
Danish Centers: Rigshospitalet, Copenhagen: S. Haunsø* and S. Ali (41); Aarhus Amtssygehus, Aarhus: K. Thygesen,* P. Søgaard, and N. Sand (80); Hillerød Hospital, Hillerad: K. Mellemgaard,* P. Fruergaard, and J. Lauenberg (105); Nakskov Hospital, Nakskov: J. Badskjaer* (28); Odense Hospital, Odense: P. Thayssen,* A. Junker, and P. Ahlquist (114); Skejby Hospital, Skejby: P. Henningsen* and L. Frost (43); Nykøbing Falster Hospital, Nykøbing: E. Feldager and L. Tingsted (46); Viborg Hospital, Viborg: O. Lederballe* and P. Schroeder (57); Svendborg Hospital, Svendborg: T. Pindborg* and B.L. Hansen (48); Vejle Hospital, Vejle: S.-J. Guul* and S. Hvidt (123); Holstebro Hospital, Holstebro: L. Hagerup,* P. Duedal, and A. Johansen (69); Fredericia Hospital, Fredericia: T.M. Jensen (26); Næstved Hospital, Næstved: A. Høegholm, H. Madsen, and H. Karsum (58); Haderslev Hospital, Haderslev: E.H. Simonsen* and J. Kaalund (42); Grenå Hospital, Grenå: F. Gammelgaard* and V. Bager (36); Skive Hospital, Skive: S. Rud (13); Glostrup Hospital, Glostrup: M. Munch (25); and Tarm Hospital, Tarm: I. Helleberg-Rasmussen* (8).
Finnish Centers: Jorvi District Hospital, Espoo: A. Jäättelä,* J. Rapola, and R. Sipilä (69); Helsinki University Central Hospital, Helsinki: K. Luomanmäki,* S. Pohjola-Sintonen, and L. Toivonen (97); Hyvinkää District Hospital, Hyvinkää: J. Ahonen* (15); Pohjois-Karjala Central Hospital, Joensuu: H. Mustaniemi,* M. Ketonen, J. Nurminen, and U. Rytkönen (99); Länsi-Pohja Central Hospital, Kemi: T. Jääskeläinen* and E. Kanniainen (35); Kuopio University Hospital, Kuopio: K. Pyörälä,* M. Helin, S. Hietakorpi, T. Hirvonen, and J. Mustonen (131); Etelä-Saimaa Central Hospital, Lappeenranta: S. Utriainen,* A. Linkola, and T. Hämäläinen (64); Loimaa District Hospital, Loimaa: E. Kaarsalo* and M. Niemelä (44); Oulu University Central Hospital, Oulu: A. Kesäniemi,* A. Jounela, M. Lilja, and O. Ukkola (112); Peijas-Rekola District Hospital, Vantaa: E. Hussi (1); Satakunta Central Hospital, Pori: P. Satomaa,* S. Vikman, and A. Ylitalo (68); Savonlinna Central Hospital, Savonlinna: M. Huttenen* and M. Kaartinen (75); Etelä-Pohjanmaa Central Hospital, Seinäjoki: R. Savola,* J. Opas, and M. Rekiaro (69); Länsi-Uusimaa District Hospital, Tammisaari: C.-J. Lindström* (6); Tampere University Hospital, Tampere: A. Pasternack,* O. Anttonen, K. Pietilä, and V. Virtanen (126); Turku University Central Hospital, Turku: M. Arstila,* K. Korpilahti, and L.-M. Voipio-Pulkki (62); Vaasa Central Hospital, Vaasa: H. Kivelä* (7); and Varkaus District Hospital, Varkaus: K. Saraste* and A. Tarkiainen (47).
Icelandic Center: University Hospital, Reykjavik: A. Kristinnsson,* J. Hognason, J.T. Sverrisson, and G. Thorgeirsson (64).
Norwegian Centers: Aust-Agder Central Hospital, Arendal: T. Gundersen,* B. Jøssang, and R. Gerdts (110); Baerum Hospital, Baerum: N.E. Landmark* and A. Andreassen (50); Diakonissehjemmets Hospital, Bergen: B.K. Øie,* J. Langørgen, and R. Fanebust (74); Østfold Central Hospital, Fredrikstad: T. Holm* and A. Remme (38); GJøvik County Hospital, Gjøvik: L. Aaberge* and K. Lima (38); Gravdal Hospital, Gravdal: H. Jentoft* (20); Hammerfest Hospital, Hammerfest: O. Rysstad* and B. Schive (36); Hedmark Central Hospital, Elverum: H. Schartum-Hansen* and T. Grønvold (80); Innherred Hospital, Levanger: B. Klykken* and T. Graven (37); Kongsberg Hospital, Kongsberg: E. Wolff-Sørensen* (24); Namdal Hospital, Namsos: R. Sudbø and K. Hegbom (31); Narvik Hospital, Narvik: Y. Rønning* (22); Rogaland Central Hospital, Stavanger: K. Dickstein,* V. Bonarjee, T. Omland, D. Nilsen, H. Grundt, A.I. Larsen, L. Woie, and C. von Brandis (278); Sandefjord Hospital, Sandefjord: K.E. Nordlie* (23); Østfold Central Hospital, Sarpsborg: K. Overskeid and K. Falk (51); Stokmarknes Hospital, Stokmarknes: J.P. Loennechen* (23); Tromsø University Hospital, Tromsø: K. Rasmussen,* I. Nermoen, and B. Bryhni (62); Ullevål Hospital, University of Oslo, Oslo: T.O. Klemsdal,* V. Valen, and E. Wilk-Larsen (59); Vest-Agder Central Hospital, Kristiansand S: B. Wik* and O. Eggen (65); and Volda County Hospital, Volda: E.A. Bae* and S. Hareide (27).
Swedish Centers: Alingsås Hospital, Alingsås: M. Willstrand* and S. Ljungberg (36); Arvika Hospital, Arvika: P. Brunmark* (45); Bolinäs Hospital, Bolinäs: G. Mascher* and E. Hammarström (6); Högland Hospital, Eksjö: S. Ekdahl* and S. Hansen (91); Central Hospital, Eskilstuna: A. Stjerna* and E. Diderholm (119); Fagersta Hospital, Fagersta: H. Berg* (8); Falköping Hospital, Falköping: K. Viidas* and U. Viidas (42); Falun Hospital, Falun: H. Saetre,* G. Ahlmark, G. Ahlberg, and B. Linde (174); Gävle Hospital, Gävle: G. Gustafsson* and R. Löfmark (50); University of Göteborg, Sahlgren's Hospital, Göteborg: M. Hartford,* J. Herlitz, K. Caidahl, and P. Währborg (104); University of Göteborg, Ostra Hospital, Göteborg: K. Swedberg,* P. Held,* and A. Sigurdsson (157); Huddinge Hospital, Huddinge: O. Nyquist,* C. Sylvén, and I. Hagerman (74); Ryhov Hospital, Jönköping: O. Svensson* and J.-E. Karlsson (65); Kungälv Hospital, Kungälv: M. Hagman* and L. Eklund (28); Köping Hospital, Köping: B. Malmros* and P. Nicol (10); Landskrona Hospital, Landskrona: T. Ragnartz,* B. Lundh, F. Gyland, M. Wikander, and R. Linné (59); Lidköping Hospital, Lidköping: J. Kjellberg* and B. Söderström (61); Lindesberg Hospital, Lindesberg: T. Fraser* (36); Ljungby Hospital, Ljungby: O. Fredholm* and K.-A. Svensson (50); Malmö General Hospital, Malmö: L. Erhardt* and R. Willenheimer (57); Mora Hospital, Mora: J. Nisell* (29); Motala Hospital, Motala: U. Rosenqvist* and B.-O. Rydén (70); Mölndal Hospital, Mölndal: B. Liander,* L. Klintberg, and H. Holmberg (76); Nacka Hospital, Nacka: A. Sjögren* and E. Loogna (58); Norrköping Hospital, Norrköping: J. Fridén,* O. Nilsson, and S.-Å. Falk (73); Oskarshamn Hospital, Oskarshamn: J. Perk* and E. Baecklund (35); Piteä Hospital, Piteä: S.-E. Marklund* and K. Läng (48); Sandviken Hospital, Sandviken: H. Brodersson* and J. Ellström (14); Skellefteå Hospital, Skellefteå: K. Boman,* J. Remmets, K. Kärki, and K. Nylén (49); Skövde Hospital, Skövde: P. Smedgård* and J. Ejdebäck (78); Karolinska Hospital, Thoracic Clinics, Stockholm: L. Rydén,* M. Edner, and C. Malmberg (75); Sabbatsberg Hospital, Stockholm: I. Liljefors,* L. Wennerström, and F. Al-Khalili (12); Södersjukhuset, Stockholm: J. Hulting* and K. Lindvall (116); Sundsvall Hospital, Sundsvall: B.-J. Möller* and M. Lycksell (35); Norra Ålvsborgs Länssjukhus NÅL, Trollhättan: H. Stakeberg* (38); Uddevalla Hospital, Uddevalla: N.-J. Abdon* and J. Solem (35); Regionsjukhuset, Umeå: U. Näslund,* O. Johnsson, J. Nilsson, and K. Öhman (42); Akademiska Hospital, Uppsala: C. Lidell* and G. Sundlöf (30); Varberg Hospital, Varberg: J. Jonsson* and C. Nemeczek (92); Värnamo Hospital, Värnamo: O. Lind,* S. Thorsén, and J. Pettersson (44); Västervik Hospital, Västervik: B. Sinnerstad* and L.-E. Larsson (45); Västerås Hospital, Västerås: G. Agert,* S. Bandh, S. Wiberg, and G. Nilsson (103); Våxjö Hospital, Växjö: B.H. Lim,* S. Östberg, G. Andersson, and S. Berlind (50); Ängelholm Hospital, Ängelholm: D. Ursing,* C.-M. Pripp, and R. Steiner (74); Regionsjukhuset, Örebro: C. Wettervik,* B. Ryttberg, M. Allared, K. Göransson, and P. Hasselgren (133); and Östersund Hospital, Östersund: R. Marsell,* B. Ritter, and T. Smedby (63).
Steering Committee: K. Swedberg (chairman), Göteborg; F. Fyhrquist, Helsinki; T. Gundersen, Arendal; S. Haunsö, Copenhagen; P. Held, Göteborg; J. Kjekshus, Baerum; K. Kristianson, Merck Sharp and Dohme Scandinavia, Bromma (non-voting); K. Pyörälä, Kuopio; K. Rasmussen, Tromsö; L. Rydén, Stockholm; P. Thayssen, Odense; K. Thygesen, Aarhus; L. Toivonen, Helsinki; H. Wedel, Nordic School of Public Health, Göteborg.
Safety Committee: C. Furberg (chairman), Bowman Gray School of Medicine, Winston-Salem N.C.; R. Campbell, University of Newcastle, Newcastle-upon-Tyne, United Kingdom; J. De Cani, University of Pennsylvania, Philadelphia; and B. Pitt, University of Michigan, Ann Arbor.
End Point Committee: T. Gundersen, P. Held, P. Thayssen, and L. Toivonen.
Administrative Coordination — Merck Sharp and Dohme: Berg, Scandinavia; S.B. Christiansen, Denmark; E. Helve, Finland; G. Moen, Norway; and H. Boström, Sweden.
Scientific Coordination: K. Swedberg (chairman); Denmark, P. Thayssen; Finland, L. Toivonen; Norway, T. Gundersen; Sweden, P. Held; Merck Sharp and Dohme, K. Kristianson, J. Rush, and S. Snapinn, Blue Bell, Pa.
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