Original Article
Warfarin in the Prevention of Stroke Associated with Nonrheumatic Atrial Fibrillation
N Engl J Med 1992; 327:1406-1412November 12, 1992
- Abstract
- Abstract
Background.
Nonrheumatic atrial fibrillation is common among the elderly and is associated with an increased risk of stroke. We investigated whether anticoagulation with warfarin would reduce this risk.
Methods.
We conducted a randomized, double-blind, placebo-controlled study to evaluate low-intensity anticoagulation with warfarin (prothrombin-time ratio, 1.2 to 1.5) in 571 men with chronic nonrheumatic atrial fibrillation; 525 patients had not previously had a cerebral infarction, whereas 46 patients had previously had such an event. The primary end point was cerebral infarction; secondary end points were cerebral hemorrhage and death.
Results.
Among the patients with no history of stroke, cerebral infarction occurred in 19 of the 265 patients in the placebo group during an average follow-up of 1.7 years (4.3 percent per year) and in 4 of the 260 patients in the warfarin group during an average follow-up of 1.8 years (0.9 percent per year). The reduction in risk with warfarin therapy was 0.79 (95 percent confidence interval, 0.52 to 0.90; P = 0.001). The annual event rate among the 228 patients over 70 years of age was 4.8 percent in the placebo group and 0.9 percent in the warfarin group (risk reduction, 0.79; P = 0.02). The only cerebral hemorrhage occurred in a 73-year-old patient in the warfarin group. Other major hemorrhages, all gastrointestinal, occurred in 10 patients: 4 in the placebo group, for a rate of 0.9 percent per year, and 6 in the warfarin group, for a rate of 1.3 percent per year. There were 37 deaths that were not preceded by a cerebral end point — 22 in the placebo group and 15 in the warfarin group (risk reduction, 0.31; P = 0.19). Cerebral infarction was more common among patients with a history of cerebral infarction (9.3 percent per year in the placebo group and 6.1 percent per year in the warfarin group) than among those without such a history.
Conclusions.
Low-intensity anticoagulation with warfarin prevented cerebral infarction in patients with nonrheumatic atrial fibrillation without producing an excess risk of major hemorrhage. This benefit extended to patients over 70 years of age. (N Engl J Med 1992;327: 1406–12.)
Media in This Article
Figure 1
Cumulative Probability of Cerebral Infarction.Table 1
Exclusion of Patients with No History of Cerebral Infarction Who Were Screened for the Study.*Article Activity
- Article
IT is generally accepted that atrial fibrillation is associated with an increased risk of stroke. The risk among patients with nonrheumatic atrial fibrillation is estimated to be five times greater than that for comparable patients in sinus rhythm.1 , 2 It is also known that the prevalence of nonrheumatic atrial fibrillation increases with age, with rates increasing from 0.04 percent per year among men under the age of 50 years3 to 9 percent per year among older men.4 Studies of low-intensity anticoagulation with warfarin, first used in the treatment of deep-vein thrombosis5 and more recently for other clinical conditions,6 have demonstrated that low-intensity anticoagulation is equal in efficacy to anticoagulation at a higher intensity in preventing thromboembolic episodes, but that it is associated with a lower risk of bleeding. To test the hypothesis that low-intensity anticoagulation would reduce the incidence of cerebral infarction among patients with nonrheumatic atrial fibrillation, we planned a prospective, randomized, double-blind study comparing the effects of low-intensity anticoagulation with warfarin with those of placebo. In this multicenter study we enrolled both patients who had not had a cerebral infarction before entering the study and patients who had had such an event. An interim analysis of the data on the patients with no history of stroke was reviewed on January 21, 1991, by the Data Monitoring Board, as specified in the protocol. (Data on patients with previous cerebral infarction were not reviewed, since there were so few such patients in the study.) Prompted by the early termination of studies with similar goals7 8 9 10 11 and by the statistically significant benefit of warfarin in this study, the board recommended that the study be terminated early; it was ended on March 1, 1991.
Methods
This Veterans Affairs Cooperative Study was conducted in 16 Department of Veterans Affairs medical centers. Patient recruitment began on June 1, 1987, and concluded as scheduled in May 1990. It was planned that each patient would be followed for three years, with the last patient scheduled to complete the study on May 31, 1993. Data collection was coordinated and analysis conducted at the Cooperative Studies Program Coordinating Center in Palo Alto, California. All study medication was distributed by the Cooperative Studies Program Research Pharmacy in Albuquerque, New Mexico. The study chairman, located in West Haven, Connecticut, was responsible for the overall conduct of the study. The protocol was approved by the institutional review board at each participating center. Informed consent was obtained from each patient.
Eligibility
Male veterans of any age, without echocardiographic evidence of rheumatic heart disease, who had atrial fibrillation documented by two electrocardiograms at least four weeks apart were considered for inclusion in the study. Their base-line prothrombin-time ratio had to be within the normal range. Patients who had previously received oral anticoagulation therapy for more than one month were required to discontinue warfarin treatment for at least six months before randomization. Aspirin and other nonsteroidal antiinflammatory agents were withdrawn if both the patient and his physician agreed. Sporadic use of aspirin or nonsteroidal antiinflammatory agents was discouraged. Other criteria for exclusion are listed in Table 1Table 1
Exclusion of Patients with No History of Cerebral Infarction Who Were Screened for the Study.*. Both patients who had no clinical evidence of a previous stroke and those who had had a clinically evident cerebral infarction at least one month before entry into the study were enrolled if they met the other criteria. Data on these two groups of patients were collected and analyzed separately.Blinding, Randomization, and Anticoagulation
There were two study teams at each center. The blinded team consisted of a cardiologist and a neurologist, acting as coinvestigators, and a study nurse. Another physician and a study clerk made up the unblinded team, which made the adjustments in drug doses. Patients at each study center were randomly assigned to receive warfarin or placebo according to lists generated by the Coordinating Center. Patients were told to assume that they were taking warfarin, to conduct themselves accordingly, and to report any bleeding.
The medication evaluated was sodium warfarin, given as 2-mg unmarked, scored tablets, and placebo tablets matched for taste and appearance (Dupont, Wilmington, Del.). The goal was to maintain the prothrombin-time ratio in the warfarin group at 1.2 to 1.5, corresponding to an International Normalized Ratio (INR) of 1.4 to 2.8. The prothrombin-time ratio was used in this study, rather than the INR, because when the study began the INR was not in general use in the United States. Furthermore, the International Sensitivity Index (ISI), which compares the sensitivity of commercial thromboplastin to that of an international reference thromboplastin, was not available for all the thromboplastin preparations used in the study hospitals.12 The available values for the ISI were between 1.5 and 2.6. To maintain blinding, adjustments were made in the dosage of placebo in accordance with randomly assigned, prearranged schedules. These schedules were designed to create a variety of maintenance doses with a built-in variability.
The first 12 weeks of the study for each patient constituted the induction period. Patients were started on a daily dose of 4 mg of warfarin, with the prothrombin-time ratio determined weekly. After the induction period, the prothrombin-time ratio was determined monthly. The dose of warfarin was adjusted in 1-mg increments so as to maintain the patient's prothrombin time in the desired therapeutic range, taking into account patient compliance, which was monitored by tablet count.
Follow-up
All the patients were followed for three years or until the study was terminated. Study medication was withdrawn if an end point occurred, if patients had a major hemorrhage, or if a permanent condition requiring exclusion developed (Table 1). Patients who had a cerebral event were followed for survival. Patients who had a reversible reason for exclusion, such as the need for surgery, were temporarily withdrawn from the study medication, which was begun again when the contraindication was no longer present. Patients were considered lost to follow-up if contact was lost for a continuous period of more than one year; data on patients lost to follow-up were censored at the time of their last study visit.
Assessment of End Points
The primary end point was clinically evident cerebral infarction. The secondary end points were cerebral hemorrhage and death. Clinical evidence of cerebral infarction was defined as a new neurologic deficit not attributable to dysfunction of a single cranial nerve, the spinal cord, or the peripheral nervous system, with persistence of the deficit or some portion of it for longer than 12 hours and an absence of evidence of intracerebral hemorrhage or tumor on the first cranial CT scan obtained after the onset of the deficit. Peripheral embolization was not considered a primary or secondary end point.
Cerebral hemorrhage was diagnosed if there was a focal neurologic deficit with evidence of parenchymal hemorrhage on the first cranial CT scan obtained after the onset of the deficit. Subdural hematoma or subarachnoid hemorrhage was not included in this definition.
Death was classified as an end point if it was not related to a cerebral end point. Deaths were further categorized as due to cardiac causes, due to noncardiac causes, or sudden and unexpected. An external End Points Committee consisting of two cardiologists and three neurologists classified all end points in a blinded fashion. Disagreements were resolved by consensus.
A major hemorrhage was defined as one that required a blood transfusion, an emergency procedure, or both to terminate bleeding or remove a hematoma or that led to admission to an intensive care unit. All other hemorrhages were classified as minor.
Statistical Analysis
All analyses were performed on an intention-to-treat basis. All comparisons were two-sided. The Kaplan–Meier method was used to estimate curves for the length of time to cerebral infarction,13 and the log-rank test was used to compare the length of time to an event in the treatment groups.14 Deaths were treated as censored events for the analysis of cerebral infarctions. Ninety-five percent confidence intervals were calculated for reductions in risk with use of the Taylor series approximation for the variance of the risk ratio.15
Two interim analyses were planned, the first in February 1991 and the second in February 1992. The results of the first interim analysis were presented to the Data Monitoring Board on January 21, 1991, and were based on data obtained through December 1, 1990. The results of published studies7 , 9 , 16 were also presented to the board. On the basis of these results and our finding in the interim analysis of a 72 percent reduction in the rate of cerebral infarction among patients given warfarin, the board recommended termination of the study, which occurred on March 1, 1991.
Results
Patients without Previous Cerebral Infarction
A total of 7982 patients with atrial fibrillation who had no history of cerebral infarction were identified, and 7444 were excluded on the basis of the criteria specified in the protocol (Table 1). The remaining 538 patients (7 percent of those screened) were randomly assigned to treatment groups. Thirteen patients (four assigned to receive placebo and nine to receive warfarin) were excluded after randomization, in accordance with accepted practices in the conduct of clinical trials,17 when it was determined that they had not met the eligibility criteria for the study. Thus, the analysis was performed on data from 525 patients — 265 randomly assigned to receive placebo and 260 to receive warfarin. The base-line characteristics of the two treatment groups were similar (Table 2Table 2
Base-Line Characteristics of Patients with No History of Cerebral Infarction, According to Treatment Group.*).Follow-up
Patients assigned to the placebo and warfarin groups were followed for an average of 1.7 and 1.8 years, respectively. Follow-up was incomplete for 74 patients (33 in the placebo group and 41 in the warfarin group). Fifty-five of them (29 in the placebo group and 26 in the warfarin group) withdrew from the study at their own request; data on these patients were censored at the time of their last visit. Nineteen patients (12 in the placebo group and 7 in the warfarin group) were lost to follow-up or could not be contacted at the end of the study. These patients were tracked through the Department of Veterans Affairs Beneficiary Identification and Record-Locating Subsystem (similar to the National Death Index), and one patient in the placebo group was determined to have died before the study was terminated.
A total of 190 patients had the study medication withdrawn and restarted at least once; the study medication was permanently withdrawn in the cases of 137 patients (56 in the placebo group and 81 in the warfarin group). The most frequent reason for withdrawal was the patient's personal decision (36 in the placebo group and 38 in the warfarin group). For many patients, the decision was probably related to the information provided to them in June 1990 about the results of similar studies.7 , 16 Another major reason for the withdrawal of the study medication was the development of a permanent reason for exclusion (19 in the placebo group and 34 in the warfarin group) (Table 1).
The study was conducted on an intention-to-treat basis; patients withdrawn from the study medication continued to have regularly scheduled follow-up visits. Medication codes were officially broken for five patients — four taking placebo and one taking warfarin. Thirteen patients (2.5 percent of those randomly assigned to treatment) reverted to sinus rhythm. These patients continued to receive the study medication.
Anticoagulation
During the maintenance period (the 13th and subsequent weeks of the study for each patient), including the times when the medication was withdrawn, patients assigned to the warfarin group had their prothrombin-time ratios in the target range an average of 56 percent of the time. Twenty-nine percent of the time the prothrombin-time ratios were less than 1.2, and 15 percent of the time they were more than 1.5.
Primary End Point
Cerebral infarction occurred in 23 patients, 19 of whom were taking placebo and 4 of whom were taking warfarin (reduction in risk, 0.79; 95 percent confidence interval, 0.52 to 0.90; P = 0.001) (Table 3Table 3
Primary and Secondary End Points in Patients with No History of Cerebral Infarction.* and Fig. 1Figure 1Cumulative Probability of Cerebral Infarction.). The annualized rate of cerebral infarction was 4.3 percent per year in the placebo group (440 patient-years) and 0.9 percent per year in the warfarin group (456 patient-years). The prothrombin-time ratios in the four warfarin-treated patients who had cerebral infarctions were 1.24, 1.27, 1.35, and 1.51 just before or at the time of the event. All were taking the study medication at the time of the event. Cerebral infarction was fatal (i.e., death occurred within 30 days of the event) in one patient from each group. Three other patients who had cerebral infarctions died more than 30 days after the event but before the termination of the study.A benefit of warfarin, as determined by a post-stratification analysis, was observed among patients more than 70 years of age (annualized event rates, 4.8 percent per year in the placebo group vs. 0.9 percent per year in the warfarin group; risk reduction, 0.79; 95 percent confidence interval, 0.34 to 0.93; P = 0.02). There were 228 such patients, of whom 88 were more than 75 years old. Of these 88 patients, 3 — all in the placebo group — had cerebral infarctions.
Secondary End Points
The single, nonfatal cerebral hemorrhage occurred in a 73-year-old patient assigned to receive warfarin (Table 3). His prothrombin-time ratio on the day of the cerebral hemorrhage was 1.46.
Twenty-two patients in the placebo group and 15 in the warfarin group died during the course of the study without a preceding cerebral event (risk reduction, 0.31; 95 percent confidence interval, -0.29 [indicating an increase in risk of 0.29] to 0.63; P = 0.19) (Table 3). The risk of a primary event or death was 53 percent lower in the warfarin group than in the placebo group (95 percent confidence interval, 0.24 to 0.71; P = 0.003).
Intercurrent Events
Major hemorrhages, all gastrointestinal, occurred in 10 patients (4 in the placebo group and 6 in the warfarin group), 52 to 95 years of age (Table 4Table 4
Intercurrent Events among Patients with No History of Cerebral Infarction.). The hemorrhages in the warfarin group occurred 2 to 24 months after randomization in patients whose prothrombin-time ratios were 1.17, 1.29, 1.35, 1.43, 1.44, and 1.57. There was one fatal noncerebral hemorrhage in the placebo group. There were no subdural or subarachnoid hemorrhages. Among patients over the age of 70, there were two major hemorrhages in each group; one in each group occurred in a patient more than 75 years of age.Minor hemorrhages, most of which originated in the upper respiratory or gastrointestinal tract, occurred 96 times in 46 placebo-treated patients and 115 times in 64 warfarin-treated patients (reduction in risk, -0.42; 95 percent confidence interval, -0.98 to -0.02; P = 0.04) (Table 4). Thrombotic vascular events were more common among the patients given placebo (16 vs. 9 in the warfarin group; annualized event rate, 3.64 vs. 1.97 percent per year; risk reduction, 0.43; 95 percent confidence interval, -0.23 to 0.74; P = 0.16).
Blinding to Treatment
At the termination of the study, each patient and his study nurse were requested to guess which medication the patient had received. Sixty-seven percent of the patients reported that they did not know, 22 percent guessed correctly (8 percent in the placebo group and 14 percent in the warfarin group), and 11 percent guessed incorrectly (3 percent in the placebo group and 8 percent in the warfarin group). For 82 percent of the patients, the nurses said they did not know which medication the patient had received. For 14 percent of the patients, the nurses guessed correctly (5 percent in the placebo group and 9 percent in the warfarin group), and for 4 percent of the patients, the nurses guessed incorrectly (2 percent in each group).
Patients with Previous Cerebral Infarction
A total of 1002 patients with nonrheumatic atrial fibrillation and a previous cerebral infarction were screened for inclusion; 47 (4.5 percent) were randomly assigned to treatment groups. Exclusions of patients with a history of cerebral infarction followed the same general pattern as for those with no such history (data not shown). One patient assigned to the placebo group was excluded after randomization; 46 patients (25 in the placebo group and 21 in the warfarin group) remained for analysis. The base-line characteristics of the patients in the two treatment groups were comparable to those of the patients with no history of stroke (data not shown). The patients in the placebo and warfarin groups were followed for an average of 1.7 and 1.6 years, respectively.
End Points and Intercurrent Events
Cerebral infarction occurred during the study in four patients in the placebo group (9.3 percent per year) and two patients in the warfarin group (6.1 percent per year) (Table 5Table 5
End Points and Major Intercurrent Events among Patients with Previous Cerebral Infarction.). This represents a reduction in risk of 0.40 in the warfarin group, but the number of patients was small and the 95 percent confidence interval for the risk reduction was very wide (-1.66 to 0.87). No cerebral hemorrhages or major hemorrhages occurred in either treatment group. Four patients assigned to receive placebo and five assigned to receive warfarin died without a preceding cerebral event.Discussion
This study demonstrates that low-intensity anticoagulation with warfarin confers substantial protection against cerebral infarction in patients with nonrheumatic atrial fibrillation, without entailing an excess risk of serious hemorrhage. Furthermore, the safety and efficacy of warfarin were evident in patients more than 70 years of age, who have the highest prevalence of atrial fibrillation. This protection seems also to apply to the recurrence of cerebral infarction, although the results are not as definitive because of the small number of patients with previous cerebral infarction in this study.
This study and three other prospective, randomized trials7 , 9 , 10 have shown that warfarin therapy reduces the incidence of cerebral infarction among patients with nonrheumatic atrial fibrillation. The patients in our study were male veterans, but the general similarity of the subjects' base-line characteristics and the comparable reduction in risk in the four studies indicate that these results have wide applicability. In the three unblinded studies of warfarin, the reduction in the risk of vascular events ranged from 67 percent to 86 percent.7 , 9 , 10 In our study there was a 79 percent reduction in the risk of cerebral infarction. The Canadian Atrial Fibrillation Study, the only other double-blind, placebo-controlled trial reported so far, was terminated early on the basis of data from the other trials and without consideration of its interim data. The study showed a nonsignificant trend in favor of warfarin.11
We found no significant increase in the risk of major hemorrhage associated with low-intensity anticoagulation with warfarin — a finding consistent with the results of the other stroke-prevention studies.7 , 9 10 11 Minor hemorrhage was more common in the warfarin group.
Patients without previous cerebral infarction constituted only 7 percent of the total number screened for this study. Twenty-three percent of those excluded had intermittent atrial fibrillation. Other investigators9 10 11 have reported that the risk of embolization in these patients is similar to that in patients with chronic atrial fibrillation. We believe that the treatment of patients with intermittent atrial fibrillation should be similar to that of patients with chronic atrial fibrillation.
In contrast to the established efficacy of warfarin, the benefit of aspirin in the prevention of stroke remains controversial. In our study, 43 percent of the patients screened were excluded because of a perceived contraindication to warfarin therapy. It is relevant, therefore, that two of the studies of patients with atrial fibrillation evaluated aspirin as an alternative to warfarin. The Danish AFASAK study found no benefit of aspirin as compared with placebo.7 A preliminary report of the Stroke Prevention in Atrial Fibrillation (SPAF) study16 showed that patients over the age of 75 did not benefit from aspirin, whereas aspirin did have benefit for patients younger than 75. In the population studied by the SPAF investigators,10 the incidence of ischemic stroke and systemic emboli was 3.6 percent per year for aspirin-treated patients, as compared with our rate of 0.9 percent per year for cerebral infarction alone in the warfarin-treated patients. Moreover, patients in the placebo group of the Boston Area Anticoagulation Trial for Atrial Fibrillation study9 were permitted to use aspirin, and no benefit was found.
Patients with lone atrial fibrillation — who have no evidence of structural heart disease, hypertension, diabetes mellitus, or precipitating factors such as thyrotoxicosis — appear to have a low incidence of systemic embolization. This group of patients, when strictly defined, makes up 2 to 4 percent of the population with chronic atrial fibrillation.18 The risk of embolization in this group is low (1.3 to 1.4 percent per year18) and not significantly different from the risk in the general population. The Framingham Study found an increased risk of stroke in this patient group.19 Their population included patients over 60 years of age, however, as well as patients with hypertension and diabetes. None of the 18 patients in our study who had lone atrial fibrillation had a cerebral infarction. This finding is consistent with the results of the SPAF study, which included 52 patients with lone atrial fibrillation, none of whom had an event.10 Thus, patients with lone atrial fibrillation probably do not require anticoagulation to reduce their risk of cerebral infarction.
All five of the atrial-fibrillation studies were terminated early by their data-monitoring boards,7 , 9 10 11 precluding the assessment of warfarin's long-term benefit. On the basis of data from our placebo group, cerebral infarction appears to be a sporadic event in patients with chronic atrial fibrillation, and the risk of an event persists even with long-standing atrial fibrillation. Although our study was based on the supposition that cerebral infarction is caused by emboli originating in the left atrium, we made no attempt to confirm this mechanism. Alternative mechanisms for cerebral infarctions are in situ thrombosis and emboli from other sources.
On the basis of the results of all completed studies, patients with intermittent or chronic atrial fibrillation should be offered warfarin unless they have lone atrial fibrillation or a contraindication to warfarin therapy, in which case aspirin therapy may be considered.
Address reprint requests to Dr. Ezekowitz at the Cardiovascular Section, 111B, Department of Veterans Affairs Medical Center, Clinical Campus, Yale University School of Medicine, 950 Campbell Ave., West Haven, CT 06516.
Supported by the Department of Veterans Affairs Cooperative Studies Program.
*The investigators and institutions participating in the study are listed in the Appendix.
We are indebted to Ms. E. Hanahan for her service as the project coordinator during the ongoing phase of the study, to Ms. P. Trent for assistance in the preparation of the manuscript, and to Ms. S. Klepper for editorial assistance.
Appendix
The investigators and institutions participating in the Stroke Prevention in Nonrheumatic Atrial Fibrillation study were as follows: Study Cochairmen: S.L. Bridgers and M.D. Ezekowitz; Study Biostatistician: K.E. James; Participating Veterans Affairs Medical Centers: Baltimore — N.H. Carliner, H.S. Panitch, C. Baker, G.L. Hershey, M. James, and B. Shelton; Boston — E. Ascher, V.L. Babikian, K. Crane-Spier, L. Fiore, A. Koufos, V. Blaustein, and H. Kleinman; Cincinnati — L. Wexler, J. Broderick, S. Allmyer, E.E. Lower, T. Brott, and T. Herold; Hines, Ill. — S.R. Gupta, L. Edwards, M. Ryan, N. Bhoopalam, and D. McCall; Little Rock, Ark. — S.M. Nazarian, M.L. Murphy, S. Thomas, A. Mansouri, and C. Arnold; Long Beach, Calif. — A. Alzarka, J. Feuer, J. R. Hyde, S. Forbes, and R.I. Sato; Minneapolis — C.C. Gornick, J.G. Davenport, L. Kvernen, W.R. Swaim, N. Carsberg, D. Ripley, and S. Wilker; Newington, Conn. — M.J. Radford, S. Patel, M. Giarniero, R. Edwards, and O. Hubenko; Northport, N.Y. — G. Mallis, G. Kaplan, J. Gustavson, M. Zarrabi, and S. Zucker; Palo Alto, Calif. — E. Atwood, G. Albers, S. Quaglietti, F. Yee, and E. Bushnell; Roseburg, Ore. — C. Carter, H. Lundh, A. Sedlacek, S. Gibson, B. Iwata, and C. Huang; San Diego, Calif. — R. Shabetai, P. Lyden, C. Nielsen, A.P. Gass, and V. Tihanyi; Seattle — J. Stratton, T. Bird, A. Leavell, G. Roth, J. Kousbaugh, J. Ritchie, and T. Glickman; Tampa, Fla. — S. Zachariah, C. Taylor, M.M. Branch, H. Saba, M. Morgan, and W.P. Nelson; Washington, D.C. — P. Carson, S.A. Houff, V. Papademetriou, M. Metcalfe, J. Zeller, L. Roman, C. Smith, and J. Swankhaus; West Haven, Conn. —E. Winter, V. Thadani, B. Cesanek, M. Drickamer, P. Alberg, L. Brass, and A.H. Gradman.
Chairman's Office, West Haven, Conn.: E. Hanahan, E.S. Teeple, and S. Klepper; Clinical Research Pharmacy, Albuquerque, N.M.: C.L. Colling, J. Boren, and M.R. Sather; Statistical Coordinating Center, Palo Alto, Calif.: K.E. James, H. Krause-Steinrauf, B. Watanaubi, R. Yen, R. Yezzi, R. Fischer, and K.K. Lee; Executive Committee: S.L. Bridgers, C.L. Colling, M.D. Ezekowitz, C.C. Gornick, K.E. James, J.F. Kurtzke, S.M. Nazarian, F.R. Rickles, and R. Shabetai; Data Monitoring Board: M. Dunn (chair), L.R. Caplan, W.M. O'Fallon, and D.A. Triplett; End Points Committee: S. Jonas (chair), L. Reik, Jr., B. Duckrow, J. Sacco, and J. Rutherford; CT Scan Committee: S.M. Nazarian (chair), S.L. Bridgers, J.P. Broderick, J. Davenport, S.R. Gupta, and V. Thadani.
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