Original Article
The Effect of Warfarin on Mortality and Reinfarction after Myocardial Infarction
N Engl J Med 1990; 323:147-152July 19, 1990
- Abstract
- Abstract
Background and Methods.
The use of oral anticoagulation in the long-term treatment of survivors of acute myocardial infarction has been highly controversial. We therefore randomly assigned 1214 patients who had recovered from acute myocardial infarction (mean interval from the onset of symptoms to randomization, 27 days) to treatment with warfarin (607 patients) or placebo (607 patients) for an average of 37 months (range, 24 to 63).
Results.
At the end of the treatment period, there had been 123 deaths in the placebo group and 94 in the warfarin group — a reduction in risk of 24 percent (95 percent confidence interval, 4 to 44 percent; P = 0.027). A total of 124 patients in the placebo group had reinfarctions, as compared with 82 in the warfarin group — a reduction of 34 percent (95 percent confidence interval, 19 to 54 percent; P = 0.0007). Furthermore, we observed a reduction of 55 percent (95 percent confidence interval, 30 to 77 percent) in the number of total cerebrovascular accidents in the warfarin group as compared with the placebo group (44 vs. 20; P = 0.0015). Serious bleeding was noted in 0.6 percent of the warfarin-treated patients per year.
Conclusions.
Long-term therapy with warfarin has an important beneficial effect after myocardial infarction and can be recommended in the treatment of patients who survive the acute phase. (N Engl J Med 1990; 323: 147–52.)
Media in This Article
Figure 1
Cumulative Rates of Death from All Causes, According to Original Treatment Assignment.Figure 2
Cumulative Rates of Reinfarction, According to Original Treatment Assignment.Article Activity
- Article
THE formation of a thrombus in a stenosed coronary artery has a causative role in the pathogenesis of acute myocardial infarction,1 , 2 and patients who recover from the acute phase are at risk for subsequent infarction.3 Oral anticoagulants have antithrombotic properties, but despite a number of clinical trials,4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 evidence of a beneficial effect of oral anticoagulants after myocardial infarction is inconclusive.21 22 23
The Warfarin Re-Infarction Study24 was initiated to assess the effect of long-term treatment with warfarin after myocardial infarction. The principal objectives were to investigate effects on the rates of mortality and reinfarction. Cerebrovascular accidents were used as a secondary end point. This paper presents the main results of the study in terms of mortality, reinfarction, and cerebrovascular accidents in the cohort randomly assigned to treatment groups.
Methods
Eligible Patients
Patients of either sex who were 75 years of age or younger at the time of discharge from the hospital after a myocardial infarction, defined according to the criteria of the World Health Organization,25 were eligible for the trial. Patients were recruited from five cardiologic centers serving the Oslo area (population, 570,000). Grounds for exclusion were as follows: the concurrent or required use of anticoagulants; the presence of malignant disease, with a life expectancy of less than two years; a risk of bleeding (e.g., a history of hemorrhagic diathesis, peptic ulcer, or the use of antiplatelet drugs); and nonmedical factors such as residence outside the study area or anticipated poor compliance. All the patients received standard medical therapy (including beta-blockers) during the hospital stay in accordance with local guidelines, and all gave informed consent in accordance with the Second Helsinki Declaration. The trial was approved by the ethics committees of all participating centers and by the National Drug Regulatory Authority.
Design of Trial
The study was designed as a placebo-controlled, randomized, double-blind trial, in which treatment groups were stratified according to the use of beta-blockers and the referring center. Randomization was performed by blocks with use of sealed envelopes containing treatment numbers corresponding to treatment packages at the randomization center. Treatment began on the day of randomization (a mean of 27 days after the infarction) and continued throughout the study.
Treatment and Procedures
The prothrombin time was measured with Thrombotest (Nycomed, Oslo, Norway), with a target range (expressed in terms of the international normalized ratio [INR]) of 2.8 to 4.8, which is approximately equivalent to a prothrombin-time ratio of 1.5 to 2.0 with a typical North American thromboplastin.26 An INR between 2.5 and 4.8 has been proposed as a target range for the prevention of arterial thrombosis.27
Blood was drawn from all patients at follow-up visits, which, after the initial stabilization of the prothrombin time, were scheduled every four to six weeks. In the placebo group the dosage was changed according to preset criteria. Special measures were taken to maintain blinding. For example, the medical technologist assigned to this project had access to the treatment code for each patient but was instructed never to communicate anything, either to the patient or to the treating physician, that could disclose the patient's treatment assignment. The prothrombin-time record for each patient was identified by a code number; after the physician had prescribed the dose, the medical technologist produced a dosage instruction for each patient as identified by the code number.
To diminish the risk of bleeding, all patients were advised not to take aspirin or other antiplatelet drugs while receiving the test medication.
Evaluation of End Points
Events were documented and verified by medical records, autopsy reports, or death certificates. Information from the patient, relatives, or witnesses provided supplementary evidence. Noncompliant patients or their general practitioners were contacted after the termination of the study and asked about clinical events and readmissions to the hospital during the time between the patient's last follow-up contact and the end of the observation period. In cases in which the history suggested a reinfarction or cerebrovascular accident, hospital records or records from the patient's primary care physician were examined. Cerebral CT scanning was performed in all patients with persistent neurologic deficits. Autopsies were performed for 46 percent of the patients who died. Major bleeding was defined as bleeding necessitating operation or blood transfusion. All other bleeding episodes were categorized as minor. The final classification of events was performed by one cardiologist and one pathologist, both blinded to treatment assignment. Vital status at the end of the study was known for all patients.
Statistical Analysis
A sample size of 1200 patients was chosen on the assumption that the two-year mortality rate would be 12.5 percent in the placebo group and that it would be lowered by 35 percent by the use of warfarin (alpha = 0.05, beta = 0.20 by two-tailed Z test). It was anticipated that all patients would be followed up until the last patient enrolled had been treated for two years.
Total mortality and total reinfarction were the main end points, whereas cerebrovascular accident was a secondary end point. All data have been analyzed on an intention-to-treat basis. This means that all events from the time of randomization until the cutoff date were counted, regardless of whether the study medication was being taken or not at the time of the event. In addition, we performed "on-treatment" analyses on the basis of actual treatment, using the results in patients who had an event while receiving the study medication or within 28 days of discontinuing it. As a primary end point, a nonfatal reinfarction would take precedence over a fatal infarction occurring later, but the fatal event would be counted.
Differences in mortality, reinfarction, and cerebrovascular "survival" times were tested by the log-rank chi-square statistic, without regard to the stratification procedures. Ninety-five percent confidence intervals were also calculated on the basis of the log-rank test statistic. Differences between other measurement variables were tested by two-sample t-tests, and variables on categorical data were evaluated by chi-square tests. In accordance with the study protocol, no interim analyses were performed. All reported P values are two-tailed.
Results
Selection of Patients and Randomization
During the accrual period, from January 10, 1983, through March 24, 1986, 1918 eligible patients were identified. Of those, 704 were excluded: 270 because they declined to participate, 15 because they had cancer, 16 because they died before randomization, 182 because they had factors contraindicating anticoagulant therapy, 156 because they required anticoagulant therapy, and 65 because they had a permanent residence outside the study area or were so physically or mentally disabled that they were not regarded as able to comply with the trial regimen. Of the 1214 patients enrolled in the trial, 607 were assigned to receive warfarin and 607 placebo. Apart from the total cholesterol level, which was higher in the warfarin group (P<0.001), the patients' characteristics were well balanced between the treatment groups (Table 1Table 1
Base-Line Characteristics of the Patients, According to Treatment Group.*). The test medication was given for an average of 37 months (range, 24 to 63).Of the 1214 patients enrolled, 214 discontinued the test medication for reasons other than the occurrence of a primary end point. The causes and relative frequencies of these withdrawals are listed in Table 2Table 2
Reasons for Withdrawal among 1214 Randomized Patients, According to Treatment Group.. Patients who had milder cerebrovascular accidents (either transient ischemic attacks or residual ischemic neurologic deficits) were not automatically withdrawn from the study.Mortality and Reinfarction
Data on mortality and reinfarction, including 95 percent confidence intervals for treatment effects, are shown in Table 3Table 3
Distribution of Events, According to Treatment Group.*. With analysis based on the intention to treat, 123 (20 percent) in the placebo group died, and 94 (15 percent) in the warfarin group died — a significant reduction in risk of 24 percent for the warfarin group as compared with the placebo group. The difference is statistically significant (chi-square = 4.9, P = 0.027 by the log-rank test) (Fig. 1Figure 1Cumulative Rates of Death from All Causes, According to Original Treatment Assignment.). When only the patients who were receiving the study medication or were within 28 days of discontinuing it for any reason ("on treatment") are considered, 92 patients in the placebo group died, as did 60 patients in the warfarin group — a reduction in risk of 35 percent. Specific causes of death are shown in Table 4Table 4
Numbers and Causes of Deaths among 1214 Patients, According to Treatment Group..Recurrent myocardial infarction (either fatal or nonfatal) occurred in 124 patients in the placebo group as compared with 82 patients in the warfarin group. The reduction in risk was 34 percent (chi-square = 11.6, P = 0.0007 by the log-rank test) (Fig. 2Figure 2
Cumulative Rates of Reinfarction, According to Original Treatment Assignment.). The corresponding figures for patients "on treatment" were 122 and 70, and the equivalent reduction in risk was 43 percent (Table 3).An effect of warfarin was present regardless of whether or not the patients were being treated concomitantly with beta-blockers. Among patients who were taking beta-blockers, there were 33 deaths among 293 patients in the warfarin group (11.3 percent), as compared with 46 deaths among 288 patients in the placebo group (16.0 percent). Among those not receiving beta-blockers, the corresponding numbers of deaths were 61 of 314 (19.4 percent) in the warfarin group, and 77 of 319 (24.1 percent) in the placebo group. The rate of reinfarction among patients receiving beta-blockers was 41 of 293 (14.0 percent) in the warfarin group and 64 of 288 (22.2 percent) in the placebo group. Among the patients who were not receiving beta-blockers, the reinfarction rates were 41 of 314 (13.1 percent) in the warfarin group and 60 of 319 (18.8 percent) in the placebo group.
Cerebrovascular Accidents
There were 55 percent fewer cerebrovascular accidents in the warfarin group (n = 20) than in the placebo group (n = 44). The difference was statistically significant (chi-square =10.1, P = 0.0015 by the log-rank test). Fourteen strokes were fatal — 4 in the warfarin group (all hemorrhagic) and 10 in the placebo group (all nonhemorrhagic). One of the hemorrhagic strokes occurred more than one year after the patient withdrew from the study. Two nonfatal hemorrhagic strokes occurred in warfarin-treated patients and none in patients receiving placebo. Considering only patients who had a stroke while receiving the study medication (or within 28 days of withdrawal), there were 61 percent fewer strokes in the warfarin group (16 vs. 41; chi-square = 12.3, P = 0.0003 by the log-rank test).
Other Thromboembolic Events
Deep venous thrombosis was diagnosed in one patient and pulmonary embolism in two patients, all in the placebo group. Two additional patients had peripheral arterial emboli; one patient in the warfarin group had an embolus in the arm in association with brachial angiography, and one patient in the placebo group had a spontaneous embolus in a leg.
Quality Control
Two methods were used to measure the degree of anticoagulation (Table 5Table 5
Overall and Time-Specific Distributions of Prothrombin Times.*). First, the distribution of all prothrombin times measured throughout the study was used. Second, the results were assessed according to the "cross-section-of-the-files" approach.28 The latter method is based on the logic that the probability that a patient's prothrombin time will be within the target range at an arbitrarily chosen time is equal to the proportion of the time during which the patient's prothrombin time is actually within this range. The data (Table 5) consistently show that two thirds of the patients had prothrombin times within the target range at any given time.Adverse Reactions
Five patients in the warfarin group had intracranial hemorrhages while receiving the study treatment; three of these events were fatal (incidence, 0.2 percent per year). Major extracranial bleeding occurred in eight patients (Table 6Table 6
Extracranial Bleeding Complications, According to Treatment Group.*). Thus, the combined incidence of major bleeding was 0.6 percent per year. Minor bleeding, requiring adjustment of the dose of the study medication, occurred in 69 patients, of whom 25 were in the placebo group. In seven of the patients who had major extracranial bleeding, it was associated with peptic ulcer, cancer, or the intake of antiplatelet drugs against our advice.Discussion
The principal objective of this trial was to determine the effect of warfarin on the incidence of death and reinfarction. A clear advantage emerged for the group that received warfarin. In addition to analyses based on the intention to treat, the data were also analyzed according to an "on-treatment" approach. The latter — considering only the patients who were actually taking the study medication — permitted us to evaluate the immediate effect of the drug treatment and avoided the "diluting" effect of counting events that occurred long after the withdrawal of the active therapeutic agent. These analyses included events that occurred during the 28 days after the study medication was discontinued, in order to allow adequate counting of events that might have been related to adverse effects of the drug.
Part of the controversy about previous trials of warfarin after myocardial infarction relates to problems inherent in the trials that yielded a positive result, of which many were observational or poorly controlled. Others did not include a placebo group, were not properly randomized, or had an inadequate sample size. A lack of benefit may be linked to an insufficient degree of anticoagulation. In a comprehensive review of 32 trials of anticoagulant agents in acute myocardial infarction, Chalmers and coworkers concluded that treatment did reduce mortality.29 Loeliger, in another review of 19 previous trials of oral anticoagulants in the prevention of death and myocardial infarction,30 found that in trials with a level of anticoagulation mainly within the INR range of 2.5 to 5,4 5 6 7 8 9 10 11 the average risk of death was lowered by 40 percent and the average risk of nonfatal reinfarction was reduced by approximately two thirds by the use of anticoagulant agents. In contrast, studies with inadequate or poor documentation of the level of anticoagulation12 13 14 15 16 17 18 19 20 21 found no difference in mortality but identified a trend favoring anticoagulant therapy in the prevention of reinfarction. Even though the method of pooling data from different trials has been criticized for not taking into account differences in protocols and the quality of the trials,31 reanalysis by more rigorous methods suggests that anticoagulants reduce mortality by about 22 percent (95 percent confidence interval, 8 to 35 percent).32 Hence, the 24 percent reduction in total mortality and the 35 percent reduction in "on-treatment" mortality observed in our study are in agreement with the pooled results.29 , 30 Similarly, our data reinforce the suggestion that treatment reduces the rate of nonfatal reinfarction by about 50 percent.29
The influence of anticoagulants on cerebrovascular accidents has not often been addressed in earlier post-infarction trials. The Sixty Plus Reinfarction Study reported 20 cerebrovascular accidents among the 439 patients in the placebo group and 12 among the 439 actively treated patients — a difference that was not statistically significant.33 A larger sample and an extended follow-up period may account for the larger reduction found in our study. Like the investigators in the Sixty Plus trial, we found that the increased risk of an intracranial hemorrhage during oral anticoagulant therapy was outweighed by the significant reduction in "undifferentiated" and thromboembolic cerebrovascular events.
During our trial, the use of thrombolytic therapy in the management of the acute phase of myocardial infarction became common. Such therapy was not controlled for by the protocol, and patients were not excluded because of treatment with thrombolytic agents. In the present trial, in which patients were enrolled from January 1983 through March 1986, however, few patients received such therapy. Theoretically, we would not expect warfarin to be less efficacious after thrombolytic therapy. Even if the occluded vessel is successfully opened by a thrombolytic agent, the risk of future thrombus formation persists. Aspirin appears to offer a benefit when given for one month after treatment with streptokinase,34 whereas data on the efficacy of warfarin after thrombolysis are sparse. In a retrospective study by Schreiber and associates, who compared aspirin and warfarin in the prevention of unstable angina, urgent coronary-artery bypass grafting, or death after thrombolytic therapy, warfarin seemed to be superior.35 However, only a trial specifically designed to explore this issue can determine the validity of their findings.
Randomization was successful in producing treatment groups similar in base-line characteristics except blood cholesterol level, which was significantly higher in the warfarin group. In the event of a clinical effect, that difference would reduce rather than magnify the differences between the experimental groups. We stratified patients according to the concomitant use of beta-blockers in order to guard against a difference between the treatment groups in this important characteristic. Because beta-blockade was not a randomly assigned treatment, the data do not allow us to assess the effect of beta-blockade. Our results suggest, however, that warfarin is effective in reducing mortality as well as reinfarction both in patients who receive beta-blockers and in those who do not.
Bleeding is the main risk associated with anticoagulant therapy, and the incidence of bleeding is closely related to the intensity of treatment.33 , 36 The well-controlled Sixty Plus Reinfarction Study reported one death due to bleeding per 206 patient-years at risk and one major bleeding episode per 55 patient-years at risk33 — an incidence of hemorrhagic complications exceeding that in our study. The differences can be explained by the higher proportion of patients with prothrombin times with an INR exceeding 4.8 in the Sixty Plus study.
In conclusion, the present study furnishes strong evidence that therapy with warfarin reduces the risk of death and reinfarction after acute myocardial infarction. The data also suggest a favorable effect on the incidence of cerebrovascular accidents. Our results imply that intensive warfarin treatment can be used with an acceptable degree of safety. Hence, if contraindications are not present, warfarin can be recommended for patients who have recovered from acute myocardial infarction.
Supported by grants from the Norwegian Council on Cardiovascular Diseases.
The following centers and investigators participated in this study: Aker University Hospital, Oslo — V. Høeg, M.D., and R. Pytte, M.D.; Bærum Hospital, Sandvtka — L. Gullestad, M.D., and J. Kjekshus, M.D., Ph.D.; Diakonhjemmet Hospital, Oslo — C. Eika, M.D., Ph.D.; Lovisenberg Hospital, Oslo —0. Bjørtuft, M.D.; Ullevål University Hospital, Oslo — M. Heldal, M.D.
The members of the study committees were as follows: Ethics Review Committee — U. Abildgaard, M.D., Ph.D., Ø. Skjæggestad, MD., Ph.D., and E. Lorentsen, M.D., Ph.D. (deceased); Steering Committee — H. Arnesen, MD., Ph.D., C. Borchgrevink, M.D., Ph.D., K. Dahlstrøm, M.Sc., H.C. Godal, M.D., Ph.D., and H. Stormorken, M.D., Ph.D.; End-Point Review Group — Ø. Skjæggestad, M.D., Ph.D., and L.A. Solberg, M.D., Ph.D.
We are indebted to Trine Opstad and Anne-Grethe Ødegaard for their collaboration in the study and to the staff at the laboratory at the Red Cross Clinic for their skillful technical assistance and enthusiastic support.
Source Information
From the Department of Medicine, Red Cross Clinic (P.S., H.A.), and the Life Insurance Companies' Institute for Medical Statistics, Ullevål University Hospital (I.H.), Oslo, Norway. Address reprint requests to Dr. Smith at the Department of Medicine, Ullevål University Hospital, N-0407 Oslo 4, Norway.
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