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Previous Volume 328:680-684 March 11, 1993 Number 10 Next

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ABSTRACT

Background Despite the widespread use of intravenous thrombolytic therapy and of immediate percutaneous transluminal coronary angioplasty for the treatment of acute myocardial infarction, randomized comparisons of the two approaches to reperfusion are lacking. We report the results of a prospective, randomized trial comparing immediate coronary angioplasty (without previous thrombolytic therapy) with intravenous streptokinase treatment.

Methods A total of 142 patients with acute myocardial infarction were randomly assigned to receive one of the two treatments. The left ventricular ejection fraction was measured by radionuclide scanning before hospital discharge. Quantitative coronary angiography was performed to assess the degree of residual stenosis in the infarct-related arteries.

Results A total of 72 patients were assigned to receive streptokinase and 70 patients to undergo immediate angioplasty. Angioplasty was technically successful in 64 of the 65 patients who underwent the procedure. Infarction recurred in nine patients assigned to receive streptokinase, but in none of those assigned to receive angioplasty (P = 0.003 ). Fourteen patients in the streptokinase group had unstable angina after their infarction, but only four in the angioplasty group (P = 0.02). The mean (±SD) left ventricular ejection fraction as measured before discharge was 45 ±12 percent in the streptokinase group and 51 ±11 percent in the angioplasty group (P = 0.004). The infarct-related artery was patent in 68 percent of the patients in the streptokinase group and 91 percent of those in the angioplasty group (P = 0.001). Quantitative coronary angiography revealed stenosis of 36 ±20 percent of the luminal diameter in the angioplasty group, as compared with 76 ±19 percent in the streptokinase group (P<0.001).

Conclusions Immediate angioplasty after acute myocardial infarction was associated with a higher rate of patency of the infarct-related artery, a less severe residual stenotic lesion, better left ventricular function, and less recurrent myocardial ischemia and infarction than was intravenous streptokinase. .

Methods

Patients

The research protocol was reviewed and approved by our institutional review board. The enrollment of patients began on August 20, 1990, and ended on February 10, 1992. Inclusion criteria were as follows: symptoms of acute myocardial infarction that persisted for more than 30 minutes, accompanied by an elevation of more than 1 mm (0.1 mV) in the ST segment in two or more contiguous electrocardiographic leads; presentation within 6 hours after the onset of symptoms (or between 6 and 24 hours, if there was evidence of continuing ischemia); an age of less than 76 years; and no contraindication to thrombolytic therapy, including previous stroke or other known intracranial disease, recent trauma or surgery, refractory hypertension, active bleeding, or prolonged cardiopulmonary resuscitation. Previous coronary-artery bypass grafting, previous Q-wave or non-Q-wave infarction, and cardiogenic shock were not reasons for exclusion. Before randomization we recorded each patient's age, sex, Killip class on admission,¹⁸ electrocardiographic site of infarction, history of infarction, heart rate, arterial pressure, time of onset of symptoms, and time of hospital admission.

Randomization and Treatment Protocol

After informed consent was obtained, the patients were randomly assigned to one of the two treatment groups by means of a closed-envelope system. All the patients received 300 mg of aspirin intravenously, followed by 300 mg of aspirin per day orally and intravenous nitroglycerin in a dose designed to maintain a systolic blood pressure of 110 mm Hg. Intravenous heparin was given in a dose designed to maintain the activated partial-thromboplastin time between two and three times the normal value for at least two days. This partial-thromboplastin time was measured twice a day. Although values more than three times the normal value occurred at least once in 57 percent of the patients, values less than two times the normal value were observed in only 13 percent. Drugs such as lidocaine, calcium-channel blockers, and -adrenergic blockers were given only at the discretion of the attending physicians. Fourteen percent of the patients in the streptokinase group and 16 percent of those in the angioplasty group received intravenous lidocaine; 31 percent and 41 percent, respectively, received calcium-channel blockers; and 39 percent and 27 percent received -adrenergic blockers. Patients assigned to streptokinase received 1.5 million units intravenously over a period of one hour. Patients assigned to undergo coronary angioplasty were moved to the catheterization laboratory as quickly as possible and underwent coronary angiography. Both coronary arteries were visualized; left ventriculography was not performed. The time from admission to the initiation of therapy was calculated as the time to the start of the streptokinase infusion or the first balloon inflation.

Study End Points

The variables we measured were the rate of recurrent ischemia before discharge, the left ventricular ejection fraction, and vessel patency. Recurrent ischemia before hospital discharge included the following: stable angina, defined as chest pain and a positive exercise test; unstable angina, defined as chest pain and changes in the ST-T segment at rest; and recurrent myocardial infarction, defined as chest pain, changes in the ST-T segment, and a second increase in the creatine kinase level to more than two times the upper limit of normal, or an increase of >200 U per liter over the previous value if the level had not dropped below the upper limit of normal. All electrocardiograms and laboratory results were reviewed for evidence of recurrent ischemia by two cardiologists blinded to the assigned therapy. Electrocardiographic changes that were required for a diagnosis of ischemia were ST-segment depression or a new elevation of the ST segment of at least 1 mm in two or more contiguous leads during chest pain; alternatively, unchanged or pseudonormal ST segments had to be present during chest pain, with the T waves becoming inverted after the pain was relieved. These inverted T waves had to have a minimal depth of 2 mm and had to develop within three hours after the recurrence of chest pain. A symptom-limited bicycle exercise test was performed with the patient in the supine position, with increments of 10 W per minute. An exercise test indicating ischemia was defined as a test with an ST depression of more than 1 mm, measured 60 msec after the J point. In patients with base-line abnormalities in the ST-T wave, a depression of more than 1 mm in the ST segment was considered to indicate ischemia.

The left ventricular ejection fraction was measured with a radionuclide technique before hospital discharge^19,20,21. The technique used in our hospital has been previously described²². Briefly, it involved the multiple-gated equilibrium method after the labeling of red cells with [99mTc]pertechnetate. A gamma camera (General Electric, Milwaukee) with a low-energy, all-purpose, parallel-hole collimator was used. The global ejection fraction was calculated automatically by computer (Star View, General Electric), with the PAGE program. The data on ejection fractions were gathered by a specialist in nuclear medicine who was blinded to the clinical data. This use of a software program whose results did not depend on the operator protected against possible bias. The reproducibility of the method is excellent, the mean (±SD) difference between duplicate measurements being 1.2 ±1.1 percent²².

Arterial patency, defined as Thrombolysis in Myocardial Infarction (TIMI) grade 2 or 3 flow in the infarct-related coronary artery,⁶ was assessed by coronary angiography. In the angioplasty group, angiography was repeated, preferably after three months, to assess the rate of restenosis²³. Only the patient's name, date of birth, and electrocardiographic site of infarction were known during the assessment of the angiogram. All infarct-related vessels were analyzed quantitatively with a personal-computer-based system of cardiovascular analysis (Cardiovascular Measurement System, Medis Medical Imaging Systems, Nuenen, the Netherlands)²⁴. The basic algorithms have been described elsewhere²⁵. The system uses a high-quality converter that allowed a selected cine frame to be projected onto a digital camera through a zoom lens. The video signal of the magnified region of interest was subsequently digitized. For calibration, the boundaries of a nontapering part of the catheter were determined automatically over a length of approximately 2 cm. To determine the contours of the vessel the user had only to indicate the beginning and end of the coronary segment to be analyzed, after which a path was computed connecting these two points²⁶. The contour procedure was then performed iteratively by resampling the image along scan lines perpendicular to the path computed in the first iteration. Next, a matrix of cost coefficients was computed that represented for each point in the resampled matrix the edge strength based on the weighted sum of the first and second derivative functions. The initial contours were found by the minimal-cost contour-detection technique applied to the cost-coefficient matrix²⁷. In the second iteration, the contours determined in the first iteration functioned as models for the subsequent determination. The edge strengths were corrected for the limited resolution of the entire imaging chain, a procedure that is particularly important for the accurate measurement of small vessels. From the final contours, a new center line was computed. A diameter was determined in absolute terms (in millimeters) by computing along the vessel center line the shortest distances between the left and right contours. The reference diameter was defined as previously described²⁷.

Statistical Analysis

All end points were analyzed according to the principle of intention to treat. Student's t-test was used to compare mean values. Comparisons of the rates of recurrent ischemia, vessel patency, and complications were made with a conventional chi-square test, but Fisher's exact test was used if there was an expected cell value of less than 5. All calculated P values are two-tailed. In our presentation of the data, continuous base-line and outcome variables are given as means ±SD, whereas discrete variables are given as absolute values and percentages.

Results

The patients' base-line clinical and angiographic characteristics are shown in Table 1. The mean time from admission to the start of the streptokinase infusion was 30 ±15 minutes. All the patients assigned to angioplasty underwent emergency angiography. The infarct-related vessel showed a flow of TIMI grade 0 in 87 percent of the patients. Two patients with open vessels were treated conservatively. Three patients with severe multivessel disease or stenosis of the left main artery underwent emergency coronary-artery bypass grafting after the insertion of an intraaortic counterpulsation balloon. The remaining 65 patients underwent immediate angioplasty of the infarct-related vessel, with success in 64 (98 percent). (The angioplasty was considered to be technically successful if there was residual stenosis of less than 50 percent on visual estimation and a flow of TIMI grade 2 or 3.) In one patient the infarct-related vessel could not be reopened: this patient underwent immediate coronary-artery bypass grafting. The time from admission to the first balloon inflation was 61 ±22 minutes.

View this table: [in this window] [in a new window]   Table 1. Base-Line Clinical and Angiographic Characteristics of the Study Patients.

 
The creatine kinase level rose to 1327 ±1304 U per liter in the streptokinase group and to 1477 ±1215 U per liter in the angioplasty group (P = 0.49). The normal value for creatine kinase is less than 100 U per liter in our hospital.

Complications and required procedures are shown in Table 2. Intercerebral bleeding and bleeding necessitating a blood transfusion were considered to be bleeding complications. There were fewer complications overall in the patients assigned to immediate angioplasty than in those assigned to streptokinase. In particular, death, bleeding, and heart failure occurred less frequently in the angioplasty group. Thirty-eight percent of the patients in the streptokinase group had recurrent ischemia, but only 9 percent of those in the angioplasty group (P<0.001) (Table 3). The frequency of stable angina was similar in the two groups, but the incidence of recurrent myocardial infarction and unstable angina was higher in the patients who received streptokinase. Additional revascularization procedures were more often necessary in the streptokinase group (Table 3). Four patients assigned to angioplasty underwent bypass surgery within 24 hours after admission, three without having undergone angioplasty. Three patients had elective bypass surgery for anatomical reasons after successful angioplasty (6, 9, and 10 days after admission). Only one patient in the angioplasty group underwent emergency repeat angioplasty for threatened reocclusion. Two patients in the angioplasty group underwent elective angioplasty of non-infarct-related arteries (7 and 11 days after admission). In the streptokinase group, 2 patients had emergency bypass surgery, 6 had elective bypass surgery (13 ±6 days after admission), 14 had emergency angioplasty, and 8 had elective angioplasty for recurrent ischemia (7 ±5 days after admission).

View this table: [in this window] [in a new window]   Table 2. Complications and Procedures in the Study Patients.

 

View this table: [in this window] [in a new window]   Table 3. Recurrent Ischemia and Additional Procedures in the Study Patients.

 
The left ventricular ejection fraction at rest was measured in all 138 survivors; it was 45 ±12 percent in the streptokinase group and 51 ±11 percent in the angioplasty group (P = 0.004). Exercise testing was performed before discharge in 63 of the 72 patients in the streptokinase group (88 percent) and 67 of the 70 in the angioplasty group (96 percent), with exercise capacities of 87 ±31 and 97 ±30 W, respectively (P = 0.07). Angina was present during exercise in 10 of 63 patients who received streptokinase (16 percent) and in 5 of 67 patients who underwent angioplasty (7 percent, P = 0.13). Ischemic ST-segment depression occurred in 41 percent of the streptokinase group (26 of 63 patients) and in 21 percent of the angioplasty group (14 of 67 patients, P = 0.01). The ejection fraction measured during exercise was 46 ±15 percent in the streptokinase group and 52 ±14 percent in the angioplasty group (P = 0.02).

Coronary angiography was performed after 21 ±31 days in 68 of the 72 patients given streptokinase. Repeat angiography was performed after 82 ±67 days in 63 of the 65 patients in the angioplasty group who actually underwent the procedure. The infarct-related vessel was patent in 68 percent of the patients who received streptokinase (49 of 72) and 91 percent of those assigned to angioplasty (64 of 70, P = 0.001). Among the patients assigned to angioplasty, only 7 percent had patent infarct-related arteries at base line, 47 percent had patent vessels 60 minutes after admission, 84 percent 90 minutes after admission, and 91 percent 120 minutes after admission and at follow-up. Quantitative angiographic analysis of the infarct-related vessels is shown in Table 4. Restenosis, defined as stenosis of more than 50 percent in the dilated vessel, was observed in 11 of 63 patients in the angioplasty group (17 percent). Although evidence has accumulated that the incidence of restenosis reaches a plateau at three months,²³ the clinical implications of restenosis will become clear only after at least six months of follow-up. Excluding all angiography without evidence of restenosis performed within three months after angioplasty, we found the rate of restenosis to be 11 of 46, or 24 percent.

View this table: [in this window] [in a new window]   Table 4. Quantitative Angiographic Data.

 
Discussion

Our study shows that in patients with acute myocardial infarction, direct coronary angioplasty results in a higher rate of patency of the infarct-related coronary arteries, less severe residual stenotic lesions, better left ventricular ejection fraction, and a lower incidence of recurrent myocardial ischemia than intravenous streptokinase.

Over the past decade, great efforts have been made to assess the optimal approach to patients with acute myocardial infarction, with much attention being directed to large-scale trials in which mortality is the primary end point. However, the funds and numbers of patients needed to support multiple large trials are simply not available²⁸. Left ventricular ejection fraction has been proposed,²⁹ as well as rejected,²⁸ as an end point in trials of acute myocardial infarction. Long-term survival after reperfusion therapy is strongly related to the left ventricular ejection fraction,³⁰ but one of the main objections to the use of the ejection fraction as an end point has been the problem of "missing values" and the consequent debate about imputing data because studies are unavailable or technically inadequate²⁸. We therefore chose a radionuclide technique that is easy to perform, requires only 10 to 15 minutes, and is not cumbersome for the patient. We were thus able to measure the ejection fraction in almost all our patients. The difference between groups in the left ventricular ejection fraction (51 percent in the angioplasty group and 45 percent in the streptokinase group) is comparable to that reported by O'Neill et al.¹⁷.

The primary target of all reperfusion therapies is the reopening of occluded coronary arteries. Two characteristics of patency are important in this regard. The first is the time needed to reestablish flow in the infarct-related artery. The patients in our angioplasty group had rates of early patency that cannot be obtained with currently available thrombolytic agents. The second is the persistence of patency of the infarct-related artery, which is related to long-term survival². The consequences of reocclusion after initially successful reperfusion are certainly a major concern³¹. However, the frequency of this phenomenon is low. The rate of patency in the patients who received streptokinase, assessed after a mean of 21 days, was 68 percent. The rate of patency in the angioplasty group was 91 percent two hours after admission, and it was still 91 percent at follow-up angiography after a mean of 82 days. So, regardless of the timing of angiography for assessment, patients who undergo angioplasty have a higher rate of patency.

The third end point of our study was recurrent myocardial ischemia. Since the mortality from acute myocardial infarction has steadily declined in recent years and is less than 10 percent in many recently published trials,^8,9,10,11 morbidity in the survivors becomes the most relevant clinical end point. Immediate angioplasty, as compared with streptokinase treatment, reduces the incidence of recurrent myocardial ischemia drastically. A composite clinical end point has recently been proposed²⁸ and used¹⁰. It includes not only recurrent infarction or angina, but also death, stroke, reocclusion, and heart failure. Freedom from any of these adverse events can then be compared. Of the 72 patients in our study who were treated with streptokinase, 34 (47 percent) had one or more of these adverse events. Of the 70 patients assigned to angioplasty, 13 (19 percent) had one or more of these adverse events. In phase 5 of the Thrombolysis and Angioplasty in Myocardial Infarction trial,¹⁰ the group receiving urokinase followed by "delayed" coronary angiography had a rate of freedom from events of 55 percent, which is comparable to the rate in our streptokinase group (53 percent), whereas those who received a combination of tissue plasminogen activator and urokinase followed by "aggressive" catheterization had a rate of 72 percent. The patients in our angioplasty group had a rate of freedom from adverse events of 81 percent, significantly better than the rate in the streptokinase group (53 percent, P = 0.001).

The participation of a cardiac surgeon becomes important if coronary angiography is performed immediately after admission. A large majority of the patients randomly assigned to angioplasty had, on anatomical grounds, a clear-cut indication for angioplasty, but there were exceptions. In our series, three patients had coronary anatomy that was highly unfavorable for angioplasty and therefore required emergency bypass surgery of all major coronary arteries, including the infarct-related vessel. Three other patients with extensive multivessel disease had direct angioplasty of the infarct-related vessel and subsequently underwent elective bypass surgery. Eight patients in the streptokinase group underwent bypass surgery for recurrent ischemia. Given that the coronary anatomy was known soon after admission in the angioplasty group, clinical decision making was influenced by anatomical considerations. Finally, the implications of this study with respect to cost effectiveness require a formal analysis, which will be performed after one year of follow-up.

We are indebted to Vera Derks for assistance in the preparation of the manuscript; to Gijs van den Brandhof for assistance in the collection of the data; to the many general practitioners of the region for their speedy referral of patients with acute myocardial infarction; and to the staff of the catheterization laboratory, without whose enthusiastic assistance this work would not have been possible.

Source Information

From the Departments of Cardiology (F.Z., M.J.B., J.C.A.H., H.S.) and Nuclear Medicine (S.R.), Ziekenhuis de Weezenlanden, Zwolle; and the Laboratory for Clinical and Experimental Image Processing, Department of Diagnostic Radiology and Nuclear Medicine, University Hospital, Leiden (J.H.C.R.) -- both in the Netherlands.

Address reprint requests to Dr. Zijlstra at Z.H. de Weezenlanden, Department of Cardiology, Groot Wezenland 20, 8011 JW Zwolle, the Netherlands.

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The physicians who participated in the study were as follows: at the Ziekenhuis de Weezenlanden, M.R.F. Bloemers, M.J. de Boer, R. Enthoven, H.A. Holtkamp, J.C.A. Hoorntje, W.J.S. Louridtz, A.C.M. van Nus, H.A. Oude Luttikhuis, P.A.J. Remkes, H. Suryapranata, and F. Zijlstra (department of cardiology); R. Bakhuizen, M.M.P. Haalebos, F.G. Leicher, and H.T. Sie (department of cardiovascular surgery); J. Damen, B.W. Mooi, A.W. Siemons, P.J.A.v.d. Starre, and J.E.A.T. Wever (department of cardiovascular anesthesiology); and S. Reiffers (department of nuclear medicine); and at University Hospital, Leiden, J.H.C. Reiber.

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