Author + information
- Received December 10, 1991
- Revision received March 16, 1992
- Accepted March 27, 1992
- Published online October 1, 1992.
- Jeffrey L. Anderson, MD, FACC∗∗,
- Lewis C. Becker, MD, FACC∗,
- Sherman G. Sorensen, MD, FACC∗,
- Labros A. Karagounis, MD∗,
- Kevin F. Browne, MD, FACC∗,
- Prediman K. Shah, MD, FACC∗,
- Douglas C. Morris, MD, FACC∗,
- Dan J. Fintel, MD, FACC∗,
- Hiltrud S. Mueller, MD, FACC∗,
- Allan M. Ross, MD, FACC∗,
- Suzanne M. Hall, MD, FACC∗,
- Jack C. Askins, MD∗,
- Andrew J. Doorey, MD, FACC∗,
- Cindy L. Grines, MD, FACC∗,
- Fidela L. Moreno, MD∗ and
- Victor J. Marder, MD∗,1
- ↵∗Address for correspondence: Jeffrey L. Anderson. MD. Division of Cardiology, LDS Hospital. 8th Avenue and C Street, Salt Lake City, Utah 84143.
Objectives. This double-blind, randomized, multicenler trial was designed to compare the effects of treatment with anistreplase (APSAC) and alteplase (rt-PA) on convalescent left ventricular function, morbidity and coronary artery patency at 1 day in patients with acute myocardial infarction.
Background. Anistreplase (APSAC) is a new, easily administered thrombolytk agent recently approved for treatment of acute myocardial infarction. Alteplase (rt-PA) is a rapidly acting, relatively fibrin-specific thrombolytic agent that is currently the most widely used agent in the United States.
Methods. Study entry requirements were age ≤ 75 years, symptom duration ≤ 4 h, ST segment elevation and no contraindications. The two study drugs, APSAC, 30 U/2 to S min, and rt-PA, 100 mg/3 h, were each given with aspirin (160 mg/day) and intravenous heparin. Prespecified end points were convalescent left ventrkular function (rest/exercise), clinical morbidity and coronary artery patency at 1 day. A total of 325 patients were entered, stratified into groups with anterior (37%) or inferior or other (63%) acute myocardial infarction, randomized to receive APSAC or rt-PA and followed up for 1 month.
Results. At entry, patient characteristics in the two groups were balanced. Convalescent ejection fraction at the predischarge study averaged 51.3% in the APSAC group and 54.2% in the rt-PA group (p < 0.05); at 1 month, ejection fraction averaged 50.2% versus 54.8%, respectively (p < 0.61). In contrast, ejection fraction showed similar augmentation with exercise at 1 month after APSAC (+4.3% points) and rt-PA (+4.6% points), and exercise times were comparable. Coronary artery patency at 1 day was high and similar in berth groups (APSAC 89%, rt-PA 86%). Mortality (APSAC 6.2%, rt-PA 7.9%) and the incidence of other serious clinical events, including stroke, ventricular tachycardia, ventricular fibrillation, heart failure within 1 month, recurrent ischemia and reinfarelion were comparable in the two groups; and mechanical interventions were applied with equal frequency. A combined clinical morbidity index was determined and showed a comparable overall outcome for the two treatments.
Conclusions. Convalescent rest ejection fraction was high after both therapies but higher after rt-PA; other clinical outcomes, including exercise function, morbidity index, and 1-day coronary artery patency, were favorable and comparable after APSAC and rt-PA.
↵1 Dr. Marder was also supported by Grant HL-30616 from the National Heart. Lung, and Blood Institute. National Institutes of Health. Bethesda. Maryland.
☆ This study was supported in pan by a grant from SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania.
☆☆ This study was presented in part at the 40th Annual Scientific Session of the American College of Cardiology, Atlanta, Georgia, March 1991.
- Received December 10, 1991.
- Revision received March 16, 1992.
- Accepted March 27, 1992.