Author + information
- Received April 15, 1997
- Revision received August 19, 1997
- Accepted August 21, 1997
- Published online December 1, 1997.
- Kenneth W. Mahaffey, MDA,*,
- Christopher B. Granger, MD, FACCA,
- Cynthia A. Toth, MDB,
- Harvey D. White, MD, FACCC,
- Amanda L. Stebbins, MSA,
- Gabriel I. Barbash, MDD,
- Alec Vahanian, MDE,
- Eric J. Topol, MD, FACCF,
- Robert M. Califf, MD, FACCA,1 (, )
- for the GUSTO-I Investigators
- ↵*Dr. Kenneth W. Mahaffey, Duke Clinical Research Institute, 2024 West Main Street, Bay A2, Durham, North Carolina 27705.
Objectives. This study sought to evaluate the incidence of ocular hemorrhage in patients with and without diabetes after thrombolytic therapy for acute myocardial infarction.
Background. Ocular hemorrhage after thrombolysis has been reported rarely. However, there is concern that the risk is increased in patients with diabetes. In fact, diabetic hemorrhagic retinopathy has been identified as a contraindication to thrombolytic therapy without clear evidence that these patients have an increased risk for ocular hemorrhage.
Methods. We identified all suspected ocular hemorrhages from bleeding complications reported in patients enrolled in the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO)-I trial. Additional information was collected on a one-page data form. We compared the incidence and location of ocular hemorrhages in patients with and without diabetes.
Results. There were 40,899 patients (99.7%) with information about diabetic history and ocular bleeding. Twelve patients (0.03%) had an ocular hemorrhage. Intraocular hemorrhage was confirmed in only one patient. There were 6,011 patients (15%) with diabetes, of whom only 1 had an ocular hemorrhage (eyelid hematoma after a documented fall). The upper 95% confidence intervals for the incidence of intraocular hemorrhage in patients with and without diabetes were 0.05% and 0.006%, respectively.
Conclusions. Ocular hemorrhage and, more important, intraocular hemorrhage after thrombolytic therapy for acute myocardial infarction is extremely uncommon. The calculated upper 95% confidence interval for the incidence of intraocular hemorrhage in patients with diabetes was only 0.05%. We conclude that diabetic retinopathy should not be considered a contraindication to thrombolysis in patients with an acute myocardial infarction.
- Received April 15, 1997.
- Revision received August 19, 1997.
- Accepted August 21, 1997.
- The American College of Cardiology