Author + information
- Received November 8, 1993
- Revision received April 8, 1994
- Accepted April 8, 1994
- Published online July 1, 1994.
- Carl J. Pepine, MD, FACC∗,
- Nancy L. Geller, PhD,
- Genell L. Knatterud, PhD,
- Martial G. Bourassa, MD, FACC,
- Bernard R. Chaitman, MD, FACC,
- Richard F. Davies, MD, FACC,
- Philip Day, RPh,
- John E. Deanfield, MD,
- A.David Goldberg, MD, FACC,
- Robert P. McMahon, PhD,
- Hiltrud Mueller, MD, FACC,
- Pamela Ouyang, MD, FACC,
- Craig Pratt, MD, FACC,
- Michael Proschan, PhD,
- William J. Rogers, MD, FACC,
- Andrew P. Selwyn, MD, FACC,
- Barry Sharaf, MD,
- George Sopko, MD,
- Peter H. Stone, MD, FACC and
- C.Richard Conti, MD, FACC
- ↵∗Address for correspondence: Dr. Carl J. Pepine, University of Florida College of Medicine, Division of Cardiovascular Medicine, P.O. Box 100277, Gainesville, Florida 32610-0277.
Objectives. The primary objectives of the Asymptomatic Cardiac Ischemia Pilot were 1) to compare the 12-week efficacy of three treatment strategies to suppress cardiac ischemia, and 2) to assess the feasibility of a prognosis trial in patients with asymptomatic cardiac ischemia.
Background. Cardiac ischemia has been associated with increased morbidity and mortality. However, most cardiac ischemia is asymptomatic, and although therapeutic strategies ranging from no medication to revascularization are being used to treat ischemia, no prospective study evaluating different treatment strategies has been reported.
Methods. Patients with angiographically documented coronary artery disease and ischemia on exercise and ambulatory electrocardiogram (ECG) in 11 clinical units were randomized to receive angina-guided medical therapy, angina-guided plus ambulatory ECG ischemia-guided medical therapy or revascularization (coronary angioplasty or bypass surgery). Patients were also randomized to receive either diltiazem plus isosorbide dinitrate or atenolol plus nifedipine when possible. After anti-ischemic medication adjustment to control angina, blinded medication was adjusted in the medical therapy groups to eliminate ischemia in the ischemia-guided group. The primary outcome was the absence of ischemia at 12 weeks. Follow-up was scheduled for 1 year.
Results. A total of 1,959 patients were screened by ambulatory ECG monitoring; 982 (49%) had asymptomatic ischemia, and 618 (65%) were enrolled in the study. Most patients were men, were >60 years old and had two or more ischemic episodes, early positive exercise tests and multivessel disease.
Conclusions. Design and baseline data for a pilot study of ischemia treatment strategies are described.
☆ This study was funded by the National Heart, Lung, and Blood Institute, Cardiac Diseases Branch, Division of Heart and Vascular Diseases, National Institutes of Health, Bethesda, Maryland, by research contracts HV-90-07, HV-90-08, HV-91-05 to HV-91-14. Study medications and placebo were donated by Zeneca Pharmaceuticals Group, Wilmington, Delaware; Marion-Merrell Dow, Kansas City, Missouri; and Pfizer, New York, New York. Support for electrocardiographic data collection was provided in part by Applied Cardiac Systems, Laguna Hills, California; Marquette Electronics, Milwaukee, Wisconsin; and Quinton Instruments, Seattle, Washington. Some centers had partial support from General Clinical Research Center grants.
- Received November 8, 1993.
- Revision received April 8, 1994.
- Accepted April 8, 1994.