Study Design

Study Design:

Patients Screened: 527
Patients Enrolled: 83
NYHA Class: Patients with NYHA class >II were excluded.
Mean Follow Up: 12 months
Mean Patient Age: 40-80 years
Female: 17
Mean Ejection Fraction: Patients with ejection fraction <40% were excluded.

Patient Populations:

Patients were enrolled if they had typical angina or documented myocardial ischemia and underwent successful implantation of a single stent of a length less than 19 mm. Patients were required to have a normal CRP level (≤0.5 mg/dl) prior to stenting and an elevated CRP level (>0.5 mg/dl) after the procedure.

Exclusions:

Unstable angina; recent myocardial infarction; stenting of restenotic lesions, total occlusions, or vein grafts; connective tissue disease; renal failure; heart failure with New York Heart Association (NYHA) class >II; ejection fraction <40%; and recent steroid use or contraindication to steroid use

Primary Endpoints:

Survival free from death, myocardial infarction, or recurrence of symptoms requiring revascularization at 12 months

Secondary Endpoints:

Restenosis (in-stent stenosis ≥50%) and late loss (minimal luminal diameter after stenting minus the value at follow-up angiography)

Drug/Procedures Used:

Patients were randomly assigned to receive oral prednisone or matching placebo beginning 72 hours after stent implantation. The dose of prednisone was 1 mg/kg for 10 days, followed by tapering doses for a total of 45 days of therapy. Follow-up angiography was performed at six months or earlier if symptoms developed, and clinical follow-up extended to one year.

Concomitant Medications:

Patients received aspirin 325 mg daily indefinitely, ticlopidine 250 mg twice daily for four weeks, and pantoprazole 40 mg daily for 45 days. Beta-blockers, calcium antagonists, nitrates, statins, and angiotensin-converting enzyme (ACE) inhibitors were given at the discretion of the investigator. Of note, less than 40% of patients were treated with beta-blockers, and 12% were treated with statins.