Comparison of efficacy and safety of lower-dose to higher-dose oral prednisone after percutaneous coronary interventions (the IMPRESS-LD study).
This study assessed clinical and angiographic efficacies of oral treatment with prednisone at low-dose (LD) versus the previous high-dose (HD) immunosuppressive dosage used after percutaneous coronary interventions (PCIs) with bare metal stents in patients with multivessel coronary artery disease. Forty-three patients with multivessel disease successfully treated with multiple PCIs were matched to the previous HD IMPRESS-2/MVD study population. The 43 patients were treated for 103 coronary stenoses and received 30-day oral prednisone treatment (LD group 1 mg/kg for 5 days, 0.5 mg/kg for 10 days, 0.25 mg/kg for 15 days) and were compared retrospectively with the 43 patients in the HD IMPRESS-2/MVD study with 116 treated coronary lesions (HD group 1 mg/kg for 10 days, 0.5 mg/kg for 20 days, 0.25 mg/kg for 15 days). The primary clinical end point was 12-month event-free survival rate (defined as freedom from death, myocardial infarction, and need for target vessel revascularization). The secondary end point was angiographic restenosis at 8 months assessed by quantitative coronary angiography. Event-free survival rates were 74% and 93% in the LD and HD groups, respectively (relative risk 4.6, 95% confidence interval 1.18 to 17.8, p = 0.019). Restenosis was observed in 4 lesions (4%) in the HD group and in 20 lesions (22%) in the LD group (p <0.001). Mean late lumen loss was 0.61 +/- 0.35 mm, and the loss index was 31.3 +/- 21.6% in the HD group compared with 0.87 +/- 0.61 mm and 52.03 +/- 25.1% in the LD group (p = 0.03 and 0.02, respectively). In conclusion, antirestenotic efficacy of oral treatment with prednisone after conventional PCI is dose sensitive. A 50% dose decrease in oral prednisone, as tested in this study, is less effective than the previously tested HD IMPRESS therapeutic scheme.
Ferrero
Valeria
V
Division of Cardiology, Università di Verona, Italy.
Ribichini
Flavio
F
Rognoni
Andrea
A
Marino
Paolo
P
Brunelleschi
Sandra
S
Vassanelli
Corrado
C
D000284:Administration, Oral; D015906:Angioplasty, Balloon, Coronary; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D016022:Case-Control Studies; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000628:therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011241:Prednisone / Q000008:administration & dosage*; D011446:Prospective Studies; D019233:Retreatment; D012189:Retrospective Studies; D012449:Safety; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011241:Prednisone