A controlled trial of corticosteroids to prevent restenosis after coronary angioplasty. M-HEART Group.
A multicenter, double-blind, placebo-controlled trial was conducted to determine if corticosteroids influence the development of restenosis after successful percutaneous transluminal coronary angioplasty (PTCA). Either placebo or 1.0 g methylprednisolone (steroid) was infused intravenously 2-24 hours before planned PTCA in 915 patients. The PTCA patient success rate was 87% (mean) in the eight centers. There were no differences in clinical or angiographic baseline variables between the two groups. End-point analysis (angiographic restenosis, death, recurrent ischemia necessitating early restudy, and coronary artery bypass graft surgery) showed that there was no significant difference comparing placebo- with steroid-treated patients. Angiographic restudy showed the lesion restenosis rate to be 39% (120 of 307 lesions) after placebo and 40% (117 of 291) after steroid treatment (p = NS). We conclude that pulse steroid pretreatment does not influence the overall restenosis rate after successful PTCA.
Pepine
C J
CJ
Department of Medicine, University of Florida, Gainesville 32610.
Hirshfeld
J W
JW
Macdonald
R G
RG
Henderson
M A
MA
Bass
T A
TA
Goldberg
S
S
Savage
M P
MP
Vetrovec
G
G
Cowley
M
M
Taussig
A S
AS
D015906:Angioplasty, Balloon, Coronary; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000473:pathology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015999:Multivariate Analysis; D011292:Premedication; D012008:Recurrence; D012307:Risk Factors
D008775:Methylprednisolone