CARDIOVASCULAR JOURNAL OF AFRICA • Vol 22, No 2, March/April 2011
AFRICA
67
Efficacy of intramuscular methyl prednisolone in
preventing restenosis after coronary artery stenting
with bare-metal stainless steel stent: a double-blind,
randomised, controlled clinical trial
M NAMDARI, M GHAFARZADEH, MA NIKOO
Abstract
The aim of this study was to compare the mid-term outcome
of patients receiving intramuscular methyl prednisolone
before and after the procedure of coronary artery stent-
ing. The study was conducted during 2007 and 2008 and
compared the two arms of the study for the rate of restenosis
six months after stenting. The control arm (100 patients)
received only the usual preventive measures but the glucocor-
ticoid arm (100 patients) received two doses of intramuscular
methyl prednisolone (40 mg) at two-week intervals, the first
at the time of the procedure. They also received the usual
preventive measures
There was no statistically significant difference between
the two arms for the rate of restenosis. When separately
analysing for three vessels and for gender, there was no
statistically significant difference either.
Lowering the dose of corticosteroid would greatly reduce
the efficacy for preventing restenosis after coronary artery
stenting. Therefore, if we are to achieve acceptable effective-
ness with intramuscular prednisolone, we should administer
increased doses at shorter intervals, which could be the
target of further studies. However, there would be more
chance of side effects with increased frequency of dosing.
Keywords:
percutaneous transluminal coronary angioplasty
stenting, restenosis, prednisolone
Submitted 14/12/09, accepted 29/3/10
Cardiovasc J Afr
2011;
22
: 67–69
DOI: CVJ-21.022
Although percutaneous transluminal coronary angioplasty stent-
ing has greatly improved the outcome of patients with coronary
artery disease,
1–3
there have been reports of restenosis in as many
as half the cases.
4,5
Many prophylactic pharmacological interven-
tions have been proposed to prevent restenosis after coronary
artery stenting.
6–8
Previous experimental and human studies
have shown that inflammation plays a key role in the process of
restenosis,
9–12
and as glucocorticoids are one of the best known
anti-inflammatory agents, theoretically, glucocorticoids should
have beneficial preventive effects. Platelet function, smooth
muscle cell proliferation and collagen synthesis as well as
inflammatory cell migration and activation are some of the steps
that are involved in the process of restenosis and are also targets
of glucocrticoid action.
13–17
Many studies have been conducted
to evaluate the clinical efficacy of this treatment modality for
avoiding restenosis, with variable and sometimes even opposing
results.
18-23
Weighing up the controversial results of these studies, it
seems that the route of administration, dosage and duration of
glucocrticoid therapy can affect the results achieved.
24,25
There
are three main routes for systemic administration of glucocorti-
coids; intravenous, intramuscular and the oral route. As the intra-
muscular route of administration is more convenient and with
fewer complications than the intravenous route, and it does not
have the problems of non-compliance that the oral route does,
we conducted this double-blind, randomised, controlled trial to
compare mid-term outcome of patients receiving intramuscular
methyl prednisolone before and after the procedure of stenting
with patients receiving only the usual preventive measures.
Methods
This double-blind, randomised clinical trial was conducted
during 2007 and 2008 in the Shahid Madani Heart Centre of
Lorestan in Iran. Patients who were admitted to hospital for
percutaneous coronary intervention with bare-metal stainless
steel stents were enrolled in the study. Exclusion criteria were
age below 40 years and having diabetes mellitus.
Two hundred patients were selected consecutively and were
randomly assigned to two groups. The groups were matched
with regard to age, gender and modifiable risk factors such as
smoking, family history, hyperlipidaemia and hypertension.
Forty-eight hours before angioplasty, one group of patients
(glucocorticoid arm) received one dose (40 mg) of intramuscu-
lar methyl prednisolone. The other group (control arm) received
nothing except the usual management, which the glucocorticoid
arm also received.
Thereafter, all patients were admitted to the critical care unit
(CCU). They were all well hydrated, had a chest X-ray, and
underwent routine laboratory studies and a diagnostic angio-
graphic study before the procedure of percutaneous coronary
angioplasty. In our centre we use clopidogrel for 45 days prior to
the procedure. Finally, percutaneous coronary angioplasty with
stenting was performed on both groups. Patients were discharged
24 hours after the procedure. Fourteen days later, the patients
Department of Cardiology, Lorestan University of Medical
Sciences, Khoramabad, Iran
M NAMDARI, MD,
Department of Medicine, Lorestan University of Medical
Sciences, Khoramabad, Iran
M GHAFARZADEH, MD
Tehran University of Medical Sciences, Farzan Clinical
Research Institute, Tehran, Iran
MA NIKOO
