CARDIOVASCULAR JOURNAL OF AFRICA • Vol 24, No 7, August 2013
274
AFRICA
Efficacy and safety of sirolimus-eluting stents versus
bare-metal stents in coronary artery disease patients
with diabetes: a meta-analysis
YANXIANG QIAO, YUAN BIAN, XIANLIANG YAN, ZHENFANG LIU, YUGUO CHEN
Abstract
Objective:
To compare by meta-analysis the efficacy and
safety of sirolimus-eluting and bare-metal stents in coronary
artery disease (CAD) patients with diabetes.
Methods:
PubMed, MEDLINE and EMBASE were searched
from 1971 to 2012. Data on the efficacy and safety of siroli-
mus-eluting and bare-metal stents in patients with diabetes
were collected. A meta-analysis was then performed on a
total of 1 259 CAD patients with diabetes from six studies.
The odds ratio (OR) was used for comparison. Subgroup
analysis was performed according to the sample size, year of
study, subjects’ geographic area and study method.
Results:
Compared with those in the bare-metal stent group
(BMS), the subjects in the sirolimus-eluting stent (SES)
group had a reduced risk for major cardiac events [OR
0.42, 95% confidence interval (CI): 024–0.74,
p
<
0.01] and
target-lesion revascularisation (OR 0.26, 95% CI: 0.11–0.59,
p
<
0.01). There was no difference for myocardial infarction
(OR 0.92, 95% CI: 0.61–1.40,
p
>
0.05) or mortality (OR 1.19,
95% CI: 0.74–1.92,
p
>
0.05). Subgroup analysis showed a
significant difference for overall risk of major cardiac events
between SES and BMS when the sample size was
≤
90 (OR
0.28, 95% CI: 0.16–0.48,
p
<
0.01), when it was a randomised
control trial (RCT) (OR 0.28, 95% CI: 0.19–0.42,
p
<
0.01),
or when it was performed on European subjects (OR 0.45,
95% CI: 0.27–0.77,
p
<
0.01). The sensitivity was not different
when one study was removed at a time.
Conclusion:
Our study confirmed that SES are safer and
more effective than BMS in CAD patients with diabetes, as
far as major cardiac events are concerned.
Keywords:
sirolimus-eluting stent, bare-metal stent, diabetes,
meta-analysis, efficacy, safety
Submitted 22/5/13, accepted 14/8/13
Cardiovasc J Afr
2013;
24
: 274–279
DOI: 10.5830/CVJA-2013-062
According to Nodari
et al.
, compared to patients without
diabetes, those with diabetes mellitus (DM) had increased
cardiovascular morbidity and mortality, and were more likely
to develop congestive heart failure (CHF).
1
Van Nunen used
coronary stents for revascularisation in acute cardiac events and
improved the prognosis, with a high success rate and favourable
early outcome.
2
The traditional bare-metal stent (BMS) was initially widely
used, with considerable efficacy and safety. However, long-
term outcome and restenosis rate has been very discouraging.
3
Recently, sirolimus-eluting stents (SES) have been increasingly
used for treating restenosis after having used BMS, as well as for
treating the native coronary narrowing.
4-7
For coronary arterial disease (CAD) patients with diabetes,
the outcome, efficacy and safety of SES and BMS remain
controversial,
8-16
mainly due to small sample sizes or low
statistical power. Meta-analysis, combining results of several
studies and producing a single estimate of major events with
enhanced precision, has been considered a powerful tool for
summarising inconsistent results from different studies.
17-20
Heterogeneity and publication bias can be detected with funnel
plots and other methodologies.
21-26
To clarify this controversy, in this study, we performed a
meta-analysis and subgroup analysis, along with heterogeneity
and publication-bias analysis, and compared the major cardiac
events, target-lesion revascularisation, myocardial infarction and
mortality rate in CAD patients with diabetes who were treated
with SES or BMS.
Methods
PubMed, MEDLINE, EMBASE, Springer, Elsevier Science
Direct, Cochrane Library and Google scholar were searched. The
following keywords were used, ‘sirolimus-eluting stents’, ‘bare-
metal stents’, ‘coronary arterial disease’, ‘diabetes’, ‘diabetic’,
‘safety’, ‘efficacy’, ‘study’ and ‘trial’. The time period was
limited from 1 January 1971 to 31 December 2012. The language
published in was limited to English only. References of the
articles were also checked for additional studies.
Studies included were randomised, controlled trials (RCT)
and non-RCT conducted in coronary artery disease patients
with diabetes treated with SES or BMS (studies with these two
methods compared), regardless of the sample size. Excluded
studies were those investigating patients with CAD or DM in
only case reports or review articles, duplicated articles, and those
with no comparison of SES and BMS.
After the investigators were trained, the data-mining form was
developed and modified. The data included study details such
as first author, year of study, year of publication, geographical
area of subjects, demographics of subjects, and events with
follow up after being treated with SES or BMS. According to
the standard protocol, two investigators (A and B) mined the
data independently, which was reviewed by the third one (C).
Discrepancies were resolved through internal and external
discussions (with the original investigators).
Department of Emergency Medicine, Qilu Hospital,
Shandong Univeristy, Shandong, China
YANXIANG QIAO, MD
YUAN BIAN, MD
XIANLIANG YAN, MD
ZHENFANG LIU, MD
YUGUO CHEN, MD, PhD,
