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RESEARCH ARTICLE
SA JOURNAL OF DIABETES & VASCULAR DISEASE
68
VOLUME 13 NUMBER 2 • DECEMBER 2016
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
Correspondence to: Yuguo Chen
Department of Emergency Medicine, Qilu Hospital, Shandong Univeristy,
Shandong, China
e-mail:
dr.yuguo.chen@gmail.comYanxiang Qiao, Yuan Bian, Xianliang Yan, Zhenfang Liu
Department of Emergency Medicine, Qilu Hospital, Shandong Univeristy,
Shandong, China
Previously published in
Cardiovasc J Afr
2013;
24
: 274–279
S Afr J Diabetes Vasc Dis
2016;
13
: 68–73
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,MEDLINEandEMBASEwere searched from
1971 to 2012. Data on the efficacy and safety of sirolimus-
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 randomized 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
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, longterm 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).