Abstract
To compare by meta-analysis the efficacy and safety of sirolimus-eluting and bare-metal stents in coronary artery disease (CAD) patients with diabetes. PubMed, MEDLINE and EMBASE were 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. 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. 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.
Highlights
Subgroup analysis showed a significant difference for overall risk of major cardiac events between sirolimus-eluting stent (SES) and bare-metal stent group (BMS) when the sample size was ≤ 90, when it was a randomised control trial (RCT), or when it was performed on European subjects
Potentially relevant reports after duplicates removed excluded by review of abstract (65 reviews; 156 not diabetic patients; 55 not reported BMS data) retrieved for detailed assessment excluded by review of full text (25 for only reported EMS data but not for comparison; 16 due to not available data) separate studies included in meta-analysis were excluded (65 were review articles, 156 were not diabetic patients, 55 did not report on BMS data)
In which the incidence of myocardial infarction was higher, our analysis showed no difference for myocardial infarctions between the groups
Summary
PubMed, MEDLINE, EMBASE, Springer, Elsevier Science Direct, Cochrane Library and Google scholar were searched. 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. The random-effects model was used for evaluating the possibility of heterogeneity of studies. Sensitivity analysis was performed to test reliability of the results, by removing one study at a time and repeating the meta-analysis
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