What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Coronary artery disease (n=16724). Intervention: Sirolimus eluting stents vs. Paclitaxel eluting stents. Primary outcome: Any stent thrombosis (OR 0.86, 95% CI 0.69-1.07, p=0.18).

February 1, 2016Open Access

Is There Any Significant Difference in Stent Thrombosis Between Sirolimus and Paclitaxel Eluting Stents?

PBPravesh Kumar BundhunInterventional Cardiology ZWZi Jia WuGuangxi Medical University MCMenghua ChenGuilin University of Technology

Key Result

Sirolimus-eluting stents showed no significant difference in the risk of any stent thrombosis compared to paclitaxel-eluting stents (OR 0.86).

Study Design

Type

Meta-Analysis (n=16,724)

Structured PICO

Do sirolimus eluting stents reduce stent thrombosis compared to paclitaxel eluting stents in patients undergoing percutaneous coronary intervention?

Population

16,724 patients from 19 RCTs (29 studies)

Intervention

Sirolimus eluting stents (SES)

Comparator

Paclitaxel eluting stents (PES)

Outcome

Stent thrombosis (ST) including ARC-defined definite, probable, possible, acute, subacute, early, late, and very late SThard clinical

This meta-analysis demonstrates that sirolimus-eluting and paclitaxel-eluting stents have comparable rates of stent thrombosis up to 5 years of follow-up.

Main Result

Effect estimate: OR 0.86 (95% CI 0.69-1.07)

Absolute Event Rate: 1.86% vs 2.08%

p-value: p=0.18

Limitations

Relatively small population of patients compared to some other large-scale meta-analyses
Combining different follow-up periods that are almost of the same length, but not exactly the same
Included patients from different categories of diseases (e.g., general CAD, STEMI, type 2 diabetes mellitus) which have different baseline risks for stent thrombosis

Abstract

Several meta-analyses have shown no significant difference in stent thrombosis (ST) between sirolimus eluting stents (SES) and paclitaxel eluting stents (PES). However, other meta-analyses have found SES to be superior to PES. Therefore, to solve this issue, we aim to compare the clinical outcomes between SES and PES during a follow-up period of about 1 or more years.We have searched Medline and EMBASE for randomized controlled trials (RCTs) comparing SES with PES. These RCTs have been carefully analyzed and then different types of ST including ST defined by the Academic Research Consortium (ARC), acute ST, late and very late ST have all been considered as the clinical endpoints in this study. A follow-up period of about 1 year, between 1 and 2 years as well as a longer follow-up period between 1 and 5 years have been considered. Data were retrieved and combined by means of a fixed-effect model because of a lower heterogeneity observed among the results. Odd ratios (OR) and 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software.Twenty-nine studies from 19 RCTs comprising of 16,724 patients (8115 patients in the SES group and 8609 patients in the PES group) satisfied the inclusion criteria and were included in this meta-analysis. No significant differences in ST have been observed between SES and PES. Results were as follow: definite ST with OR: 0.87; 95% CI: 0.64-1.18, P = 0.36; probable ST with OR:0.72; 95% CI: 0.42-1.21, P = 0.21; definite, probable and/or possible ST with OR: 0.94; 95% CI: 0.75-1.17, P = 0.57; acute ST with OR: 0.99; 95% CI: 0.38-2.56, P = 0.98; subacute ST with OR: 0.72; 95% CI: 0.41-1.25, P = 0.25; early ST with OR: 0.81; 95% CI: 0.53-1.25, P = 0.34; late ST with OR: 0.72; 95% CI: 0.39-1.34, P = 0.30; very late ST with OR: 1.02; 95% CI: 0.72-1.44, P = 0.92; and any ST with OR: 0.86; 95% CI: 0.69-1.07, P = 0.18. Long-term ST between 1 and 5 years with OR: 0.93; 95% CI: 0.71-1.22, P = 0.60 was also not significantly different.No significant difference in ST has been observed between patients treated with either SES or PES. Hence SES and PES can both be considered almost equally effective.

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