Elsevier

American Heart Journal

Volume 165, Issue 2, February 2013, Pages 241-250.e4
American Heart Journal

Clinical Investigation
Interventional Cardiology
Safety and efficacy of everolimus- versus sirolimus-eluting stents: A systematic review and meta-analysis of 11 randomized trials

https://doi.org/10.1016/j.ahj.2012.08.007Get rights and content

Background

While EES have proven superior to paclitaxel-eluting stents, it remains uncertain whether EES improve clinical outcomes compared to SES, which are the most efficacious among the first-generation drug-eluting stents. We performed a meta-analysis of randomized trials comparing the efficacy and safety of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary intervention.

Methods

From online and offline search until December 2011, we identified 11 randomized trials (total 12,869 patients). The primary endpoint was major adverse cardiac events.

Results

The risk of major adverse cardiac events did not differ significantly between the patients treated with EES versus SES [OR, 0.90 (95% CI, 0.77-1.04); P = .162]. However, we found a significant reduction in the risk of repeat revascularization in the EES arm [OR, 0.85 (95% CI, 0.71-1.00); P = .047]. There were no significant differences regarding the risk of cardiac death [OR, 0.97 (95% CI, 0.74-1.27); P = .834], or myocardial infarction [OR, 0.95 (95% CI, 0.75-1.20), P = .656]. The risk of definite or probable stent thrombosis tended to be lower [OR, 0.68 (95% CI, 0.45-1.02); P = .065], while definite ST was significantly lower [OR, 0.44 (95% CI, 0.25-0.80); P = .007] with EES.

Conclusions

In a large systematic overview of comparative trials involving percutaneous revascularization with drug-eluting stents, treatment with EES significantly reduced the risk of repeat revascularization and definite ST compared to SES. We found no significant differences in the risk of cardiac death or myocardial infarction.

Section snippets

Search strategy, data extraction, and bias assessment

We included in our analysis all reported randomized controlled trials (RCT) that compared EES (Xience V [Abbott Vascular, Santa Clara, California] and Promus [Boston Scientific, Natick, Massachusetts]) with SES (Cypher, Cordis Coporation, Bridgewater, New Jersey) in patients with coronary artery disease.

We performed an electronic search of the United States National Library of Medicine (PubMed, at www.pubmed.gov), the United States National Institutes of Health clinical trials registry (//www.clinicaltrials.gov

Results

As shown in Figure 1, this meta-analysis finally included 11 RCTs,2, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 1 of which has been presented at meetings, but not published in its full form.24 Among a total of 12,869 patients that were studied, 6,894 (53.6%) were allocated to receive EES, and 5,975 (46.4%) to SES. The inter-observer agreement for study selection was high with к = 0.98.

The main characteristics of individual studies are summarized in the Table. The follow-up period ranged from 6 to

Discussion

Whether advanced generation DES are superior to selected first generation DES is uncertain, and comparative trials have demonstrated inconsistent results. In the most comprehensive meta-analysis of comparative EES versus SES trials, EES significantly reduced the risk of repeat revascularization compared to SES, which in turn led to a tendency toward a lower risk of MACE. We found no significant differences in the risk of cardiac death or MI between the use of EES and SES. However, the rate of

Conclusions

In this meta-analysis of 11 randomized trials, the use of EES compared to SES was shown to reduce the risk for repeat revascularization and the risk of definite ST. We found no significant differences in the risk of cardiac death or MI, while definite or probable ST tended to occur in a decreased rate with marginal significance. Future studies and analyses with longer duration of follow-up are needed to confirm our results in the long-term perspectives.

Disclosures

The authors have no potential financial conflicts on this subject.

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