Safety and Efficacy of Everolimus vs Serolimus Eluting Stents
Safety and Efficacy of Everolimus vs Serolimus Eluting Stents
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.
The everolimus-eluting stent (EES) is a second-generation drug-eluting stent (DES) incorporating a thin-strut cobalt chromium stent platform combined with the drug everolimus contained in a durable, biocompatible polymer coating. After its introduction into the market, EES have rapidly replaced the first-generation DES, largely due to an expectation for improved safety and device performance (e.g., deliverability) while maintaining similar efficacy. We, among others, showed EES was comparable, in terms of inhibiting neointimal growth, to sirolimus-eluting stent (SES), which was the most efficacious of the first-generation DES. With an increasing number of studies comparing the 2 stents in a variety of study populations, results have been inconsistent, reporting EES with at least statistical noninferiority, and sometimes superiority when compared to SES. EES and SES both contain rapamycin analogues, everolimus and sirolimus, but are different in the dose of drug, stent platform and polymer technology. It is of great interest whether we can consider EES to be an improved stent over SES in terms of the need for repeat revascularization. In addition, the risk of stent thrombosis (ST) is a matter of concern since ST is the Achilles' heel of DES, which is presumably associated with delayed healing.
As the rate of adverse events is quite low in both of the stents, a large sample size is required to statistically examine the small differences between the stents. Summarizing results from different individual studies, meta-analysis has the potential to increase the statistical power and reduce individual trial bias. In this study, we performed a systematic overview of randomized trials to compare the efficacy and safety of EES versus SES in patients undergoing percutaneous coronary intervention (PCI).
Abstract and Introduction
Abstract
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.
Introduction
The everolimus-eluting stent (EES) is a second-generation drug-eluting stent (DES) incorporating a thin-strut cobalt chromium stent platform combined with the drug everolimus contained in a durable, biocompatible polymer coating. After its introduction into the market, EES have rapidly replaced the first-generation DES, largely due to an expectation for improved safety and device performance (e.g., deliverability) while maintaining similar efficacy. We, among others, showed EES was comparable, in terms of inhibiting neointimal growth, to sirolimus-eluting stent (SES), which was the most efficacious of the first-generation DES. With an increasing number of studies comparing the 2 stents in a variety of study populations, results have been inconsistent, reporting EES with at least statistical noninferiority, and sometimes superiority when compared to SES. EES and SES both contain rapamycin analogues, everolimus and sirolimus, but are different in the dose of drug, stent platform and polymer technology. It is of great interest whether we can consider EES to be an improved stent over SES in terms of the need for repeat revascularization. In addition, the risk of stent thrombosis (ST) is a matter of concern since ST is the Achilles' heel of DES, which is presumably associated with delayed healing.
As the rate of adverse events is quite low in both of the stents, a large sample size is required to statistically examine the small differences between the stents. Summarizing results from different individual studies, meta-analysis has the potential to increase the statistical power and reduce individual trial bias. In this study, we performed a systematic overview of randomized trials to compare the efficacy and safety of EES versus SES in patients undergoing percutaneous coronary intervention (PCI).
