Efficacy Of Everolimus-eluting Stents Research Articles

The Real World Experience of the Everolimus‐Eluting Coronary Stent System: Audit of Everolimus‐Eluting Coronary Stents

To investigate the safety and efficacy of everolimus-eluting stents (EES) in a real world population, including those with high-risk characteristics and complex lesions. In this report, we analyze 2-year outcomes in 500 consecutive unselected patients treated with EES between April 2007 and March 2008. All patients were followed for 2 years for adverse events. There were 995 EES deployed in 792 lesions. The indication for the coronary procedure was acute coronary syndrome in 94.2% of patients. Bifurcations were involved in 21% of lesions, 3.5% degenerated vein grafts, 2.7% left main stem stenoses, 33% multivessel disease, 4.5% in-stent restenosis, and 79.1% AHA/ACC classification B2/C lesions. The major adverse cardiac event rate (composite of cardiovascular death, acute myocardial infarction, target lesion revascularization) was 10.6%. Target lesion revascularization was required in 4.0% patients, 1.4% for in-stent thrombosis. These event rates are comparable with studies involving lower risk patients and less complex coronary lesions. The use of EES, even in this real world, high-risk population, continues to demonstrate safety and efficacy rates comparable with current studies in more selected patient groups and, therefore, may justify current practice to utilize EES in "off label" situations.

The SPIRIT V Study: A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions

The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy. Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients. The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success). At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year. Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice) trials.

Clinical safety and efficacy of everolimus-eluting stents compared to paclitaxel-eluting stents in patients with coronary artery disease

Background. The everolimus-eluting stent (EES) is a second-generation drug-eluting stent (DES) which is designed to provide better stent deliverability, deployment, safety, and efficacy. We performed a meta-analysis to evaluate the relative safety and efficacy of the EES compared with the paclitaxel-eluting stent (PES).Methods. The published literature was scanned by formal searches of electronic databases from January 2001 to August 2010. All randomized trials comparing EES versus PES and reporting the clinical outcomes were examined for analysis.Results. A total of four randomized trials were included, involving 6,788 patients. EES were superior to PES with respect to the major adverse cardiac events (cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)) within 1-year follow-up (OR 0.57; P < 0.001). The 1-year rates of MI, ischemia-driven TLR, and definite or probable stent thrombosis (ST) were also lower with EES than with PES (OR 0.57, P < 0.001 for MI; OR 0.48, P < 0.001 for TLR; OR 0.34, P < 0.001 for ST). There was no significant difference between EES and PES with respect to cardiac mortality (OR 0.93; P = 0.81).Conclusion. The EES is superior to the PES in terms of 1-year safety and efficacy.

TCT-276: Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents: A Meta-Analysis of 4 Trials

TCT-276: Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents: A Meta-Analysis of 4 Trials

Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents

In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported. A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length < or =28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for > or =6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P=0.10) and myocardial infarctions (0.5% versus 1.7%; P=0.12), with similar rates of cardiac death (0.3% versus 0.3%; P=1.0) and target vessel revascularization (2.9% versus 3.0%; P=1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P=0.04) and a 45% reduction in major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P=0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients (P=0.10). Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.