Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents

Abstract

Background-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. Methods and Results-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 Յ28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for Ն6 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%; Pϭ0.10) and myocardial infarctions (0.5% versus 1.7%; Pϭ0.12), with similar rates of cardiac death (0.3% versus 0.3%; Pϭ1.0) and target vessel revascularization (2.9% versus 3.0%; Pϭ1.0). 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; Pϭ0.04) 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; Pϭ0.004). 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 (Pϭ0.10). Conclusions-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. (Circulation. 2009;119:680-686.)

Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines

“…Newer DES (generation 3 DES) may need DAPT absolutely for only 3-6 months. 49 There are a number of on-going trials comparing short duration (3 months) versus standard duration (12 months) of DAPT administration. 50 4.…”

TWENTE Study: The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente: study design, rationale and objectives

“…[8][9][10][11][12] But the study populations of most regulatory trials differ substantially from the patients treated in a 'real world scenario'. This discrepancy is underlined by the different rates of stent thrombosis in low-risk patients (as included in many regulatory trials) vs. high-risk patients and/or patients treated with DES in offlabel scenarios.…”

“…Pivotal clinical trials have demonstrated the safety and efficacy of both stents. [8][9][10][11][12] The positive clinical results may reflect superior drug characteristics, polymer morphology, 13,14 and biocompatibility, [15][16][17] which may account for a better endothelialisation compared with older-generation DES. 18 When we started the present study no data from prospective randomised head-to-head comparisons between these two DES in a real-world scenario were available.…”

Ready for a comeback of natural products in oncology

“…It is the Everolimus is an antiproliferative agent primarily directed at cancer cells, but it is useful in other therapeutic domains as well, in particular for patients with coronary artery disease. A cobalt-chromium stent eluting everolimus was found to be more effective than a paclitaxeleluting stent, with fewer major adverse cardiac events [30].…”