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      Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.

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          Abstract

          In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes.

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          Most cited references26

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          Long-Term Safety of Drug-Eluting and Bare-Metal Stents: Evidence From a Comprehensive Network Meta-Analysis.

          Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety and efficacy of these devices are unknown. Many recent studies have now reported extended follow-up data.
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            Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk.

            When it is required to establish a materially significant difference between two treatments, or, alternatively, to show that two treatments are equivalent, standard test statistics and sample size formulae based on a null hypothesis of no difference no longer apply. This paper reviews some of the test statistics and sample size formulae proposed for comparative binomial trials when the null hypothesis is of a specified non-zero difference or non-unity relative risk. Methods based on restricted maximum likelihood estimation are recommended and applied to studies of pertussis vaccine.
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              Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease.

              Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points. We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80). Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.) 2010 Massachusetts Medical Society
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                Author and article information

                Journal
                N. Engl. J. Med.
                The New England journal of medicine
                1533-4406
                0028-4793
                Nov 12 2015
                : 373
                : 20
                Affiliations
                [1 ] From Cleveland Clinic, Cleveland (S.G.E.), the Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati (D.J.K.), and Mercy St. Vincent's Medical Center, Toledo (A. Kini) - all in Ohio; Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.); St. Joseph's Hospital Health Center, Liverpool, NY (R.P.C.); Scottsdale Healthcare, Scottsdale, AZ (D.G.R.); Scripps Clinic, La Jolla (P.S.T.), and Abbott Vascular, Santa Clara (R.M., Z.Z., C.S.) - both in California; Baptist Medical Center, Jacksonville, FL (M.R.L.); Mount Sinai Medical Center (A. Kabour), Columbia University Medical Center (S.O.M., G.W.S.), and the Cardiovascular Research Foundation (G.W.S.) - all in New York; and the Beth Israel Deaconess Medical Center, Boston (J.J.P.).
                Article
                10.1056/NEJMoa1509038
                26457558
                cb6e4096-4f6e-4cb2-b0c3-c306c15d5ec7
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