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      Comparison of Zotarolimus- and Everolimus-Eluting Coronary Stents : Final 5-Year Report of the RESOLUTE All-Comers Trial

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          Abstract

          Supplemental Digital Content is available in the text.

          Abstract

          Background—

          Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial.

          Methods and Results—

          RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P=0.12).

          Conclusions—

          At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria.

          Clinical Trial Registration—

          URL: http://www.clinicaltrials.gov. Unique identifier: NCT00617084.

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          Most cited references 28

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          Guidelines on myocardial revascularization.

           W Wijns,  P Kolh,  N Danchin (2010)
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            Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.

            Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization. We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days. The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined. In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed. Copyright 2003 Massachusetts Medical Society
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              A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

              The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.
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                Author and article information

                Journal
                Circ Cardiovasc Interv
                Circ Cardiovasc Interv
                HCV
                Circulation. Cardiovascular Interventions
                Lippincott Williams & Wilkins
                1941-7640
                1941-7632
                June 2015
                16 June 2015
                : 8
                : 6
                : 1-8
                Affiliations
                From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
                Author notes
                Correspondence to Patrick W. Serruys, MD, PhD, FESC, PO Box 2125, 3000 CC Rotterdam, The Netherlands. E-mail patrick.w.j.c.serruys@ 123456gmail.com
                Article
                00007
                10.1161/CIRCINTERVENTIONS.114.002230
                4495878
                26047993
                © 2015 The Authors.

                Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.

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