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      Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis

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          Abstract

          Objectives To investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES).

          Design Network meta-analysis of randomised controlled trials.

          Data sources and study selection Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES.

          Primary outcomes Safety (death, myocardial infarction, definite or probable stent thrombosis) and efficacy (target lesion and target vessel revascularisation) assessed at up to one year and beyond.

          Results 60 randomised controlled trials were compared involving 63 242 patients with stable coronary artery disease or acute coronary syndrome treated with a DES. At one year, there were no differences in mortality among devices. Resolute and Endeavor zotarolimus-ES, everolimus-ES, and sirolimus-ES, but not biodegradable polymer biolimus-ES, were associated with significantly reduced odds of myocardial infarction (by 29-34%) compared with paclitaxel-ES. Compared with everolimus-ES, biodegradable polymer biolimus-ES were associated with significantly increased odds of myocardial infarction (by 29%), while Endeavor zotarolimus-ES and paclitaxel-ES were associated with significantly increased odds of stent thrombosis. All investigated DES were similar with regards to efficacy endpoints, except for Endeavor zotarolimus-ES and paclitaxel-ES, which were associated with significantly increased the odds of target lesion and target vessel revascularisations compared with other devices. Direction of results beyond one year did not diverge from the findings for up to one year follow-up. Bayesian probability curves showed a gradient in the magnitude of effect, with everolimus-ES and Resolute zotarolimus-ES offering the highest safety profiles.

          Conclusions The newer durable polymer everolimus-ES and Resolute zotarolimus-ES and the biodegradable polymer biolimus-ES maintain the efficacy of sirolimus-ES; however, for safety endpoints, differences become apparent, with everolimus-ES and Resolute zotarolimus-ES emerging as the safest stents to date.

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          Most cited references 94

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          Guidelines on myocardial revascularization.

           W Wijns,  P Kolh,  N Danchin (2010)
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            Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study.

            Stent thrombosis is a safety concern associated with use of drug-eluting stents. Little is known about occurrence of stent thrombosis more than 1 year after implantation of such stents. Between April, 2002, and Dec, 2005, 8146 patients underwent percutaneous coronary intervention with sirolimus-eluting stents (SES; n=3823) or paclitaxel-eluting stents (PES; n=4323) at two academic hospitals. We assessed data from this group to ascertain the incidence, time course, and correlates of stent thrombosis, and the differences between early (0-30 days) and late (>30 days) stent thrombosis and between SES and PES. Angiographically documented stent thrombosis occurred in 152 patients (incidence density 1.3 per 100 person-years; cumulative incidence at 3 years 2.9%). Early stent thrombosis was noted in 91 (60%) patients, and late stent thrombosis in 61 (40%) patients. Late stent thrombosis occurred steadily at a constant rate of 0.6% per year up to 3 years after stent implantation. Incidence of early stent thrombosis was similar for SES (1.1%) and PES (1.3%), but late stent thrombosis was more frequent with PES (1.8%) than with SES (1.4%; p=0.031). At the time of stent thrombosis, dual antiplatelet therapy was being taken by 87% (early) and 23% (late) of patients (p<0.0001). Independent predictors of overall stent thrombosis were acute coronary syndrome at presentation (hazard ratio 2.28, 95% CI 1.29-4.03) and diabetes (2.03, 1.07-3.83). Late stent thrombosis was encountered steadily with no evidence of diminution up to 3 years of follow-up. Early and late stent thrombosis were observed with SES and with PES. Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis.
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                Author and article information

                Contributors
                Role: assistant professor of medicine and director of research
                Role: resident
                Role: resident
                Role: aggregate professor of medicine
                Role: research fellow
                Role: professor of medicine
                Role: professor of medicine
                Role: professor of medicine
                Role: professor of medicine
                Role: professor of medicine
                Role: assistant professor of medicine
                Role: professor of medicine
                Role: professor of medicine
                Role: professor of medicine
                Role: profesor of medicine
                Role: cardiologist
                Role: professor of medicine
                Role: interventional cardiologist
                Journal
                BMJ
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2013
                2013
                6 November 2013
                : 347
                Affiliations
                [1 ]Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
                [2 ]Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands
                [3 ]Department of Cardiology, Academisch Medisch Centrum, Universiteit van Amsterdam, Netherlands
                [4 ]Department of Cardiovascular Science, Catholic University, Rome, Italy
                [5 ]Piedmont Heart Institute, Atlanta, GA, USA
                [6 ]Department of Cardiology, Christ Hospital Heart and Vascular Center/Lindner Research Center, Cincinnati, OH, USA
                [7 ]Division of Cardiology, MedStar Washington Hospital Center, Washington DC, USA
                [8 ]Department of Cardiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
                [9 ]Department of Cardiology, MonashHeart, Monash Medical Centre and Monash University, Melbourne, Australia
                [10 ]Department of Cardiology, Emory University School of Medicine, Atlanta, USA
                [11 ]Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
                [12 ]Department of Cardiology, UMC St Radboud, Nijmegen, Netherlands
                [13 ]Department of Cardiology, Padjadjaran University Hospital Hasan Sadikin, Bandung, Indonesia
                [14 ]Unità Ospedaliera di Cardiologia, Ospedale Maggiore, Bologna, Italy
                [15 ]Health Technology and Services Research, MIRA-Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands
                [16 ]Department of Cardiology, Isala Klinieken, 8025 AB Zwolle, Netherlands
                Author notes
                Correspondence to: E Kedhi ekedhi@ 123456yahoo.com
                Article
                nave013990
                10.1136/bmj.f6530
                3819044
                © Navarese et al 2013

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

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