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. 2013 Nov 6:347:f6530.
doi: 10.1136/bmj.f6530.

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

Eliano P Navarese  1 , Kenneth Tandjung, Bimmer Claessen, Felicita Andreotti, Mariusz Kowalewski, David E Kandzari, Dean J Kereiakes, Ron Waksman, Laura Mauri, Ian T Meredith, Aloke V Finn, Hyo-Soo Kim, Jacek Kubica, Harry Suryapranata, Toni Mustahsani Aprami, Giuseppe Di Pasquale, Clemens von Birgelen, Elvin Kedhi
Affiliations

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

Eliano P Navarese et al. BMJ. .

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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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that DEK has received research/grant support from Boston Scientific, Medtronic, and Abbott Vascular and has served as consultant for Boston Scientific, Medtronic, and Micell Technologies; DJK has received grant/research support from, been a consultant to, and served on the advisory board for Abbott Vascular and Boston Scientific; CvB is a consultant to and/or has received lecture fees or travel expenses from Abbott Vascular, Boston Scientific, and Medtronic; The Cardiology Research Department of Thoraxcentrum Twente has received educational and/or research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic; AVF has sponsored research agreements with Boston Scientific and Medtronic Vascular and serves on the advisory board for Medtronic Vascular; EK is a consultant to and/or has received lecture fees or travel expenses from Abbott Vascular, and Medtronic; The Maasstad Cardiology Department (previous working place) has received educational and/or research grants funded by Abbott Vascular, Boston Scientific, Terumo Europe, and Medtronic; ITM serves as a consultant to Boston Scientific and Medtronic. All the other authors report no conflict of interest related to the present article.

Figures

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Fig 1 Evidence network among stents included in meta-analysis. Links between stent types represent direct (lines) comparison studies. Nodes denote stent type; thickness of link indicates number of direct comparisons. SES=sirolimus eluting stent; PES=paclitaxel eluting stent; EES=everolimus eluting stent; ZES-E=Endeavor zotarolimus eluting stent; BP-BES=biodegradable polymer biolimus eluting stent; ZES-R=Resolute zotarolimus eluting stent
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Fig 2 Pooled odds ratio and 95% credible intervals determined by network meta-analysis for mortality. BP=biodegradable polymer; E=Endeavor; R=Resolute
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Fig 3 Pooled odds ratio and 95% credible intervals determined by network meta-analysis for myocardial infarction. BP=biodegradable polymer; E=Endeavor; R=Resolute
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Fig 4 Pooled odds ratio and 95% credible intervals determined by network meta-analysis for definite or probable stent thrombosis. BP=biodegradable polymer; E=Endeavor; R=Resolute
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Fig 5 Pooled odds ratio and 95% credible intervals determined by network meta-analysis for target lesion revascularisation. BP=biodegradable polymer; E=Endeavor; R=Resolute
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Fig 6 Pooled odds ratio and 95% credible intervals determined by network meta-analysis for target vessel revascularisation. BP=biodegradable polymer; E=Endeavor; R=Resolute
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Fig 7 Posterior probabilities of different risk thresholds (odds ratios) for each stent compared with sirolimus eluting stent (reference treatment). Curves can be used to examine overall safety and efficacy profile of specific DES compared with reference treatment sirolimus-ES (SES) (identity line=unit value); improved safety and efficacy profiles indicated by highest leftward shift of curve, as shown with Resolute zotarolimus-ES (ZES-R) and everolimus-ES (EES) with regard to mortality and myocardial infarction; curves allow inferences to extract probabilities of specific risk thresholds corresponding to minimal odds ratio compared with sirolimus-ES as reference treatment. For example, compared with sirolimus-ES, there is probability of 65% that Resolute zotarolimus-ES reduce odds of mortality by at least 20% corresponding to odds ratio of 0.80; conversely, this probability is estimated to be close to 0% with biodegradable polymer biolimus-ES (BP-BES), meaning no additional mortality benefit provided by biodegradable polymer biolimus-ES compared with sirolimus-ES; there is a probability of 56% and 49%, respectively, that Resolute zotarolimus-ES and everolimus-ES reduced odds of myocardial infarction by at least 10% corresponding to odds ratio of 0.90 but this probability is estimated close to 0% with biodegradable polymer biolimus-ES, meaning no additional myocardial infarction benefits provided by biodegradable polymer biolimus-ES compared with sirolimus-ES (reference treatment). PES=paclitaxel eluting stent; ZES-E=Endeavor zotarolimus-ES
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References

    1. Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation 2007;115:1440-55. - PubMed
    1. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. 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. Lancet 2007;369:667-78. - PubMed
    1. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193-202. - PubMed
    1. Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D’Ascenzo F, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet 2012;379:1393-402. - PubMed
    1. Bangalore S, Kumar S, Fusaro M, Amoroso N, Attubato MJ, Feit F, et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation 2012;125:2873-91. - PubMed

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