Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates

Marco Valgimigli, Athanasios Patialiakas, Attila Thury, Eugene McFadden, Salvatore Colangelo, Gianluca Campo, Matteo Tebaldi, Imre Ungi, Stefano Tondi, Marco Roffi, Alberto Menozzi, Nicoletta De Cesare, Roberto Garbo, Emanuele Meliga, Luca Testa, Henrique Mesquita Gabriel, Flavio Airoldi, Marco Ferlini, Francesco Liistro, Antonio DellavallePascal Vranckx, Carlo Briguori

Research output: Contribution to journalArticle

Abstract

Background The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. Objectives This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). Methods We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). Results Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p <0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). Conclusions Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319)

Original languageEnglish
Pages (from-to)805-815
Number of pages11
JournalJournal of the American College of Cardiology
Volume65
Issue number8
DOIs
Publication statusPublished - Mar 3 2015

Fingerprint

Drug-Eluting Stents
Stents
Metals
zotarolimus
Polymers
Thrombosis
Myocardial Infarction
Hemorrhage
Therapeutics

Keywords

  • drug-eluting stent(s)
  • dualantiplatelet therapy
  • high bleeding risk
  • high thrombotic risk
  • zotarolimus-eluting stent(s)

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Valgimigli, M., Patialiakas, A., Thury, A., McFadden, E., Colangelo, S., Campo, G., ... Briguori, C. (2015). Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. Journal of the American College of Cardiology, 65(8), 805-815. https://doi.org/10.1016/j.jacc.2014.11.053

Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. / Valgimigli, Marco; Patialiakas, Athanasios; Thury, Attila; McFadden, Eugene; Colangelo, Salvatore; Campo, Gianluca; Tebaldi, Matteo; Ungi, Imre; Tondi, Stefano; Roffi, Marco; Menozzi, Alberto; De Cesare, Nicoletta; Garbo, Roberto; Meliga, Emanuele; Testa, Luca; Gabriel, Henrique Mesquita; Airoldi, Flavio; Ferlini, Marco; Liistro, Francesco; Dellavalle, Antonio; Vranckx, Pascal; Briguori, Carlo.

In: Journal of the American College of Cardiology, Vol. 65, No. 8, 03.03.2015, p. 805-815.

Research output: Contribution to journalArticle

Valgimigli, M, Patialiakas, A, Thury, A, McFadden, E, Colangelo, S, Campo, G, Tebaldi, M, Ungi, I, Tondi, S, Roffi, M, Menozzi, A, De Cesare, N, Garbo, R, Meliga, E, Testa, L, Gabriel, HM, Airoldi, F, Ferlini, M, Liistro, F, Dellavalle, A, Vranckx, P & Briguori, C 2015, 'Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates', Journal of the American College of Cardiology, vol. 65, no. 8, pp. 805-815. https://doi.org/10.1016/j.jacc.2014.11.053
Valgimigli, Marco ; Patialiakas, Athanasios ; Thury, Attila ; McFadden, Eugene ; Colangelo, Salvatore ; Campo, Gianluca ; Tebaldi, Matteo ; Ungi, Imre ; Tondi, Stefano ; Roffi, Marco ; Menozzi, Alberto ; De Cesare, Nicoletta ; Garbo, Roberto ; Meliga, Emanuele ; Testa, Luca ; Gabriel, Henrique Mesquita ; Airoldi, Flavio ; Ferlini, Marco ; Liistro, Francesco ; Dellavalle, Antonio ; Vranckx, Pascal ; Briguori, Carlo. / Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. In: Journal of the American College of Cardiology. 2015 ; Vol. 65, No. 8. pp. 805-815.
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abstract = "Background The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. Objectives This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). Methods We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). Results Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5{\%}) reached the primary endpoint, compared with 178 patients (22.1{\%}) in the BMS group (hazard ratio: 0.76; 95{\%} confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9{\%} vs. 8.1{\%}; p <0.001) and TVR rates (5.9{\%} vs.10.7{\%}; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0{\%} vs. 4.1{\%}; p = 0.019). Conclusions Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319)",
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T1 - Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates

AU - Valgimigli, Marco

AU - Patialiakas, Athanasios

AU - Thury, Attila

AU - McFadden, Eugene

AU - Colangelo, Salvatore

AU - Campo, Gianluca

AU - Tebaldi, Matteo

AU - Ungi, Imre

AU - Tondi, Stefano

AU - Roffi, Marco

AU - Menozzi, Alberto

AU - De Cesare, Nicoletta

AU - Garbo, Roberto

AU - Meliga, Emanuele

AU - Testa, Luca

AU - Gabriel, Henrique Mesquita

AU - Airoldi, Flavio

AU - Ferlini, Marco

AU - Liistro, Francesco

AU - Dellavalle, Antonio

AU - Vranckx, Pascal

AU - Briguori, Carlo

PY - 2015/3/3

Y1 - 2015/3/3

N2 - Background The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. Objectives This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). Methods We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). Results Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p <0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). Conclusions Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319)

AB - Background The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. Objectives This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). Methods We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). Results Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p <0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). Conclusions Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319)

KW - drug-eluting stent(s)

KW - dualantiplatelet therapy

KW - high bleeding risk

KW - high thrombotic risk

KW - zotarolimus-eluting stent(s)

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