Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents

Philippe Garot; Marie-Claude Morice; Damras Tresukosol; Stuart J. Pocock; Ian T. Meredith; Alexandre Abizaid; Didier Carrié; Christoph Naber; Andres Iñiguez; Suneel Talwar; Ian B.A. Menown; Evald H. Christiansen; John Gregson; Samuel Copt; Thomas Hovasse; Philipp Lurz; Luc Maillard; Florian Krackhardt; Paul Ong; Jonathan Byrne; Simon Redwood; Ute Windhövel; Samantha Greene; Hans-Peter Stoll; Philip Urban

doi:10.1016/j.jacc.2016.10.009

Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents

Philippe Garot, Marie-Claude Morice, Damras Tresukosol, Stuart J. Pocock, Ian T. Meredith, Alexandre Abizaid, Didier Carrié, Christoph Naber, Andres Iñiguez, Suneel Talwar, Ian B.A. Menown, Evald H. Christiansen, John Gregson, Samuel Copt, Thomas Hovasse, Philipp Lurz, Luc Maillard, Florian Krackhardt, Paul Ong, Jonathan ByrneSimon Redwood, Ute Windhövel, Samantha Greene, Hans-Peter Stoll, Philip Urban

Research output: Contribution to journal › Article › peer-review

96 Citations (Scopus)

378 Downloads (Pure)

Abstract

Background For patients at high risk for bleeding, a polymer-free metallic stent coated with biolimus-A9 followed by one-month dual antiplatelet therapy was safer and more effective than a bare metal stent at one year. Objectives Longer-term follow-up is needed to determine whether these benefits are maintained. Methods In a prospective, multi-center, double blind trial, we randomly assigned 2466 high bleeding risk patients to receive a drug coated stent (DCS) or a bare metal stent (BMS) followed by one month dual antiplatelet therapy and 98.1% completed a two-year follow-up. The primary safety end point was a composite of cardiac death, myocardial infarction (MI), or stent thrombosis (ST). The primary efficacy end point was clinically driven target-lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS (12.6%) and 180 BMS patients (15.3%) (hazard ratio 0.80; 95% CI, 0.64 to 0.99; p=0.039). Clinically driven target-lesion revascularization occurred for 77 DCS (6.8%) and 136 BMS patients (12.0%) (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P<0.0001). Major bleeding occurred in 8.9% DCS and 9.2% BMS patients (p=0.95), and a coronary thrombotic event (MI and/or ST) in 8.2% DCS and 10.6% BMS patients (p=0.045). Mortality was 27.1% one year after a major bleed, and 26.3% one year after a thrombotic event. At two years, multivariate correlates of major bleeding were age > 75, anemia, raised plasma creatinine and planned long-term anticoagulation. Correlates of the primary safety endpoint were age anemia, congestive heart failure, multivessel disease, number of stents implanted and use of a BMS rather than a DCS. Conclusions The safety and efficacy benefits of DCS over BMS were maintained up to two years in high bleeding risk patients. During that period, overall rates of major bleeding and coronary thrombotic events were no different and associated with a substantial and comparable mortality risk.

Original language	English
Journal	Journal of the American College of Cardiology
Early online date	30 Oct 2016
DOIs	https://doi.org/10.1016/j.jacc.2016.10.009
Publication status	E-pub ahead of print - 30 Oct 2016

Keywords

drug-coated stent
DAPT
bleeding
thrombosis
bare-metal stent

Access to Document

10.1016/j.jacc.2016.10.009Licence: CC BY-NC-ND

Two-Year Outcomes_GAROT_Accepted7October2016_GREEN AAMAccepted author manuscript, 1.1 MBLicence: CC BY-NC-ND

Cite this

Garot, P., Morice, M-C., Tresukosol, D., Pocock, S. J., Meredith, I. T., Abizaid, A., Carrié, D., Naber, C., Iñiguez, A., Talwar, S., Menown, I. B. A., Christiansen, E. H., Gregson, J., Copt, S., Hovasse, T., Lurz, P., Maillard, L., Krackhardt, F., Ong, P., ... Urban, P. (2016). Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2016.10.009

@article{5ee18e3823094a67925f25e74518014e,

title = "Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents",

abstract = "Background For patients at high risk for bleeding, a polymer-free metallic stent coated with biolimus-A9 followed by one-month dual antiplatelet therapy was safer and more effective than a bare metal stent at one year. Objectives Longer-term follow-up is needed to determine whether these benefits are maintained. Methods In a prospective, multi-center, double blind trial, we randomly assigned 2466 high bleeding risk patients to receive a drug coated stent (DCS) or a bare metal stent (BMS) followed by one month dual antiplatelet therapy and 98.1% completed a two-year follow-up. The primary safety end point was a composite of cardiac death, myocardial infarction (MI), or stent thrombosis (ST). The primary efficacy end point was clinically driven target-lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS (12.6%) and 180 BMS patients (15.3%) (hazard ratio 0.80; 95% CI, 0.64 to 0.99; p=0.039). Clinically driven target-lesion revascularization occurred for 77 DCS (6.8%) and 136 BMS patients (12.0%) (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P<0.0001). Major bleeding occurred in 8.9% DCS and 9.2% BMS patients (p=0.95), and a coronary thrombotic event (MI and/or ST) in 8.2% DCS and 10.6% BMS patients (p=0.045). Mortality was 27.1% one year after a major bleed, and 26.3% one year after a thrombotic event. At two years, multivariate correlates of major bleeding were age > 75, anemia, raised plasma creatinine and planned long-term anticoagulation. Correlates of the primary safety endpoint were age anemia, congestive heart failure, multivessel disease, number of stents implanted and use of a BMS rather than a DCS. Conclusions The safety and efficacy benefits of DCS over BMS were maintained up to two years in high bleeding risk patients. During that period, overall rates of major bleeding and coronary thrombotic events were no different and associated with a substantial and comparable mortality risk.",

keywords = "drug-coated stent, DAPT, bleeding, thrombosis, bare-metal stent",

author = "Philippe Garot and Marie-Claude Morice and Damras Tresukosol and Pocock, {Stuart J.} and Meredith, {Ian T.} and Alexandre Abizaid and Didier Carri{\'e} and Christoph Naber and Andres I{\~n}iguez and Suneel Talwar and Menown, {Ian B.A.} and Christiansen, {Evald H.} and John Gregson and Samuel Copt and Thomas Hovasse and Philipp Lurz and Luc Maillard and Florian Krackhardt and Paul Ong and Jonathan Byrne and Simon Redwood and Ute Windh{\"o}vel and Samantha Greene and Hans-Peter Stoll and Philip Urban",

year = "2016",

month = oct,

day = "30",

doi = "10.1016/j.jacc.2016.10.009",

language = "English",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier USA",

}

Garot, P, Morice, M-C, Tresukosol, D, Pocock, SJ, Meredith, IT, Abizaid, A, Carrié, D, Naber, C, Iñiguez, A, Talwar, S, Menown, IBA, Christiansen, EH, Gregson, J, Copt, S, Hovasse, T, Lurz, P, Maillard, L, Krackhardt, F, Ong, P, Byrne, J , Redwood, S, Windhövel, U, Greene, S, Stoll, H-P & Urban, P 2016, 'Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents', Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2016.10.009

TY - JOUR

T1 - Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents

AU - Garot, Philippe

AU - Morice, Marie-Claude

AU - Tresukosol, Damras

AU - Pocock, Stuart J.

AU - Meredith, Ian T.

AU - Abizaid, Alexandre

AU - Carrié, Didier

AU - Naber, Christoph

AU - Iñiguez, Andres

AU - Talwar, Suneel

AU - Menown, Ian B.A.

AU - Christiansen, Evald H.

AU - Gregson, John

AU - Copt, Samuel

AU - Hovasse, Thomas

AU - Lurz, Philipp

AU - Maillard, Luc

AU - Krackhardt, Florian

AU - Ong, Paul

AU - Byrne, Jonathan

AU - Redwood, Simon

AU - Windhövel, Ute

AU - Greene, Samantha

AU - Stoll, Hans-Peter

AU - Urban, Philip

PY - 2016/10/30

Y1 - 2016/10/30

N2 - Background For patients at high risk for bleeding, a polymer-free metallic stent coated with biolimus-A9 followed by one-month dual antiplatelet therapy was safer and more effective than a bare metal stent at one year. Objectives Longer-term follow-up is needed to determine whether these benefits are maintained. Methods In a prospective, multi-center, double blind trial, we randomly assigned 2466 high bleeding risk patients to receive a drug coated stent (DCS) or a bare metal stent (BMS) followed by one month dual antiplatelet therapy and 98.1% completed a two-year follow-up. The primary safety end point was a composite of cardiac death, myocardial infarction (MI), or stent thrombosis (ST). The primary efficacy end point was clinically driven target-lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS (12.6%) and 180 BMS patients (15.3%) (hazard ratio 0.80; 95% CI, 0.64 to 0.99; p=0.039). Clinically driven target-lesion revascularization occurred for 77 DCS (6.8%) and 136 BMS patients (12.0%) (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P<0.0001). Major bleeding occurred in 8.9% DCS and 9.2% BMS patients (p=0.95), and a coronary thrombotic event (MI and/or ST) in 8.2% DCS and 10.6% BMS patients (p=0.045). Mortality was 27.1% one year after a major bleed, and 26.3% one year after a thrombotic event. At two years, multivariate correlates of major bleeding were age > 75, anemia, raised plasma creatinine and planned long-term anticoagulation. Correlates of the primary safety endpoint were age anemia, congestive heart failure, multivessel disease, number of stents implanted and use of a BMS rather than a DCS. Conclusions The safety and efficacy benefits of DCS over BMS were maintained up to two years in high bleeding risk patients. During that period, overall rates of major bleeding and coronary thrombotic events were no different and associated with a substantial and comparable mortality risk.

AB - Background For patients at high risk for bleeding, a polymer-free metallic stent coated with biolimus-A9 followed by one-month dual antiplatelet therapy was safer and more effective than a bare metal stent at one year. Objectives Longer-term follow-up is needed to determine whether these benefits are maintained. Methods In a prospective, multi-center, double blind trial, we randomly assigned 2466 high bleeding risk patients to receive a drug coated stent (DCS) or a bare metal stent (BMS) followed by one month dual antiplatelet therapy and 98.1% completed a two-year follow-up. The primary safety end point was a composite of cardiac death, myocardial infarction (MI), or stent thrombosis (ST). The primary efficacy end point was clinically driven target-lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS (12.6%) and 180 BMS patients (15.3%) (hazard ratio 0.80; 95% CI, 0.64 to 0.99; p=0.039). Clinically driven target-lesion revascularization occurred for 77 DCS (6.8%) and 136 BMS patients (12.0%) (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P<0.0001). Major bleeding occurred in 8.9% DCS and 9.2% BMS patients (p=0.95), and a coronary thrombotic event (MI and/or ST) in 8.2% DCS and 10.6% BMS patients (p=0.045). Mortality was 27.1% one year after a major bleed, and 26.3% one year after a thrombotic event. At two years, multivariate correlates of major bleeding were age > 75, anemia, raised plasma creatinine and planned long-term anticoagulation. Correlates of the primary safety endpoint were age anemia, congestive heart failure, multivessel disease, number of stents implanted and use of a BMS rather than a DCS. Conclusions The safety and efficacy benefits of DCS over BMS were maintained up to two years in high bleeding risk patients. During that period, overall rates of major bleeding and coronary thrombotic events were no different and associated with a substantial and comparable mortality risk.

KW - drug-coated stent

KW - DAPT

KW - bleeding

KW - thrombosis

KW - bare-metal stent

U2 - 10.1016/j.jacc.2016.10.009

DO - 10.1016/j.jacc.2016.10.009

M3 - Article

SN - 0735-1097

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

ER -

Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents

Abstract

Keywords

Access to Document

Fingerprint

Cite this