2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents

Philippe Garot, Marie-Claude Laude Morice, Damras Tresukosol, Stuart J Pocock, Ian T. Meredith, Alexandre Abizaid, Didier Carrié, Christoph K Naber, Andres Iñiguez, Suneel Talwar, Ian B.A. Menown, Evald H Christiansen, John N S Gregson, Samuel Copt, Thomas Hovasse, Philipp C. Lurz, Luc Maillard, Florian Krackhardt, Paul Ong, Jonathan Byrne & 6 others Simon Redwood, Ute Windhövel, Samantha Greene, Hans-Peter Stoll, Philip Urban, for the LEADERS FREE Investigators

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. Objectives This study analyzed 2-year outcomes to determine whether these benefits are maintained. Methods In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, 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 Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180)

Original languageEnglish
Pages (from-to)162-171
Number of pages10
JournalJournal of the American College of Cardiology
Volume69
Issue number2
DOIs
Publication statusPublished - 17 Jan 2017

Keywords

  • bare-metal stent
  • bleeding
  • drug-coated stent
  • dual antiplatelet therapy
  • thrombosis

Cite this

Garot, P., Morice, M-C. L., Tresukosol, D., Pocock, S. J., Meredith, I. T., Abizaid, A., ... for the LEADERS FREE Investigators (2017). 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. Journal of the American College of Cardiology, 69(2), 162-171. https://doi.org/10.1016/j.jacc.2016.10.009
Garot, Philippe ; Morice, Marie-Claude Laude ; Tresukosol, Damras ; Pocock, Stuart J ; Meredith, Ian T. ; Abizaid, Alexandre ; Carrié, Didier ; Naber, Christoph K ; Iñiguez, Andres ; Talwar, Suneel ; Menown, Ian B.A. ; Christiansen, Evald H ; Gregson, John N S ; Copt, Samuel ; Hovasse, Thomas ; Lurz, Philipp C. ; Maillard, Luc ; Krackhardt, Florian ; Ong, Paul ; Byrne, Jonathan ; Redwood, Simon ; Windhövel, Ute ; Greene, Samantha ; Stoll, Hans-Peter ; Urban, Philip ; for the LEADERS FREE Investigators. / 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. In: Journal of the American College of Cardiology. 2017 ; Vol. 69, No. 2. pp. 162-171.
@article{a5f3cdaf9d634614ad8a593a6f2841d7,
title = "2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents",
abstract = "Background A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. Objectives This study analyzed 2-year outcomes to determine whether these benefits are maintained. Methods In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3{\%}) (hazard ratio: 0.80; 95{\%} confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0{\%}) (hazard ratio: 0.54; 95{\%} confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9{\%} of DCS and 9.2{\%} of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2{\%} of DCS and 10.6{\%} of BMS patients (p = 0.045). One-year mortality was 27.1{\%} for a major bleed and 26.3{\%} for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, 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 Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180)",
keywords = "bare-metal stent, bleeding, drug-coated stent, dual antiplatelet therapy, thrombosis",
author = "Philippe Garot and Morice, {Marie-Claude Laude} and Damras Tresukosol and Pocock, {Stuart J} and Meredith, {Ian T.} and Alexandre Abizaid and Didier Carri{\'e} and Naber, {Christoph K} and Andres I{\~n}iguez and Suneel Talwar and Menown, {Ian B.A.} and Christiansen, {Evald H} and Gregson, {John N S} and Samuel Copt and Thomas Hovasse and Lurz, {Philipp C.} 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 and {for the LEADERS FREE Investigators}",
year = "2017",
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language = "English",
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pages = "162--171",
journal = "Journal of the American College of Cardiology",
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Garot, P, Morice, M-CL, Tresukosol, D, Pocock, SJ, Meredith, IT, Abizaid, A, Carrié, D, Naber, CK, Iñiguez, A, Talwar, S, Menown, IBA, Christiansen, EH, Gregson, JNS, Copt, S, Hovasse, T, Lurz, PC, Maillard, L, Krackhardt, F, Ong, P, Byrne, J, Redwood, S, Windhövel, U, Greene, S, Stoll, H-P, Urban, P & for the LEADERS FREE Investigators 2017, '2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents' Journal of the American College of Cardiology, vol. 69, no. 2, pp. 162-171. https://doi.org/10.1016/j.jacc.2016.10.009

2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. / Garot, Philippe; Morice, Marie-Claude Laude; Tresukosol, Damras; Pocock, Stuart J; Meredith, Ian T.; Abizaid, Alexandre; Carrié, Didier; Naber, Christoph K; Iñiguez, Andres; Talwar, Suneel; Menown, Ian B.A.; Christiansen, Evald H; Gregson, John N S; Copt, Samuel; Hovasse, Thomas; Lurz, Philipp C.; Maillard, Luc; Krackhardt, Florian; Ong, Paul; Byrne, Jonathan; Redwood, Simon; Windhövel, Ute; Greene, Samantha; Stoll, Hans-Peter; Urban, Philip; for the LEADERS FREE Investigators.

In: Journal of the American College of Cardiology, Vol. 69, No. 2, 17.01.2017, p. 162-171.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents

AU - Garot, Philippe

AU - Morice, Marie-Claude Laude

AU - Tresukosol, Damras

AU - Pocock, Stuart J

AU - Meredith, Ian T.

AU - Abizaid, Alexandre

AU - Carrié, Didier

AU - Naber, Christoph K

AU - Iñiguez, Andres

AU - Talwar, Suneel

AU - Menown, Ian B.A.

AU - Christiansen, Evald H

AU - Gregson, John N S

AU - Copt, Samuel

AU - Hovasse, Thomas

AU - Lurz, Philipp C.

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

AU - for the LEADERS FREE Investigators

PY - 2017/1/17

Y1 - 2017/1/17

N2 - Background A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. Objectives This study analyzed 2-year outcomes to determine whether these benefits are maintained. Methods In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, 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 Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180)

AB - Background A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. Objectives This study analyzed 2-year outcomes to determine whether these benefits are maintained. Methods In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, 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 Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180)

KW - bare-metal stent

KW - bleeding

KW - drug-coated stent

KW - dual antiplatelet therapy

KW - thrombosis

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U2 - 10.1016/j.jacc.2016.10.009

DO - 10.1016/j.jacc.2016.10.009

M3 - Article

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SP - 162

EP - 171

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 2

ER -