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

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

UR - http://www.scopus.com/inward/record.url?scp=85008703775&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2016.10.009

DO - 10.1016/j.jacc.2016.10.009

M3 - Article

VL - 69

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 -