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
C2 - 27806919
AN - SCOPUS:85008703775
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 -