AIMS: This study investigated the differences in clinical outcomes between patients with bifurcation lesions (BL) treated with a biolimus-eluting stent (BES) with a biodegradable polymer, and a sirolimus-eluting stent (SES) with a durable polymer. METHODS AND RESULTS: The clinical outcomes were assessed in the 497 patients (BES 258, SES 239) enrolled in the multicentre, randomised LEADERS trial who underwent treatment of ≥1 BL (total=534 BL). At 12-months follow-up there was no significant difference in the primary endpoint of MACE, a composite of cardiac death, myocardial infarction and clinically indicated target vessel revascularisation (BES 12.8% vs. SES 16.3%, p=0.31). Patients treated with BES had comparable rates of cardiac death (BES 2.7% vs. SES 2.9%, p=1.00), numerically higher rates of myocardial infarction (BES 8.9% vs. SES 5.4%, p=0.17), and significantly lower rates of clinically indicated target vessel revascularisation (4.3% vs. 11.3%, p=0.004) when compared to those treated with SES. The rate of stent thrombosis at 12-months was 4.3% and 3.8% for BES and SES, respectively (p=0.82). CONCLUSIONS: In the treatment of BL the use of BES lead to superior efficacy and comparable safety compared to SES.
RCT Entities:
AIMS: This study investigated the differences in clinical outcomes between patients with bifurcation lesions (BL) treated with a biolimus-eluting stent (BES) with a biodegradable polymer, and a sirolimus-eluting stent (SES) with a durable polymer. METHODS AND RESULTS: The clinical outcomes were assessed in the 497 patients (BES 258, SES 239) enrolled in the multicentre, randomised LEADERS trial who underwent treatment of ≥1 BL (total=534 BL). At 12-months follow-up there was no significant difference in the primary endpoint of MACE, a composite of cardiac death, myocardial infarction and clinically indicated target vessel revascularisation (BES 12.8% vs. SES 16.3%, p=0.31). Patients treated with BES had comparable rates of cardiac death (BES 2.7% vs. SES 2.9%, p=1.00), numerically higher rates of myocardial infarction (BES 8.9% vs. SES 5.4%, p=0.17), and significantly lower rates of clinically indicated target vessel revascularisation (4.3% vs. 11.3%, p=0.004) when compared to those treated with SES. The rate of stent thrombosis at 12-months was 4.3% and 3.8% for BES and SES, respectively (p=0.82). CONCLUSIONS: In the treatment of BL the use of BES lead to superior efficacy and comparable safety compared to SES.
Authors: Guy F A Prado; Expedito E Ribeiro; Pedro H M C Melo; Fabio A Pinton; Antonio Esteves-Filho; Celso K Takimura; Jose Mariani; Luiz J Kajita; Gilberto Marchiori; Breno de Alencar Araripe Falcao; Micheli Z Galon; Paulo R Soares; Silvio Zalc; Pedro A Lemos Journal: Cardiovasc Diagn Ther Date: 2015-12
Authors: Jacek Legutko; Wojciech Zasada; Grzegorz L Kałuża; Grzegorz Heba; Lukasz Rzeszutko; Jacek Jakala; Jacek Dragan; Artur Klecha; Dawid Giszterowicz; Wojciech Dobrowolski; Lukasz Partyka; Swaminathan Jayaraman; Dariusz Dudek Journal: Indian Heart J Date: 2013-07-21