Author/Authors :
Alfonso، نويسنده , , Fernando and Pérez-Vizcayno، نويسنده , , Maria Jose and Cلrdenas، نويسنده , , Alberto and Garcيa del Blanco، نويسنده , , Bruno and Seidelberger، نويسنده , , Bernhard and Iٌiguez، نويسنده , , Andrés and Gَmez-Recio، نويسنده , , Manuel and Masotti، نويسنده , , Mَnica and Velلzquez، نويسنده , , M. Teresa and Sanchيs، نويسنده , , Juan and Garcيa-Touchard، نويسنده , , Arturo and Zueco، نويسنده , , Javier and Bethencourt، نويسنده , , Armando and Melgares، نويسنده , , Rafael and Cequier، نويسنده , , Angel and Dominguez-Melcَn، نويسنده , , Antonio and Mainar، نويسنده , , Vicente and Lَpez-Mيnguez، نويسنده , , José R. and Moreu، نويسنده , , José and Martي، نويسنده , , Vicens and Moreno، نويسنده , , Raْl and Jiménez-Quevedo، نويسنده , , Pilar and Gonzalo، نويسنده , , Nieves and Fernلndez، نويسنده , , Cristina and Macaya، نويسنده , , Carlos، نويسنده ,
Abstract :
Objectives
tudy sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR).
ound
ent of patients with ISR remains a challenge.
s
as a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 monthsʹ follow-up.
s
l of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups.
sions
ients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953)
