A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent-In-Stent Restenosis
Por:
Alfonso, F, Perez-Vizcayno, MJ, Cardenas, A, del Blanco, BG, Seidelberger, B, Iniguez, A, Gomez-Recio, M, Masotti, M, Velazquez, MT, Sanchis, J, Garcia-Touchard, A, Zueco, J, Bethencourt, A, Melgares, R, Cequier, A, Dominguez, A, Mainar, V, Lopez-Minguez, JR, Moreu, J, Marti, V, Moreno, R, Jimenez-Quevedo, P, Gonzalo, N, Fernandez, C, Macaya, C
Publicada:
15 abr 2014
Resumen:
Objectives This study 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).
Background Treatment of patients with ISR remains a challenge.
Methods This was 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 months' follow-up.
Results A total 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.
Conclusions In patients 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) (C) 2014 by the American College of Cardiology Foundation
Filiaciones:
Alfonso, F:
Hosp Univ La Princesa, Madrid, Spain
Hosp Univ Clin San Carlos, Madrid, Spain
Perez-Vizcayno, MJ:
Hosp Univ Clin San Carlos, Madrid, Spain
Cardenas, A:
Hosp Univ Clin San Carlos, Madrid, Spain
del Blanco, BG:
Hosp Univ Vall dHebron, Barcelona, Spain
Seidelberger, B:
Hosp Univ La Princesa, Madrid, Spain
Iniguez, A:
Complejo Hosp Univ Vigo, Pontevedra, Spain
Gomez-Recio, M:
Hosp Univ Torrecardenas, Almeria, Spain
Masotti, M:
Hosp Univ Clin Barcelona, Barcelona, Spain
Velazquez, MT:
Hosp Univ 12 Octubre, Madrid, Spain
Sanchis, J:
Hosp Univ Clin Valencia, Valencia, Spain
Garcia-Touchard, A:
Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain
Zueco, J:
Hosp Univ Marques Valdecilla, Santander, Spain
Bethencourt, A:
Hosp Univ Son Espases, Palma De Mallorca, Spain
Melgares, R:
Hosp Univ Virgen Nieves, Granada, Spain
Cequier, A:
Hosp Univ Bellvitge, Barcelona, Spain
Dominguez, A:
Hosp Univ Virgen Victoria, Malaga, Spain
Mainar, V:
Hosp Univ Alicante, Alicante, Spain
Lopez-Minguez, JR:
Hosp Univ Infanta Cristina Badajoz, Badajoz, Spain
Moreu, J:
Hosp Univ Virgen Salud Toledo, Toledo, Spain
Marti, V:
Hosp Univ St Pau, Barcelona, Spain
Moreno, R:
Hosp Univ La Paz, Madrid, Spain
Jimenez-Quevedo, P:
Hosp Univ Clin San Carlos, Madrid, Spain
Gonzalo, N:
Hosp Univ Clin San Carlos, Madrid, Spain
Fernandez, C:
Hosp Univ Clin San Carlos, Madrid, Spain
Macaya, C:
Hosp Univ Clin San Carlos, Madrid, Spain
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