A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent-In-Stent Restenosis

被引：206

作者：

Alfonso, Fernando ^{[1
,2
]}

Jose Perez-Vizcayno, Maria ^{[2
]}

Cardenas, Alberto ^{[2
]}

Garcia del Blanco, Bruno ^{[3
]}

Seidelberger, Bernhard ^{[1
]}

Iniguez, Andres ^{[4
]}

Gomez-Recio, Manuel ^{[5
]}

Masotti, Monica ^{[6
]}

Teresa Velazquez, M. ^{[7
]}

Sanchis, Juan ^{[8
]}

Garcia-Touchard, Arturo ^{[9
]}

Zueco, Javier ^{[10
]}

Bethencourt, Armando ^{[11
]}

Melgares, Rafael ^{[12
]}

Cequier, Angel ^{[13
]}

Dominguez, Antonio ^{[14
]}

Mainar, Vicente ^{[15
]}

Lopez-Minguez, Jose R. ^{[16
]}

Moreu, Jose ^{[17
]}

Marti, Vicens ^{[18
]}

Moreno, Raul ^{[19
]}

Jimenez-Quevedo, Pilar ^{[2
]}

Gonzalo, Nieves ^{[2
]}

Fernandez, Cristina ^{[2
]}

Macaya, Carlos ^{[2
]}

机构：

[1] Hosp Univ La Princesa, Madrid, Spain

[2] Hosp Univ Clin San Carlos, Madrid, Spain

[3] Hosp Univ Vall dHebron, Barcelona, Spain

[4] Complejo Hosp Univ Vigo, Pontevedra, Spain

[5] Hosp Univ Torrecardenas, Almeria, Spain

[6] Hosp Univ Clin Barcelona, Barcelona, Spain

[7] Hosp Univ 12 Octubre, Madrid, Spain

[8] Hosp Univ Clin Valencia, Valencia, Spain

[9] Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain

[10] Hosp Univ Marques Valdecilla, Santander, Spain

[11] Hosp Univ Son Espases, Palma De Mallorca, Spain

[12] Hosp Univ Virgen Nieves, Granada, Spain

[13] Hosp Univ Bellvitge, Barcelona, Spain

[14] Hosp Univ Virgen Victoria, Malaga, Spain

[15] Hosp Univ Alicante, Alicante, Spain

[16] Hosp Univ Infanta Cristina Badajoz, Badajoz, Spain

[17] Hosp Univ Virgen Salud Toledo, Toledo, Spain

[18] Hosp Univ St Pau, Barcelona, Spain

[19] Hosp Univ La Paz, Madrid, Spain

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2014年 / 63卷 / 14期

关键词：

device thrombosis; drug-eluting balloon; everolimus-eluting stent; in-stent restenosis; ANGIOPLASTY; IMPLANTATION; MULTICENTER; CATHETER; METAANALYSIS; RECURRENCES; TRIALS;

D O I：

10.1016/j.jacc.2013.12.006

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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

引用

页码：1378 / 1386

页数：9

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