A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent-In-Stent Restenosis: The RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent)

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• 作者：Fernando Alfonso ; MD^&lowast ; ; ^&dagger ; ; ^{falf@hotmail.com" class="auth_mail} ; Maria Jose Pé ; rez-Vizcayno ; MD^&dagger ; ; Alberto Cá ; rdenas ; MD^&dagger ; ; Bruno Garcí ; a del Blanco ; MD^&Dagger ; ; Bernhard Seidelberger ; MD^&lowast ; ; André ; s Iñ ; iguez ; MD^§ ; ; Manuel Gó ; mez-Recio ; MD^鈥?/sup> ; Mó ; nica Masotti ; MD^¶ ; ; M. Teresa Velá ; zquez ; MD^# ; Juan Sanchí ; s ; MD^&lowast ; &lowast ; ; Arturo Garcí ; a-Touchard ; MD^&dagger ; &dagger ; ; Javier Zueco ; MD^&Dagger ; &Dagger ; ; Armando Bethencourt ; MD^§ ; § ; ; Rafael Melgares ; MD^{鈥栤€?/sup>} ; Angel Cequier ; MD^¶ ; ¶ ; ; Antonio Dominguez ; MD^## ; Vicente Mainar ; MD^&lowast ; &lowast ; &lowast ; ; José ; R. Ló ; pez-Mí ; nguez ; MD^&dagger ; &dagger ; &dagger ; ; José ; Moreu ; MD^&Dagger ; &Dagger ; &Dagger ; ; Vicens Martí ; MD^§ ; § ; § ; ; Raú ; l Moreno ; MD^{鈥栤€栤€?/sup>} ; Pilar Jimé ; nez-Quevedo ; MD^&dagger ; ; Nieves Gonzalo ; MD^&dagger ; ; Cristina Ferná ; ndez ; MD^&dagger ; ; Carlos Macaya ; MD^&dagger ; ; for the RIBS V Study Investigators ; under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology
• 关键词：device thrombosis ; drug-eluting balloon ; everolimus-eluting stent ; in-stent restenosis
• 刊名：Journal of the American College of Cardiology
• 出版年：15 April, 2014
• 年：2014
• 卷：63
• 期：14
• 页码：1378-1386
• 全文大小：503 K

文摘

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Objectives

This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES)聽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 卤 0.6 mm vs. 2.01 卤 0.6 mm, p聽<聽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 卤 17% vs. 25 卤 20%, p聽< 0.001). However, late loss (0.04 卤 0.5 mm vs. 0.14 卤 0.5 mm, p聽= 0.14) and binary restenosis rate (4.7% vs. 9.5%, p聽= 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聽= 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p聽= 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聽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]; )