3-Year Clinical Follow-Up of the RIBS IV Clinical Trial A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents

被引：85

作者：

Alfonso, Fernando ^{[1
]}

Jose Perez-Vizcayno, Maria ^{[2
,3
]}

Cuesta, Javier ^{[1
]}

Garcia del Blanco, Bruno ^{[4
]}

Garcia-Touchard, Arturo ^{[5
]}

Ramon Lopez-Minguez, Jose ^{[6
]}

Masotti, Monica ^{[7
]}

Zueco, Javier ^{[8
]}

Cequier, Angel ^{[9
]}

Velazquez, Maite ^{[10
]}

Moreno, Raul ^{[11
]}

Mainar, Vicente ^{[12
]}

Dominguez, Antonio ^{[13
]}

Moris, Cesar ^{[14
]}

Molina, Eduardo ^{[15
]}

Rivero, Fernando ^{[1
]}

Jimenez-Quevedo, Pilar ^{[2
,3
]}

Gonzalo, Nieves ^{[2
,3
]}

Fernandez-Perez, Cristina ^{[2
,3
]}

机构：

[1] Hosp Univ La Princesa, Madrid, Spain

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

[3] Fdn Interhosp Invest Cardiovasc, Madrid, Spain

[4] Hosp Univ Vall dHebron, Barcelona, Spain

[5] Hosp Univ Puerta de Hierro Majadahonda, Madrid, Spain

[6] Hosp Univ Infanta Cristina, Badajoz, Spain

[7] Hosp Univ Clin Barcelona, Barcelona, Spain

[8] Hosp Univ Marques de Valdecilla, Santander, Spain

[9] Hosp Univ Belvitge, Barcelona, Spain

[10] Hosp Univ 12 Octubre, Madrid, Spain

[11] Hosp Univ La Paz, Madrid, Spain

[12] Hosp Univ Alicante, Alicante, Spain

[13] Hosp Univ Virgen de la Victoria, Malaga, Spain

[14] Hosp Univ Cent Asturias, Oviedo, Spain

[15] Hosp Univ Virgen de la Nieves, Granada, Spain

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2018年 / 11卷 / 10期

关键词：

drug-eluting ballon(s); drug-eluting stent(s); everolimus-eluting stent(s); in-stent restenosis; PACLITAXEL-COATED BALLOON; BARE-METAL STENTS; ISAR-DESIRE; ANGIOPLASTY; MULTICENTER; CATHETER; IMPLANTATION; EFFICACY; INSIGHTS;

D O I：

10.1016/j.jcin.2018.02.037

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 long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). BACKGROUND Treatment of patients with DES-ISR remains a challenge. METHODS The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. RESULTS A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 +/- 0.7 mm vs. 1.80 +/- 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. CONCLUSIONS The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940) Published by Elsevier on behalf of the American College of Cardiology Foundation.

引用

页码：981 / 991

页数：11

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