Long-Term Results of Bioresorbable Vascular Scaffolds in Patients With In-Stent Restenosis The RIBS VI Study

被引：4

作者：

Cuesta, Javier ^{[1
]}

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

del Blanco, Bruno Garcia ^{[4
]}

Bosa, Francisco ^{[5
]}

de Prado, Armando Perez ^{[6
]}

Rumoroso, Jose Ramon ^{[7
,11
]}

Romaguera, Rafael ^{[8
]}

Gutierrez, Hipolito ^{[9
]}

Touchard, Arturo Garcia ^{[10
]}

Lopez-Minguez, Jose Ramon ^{[9
]}

Trillo, Ramiro ^{[12
]}

Hernandez, Jose Maria de la Torre ^{[13
]}

Moreno, Raul ^{[14
]}

Velazquez, Maite ^{[15
]}

Moris, Cesar ^{[16
]}

Kockar, Marcelo Jimenez ^{[17
]}

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

Bastante, Teresa ^{[1
]}

del Val, David ^{[1
]}

Rivero, Fernando ^{[1
]}

Alfonso, Fernando ^{[1
]}

机构：

[1] Hosp Univ La Princesa, Madrid, Spain

[2] Fdn Interhosp Invest Cardiovasc, Madrid, Spain

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

[4] Hosp Univ Vall dHebron, Barcelona, Spain

[5] Hosp Univ Canarias, Santa Cruz De Tenerife, Spain

[6] Hosp Univ Leon, Leon, Spain

[7] Hosp Galdakao, Vizcaya, Spain

[8] Hosp Univ Bellvitge, Barcelona, Spain

[9] Hosp Univ Valladolid, Valladolid, Spain

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

[11] Hosp Univ Infanta Cristina, Badajoz, Spain

[12] Hosp Clin Univ Santiago, Santiago De Compostela, Spain

[13] Hosp Univ Marques Valdecilla, Santander, Spain

[14] Hosp Univ La Paz, Madrid, Spain

[15] Hosp Univ 12 Octubre, Madrid, Spain

[16] Hosp Univ Cent Asturias, Oviedo, Spain

[17] Hosp Santa Creu & Sant Pau, Barcelona, Spain

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2024年 / 17卷 / 15期

关键词：

bioresorbable vascular scaffold; drug-eluting balloons; drug-eluting stent(s); in-stent restenosis; ELUTING STENT; IMPLANTATION; OUTCOMES; BALLOON;

D O I：

10.1016/j.jcin.2024.05.038

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND In patients with in-stent restenosis (ISR) bioresorbable vascular scaffolds (BVS) provide similar results to drug-coated balloons (DCBs) but are inferior to drug-eluting stents (DES) at 1 year. However, the long-term efficacy of BVS in these patients remains unknown. OBJECTIVES This study sought to assess the long-term safety and efficacy of BVS in patients with ISR. METHODS RIBS VI (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment; NCT02672878) and RIBS VI Scoring (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon; NTC03069066) are prospective multicenter studies designed to evaluate the results of BVS in patients with ISR (N = 220). The inclusion and exclusion criteria were identical to those used in the RIBS IV (ISR of DES) (Restenosis Intra-stent of Drug-eluting Stents: Drug-eluting Balloon vs Everolimus-eluting Stent; NCT01239940) and RIBS V (ISR of bare-metal stents) (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent; NCT01239953) randomized trials (including 249 ISR patients treated with DCBs and 249 ISR patients treated with DES). A prespecified comparison of the long-term results obtained with these treatment modalities (ie, DES, DCBs, and BVS) was performed. RESULTS Clinical follow-up at 3 years was obtained in all (100%) 718 patients. The 3-year target lesion revascularization rate after BVS was 14.1% (vs 12.9% after DCBs [not significant], and 5.2% after DES [HR: 2.80; 95% CI: 1.47-5.36; P = 0.001]). In a landmark analysis (>1 year), the target lesion revascularization rate after BVS was higher than after DES (adjusted HR: 3.41; 95% CI: 1.15-10.08) and DCBs (adjusted HR: 3.33; 95% CI: 1.14-9.70). Very late vessel thrombosis was also more frequent with BVS (BVS: 1.8%, DCBs: 0.4%, DES: 0%; P = 0.03). CONCLUSIONS In patients with ISR, late clinical results of DES are superior to those obtained with DCBs and BVS. Beyond the first year, DCBs are safer and more effective than BVS. (c) 2024 by the American College of Cardiology Foundation.

引用

页码：1825 / 1836

页数：12

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