Hospital Universitario de La Princesa, Madrid, Spain.
Fundación Interhospitalaria Investigación Cardiovascular and Hospital Universitario Clínico San Carlos, Madrid, Spain.
JACC Cardiovasc Interv. 2024 Aug 12;17(15):1825-1836. doi: 10.1016/j.jcin.2024.05.038.
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.
This study sought to assess the long-term safety and efficacy of BVS in patients with ISR.
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.
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).
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.
在支架内再狭窄（ISR）患者中，生物可吸收血管支架（BVS）的效果与药物涂层球囊（DCB）相似，但在 1 年时逊于药物洗脱支架（DES）。然而，这些患者中 BVS 的长期疗效仍不清楚。
本研究旨在评估 ISR 患者中 BVS 的长期安全性和疗效。
RIBS VI（再狭窄支架内：生物可吸收血管支架治疗；NCT02672878）和 RIBS VI 评分（再狭窄支架内：生物可吸收血管支架治疗评分球囊；NTC03069066）是两项前瞻性多中心研究，旨在评估 BVS 在 ISR 患者中的结果（N=220）。纳入和排除标准与 RIBS IV（DES 的 ISR）（药物洗脱支架的再狭窄支架内：药物洗脱球囊与依维莫司洗脱支架；NCT01239940）和 RIBS V（裸金属支架的 ISR）（裸金属支架的再狭窄支架内：紫杉醇洗脱球囊与依维莫司洗脱支架；NCT01239953）随机试验相同（包括 249 例 ISR 患者接受 DCB 治疗和 249 例 ISR 患者接受 DES 治疗）。对这些治疗方式（即 DES、DCB 和 BVS）的长期结果进行了预设比较。
所有（100%）718 例患者均获得了 3 年临床随访。BVS 治疗后 3 年的靶病变血运重建率为 14.1%（与 DCB 组（无显著差异）12.9%和 DES 组 5.2%相比）[风险比：2.80；95%置信区间：1.47-5.36；P=0.001]。在 1 年以上的里程碑分析中，BVS 治疗后的靶病变血运重建率高于 DES（校正风险比：3.41；95%置信区间：1.15-10.08）和 DCB（校正风险比：3.33；95%置信区间：1.14-9.70）。BVS 组也更常发生晚期血管血栓形成（BVS：1.8%，DCB：0.4%，DES：0%；P=0.03）。
在 ISR 患者中，DES 的晚期临床结果优于 DCB 和 BVS。在第 1 年之后，DCB 比 BVS 更安全且更有效。
