Hospital Universitario de La Princesa, Madrid, Spain.
Hospital Universitario Clínico San Carlos, Madrid, and Fundación Interhospitalaria Investigacion Cardiovascular, Madrid, Spain.
JACC Cardiovasc Interv. 2018 May 28;11(10):981-991. doi: 10.1016/j.jcin.2018.02.037.
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).
Treatment of patients with DES-ISR remains a challenge.
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.
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.
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).
本研究旨在比较药物洗脱球囊（DEB）和依维莫司洗脱支架（EES）治疗药物洗脱支架内再狭窄（ISR）的长期安全性和疗效。
治疗药物洗脱支架内再狭窄（ISR）患者仍然是一个挑战。
RIBS IV（药物洗脱支架内再狭窄：药物洗脱球囊与依维莫司洗脱支架）试验是一项前瞻性多中心随机临床试验，比较了 DEB 和 EES 在药物洗脱支架内再狭窄（ISR）患者中的应用。本研究的主要目的是预先设定比较这两种干预措施 3 年临床结果。
共 309 例药物洗脱支架内再狭窄患者被随机分为 DEB 组（n=154）或 EES 组（n=155）。血管造影随访时，EES 组的节段内最小管腔直径较大（2.03±0.7mm vs.1.80±0.6mm；p<0.01）。所有入组患者均获得 3 年临床随访（100%）。EES 组的心脏死亡、心肌梗死和靶病变血运重建的联合临床终点显著降低（19[12.3%]vs.31[20.1%]；p=0.04；风险比：0.57[95%置信区间：0.34 至 0.96]），这主要是由于靶病变血运重建的需求降低（11[7.1%]vs.24[15.6%]；p=0.015；风险比：0.43[95%置信区间：0.21 至 0.87]）。两组之间“晚期”（>1 年）靶病变血运重建（2.6%vs.4%）和靶血管血运重建（4%vs.6.6%）的需求相似。两组 3 年时的心脏死亡（3.9%vs.3.2%）、心肌梗死（2.6%vs.4.5%）和支架血栓形成（1.3%vs.2.6%）发生率也相似。
这项随机临床试验的 3 年临床随访结果表明，在药物洗脱支架内再狭窄患者中，EES 较 DEB 降低了再次介入的需求。（药物洗脱支架内再狭窄：药物洗脱球囊与依维莫司洗脱支架 [RIBS IV]；NCT01239940）。
