Hospital Universitario de La Princesa, Madrid, Spain.
Fundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain; Hospital Universitario Clínico San Carlos, Madrid, Spain.
JACC Cardiovasc Interv. 2016 Jun 27;9(12):1246-1255. doi: 10.1016/j.jcin.2016.03.037. Epub 2016 Jun 20.
The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR).
The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown.
The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire.
A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms.
The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953).
本研究旨在比较药物洗脱支架（DES）和药物洗脱球囊（DCB）在裸金属支架内再狭窄（ISR）患者中的长期疗效。
目前治疗方式在 ISR 患者中的相对长期临床疗效尚不清楚。
对 RIBS V（裸金属支架内再狭窄：药物洗脱球囊与依维莫司洗脱支架植入）随机临床试验中纳入的患者进行 3 年临床随访（预设终点）分析。所有患者每年均使用预先设定的结构化问卷进行随访。
共 189 例 ISR 患者接受了 EES（n=94）或 DCB（n=95）治疗。所有患者均获得了 1 年、2 年和 3 年的临床随访（100%）。与 DCB 治疗组相比，EES 治疗组获得了更好的血管造影结果，包括随访时更大的最小管腔直径（主要研究终点；2.36±0.6mm vs. 2.01±0.6mm；p<0.001）。3 年时，DCB 组和 EES 组的心脏死亡（2% vs. 1%）、心肌梗死（4% vs. 5%）和靶血管血运重建（9% vs. 5%）发生率相似。然而，重要的是，EES 组 3 年时靶病变血运重建率显著较低（2% vs. 8%；p=0.04；风险比：0.23；95%置信区间：0.06 至 0.93）。2 组间“晚期”（>1 年）靶血管（3[3.2%] vs. 3[3.2%]；p=0.95）和靶病变（1[1%] vs. 2[2.1%]；p=0.54）血运重建的需求较低且相似。2 组间明确或可能的支架血栓形成（1% vs. 0%）发生率也相似。
RIBS V 临床试验的 3 年临床随访证实了 EES 和 DCB 在治疗 ISR 患者中的安全性和疗效持久。在这种情况下，EES 可降低靶病变血运重建的需求，尤其是在长期随访中。（RIBS V[裸金属支架内再狭窄：紫杉醇洗脱球囊与依维莫司洗脱支架][RIBS V]；NCT01239953）。
