Complejo Hospitalario de Toledo, Toledo, Spain.
EuroIntervention. 2019 Dec 20;15(12):e1081-e1089. doi: 10.4244/EIJ-D-19-00206.
The durable fluoroacrylate polymer-based sirolimus-eluting stent (Angiolite SES) has shown promising preclinical and clinical results regarding inflammatory vascular reaction and neointimal healing. We aimed to compare performance between the Angiolite SES and an everolimus-eluting stent (EES) in patients with coronary artery disease.
The ANGIOLITE trial, a prospective, randomised, multicentre trial, compared the restenosis parameters of both stents in de novo coronary lesions. The primary endpoint was late lumen loss at six-month angiographic follow-up. In-stent healing was assessed by optical coherence tomography (OCT). The main clinical endpoint was target lesion failure (TLF) evaluated up to 24 months. A total of 223 patients were randomised 1:1 to EES or SES. At six months, in-stent late lumen loss was 0.08 mm (±0.38) for EES vs 0.04 mm (±0.39) for SES (difference=-0.04 mm, 95% CI: -0.15, 0.07, p for non-inferiority=0.002). By OCT, the rate of uncovered to total number of struts score >30% was comparable between the groups whereas neointimal thickness was reduced in the SES arm (9.0% [7.6, 10.6] vs 9.9% [8.5, 11.3], p=0.41; and 86.4 [81.6, 91.2] µm vs 72.1 [68.2, 76.0] µm, p<0.01, respectively). At 24 months, TLF occurred in eight patients (7.6% [3.3, 14.5]) in the EES arm and in seven patients (7.1% [2.9, 14.0]) in the SES arm (p=0.88). The definite/probable stent thrombosis rate was comparable between the groups (1.9% [0.2, 6.7] vs 1.0% [0.0, 5.5] EES vs SES, respectively; p=0.59).
This trial demonstrates similar antirestenotic efficacy at midterm follow-up of the Angiolite SES vs an EES. Clinical endpoints were comparable between the groups at two-year follow-up. Visual summary. Main results of the ANGIOLITE trial.
基于耐用的氟丙烯酸聚合物的西罗莫司洗脱支架（Angiolite SES）在炎症性血管反应和新生内膜愈合方面表现出有前途的临床前和临床结果。我们旨在比较冠状动脉疾病患者中 Angiolite SES 和依维莫司洗脱支架（EES）的性能。
前瞻性、随机、多中心的 ANGIOLITE 试验比较了两种支架在新发冠状动脉病变中的再狭窄参数。主要终点是 6 个月血管造影随访时的晚期管腔丢失。通过光学相干断层扫描（OCT）评估支架内愈合。主要临床终点是 24 个月时评估的靶病变失败（TLF）。总共 223 名患者按 1:1 随机分为 EES 或 SES 组。6 个月时，EES 组的支架内晚期管腔丢失为 0.08 毫米（±0.38），SES 组为 0.04 毫米（±0.39）（差值为-0.04 毫米，95%CI：-0.15，0.07，非劣效性 p 值=0.002）。通过 OCT，两组之间的未覆盖的支架总数比>30%的比例相当，而 SES 臂的新生内膜厚度减少（9.0%[7.6，10.6] vs 9.9%[8.5，11.3]，p=0.41；86.4[81.6，91.2]μm vs 72.1[68.2，76.0]μm，p<0.01）。24 个月时，EES 臂有 8 例（7.6%[3.3，14.5]）和 SES 臂有 7 例（7.1%[2.9，14.0]）发生 TLF（p=0.88）。两组之间的明确/可能的支架血栓形成率相当（1.9%[0.2，6.7] vs 1.0%[0.0，5.5]EES 与 SES，分别；p=0.59）。
本试验表明，Angiolite SES 与 EES 在中期随访时具有相似的抗再狭窄效果。两组在两年随访时的临床终点无差异。直观总结。ANGIOLITE 试验的主要结果。
