Universität Giessen, Giessen, Germany.
EuroIntervention. 2020 Jul 17;16(4):e328-e334. doi: 10.4244/EIJ-D-19-00051.
Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please).
AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups.
In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months.
NCT02151812 (http://clinicaltrials.gov/).
冠状动脉支架内再狭窄的治疗具有挑战性。使用药物涂层球囊（DCB）是一种有前途的技术，可以在不增加另一个金属层的情况下治疗支架内再狭窄。AGENT ISR 随机试验的目的是评估先前治疗过的病变中存在支架内再狭窄的患者，分别接受新型涂层配方的 DCB（Agent）或标准 DCB（SeQuent Please）治疗后的血管造影和临床结果。
AGENT ISR 是一项多中心、随机、开放标签、非劣效性研究，比较了 Agent 和 SeQuent Please DCB。共有 11 个欧洲站点的 125 名（平均年龄约 68 岁，18%为女性）先前治疗过的病变长度<28mm 的支架内再狭窄患者随机分为 Agent 组（n=65）或 SeQuent Please 组（n=60）。在 Agent 组（51 例）中，6 个月时的支架内晚期管腔丢失为 0.397±0.43mm，非劣于 SeQuent Please 组（49 例）的 0.393±0.536mm（51 例），因为两组间差异的双侧 95%置信区间上限小于预设的非劣效性边界 0.20（差异 0.004，95%CI[-0.189，0.196]；p非劣效性=0.046）。在一年时，Agent 组的死亡率为 3.1%，SeQuent Please 组为 1.7%（p>0.99），靶病变血运重建率分别为 7.7%和 10.0%（p=0.89），支架内血栓形成率分别为 0%和 3.3%（p=0.44）。两组的生活质量均有相似的改善。
在这两种 DCB 的头对头比较中，Agent 在 6 个月时支架内晚期管腔丢失方面被证明非劣效于 SeQuent Please。
NCT02151812（http://clinicaltrials.gov/）。
