Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
EuroIntervention. 2020 Apr 17;15(17):1527-1533. doi: 10.4244/EIJ-D-19-00723.
Drug-coated balloons (DCB) may avoid stent-associated long-term complications. This trial compared the clinical outcomes of patients with non-ST-elevation myocardial infarction (NSTEMI) treated with either DCB or stents.
A total of 210 patients with NSTEMI were enrolled in a randomised, controlled, non-inferiority multicentre trial comparing a paclitaxel iopromide-coated DCB with primary stent treatment. The main inclusion criterion was an identifiable culprit lesion without angiographic evidence of large thrombus. The primary endpoint was target lesion failure (TLF; combined clinical endpoint consisting of cardiac or unknown death, reinfarction, and target lesion revascularisation) after nine months. Secondary endpoints included total major adverse cardiovascular events (MACE) and individual clinical endpoints. Mean age was 67±12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. One hundred and four patients were randomised to DCB, 106 to stent treatment. In the stent group, 56% of patients were treated with BMS, 44% with current-generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2±0.7 months, DCB treatment was non-inferior to stent treatment with a TLF rate of 3.8% versus 6.6% (intention-to-treat, p=0.53). There was no significant difference between BMS and current-generation DES. The total MACE rate was 6.7% for DCB versus 14.2% for stent treatment (p=0.11), and 5.9% versus 14.4% in the per protocol analysis (p=0.056), respectively.
In patients with NSTEMI, treatment of coronary de novo lesions with DCB was non-inferior to stenting with BMS or DES. These data warrant further investigation of DCB in this setting, in larger trials with DES as comparator (ClinicalTrials.gov Identifier: NCT01489449).
药物涂层球囊（DCB）可能避免支架相关的长期并发症。本试验比较了非 ST 段抬高型心肌梗死（NSTEMI）患者接受 DCB 或支架治疗的临床结果。
共纳入 210 例 NSTEMI 患者，进行一项随机、对照、非劣效性多中心试验，比较紫杉醇伊普罗胺涂层 DCB 与初次支架治疗。主要纳入标准为存在可识别的罪犯病变，且无大血栓的血管造影证据。主要终点为 9 个月时的靶病变失败（TLF；包括心源性或不明原因死亡、再梗死和靶病变血运重建的复合临床终点）。次要终点包括总主要不良心血管事件（MACE）和单个临床终点。平均年龄为 67±12 岁，67%为男性，62%为多血管病变，31%为糖尿病患者。104 例患者随机分为 DCB 组，106 例患者分为支架治疗组。支架组中，56%的患者接受 BMS 治疗，44%的患者接受新一代 DES 治疗。DCB 组中，85%的患者仅接受 DCB 治疗，15%的患者接受额外的支架植入。在 9.2±0.7 个月的随访期间，DCB 治疗与支架治疗的 TLF 率分别为 3.8%和 6.6%（意向治疗，p=0.53），非劣效。BMS 与新一代 DES 之间无显著差异。DCB 的总 MACE 率为 6.7%，支架治疗组为 14.2%（p=0.11），按方案分析分别为 5.9%和 14.4%（p=0.056）。
在 NSTEMI 患者中，DCB 治疗冠状动脉新发病变与 BMS 或 DES 支架治疗的效果相当。这些数据支持在更大的 DES 对照试验中进一步研究 DCB 在该人群中的应用（ClinicalTrials.gov 标识符：NCT01489449）。
