Department of Cardiology, University of Galway, Galway, Ireland.
Department of Cardiology, University of Galway, Galway, Ireland.
JACC Cardiovasc Interv. 2023 Dec 11;16(23):2884-2896. doi: 10.1016/j.jcin.2023.09.026. Epub 2023 Oct 23.
There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD).
This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB.
This prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain.
Angiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean ± SD angiographic net gains were 0.25 ± 0.40 mm with SCBs vs 0.48 ± 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (P = 0.173), with an absolute difference of -0.23 mm (95% CI: -0.37 to -0.09) secondary to a smaller late loss (0.00 ± 0.32 mm vs 0.32 ± 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22-5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean angiography-derived fractional flow ratio at follow-up was 0.86 ± 0.15 following treatment with SCBs and 0.91 ± 0.09 following PCBs (P = 0.026); a fractional flow ratio ≤0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively.
The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo.
目前尚无比较西罗莫司涂层球囊（SCB [MagicTouch，Concept Medical]）与紫杉醇涂层球囊（PCB [SeQuent Please Neo，B. Braun]）治疗新发小血管病变（SVD）的疗效数据。
本研究旨在比较 PCB 和 SCB 治疗新发 SVD 的 6 个月时定量冠状动脉造影结果。
这是一项前瞻性、多中心、非劣效性试验，将 121 例（129 处 SVD 病变）患者随机分为 SCB 或 PCB 治疗组，采用光学相干断层扫描确定球囊大小。主要终点是 6 个月时血管造影净管腔获得的非劣效性。
109 例（90.1%）患者完成了意向治疗分析的血管造影随访。SCB 组的平均（± SD）血管造影净增益为 0.25 ± 0.40mm，PCB 组为 0.48 ± 0.37mm，SCB 组未能达到 0.30mm 的非劣效性标准（P=0.173），绝对差值为-0.23mm（95%CI：-0.37 至-0.09），这归因于 PCB 组较小的晚期丢失（0.00 ± 0.32mm 比 0.32 ± 0.47mm；P＜0.001）和更频繁的晚期管腔扩张（53.7%比 30.0%；比值比：2.60；95%CI：1.22-5.67；P=0.014）。SCB 和 PCB 治疗后，分别有 32.8%和 12.5%的患者发生二元再狭窄（比值比：3.41；95%CI：1.36-9.44；P=0.012）。SCB 治疗后随访时的平均血管造影衍生的血流分数比为 0.86 ± 0.15，PCB 治疗后为 0.91 ± 0.09（P=0.026）；SCB 和 PCB 治疗后，分别有 13 处和 5 处血管的血流分数比≤0.80。
与 PCB SeQuent Please Neo 相比，SCB MagicTouch 在 6 个月时的血管造影净管腔获得未能显示非劣效性。
