Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: https://twitter.com/psadeghipour.
Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
JACC Cardiovasc Interv. 2022 Feb 14;15(3):308-317. doi: 10.1016/j.jcin.2021.11.025.
This study sought to compare the safety and efficacy of the balloon-expandable stent (BES) and the self-expandable stent (SES) in the endovascular treatment of coarctation of aorta.
Coarctoplasty with stents has conferred promising results. Although several nonrandomized studies have approved the safety and efficacy of the BES and the SES, no high-quality evidence exists for this comparison.
In the present open-label, parallel-group, blinded endpoint randomized pilot clinical trial, adult patients with de novo native aortic coarctation were randomized into Cheatham-platinum BES and uncovered nitinol SES groups. The primary outcome of the study was a composite of procedural and vascular complications. The secondary outcomes of the study consisted of the incidence of aortic recoarctation, thoracic aortic aneurysm/pseudoaneurysm formation, and residual hypertension at a 12-month follow-up.
Among 105 patients who were screened between January 2017 and December 2019, 92 eligible patients (32 women [34.8%]) with a median age of 30 years (IQR: 20-36 years) were randomized equally into the BES and SES groups. The composite of procedural and vascular complications occurred in 10.9% of the BES group and 2.2% of the SES group (odds ratio: 0.18; 95% CI: 0.02-1.62; P = 0.20). Aortic recoarctation occurred in 5 patients (5.4%), 3 patients (6.5%) in the BES group and 2 patients (4.3%) in the SES group (odds ratio: 0.65; 95% CI: 0.10-4.09; P = 0.64). Only 1 patient (1.1%) was complicated by aortic pseudoaneurysm. Hypertension control was achieved in 50% of the study population, with an equal distribution in the 2 study groups at the 12-month follow-up.
Both the BES and the SES were safe and effective in the treatment of native coarctation.
本研究旨在比较球囊扩张支架（BES）和自膨式支架（SES）在主动脉缩窄血管内治疗中的安全性和疗效。
支架缩窄成形术已取得良好的效果。虽然几项非随机研究已经证实了 BES 和 SES 的安全性和有效性，但目前尚无高质量的证据支持这两种支架的比较。
在本项开放标签、平行组、盲终点随机临床试验中，将初发的成人先天性主动脉缩窄患者随机分为 Cheatham-Platinum BES 组和 uncovered nitinol SES 组。该研究的主要终点为复合程序和血管并发症。该研究的次要终点包括 12 个月随访时主动脉再狭窄、胸主动脉瘤/假性动脉瘤形成和残余高血压的发生率。
在 2017 年 1 月至 2019 年 12 月期间，共筛选了 105 例患者，其中 92 例符合条件的患者（32 例女性[34.8%]）纳入研究，平均年龄为 30 岁（IQR：20-36 岁），两组患者被等分为 BES 组和 SES 组。BES 组和 SES 组的复合程序和血管并发症发生率分别为 10.9%和 2.2%（比值比：0.18；95%CI：0.02-1.62；P=0.20）。5 例患者（5.4%）发生主动脉再狭窄，BES 组 3 例（6.5%），SES 组 2 例（4.3%）（比值比：0.65；95%CI：0.10-4.09；P=0.64）。仅有 1 例患者（1.1%）发生主动脉假性动脉瘤。在研究人群中，50%的患者达到了高血压控制目标，两组在 12 个月的随访时，这一比例相当。
BES 和 SES 治疗先天性主动脉缩窄均安全有效。
