Department of Cardiology, Our Lady's Children's Hospital, Dublin, Ireland.
German Heart Center, Munich, Germany.
Catheter Cardiovasc Interv. 2019 Feb 1;93(2):316-321. doi: 10.1002/ccd.27899. Epub 2018 Nov 4.
The aim of this study was to compare the efficacy and safety of the Occlutech Figulla Flex II Occluder (OFFII) with the Amplatzer Septal Occluder (ASO) in patients > 8kg undergoing transcatheter ASD closure.
Randomized, controlled, multi-center prospective clinical trial with randomization 2:1 in favor of the OFFII. Primary efficacy endpoint was the rate of successful device placement and defect closure without major complications at hospital discharge. All data were assessed through a core laboratory. Interim analysis was performed when 70% of the patients were treated to evaluate for noninferiority. From a total of 176 randomized subjects, interim analysis was performed on the first 158 patients (65.2% female) (107 OFFII/51 ASO) undergoing device closure at a median weight of 42 kg (range 13-125 kg). Seventy-six percent (120 patients) completed 6-month follow-up. Successful device placement (first attempt) was achieved in 99.1% of the OFF group vs 90.2% of the ASO group (P < 0.05). Early efficacy success was achieved in 94.4% of the OFFII group vs 90.2% of the ASO group (P < 0.001). The incidence of major complications was 5.6% for the OFFII group compared to 9.8% for the ASO.
The OFFII device was not inferior to the ASO with less complications and greater efficacy than the ASO.
本研究旨在比较 Occlutech Figulla Flex II Occluder（OFFII）与 Amplatzer 房间隔缺损封堵器（ASO）在 >8kg 行经导管 ASD 封堵术患者中的疗效和安全性。
这是一项随机、对照、多中心前瞻性临床试验，采用 2:1 的随机分组，OFFII 组占优势。主要疗效终点为出院时无主要并发症的器械放置成功率和缺损封堵率。所有数据均通过核心实验室评估。当 70%的患者接受治疗时，进行中期分析以评估非劣效性。在总共 176 名随机患者中，对前 158 名患者（65.2%为女性）（107 名 OFFII/51 名 ASO）进行了中期分析，这些患者在中位数体重为 42kg（范围 13-125kg）时接受了器械封堵。76%（120 名）完成了 6 个月的随访。OFF 组 99.1%的患者（120 名）和 ASO 组 90.2%的患者（P<0.05）首次尝试成功放置器械。OFFII 组早期疗效成功率为 94.4%，ASO 组为 90.2%（P<0.001）。OFFII 组主要并发症发生率为 5.6%，ASO 组为 9.8%。
与 ASO 相比，OFFII 器械的并发症更少，疗效更好，不劣于 ASO。
