Health Technology Assessment Agency (Agencia de Evaluación de Tecnologías Sanitarias/AETS), Carlos III Institute of Health, Madrid, Spain.
Health Technology Assessment Agency (Agencia de Evaluación de Tecnologías Sanitarias/AETS), Carlos III Institute of Health, Madrid, Spain.
J Vasc Surg Venous Lymphat Disord. 2020 Mar;8(2):287-296. doi: 10.1016/j.jvsv.2019.09.010. Epub 2020 Jan 6.
The objective of this study was to assess the effectiveness, safety, and quality of care afforded by cyanoacrylate ablation (CA) vs existing options in treating great saphenous vein incompetence.
We conducted a systematic review; used the Grading of Recommendations Assessment, Development, and Evaluation framework; assessed the quality of randomized clinical trials using the Cochrane risk of bias tool; and performed a meta-analysis on the available comparative measurements.
Three comparative studies, two randomized controlled trials and one observational study comprising 1057 participants, were included for effectiveness assessment purposes. The safety assessment also included 10 case series. Available evidence allowed comparison of CA with radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) but not with other treatments. The comparative effectiveness analysis showed that whereas all three treatments reduced disease severity, none was significantly better than any other in terms of effectiveness. In terms of safety, however, CA devices gave rise to fewer adverse events and less severity at 12 months of follow-up than did EVLA or RFA. Other important advantages of CA over EVLA or RFA were linked to quality of care; patients reported less pain during intervention with CA than with RFA or EVLA devices and registered shorter intervention and recovery times. Furthermore, tumescent anesthesia and compression bandages were not necessary, making this technique more comfortable for the patients than endothermal techniques.
Compared with EVLA and RFA, CA treatments yield comparable effectiveness outcomes and lead to less frequent and fewer mild adverse events, without difference in major adverse events. Furthermore, CA devices have advantages in terms of quality of care indicators, such as pain during intervention, treatment and recovery times, lower use of anesthesia, and zero use of compression bandages after treatment.
本研究旨在评估氰基丙烯酸酯消融(CA)与现有治疗大隐静脉功能不全方法相比的疗效、安全性和护理质量。
我们进行了系统评价;使用推荐评估、制定和评估分级框架;使用 Cochrane 偏倚风险工具评估随机临床试验的质量;并对可用的对照测量进行了荟萃分析。
纳入了三项比较研究,其中两项为随机对照试验,一项为观察性研究,共 1057 名参与者,用于评估疗效。安全性评估还包括 10 个病例系列。现有证据允许将 CA 与射频消融(RFA)和静脉内激光消融(EVLA)进行比较,但不能与其他治疗方法进行比较。比较有效性分析表明,虽然所有三种治疗方法均降低了疾病严重程度,但在疗效方面,没有一种方法明显优于其他方法。然而,就安全性而言,CA 设备在 12 个月随访时引起的不良事件和严重程度比 EVLA 或 RFA 少。CA 相对于 EVLA 或 RFA 的其他重要优势与护理质量有关;与 RFA 或 EVLA 设备相比,患者在介入过程中报告的疼痛较少,并且干预和恢复时间较短。此外,不需要肿胀麻醉和压缩绷带,使这种技术比内生技术更舒适。
与 EVLA 和 RFA 相比,CA 治疗的疗效结果相当,导致不良事件发生频率较低且程度较轻,重大不良事件无差异。此外,CA 设备在护理质量指标方面具有优势,如介入期间的疼痛、治疗和恢复时间、麻醉使用率降低以及治疗后无需使用压缩绷带。