目的:使用经皮腔内血管成形术(PTA)和/或支架置入治疗血液透析依赖患者胸中央静脉阻塞(TCVO)后的安全性和有效性结果,以建立客观性能目标(OPG)。
方法:对发表于01/01/2000-08/31/2021的文章进行了系统的文献综述和荟萃分析。疗效结果包括6个月和12个月的主要通畅率;安全性结果包括分类为通路丧失的不良事件(AE),手术相关不良事件(PAEs),和严重不良事件(SAE)。OPG来自主要通畅率和SAE率的95%置信区间的上限和下限。
结果:在评论的66篇文章中,17符合纳入标准(PTA:n=4,支架放置:n=5,PTA/支架:n=8)。PTA的6个月和12个月的主要通畅率分别为50.9%和36.7%,分别。基于这些发现,建议的6个月和12个月的主要通畅性OPGs相对于PTA的优势分别为66.5%和52.6%,分别为非劣效性39.0%和25.7%,分别。对于支架放置,6个月和12个月的原发性通畅率分别为69.7%和47.9%,分别;建议的6个月和12个月的原发性通畅性OPG识别优势分别为82.1%和64.1%,分别为59.3%和35.8%,分别。PTA和支架置入的SAE率分别为3.8%和8.1%,分别。对于PTA和支架放置的非劣效性与优越性的建议安全性OPG为10.1%与1.4%和13.6%与4.8%,分别。
结论:来自PTA和支架放置的真实世界研究的OPGs可以作为未来干预措施的基准。
To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs).
A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates.
Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6- and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively.
The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population.