Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London, UK.
Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London, UK.
J Vasc Surg Venous Lymphat Disord. 2023 Jul;11(4):866-875.e1. doi: 10.1016/j.jvsv.2023.03.017. Epub 2023 Apr 7.
Post-thrombotic syndrome (PTS) is a common complication of deep vein thrombosis (DVT) that can result in significant morbidity for the patient with detrimental impact on their quality of life. Evidence supporting lytic catheter-based interventions (LCBI) undertaken for early thrombus reduction in acute proximal DVT for the prevention of PTS is conflicting. Despite this, rates of LCBIs are increasing. To summaries the existing evidence and pool treatment effects, a meta-analysis of randomized controlled trials assessing the efficacy of LCBIs in proximal acute DVT for the prevention of PTS was undertaken.
This meta-analysis was undertaken aligning with PRISMA guidelines following a protocol pre-registered on PROSPERO. Online searches of Medline and Embase databases, as well as the gray literature, were performed up to December 2022. Included articles were randomized controlled trials that studied the use of LCBIs with additional anticoagulation vs anticoagulation alone and had determined follow-up periods. Outcomes of interest were PTS development, moderate to severe PTS, major bleeding episodes, and quality-of-life measures. Subgroup analyses were performed for DVTs involving the iliac vein and/r common femoral vein. Meta-analysis was performed using a fixed effects model. Quality assessment was performed using the Cochrane Risk of Bias and GRADE assessment tools.
Three trials were included in the final meta-analysis, the Post-thrombotic Syndrome after Catheter-directed Thrombolysis for Deep Vein Thrombosis (CaVenT), Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT), and Ultrasound-accelerated Catheter-directed Thrombolysis Versus Anticoagulation for the Prevention of Post-thrombotic Syndrome (CAVA) trials, comprising 987 patients. Patients undergoing LCBIs had a reduced risk of PTS (relative risk [RR], 0.84; 95% confidence interval [CI], 0.74-0.95; P = .006) and a lower risk of developing moderate to severe PTS (RR, 0.75; 95% CI, 0.58-0.97; P = .03). LBCIs increased the risk of having a major bleed (RR, 2.03; 95% CI, 1.08-3.82; P = .03). In the iliofemoral DVT subgroup analysis, there was a trend toward decreasing the risk of developing PTS and moderate to severe PTS (P = .12 and P = .05, respectively). There was no significant difference in quality-of-life score (as measured by the Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms) between the two groups (P = .51).
Pooling of current best evidence suggests that LCBIs in acute proximal DVT decreases the rate of PTS and moderate to severe PTS with a number needed to treat of 12 and 18, respectively. However, this is complicated by a significantly higher rate of major bleeding with a number needed to treat of 37. This evidence supports the use of LCBIs in selected patients, including those who are at low risk of major bleeding.
血栓后综合征(PTS)是深静脉血栓(DVT)的常见并发症,会给患者带来显著的发病率,对其生活质量产生不利影响。支持在急性近端 DVT 中进行基于导管的溶栓(LCBI)以减少早期血栓,从而预防 PTS 的证据存在矛盾。尽管如此,LCBI 的使用率仍在上升。为了总结现有证据并汇总治疗效果,对评估 LCBI 在急性近端 DVT 中预防 PTS 中的疗效的随机对照试验进行了荟萃分析。
本荟萃分析根据 PRISMA 指南进行,遵循预先在 PROSPERO 上注册的方案。对 Medline 和 Embase 数据库以及灰色文献进行了在线搜索,截至 2022 年 12 月。纳入的文章为随机对照试验,研究了使用 LCBI 联合抗凝治疗与单独抗凝治疗在预防 PTS 方面的效果,并确定了随访时间。感兴趣的结局包括 PTS 发展、中重度 PTS、主要出血事件和生活质量测量。进行了涉及髂静脉和/或股总静脉的 DVT 的亚组分析。使用固定效应模型进行荟萃分析。使用 Cochrane 偏倚风险和 GRADE 评估工具进行质量评估。
最终的荟萃分析纳入了三项试验,即导管定向溶栓治疗深静脉血栓后血栓后综合征(CaVenT)、急性静脉血栓形成:血栓切除术联合辅助导管定向溶栓(ATTRACT)和超声加速导管定向溶栓与抗凝预防血栓后综合征(CAVA)试验,共纳入 987 例患者。接受 LCBI 的患者 PTS 风险降低(相对风险 [RR],0.84;95%置信区间 [CI],0.74-0.95;P=.006),中重度 PTS 风险降低(RR,0.75;95%CI,0.58-0.97;P=.03)。LCBI 增加了发生重大出血的风险(RR,2.03;95%CI,1.08-3.82;P=.03)。在髂股静脉 DVT 亚组分析中,PTS 和中重度 PTS 的风险呈下降趋势(P=.12 和 P=.05)。两组之间的生活质量评分(用静脉功能不全流行病学和经济研究 - 生活质量/症状量表测量)没有显著差异(P=.51)。
当前最佳证据的汇总表明,在急性近端 DVT 中进行 LCBI 可降低 PTS 和中重度 PTS 的发生率,分别为 12 和 18,需要治疗的数量分别为 12 和 18。然而,这与主要出血的发生率显著增加有关,需要治疗的数量为 37。这一证据支持在特定患者中使用 LCBI,包括那些大出血风险较低的患者。