急性髂股静脉血栓形成的血管内血栓切除术。
Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis.
机构信息
Inova Heart and Vascular Institute, Inova Alexandria Hospital, VA (A.J.C.).
Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.
出版信息
Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.
BACKGROUND
The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis.
METHODS
Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes.
RESULTS
Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21).
CONCLUSIONS
In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.
背景
先前的 ATTRACT 试验（急性静脉血栓形成：血栓切除术联合导管直接溶栓）报告称，在急性近端深静脉血栓形成患者中，药物机械性导管溶栓（PCDT）并不能预防血栓后综合征（PTS）。在当前的分析中，我们检查了 PCDT 在 ATTRACT 患者中的髂股深静脉血栓形成中的作用。
方法
在一项大型多中心随机试验中，391 名患有涉及髂或股总静脉的急性深静脉血栓形成的患者被随机分配至接受 PCDT 联合抗凝治疗或单独抗凝治疗（无 PCDT），并随访 24 个月，以比较短期和长期结局。
结果
在 6 至 24 个月期间，PTS 的发生没有差异（Villalta 量表≥5 或溃疡：PCDT 组为 49%，无 PCDT 组为 51%；风险比，0.95；95%CI，0.78-1.15；P=0.59）。PCDT 导致 PTS 严重程度降低，表现为平均 Villalta 和静脉临床严重程度评分降低（在 6、12、18 和 24 个月时比较，P<0.01），以及更少的中度或重度 PTS 患者（Villalta 量表≥10 或溃疡：18% 对 28%；风险比，0.65；95%CI，0.45-0.94；P=0.021）或重度 PTS 患者（Villalta 量表≥15 或溃疡：8.7%对 15%；风险比，0.57；95%CI，0.32-1.01；P=0.048；和静脉临床严重程度评分≥8：6.6%对 14%；风险比，0.46；95%CI，0.24-0.87；P=0.013）。从基线开始，PCDT 导致腿部疼痛和肿胀的减轻更大（在第 10 天和第 30 天比较时，P<0.01），静脉疾病特异性生活质量的改善更大（静脉功能不全流行病学和经济研究质量生活单位差异通过 24 个月为 5.6，P=0.029），但一般生活质量无差异（SF-36 精神和身体成分综合评分在 24 个月内比较，P>0.2）。在接受 PCDT 与无 PCDT 的患者中，10 天内主要出血发生率分别为 1.5%和 0.5%（P=0.32），24 个月内复发性静脉血栓栓塞的发生率分别为 13%和 9.2%（P=0.21）。
结论
在急性髂股深静脉血栓形成患者中，PCDT 并不影响 PTS 的发生或复发性静脉血栓栓塞。然而，PCDT 显著减轻了早期腿部症状，并在 24 个月时降低了 PTS 严重程度评分，减少了发生中度或重度 PTS 的患者比例，并使静脉疾病特异性生活质量得到了更大的改善。
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