Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial
Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial
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药物机械导管溶栓治疗急性股腘深静脉血栓形成：一项分层随机试验的分析
DOI：
10.1055/s-0039-1677795
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发表时间：
2019-04-01
影响因子：
6.7
通讯作者：
Vedantham, Suresh
中科院分区：
文献类型：
--
作者：
Kearon, Clive;Gu, Chu-Shu;Vedantham, Suresh
背景与目的急性静脉血栓形成：辅助导管定向溶栓取栓试验报道，药物机械导管定向溶栓(PCDT)不能减少血栓形成后综合征(PTS)的发生，但可减轻中、重度PTS和PTS症状的严重程度。在这项分析中，我们研究了经皮冠状动脉腔内成形术(PCDT)在股静脉深静脉血栓形成(DVT)患者(未累及更多近端静脉)中的作用。患者与方法在CATRACT试验中，300例DVT受累于股静脉但未累及股总静脉或髂总静脉，随机分为两组，分别接受PCDT或单纯抗凝(非PCDT)治疗。结果术后6~24个月，PCDT组与非PCDT组患者PTS评分、一般或疾病生活质量评分均无差异(P>；=5：危险比[RR]=0.97；95%可信区间[CI]，0.75~1.24)；中、重度PTS评分：RR=0.93；95%CI，0.57~1.52。从基线到第10天和第30天，两个治疗组在改善腿部疼痛或肿胀方面没有差异。从基线到10天，发生大出血的患者有3例，没有发生大出血的患者有8例(p=0.032)，有出血的患者有8例，没有发生大出血的患者有2例。在24个月内，16例经皮冠状动脉腔内成形术(PCDT)患者和12例未经皮冠状动脉腔内成形术(PCDT)患者发生了再发静脉血栓(p=0.24)。结论股-窝DVT患者经皮冠状动脉腔内成形术(PCDT)不能改善近期或远期疗效，但会增加出血。因此，不应将经皮冠状动脉腔内成形术(PCDT)作为股-窝DVT的初始治疗。
Background and Objectives The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce post-thrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal deep vein thrombosis (DVT) (without involvement of more proximal veins).Patients and Methods Within the ATTRACT trial, 300 patients had DVT involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (no PCDT). Patients were followed for 24 months.Results From 6 to 24 months, between the PCDT versus no PCDT arms, there was: no difference in any PTS (Villalta scale >= 5: risk ratio [RR] = 0.97; 95% confidence interval [CI], 0.75-1.24); moderate-or-severe PTS (Villalta scale >= 10: RR = 0.93; 95% CI, 0.57-1.52); severity of PTS scores; or general or disease-specific quality of life (p > 0.5 for all comparisons). From baseline to both 10 and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three versus none (p = 0.06) and any bleeding occurred in eight versus two (p = 0.032) PCDT versus no PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDT patients (p = 0.24).Conclusion In patients with femoral-popliteal DVT, PCDT did not improve short- or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT.