目的:消融后深静脉血栓(DVT)是Varithena™polidocanol内静脉微泡沫(PEM)消融后潜在的严重并发症。评估了以下主要结果:(1)辅助阿哌沙班抗凝或(2)机械DVS盐水冲洗是否可以减少SFJ血栓扩展(PASTE)和/或DVT,GSVPEM消融后。
方法:Varithena™1%PEM消融术患者随机分为:1)SFJ压缩,2)加压和DVS盐水冲洗,或3)压缩,DVS盐水冲洗,术后5天口服5mgBID阿哌沙班抗凝。PEM消融后7-10天获得双重成像,并在该时间点比较两组之间的PASTE/DVT发生率(主要终点)。
结果:257例患者的304条肢接受了PEM治疗。103条肢体接受SFJ压缩(C组,33.8%),101接受压迫和深静脉冲洗(D组,32.9%),接受了100次压缩,深齐平,和抗凝(A组,33.2%)。平均超声随访时间为9.7天(所有患者),原发性GSV闭合率为92.4%。SFJPASTE(II-IV)发生率为0.9%,1.0%,和0%(C组,D,A,分别)。DVT发生率为16.7%,14.7%,和1.98%(C组,D,A,卡方,p=0.002)。接受阿哌沙班抗凝治疗的A组患者与C组相比DVT显著降低(1.98%vs16.7%,ChiSquare,p<0.001);同样,与D组相比,A组患者DVT发生率显着降低(14.7%vs.1.98%,卡方p=0.00162),而C组和D组无统计学差异(16.7%vs14.7%,卡方,p=0.60)。
结论:(1)无辅助DVS冲洗,抗凝也不能降低临床相关的SFJPASTE(II-IV)发生率,无论辅助DVS冲洗或抗凝,所有组均保持同样低的水平,范围在0%-1%之间。这显着低于先前的报告(2.3%-4.1%)。(2)DVS冲洗对DVT产生率无影响。单独使用SFJ压迫或DVS冲洗压迫观察PEM诱发的DVT发生率(16.7%和14.7%,分别)显着高于以前的报告(2.5%-9.6%)。这可能与本研究中处理的AK/BKGSV区域的更大程度有关。(3)术后5天5mgBID口服阿哌沙班抗凝能显著降低DVT发生率至1.98%,与非抗凝患者相比(16.7%)。这与EVTA后报告的DVT率(0.7-1.7%)相当。(4)术后阿哌沙班抗凝可能对减少PEM消融术后DVT的发生具有显著的预防作用。
Postablation deep vein thrombosis (DVT) represents a potentially serious complication after Varithena polidocanol endovenous microfoam (PEM) ablation. The following primary outcomes were assessed: whether (1) adjunctive apixaban anticoagulation or (2) mechanical deep venous system (DVS) saline flushing could decrease saphenofemoral junction (SFJ) thrombus extension (postablation superficial thrombus extension [PASTE]) and/or DVT compared with compression alone, after great saphenous vein (GSV) PEM ablation.
Varithena 1% PEM ablation patients were randomized to (1) SFJ compression, (2) compression and DVS saline flushing, or (3) compression, DVS saline flushing, and 5 days of postprocedural 5 mg oral apixaban anticoagulation twice daily. Duplex imaging was obtained 7 to 10 days after PEM ablation and PASTE/DVT incidence (primary end point) was compared between groups at this time point.
We treated 304 limbs in 257 patients with PEM. Overall, 103 limbs received SFJ compression (group C, 33.8%), 101 received compression and deep venous flushing (group D, 32.9%), and 100 received compression, deep flush, and anticoagulation (group A, 33.2%). Mean ultrasound follow-up time was 9.7 days (all patients) with a primary GSV closure rate of 92.4%. SFJ PASTE (II-IV) occurred in 0.9%, 1.0%, and 0% (groups C, D, and A, respectively). DVT occurred in 16.7%, 14.7%, and 1.98% (groups C, D, and A; χ2, P = .002). Patients in group A receiving apixaban anticoagulation had a significant reduction in DVT compared with patients in group C (1.98% vs 16.7%, χ2; P < .001); likewise, patients in group A had a significantly decreased DVT occurrence compared with group D (14.7% vs 1.98%; χ2, P = .00162), whereas patients in groups C and D were not statistically different (16.7% vs 14.7%; χ2, P = .60).
(1) Neither adjunctive DVS flushing nor anticoagulation decreased clinically relevant SFJ PASTE (II-IV) incidence, which remained similarly low across all groups and ranged between 0% and 1%, regardless of adjunctive DVS flushing or anticoagulation. This rate was significantly lower than prior reports (2.3%-4.1%). (2) DVS flushing had no influence on the rate of DVT. Observed PEM-induced DVT incidence using SFJ compression alone or compression with DVS flushing (16.7% and 14.7%, respectively) was significantly higher than prior reports (2.5%-9.6%). This finding may relate to the greater extent of AK/BK GSV territory treated in the present study. (3) Five days of postprocedural oral apixaban anticoagulation, 5 mg given twice daily, significantly decreased DVT occurrence to 1.98%, compared with nonanticoagulated patients (16.7%). This finding is comparable with the DVT rates reported after endovenous thermal ablation (0.7-1.7%). (4) Postprocedural apixaban anticoagulation may have a significant preventive role in decreasing DVT occurrence after PEM ablation.