Aschwanden Markus, Jeanneret Christina, Koller Michael T, Thalhammer Christoph, Bucher Heiner C, Jaeger Kurt A
Department of Angiology, University Hospital Basel, Basel, Switzerland.
J Vasc Surg. 2008 May;47(5):1015-21. doi: 10.1016/j.jvs.2008.01.008. Epub 2008 Apr 18.
Compression stockings are widely applied after acute proximal deep vein thrombosis, but their efficacy in preventing the post-thrombotic syndrome remains controversial. This study assessed the effect of prolonged compression therapy after a standard treatment of 6 months after acute deep vein thrombosis.
Of 900 patients screened, we randomly allocated 169 patients with a first or recurrent proximal deep vein thrombosis after receiving 6 months of standard treatment to wear compression stockings or not. Primary efficacy analysis was performed on the end point of emerging skin changes (C4-C6 according to the CEAP classification). Secondary analysis was done on symptoms associated with post-thrombotic syndrome. All analyses were done according to the intention-to-treat principle.
The primary end point occurred in 11 patients (13.1%) in the treatment group compared with 17 (20.0%) in the control group (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.28-1.28; P = .19). Mean follow-up was 3.2 years and 2.9 years, respectively. Five additional patients in the control group required compression therapy owing to post-thrombotic signs and symptoms not included in the primary end point. No venous ulceration was observed in either group. Within subgroup analyses of the primary end point, we observed a large sex-specific difference between women (HR, 0.11; 95% CI, 0.02-0.91) and men (HR, 1.07; 95% CI, 0.42-2.73). Symptom relief was significant in favor of compression treatment during the first year but not thereafter.
Prolonged compression therapy after proximal deep vein thrombosis significantly reduces symptoms and may prevent post-thrombotic skin changes. Whether these findings translate to the prevention of advanced disease states with ulcerations remains unclear.
压力袜在急性近端深静脉血栓形成后被广泛应用，但其预防血栓形成后综合征的疗效仍存在争议。本研究评估了急性深静脉血栓形成6个月标准治疗后延长压迫治疗的效果。
在900例筛查患者中，我们将169例接受6个月标准治疗后首次或复发性近端深静脉血栓形成的患者随机分为是否穿压力袜两组。对出现皮肤变化（根据CEAP分类为C4 - C6）这一终点进行主要疗效分析。对与血栓形成后综合征相关的症状进行次要分析。所有分析均按照意向性分析原则进行。
治疗组11例患者（13.1%）出现主要终点事件，而对照组为17例（20.0%）（风险比[HR]，0.60；95%置信区间[CI]，0.28 - 1.28；P = 0.19）。平均随访时间分别为3.2年和2.9年。对照组另外有5例患者因主要终点未包含的血栓形成后体征和症状而需要压迫治疗。两组均未观察到静脉溃疡。在主要终点的亚组分析中，我们观察到女性（HR，0.11；95% CI，0.02 - 0.91）和男性（HR，1.07；95% CI，0.42 - 2.73）之间存在很大的性别差异。在第一年，压迫治疗在症状缓解方面有显著优势，但之后则不然。
近端深静脉血栓形成后延长压迫治疗可显著减轻症状，并可能预防血栓形成后皮肤变化。这些发现是否能转化为预防伴有溃疡的晚期疾病状态尚不清楚。
