Center for Thrombosis and Hemostasis, University Medical Hospital of the Johannes Gutenberg University, Mainz, Germany.
Department of Clinical Medicine, ASO S. Croce e Carle, Cuneo, Italy.
J Thromb Haemost. 2017 Nov;15(11):2176-2183. doi: 10.1111/jth.13840. Epub 2017 Oct 19.
Essentials Late sequelae of isolated superficial vein thrombosis (iSVT) have rarely been investigated. We studied 411 consecutive outpatients with acute iSVT with a median follow-up of three years. Male sex and cancer are risk factors for future deep vein thrombosis or pulmonary embolism. Patients without cancer appear to be at a negligible risk for death.
Background Studies of long-term thromboembolic complications and death following acute isolated superficial vein thrombosis (iSVT) of the lower extremities are scarce. Objectives To investigate the course of iSVT in the setting of an observational multicenter study. Methods We collected longitudinal data of 411 consecutive outpatients with acute, symptomatic, objectively diagnosed iSVT who were previously included in the cross-sectional ICARO study. Four patients followed for < 30 days and 79 with concomitant deep vein thrombosis (DVT) or pulmonary embolism (PE) were excluded from the present analysis. The primary outcome was symptomatic DVT or PE. The safety outcomes were major bleeding and all-cause death. Results The median follow-up time was 1026 days (interquartile range 610-1796). Symptomatic DVT/PE occurred in 52 (12.9%) patients, giving annualized rates of 1.3% (95% confidence interval [CI] 0.3-3.9%) on anticoagulant treatment and 4.4% (95% CI 3.2-5.8%) off anticoagulant treatment. Male sex (adjusted hazard ratio [HR] 2.03 [95% CI 1.16-3.54]) and active solid cancer (adjusted HR 3.14 [95% CI 1.11-8.93]) were associated with future DVT/PE, whereas prior DVT/PE failed to show significance, most likely because of bias resulting from prolonged anticoagulant treatment. Three major bleeding events occurred on treatment, giving an annualized rate of 1.4% (95 CI 0.3-4.0%). Death was recorded in 16 patients (annualized rate: 1.1% [95% CI 0.6-1.7%]), and was attributable to cancer (n = 8), PE (n = 1), cardiovascular events (n = 3), or other causes (n = 4). Conclusions The long-term risk of DVT/PE after anticoagulant discontinuation for acute iSVT is clinically relevant, especially in males and in the presence of active cancer. The risk of death appears to be negligible in patients without cancer.
研究急性下肢孤立性浅静脉血栓形成（iSVT）后长期血栓栓塞并发症和死亡的情况。
我们收集了 411 例急性、有症状、经客观诊断的 iSVT 连续门诊患者的纵向数据，这些患者之前均被纳入了 ICARO 研究的横断面研究。本分析排除了随访时间<30 天的 4 例患者和合并深静脉血栓形成（DVT）或肺栓塞（PE）的 79 例患者。主要结局为有症状的 DVT/PE。安全性结局为大出血和全因死亡。
中位随访时间为 1026 天（四分位距 610-1796）。52 例（12.9%）患者发生有症状的 DVT/PE，抗凝治疗时的年发生率为 1.3%（95%可信区间[CI] 0.3-3.9%），未抗凝治疗时的年发生率为 4.4%（95%CI 3.2-5.8%）。男性（校正后的危险比[HR] 2.03[95%CI 1.16-3.54]）和活动性实体癌（校正 HR 3.14[95%CI 1.11-8.93]）与未来的 DVT/PE 相关，而既往的 DVT/PE 未显示出显著意义，这可能是由于延长抗凝治疗导致的偏倚。治疗期间发生 3 例大出血事件，年发生率为 1.4%（95%CI 0.3-4.0%）。16 例患者死亡（年发生率：1.1%[95%CI 0.6-1.7%]），归因于癌症（n=8）、PE（n=1）、心血管事件（n=3）或其他原因（n=4）。
急性 iSVT 抗凝治疗停止后，DVT/PE 的长期风险具有临床意义，尤其是在男性和存在活动性癌症的患者中。在无癌症的患者中，死亡风险似乎可以忽略不计。
