Eichinger S, Pabinger I, Stümpflen A, Hirschl M, Bialonczyk C, Schneider B, Mannhalter C, Minar E, Lechner K, Kyrle P A
Department of Internal Medicine I, University of Vienna, Austria.
Thromb Haemost. 1997 Apr;77(4):624-8.
Thromboprophylaxis with oral anticoagulants up to six months is established in patients after a first venous thromboembolic event (VTE). The risk of recurrent VTE is still considerable thereafter, and it is uncertain whether some patients might benefit from extended anti-coagulation. We performed a prospective, multicenter trial (4 thrombosis centers) and evaluated in 380 patients with a first or recurrent VTE (patients with a deficiency of antithrombin, protein C, protein S or plasminogen; cancer; or an antiphospholipid antibody syndrome were excluded) the risk of recurrence after discontinuation of secondary thromboprophylaxis with oral anticoagulants. It was the aim of the study to evaluate whether patients, with factor V Leiden are at an increased risk of recurrent VTE. 112 (29.5%) patients were carriers of factor V Leiden (26.9% heterozygous, 2.6% homozygous). After a median observation time of 19.3 months the overall recurrence rate of VTE was 9.9%. Recurrent deep vein thrombosis and/or pulmonary embolism occurred in 26 of 268 patients without factor V Leiden (9.7%) and in 10 of 112 patients with factor V Leiden (8.9%). The probability of recurrent VTE two years after discontinuation of oral anticoagulants was 12.4% (95% CI 7.8-17) in patients without factor V Leiden and was 10.6% (95% CI 3.8-17.4) in carriers of the mutation. This difference was statistically not significant. Patients with factor V Leiden are not at a higher risk of recurrent VTE within two years after discontinuation of oral anticoagulants than patients without factor V Leiden. Balancing the risk of recurrent VTE and bleeding from oral anticoagulants, patients with factor V Leiden are not likely to benefit from oral anticoagulant therapy extended beyond six months.
对于首次发生静脉血栓栓塞事件（VTE）后的患者，使用口服抗凝剂进行长达6个月的血栓预防已得到确立。此后，复发性VTE的风险仍然相当高，并且不确定一些患者是否可能从延长抗凝治疗中获益。我们进行了一项前瞻性、多中心试验（4个血栓形成中心），并在380例首次发生或复发性VTE的患者中（排除抗凝血酶、蛋白C、蛋白S或纤溶酶原缺乏症患者；癌症患者；或抗磷脂抗体综合征患者）评估了停用口服抗凝剂进行二级血栓预防后复发的风险。该研究的目的是评估携带因子V莱顿突变的患者复发性VTE风险是否增加。112例（29.5%）患者为因子V莱顿突变携带者（26.9%为杂合子，2.6%为纯合子）。在中位观察时间19.3个月后，VTE的总体复发率为9.9%。在268例非因子V莱顿突变患者中有26例（9.7%）发生复发性深静脉血栓形成和/或肺栓塞，在112例因子V莱顿突变患者中有10例（8.9%）发生。停用口服抗凝剂两年后，非因子V莱顿突变患者复发性VTE的概率为12.4%（95%CI 7.8-17），突变携带者为10.6%（95%CI 3.8-17.4）。这种差异在统计学上不显著。停用口服抗凝剂后两年内，携带因子V莱顿突变的患者复发性VTE的风险并不高于非因子V莱顿突变的患者。权衡复发性VTE的风险和口服抗凝剂引起出血的风险，携带因子V莱顿突变的患者不太可能从超过6个月的口服抗凝治疗中获益。
