Eichinger Sabine, Weltermann Ansgar, Mannhalter Christine, Minar Erich, Bialonczyk Christine, Hirschl Mirko, Schönauer Verena, Lechner Klaus, Kyrle Paul A
Department of Internal Medicine I, Division of Hematology and Hemostasis, University of Vienna, Waehringer Guertel 18-20, 1090 Wien, Austria.
Arch Intern Med. 2002 Nov 11;162(20):2357-60. doi: 10.1001/archinte.162.20.2357.
Factor V (FV) Leiden is a risk factor for venous thrombosis (VT). Data on its influence on the risk of recurrent venous thromboembolism (VTE) are controversial owing to different study designs and patient cohorts.
We reevaluated the risk of recurrence among heterozygous carriers and noncarriers of FV Leiden with a first spontaneous proximal VT of the leg and/or pulmonary embolism. Patients with secondary VTE, homozygous FV Leiden, natural inhibitor deficiencies, lupus anticoagulant, cancer, or long-term anticoagulation were excluded. The study end point was objectively documented, symptomatic, recurrent VTE.
After discontinuation of oral anticoagulant therapy for a first VTE, we prospectively observed 287 patients, 83 (29%) of whom were heterozygous for FV Leiden. Recurrent VTE was seen in 17 (20%) of 83 patients with and 44 (21.6%) of 204 without FV Leiden. The probability of recurrence among heterozygotes was 12% (95% confidence interval [CI], 8%-16%), 27% (95% CI, 21%-33%), and 27% (95% CI, 21%-33%) after 2, 4, and 6 years, respectively, and was not higher than that among patients without the mutation (16%, 23%, and 34%, respectively). The relative risk of recurrence in heterozygotes was 0.9 (95% CI, 0.5-1.6; P =.60) after adjustment for confounding variables. The risk of recurrence among patients with and without FV Leiden was not different when sex distribution or duration of anticoagulation therapy was taken into account.
The risk of recurrence is similar among carriers and noncarriers of FV Leiden. Heterozygous patients should receive secondary thromboprophylaxis for a similar length of time as patients without FV Leiden.
凝血因子V（FV）莱顿突变是静脉血栓形成（VT）的一个危险因素。由于研究设计和患者队列不同，关于其对复发性静脉血栓栓塞症（VTE）风险影响的数据存在争议。
我们重新评估了患有首次自发性下肢近端VT和/或肺栓塞的FV莱顿杂合子携带者和非携带者的复发风险。排除继发性VTE、纯合子FV莱顿突变、天然抑制剂缺乏、狼疮抗凝物、癌症或长期抗凝治疗的患者。研究终点为客观记录的、有症状的复发性VTE。
在首次VTE的口服抗凝治疗停药后，我们前瞻性观察了287例患者，其中83例（29%）为FV莱顿杂合子。83例FV莱顿突变患者中有17例（20%）发生复发性VTE，204例无FV莱顿突变患者中有44例（21.6%）发生复发性VTE。杂合子在2年、4年和6年后的复发概率分别为12%（95%置信区间[CI]，8%-16%）、27%（95%CI，21%-33%）和27%（95%CI，21%-33%），且不高于无该突变患者（分别为16%、23%和34%）。校正混杂变量后，杂合子复发的相对风险为0.9（95%CI，0.5-1.6；P = 0.60）。考虑性别分布或抗凝治疗持续时间时，有和无FV莱顿突变患者的复发风险无差异。
FV莱顿突变携带者和非携带者的复发风险相似。杂合子患者应接受与无FV莱顿突变患者相似时长的二级血栓预防。
