Palareti Gualtiero, Cosmi Benilde, Legnani Cristina, Tosetto Alberto, Brusi Carlotta, Iorio Alfonso, Pengo Vittorio, Ghirarduzzi Angelo, Pattacini Corrado, Testa Sophie, Lensing Anthonie W A, Tripodi Armando
Department of Angiology and Blood Coagulation, S. Orsola-Malpighi University Hospital, Bologna, Italy.
N Engl J Med. 2006 Oct 26;355(17):1780-9. doi: 10.1056/NEJMoa054444.
The optimal duration of oral anticoagulation in patients with idiopathic venous thromboembolism is uncertain. Testing of D-dimer levels may play a role in the assessment of the need for prolonged anticoagulation.
We performed D-dimer testing 1 month after the discontinuation of anticoagulation in patients with a first unprovoked proximal deep-vein thrombosis or pulmonary embolism who had received a vitamin K antagonist for at least 3 months. Patients with a normal D-dimer level did not resume anticoagulation, whereas those with an abnormal D-dimer level were randomly assigned either to resume or to discontinue treatment. The study outcome was the composite of recurrent venous thromboembolism and major bleeding during an average follow-up of 1.4 years.
The D-dimer assay was abnormal in 223 of 608 patients (36.7%). A total of 18 events occurred among the 120 patients who stopped anticoagulation (15.0%), as compared with 3 events among the 103 patients who resumed anticoagulation (2.9%), for an adjusted hazard ratio of 4.26 (95% confidence interval [CI], 1.23 to 14.6; P=0.02). Thromboembolism recurred in 24 of 385 patients with a normal D-dimer level (6.2%). Among patients who stopped anticoagulation, the adjusted hazard ratio for recurrent thromboembolism among those with an abnormal D-dimer level, as compared with those with a normal D-dimer level, was 2.27 (95% CI, 1.15 to 4.46; P=0.02).
Patients with an abnormal D-dimer level 1 month after the discontinuation of anticoagulation have a significant incidence of recurrent venous thromboembolism, which is reduced by the resumption of anticoagulation. The optimal course of anticoagulation in patients with a normal D-dimer level has not been clearly established. (ClinicalTrials.gov number, NCT00264277 [ClinicalTrials.gov].).
特发性静脉血栓栓塞症患者口服抗凝治疗的最佳时长尚不确定。D - 二聚体水平检测可能有助于评估是否需要延长抗凝治疗时间。
我们对首次发生无诱因近端深静脉血栓形成或肺栓塞且接受维生素K拮抗剂治疗至少3个月的患者，在停用抗凝药物1个月后进行D - 二聚体检测。D - 二聚体水平正常的患者不再恢复抗凝治疗，而D - 二聚体水平异常的患者则被随机分配继续或停止治疗。研究结局为平均随访1.4年期间复发性静脉血栓栓塞症和大出血的复合情况。
608例患者中223例（36.7%）D - 二聚体检测异常。在停止抗凝治疗的120例患者中，共发生18起事件（15.0%），而在恢复抗凝治疗的103例患者中发生3起事件（2.9%），校正风险比为4.26（95%置信区间[CI]，1.23至14.6；P = 0.02）。D - 二聚体水平正常的385例患者中有24例（6.2%）出现血栓栓塞复发。在停止抗凝治疗的患者中，D - 二聚体水平异常者与D - 二聚体水平正常者相比，复发性血栓栓塞的校正风险比为2.27（95%CI，1.15至4.46；P = 0.02）。
抗凝治疗停药1个月后D - 二聚体水平异常的患者复发性静脉血栓栓塞症发生率显著，恢复抗凝治疗可降低该发生率。D - 二聚体水平正常的患者最佳抗凝疗程尚未明确确立。（临床试验注册号，NCT00264277 [ClinicalTrials.gov]。）
