医学
危险系数
前瞻性队列研究
肺栓塞
置信区间
深静脉
静脉血栓栓塞
静脉血栓形成
临床终点
血栓形成
比例危险模型
队列
队列研究
析因分析
外科
内科学
临床试验
作者
Paul A. Kyrle,Lisbeth Eischer,Hana Šinkovec,Paul Gressenberger,Gary Tse,Marianne Brodmann,Georg Heinze,Sabine Eichinger
标识
DOI:10.1093/eurheartj/ehad618
摘要
Abstract Background and Aims Patients with unprovoked venous thromboembolism (VTE) have a high recurrence risk, and guidelines suggest extended-phase anticoagulation. Many patients never experience recurrence but are exposed to bleeding. The aim of this study was to assess the performance of the Vienna Prediction Model (VPM) and to evaluate if the VPM accurately identifies these patients. Methods In patients with unprovoked VTE, the VPM was performed 3 weeks after anticoagulation withdrawal. Those with a predicted 1-year recurrence risk of ≤5.5% were prospectively followed. Study endpoint was recurrent VTE over 2 years. Results A total of 818 patients received anticoagulation for a median of 3.9 months. 520 patients (65%) had a predicted annual recurrence risk of ≤5.5%. During a median time of 23.9 months, 52 patients had non-fatal recurrence. The recurrence risk was 5.2% [95% confidence interval (CI) 3.2–7.2] at 1 year and 11.2% (95% CI 8.3–14) at 2 years. Model calibration was adequate after 1 year. The VPM underestimated the recurrence risk of patients with a 2-year recurrence rate of >5%. In a post-hoc analysis, the VPM’s baseline hazard was recalibrated. Bootstrap validation confirmed an ideal ratio of observed and expected recurrence events. The recurrence risk was highest in men with proximal deep-vein thrombosis or pulmonary embolism and lower in women regardless of the site of incident VTE. Conclusions In this prospective evaluation of the performance of the VPM, the 1-year rate of recurrence in patients with unprovoked VTE was 5.2%. Recalibration improved identification of patients at low recurrence risk and stratification into distinct low-risk categories.
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