Haemostasis and Thrombosis Unit, Haematology Department, San Bortolo Hospital, Via Rodolfi 37, 36100, Vicenza, Italy.
Haemostasis and Thrombosis Centre, Cremona Hospital, 26100, Cremona, Italy.
Intern Emerg Med. 2019 Nov;14(8):1307-1315. doi: 10.1007/s11739-019-02148-7. Epub 2019 Jul 15.
The primary study objective is to compare the outcomes of patients taking oral anticoagulant medications in two distinct populations treated according to different management models (comprehensive vs. usual care). (Design: regional prospective cohort study; setting: hospital admission data from two regions). Eligible partecipants were patients taking oral anticoagulant drugs (vitamin K antagonist or direct oral anticoagulants), residents in the Vicenza and Cremona districts from February 1st, 2016 to June 30th, 2017. Patients were identified by accessing the administrative databases of patient drug prescriptions. The primary study outcome was admission to the Emergency Department for stroke, systemic arterial embolism, recurrence of venous thromboembolism or major bleeding. The study evaluated outcomes in 14,226 patients taking oral anticoagulants, of whom 6725 being followed in Cremona with a comprehensive management model. There were 19 and 45 thromboembolic events over 6205 and 6530 patient-years in the Cremona and Vicenza cohort, respectively (IRR 0.44, 95% CI 0.24-0.77). The reduction of events in the Cremona cohort was almost entirely explained by a decrease of events in patients taking VKA (IRR 0.41, 95% CI 0.20-0.78) but not DOACs (IRR 1.08, 95% CI 0.25-5.24). The rate of major bleeding was non-significantly higher in Cremona than in Vicenza (IRI 1.32; 95% CI 0.74-2.40). Across the two cohorts, the risk of bleeding was lower in patients being treated with DOACs rather than warfarin (10/4574 vs. 42/8161 event/person-years, respectively, IRR 0.42 95% CI 0.19-0.86). We conclude that a comprehensive management model providing centralized dose prescription and follow-up may significantly reduce the rate of thromboembolic complications, without substantially increasing the number of bleeding complications. Patients treated with direct oral anticoagulants appear to have a rate of thromboembolic complications comparable to VKA patients under the best management model, with a reduction of major bleeding.
主要研究目的是比较两种不同管理模式（综合管理与常规护理）下接受抗凝药物治疗的患者的结局。（设计：区域性前瞻性队列研究；地点：来自两个地区的医院入院数据）。合格参与者为服用口服抗凝药物（维生素 K 拮抗剂或直接口服抗凝剂）的患者，2016 年 2 月 1 日至 2017 年 6 月 30 日居住在维琴察和克雷莫纳地区。通过访问患者药物处方的行政数据库来确定患者。主要研究结果是因中风、系统性动脉栓塞、静脉血栓栓塞复发或大出血而入住急诊部。该研究评估了 14226 名服用口服抗凝剂的患者的结局，其中 6725 名在克雷莫纳接受综合管理模式治疗。在克雷莫纳和维琴察队列中，分别有 19 例和 45 例血栓栓塞事件，发生在 6205 例和 6530 例患者年中（IRR 0.44，95%CI 0.24-0.77）。克雷莫纳队列中事件的减少几乎完全归因于接受 VKA 治疗的患者中事件的减少（IRR 0.41，95%CI 0.20-0.78），但 DOACs 患者中无此情况（IRR 1.08，95%CI 0.25-5.24）。克雷莫纳的大出血发生率显著高于维琴察（IRI 1.32；95%CI 0.74-2.40）。在两个队列中，与华法林相比，使用 DOAC 治疗的患者出血风险较低（分别为每 4574 例患者中有 10 例和每 8161 例患者中有 42 例事件/人年，IRR 0.42，95%CI 0.19-0.86）。我们得出结论，提供集中剂量处方和随访的综合管理模式可能会显著降低血栓栓塞并发症的发生率，而不会明显增加出血并发症的数量。在最佳管理模式下，直接口服抗凝剂治疗的患者血栓栓塞并发症的发生率与 VKA 患者相当，大出血的发生率降低。
