Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Thromb Res. 2023 Jul;227:1-7. doi: 10.1016/j.thromres.2023.05.006. Epub 2023 May 11.
Despite widely available risk stratification tools, safe and effective anticoagulants, and guideline recommendations, anticoagulation for stroke prevention in atrial fibrillation (AF) is under-prescribed in ambulatory patients. To assess the impact of alert-based computerized decision support (CDS) on anticoagulation prescription in ambulatory patients with AF and high-risk for stroke, we conducted this randomized controlled trial.
Patients with AF and CHADSVASc score ≥ 2 who were not prescribed anticoagulation and had a clinic visit at Brigham and Women's Hospital were enrolled. Patients were randomly allocated, according to Attending Physician of record, to intervention (alert-based CDS) versus control (no notification). The primary efficacy outcome was the frequency of anticoagulant prescription.
The CDS tool assigned 395 and 403 patients to the alert and control groups, respectively. Alert patients were more likely to be prescribed anticoagulation within 48 h of the clinic visit (15.4 % vs. 7.7 %, p < 0.001) and at 90 days (17.2 % vs. 9.9 %, p < 0.01). Direct oral anticoagulants were the predominantly prescribed form of anticoagulation. No significant differences were observed in stroke, TIA, or systemic embolic events (0 % vs. 0.8 %, p = 0.09), symptomatic VTE (0.5 % vs. 1 %, p = 0.43), all-cause mortality (2 % vs. 0.7 %, p = 0.12), or major adverse cardiovascular events (2.8 % vs. 2.5 %, p = 0.79) at 90 days.
An alert-based CDS strategy increased a primary efficacy outcome of anticoagulation in clinic patients with AF and high-risk for stroke who were not receiving anticoagulation at the time of the office visit. The study was likely underpowered to assess an impact on clinical outcomes.
ClinicalTrials.gov Identifier- NCT02958943.
尽管有广泛可用的风险分层工具、安全有效的抗凝药物以及指南建议，但在门诊患者中，心房颤动（AF）的卒中预防抗凝治疗仍未得到充分应用。为评估基于警示的计算机化决策支持（CDS）对 AF 合并高卒中风险但未接受抗凝治疗的门诊患者的抗凝治疗处方的影响，我们开展了这项随机对照试验。
我们招募了在布莱根妇女医院就诊且未接受抗凝治疗、AF 且 CHADSVASc 评分≥2 的患者。根据记录的主治医生，将患者随机分配至干预组（基于警示的 CDS）或对照组（无通知）。主要疗效结局是抗凝药物处方的频率。
CDS 工具将 395 名和 403 名患者分别分配至警示组和对照组。警示组患者在就诊后 48 小时内更有可能开具抗凝药物（15.4%比 7.7%，p<0.001），在 90 天时也更有可能开具抗凝药物（17.2%比 9.9%，p<0.01）。直接口服抗凝药物是主要的抗凝药物类型。在卒中、TIA 或全身性栓塞事件（0%比 0.8%，p=0.09）、有症状的静脉血栓栓塞症（0.5%比 1%，p=0.43）、全因死亡率（2%比 0.7%，p=0.12）或主要不良心血管事件（2.8%比 2.5%，p=0.79）方面，90 天时未观察到显著差异。
基于警示的 CDS 策略增加了一个主要疗效结局，即在未接受抗凝治疗的 AF 合并高卒中风险的门诊患者中，增加了抗凝治疗的可能性。该研究可能因效力不足而无法评估对临床结局的影响。
ClinicalTrials.gov 标识符-NCT02958943。
