Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2).

BACKGROUND: 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. METHODS: Patients with AF and CHA2DS2-VASc 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier- NCT02958943.

Patients with myeloproliferative neoplasms and COVID-19 have increased rates of arterial thrombosis.

Background: Both coronavirus disease-2019 (COVID-19) and myeloproliferative neoplasms (MPNs) are associated with systemic inflammation and risk of thrombosis. Risk of thrombosis in patients with COVID with and without MPNs has not been extensively studied. Methods: Retrospective cohort study of 44 patients with MPNs and 1114 patients without MPNs positive for SARS-COV-2. Outcomes were arterial thrombosis (AT), venous thromboembolism (VTE), bleeding, and death. Time-to-event analysis was performed using competing risk regression model and Cox proportional hazards. Results: AT occurred more frequently in patients with MPN (7% vs. 1%, p = 0.03). Rates of VTE (7% vs. 5%, p = 0.73), bleeding (7% vs. 2%, p = 0.06), and death (9% vs. 6%, p = 0.32) were similar. MPN patients were older and had more cardiovascular comorbidities. After time-to-event competing-risk regression adjusting for age, MPN patients had higher risk of AT (subdivision hazards ratio 3.95, 95% CI 1.09-14.39) but not VTE, bleeding, or death. Conclusions: Among patients with COVID-19, MPN patients had higher risk of arterial thrombosis but not VTE, bleeding, and death compared with non-MPN patients. Larger studies are needed to confirm our findings given the limited sample size.

Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in Patients with Provoked Venous Thromboembolism and Enduring Risk Factors: Rationale and Design of the HI-PRO Trial.

Patients with acute venous thromboembolism (VTE) in the setting of transient provoking factors are typically treated with short-term anticoagulation. However, the risk of recurrence may be increased in the presence of enduring risk factors. In such patients, the optimal duration of treatment remains uncertain. HI-PRO is a single-center, double-blind randomized trial. Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) following a major provoking factor, including major surgery or major trauma, who completed at least 3 months of standard-dose therapeutic anticoagulation and have at least one enduring risk factor (such as obesity or heart failure) will be considered for inclusion. Patients will be randomized to apixaban 2.5 mg twice daily or placebo for 12 months. The primary efficacy outcome will be symptomatic recurrent VTE-a composite of DVT and/or PE at 12 months after randomization. Secondary efficacy outcomes include a composite of death due to cardiovascular causes, nonfatal myocardial infarction, stroke or systemic embolism, major adverse limb events, or coronary or peripheral ischemia requiring revascularization at 12 months, and individual components of these outcomes. The primary safety outcome is major bleeding according to the International Society on Thrombosis and Haemostasis definition. The study plans to enroll 600 patients (300 per arm) to have 80% power for detecting a 75% relative risk reduction in the primary outcome. Active recruitment began in March 2021. HI-PRO will provide clinically meaningful data on whether patients with provoked VTE and enduring risk factors have fewer adverse clinical outcomes if prescribed low-intensity extended-duration anticoagulation.