Comparison of apixaban versus aspirin for the prevention of latent bioprosthetic aortic valve thrombosis: study protocol for a prospective randomized trial.

BACKGROUND: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagulants or acetylsalicylic acid should be considered for the first 3 months. Hypo-attenuated leaflet thickening on cardiac computed tomography has been associated with latent bioprosthetic valve thrombosis and may be prevented with anticoagulation. We hypothesize that anticoagulation with apixaban is superior to single antiplatelet therapy with acetylsalicylic acid in reducing hypo-attenuated leaflet thickening of bioprosthetic aortic valve prostheses. METHODS: In this prospective, open-label, randomized trial, patients undergoing isolated aortic valve replacement surgery with rapid deployment bioprosthetic valves will be randomized. The treatment group will receive 5 mg of apixaban twice a day for the first 3 months and 100 mg of acetylsalicylic acid thereafter. The control group will be administered 100 mg of acetylsalicylic acid once a day, indefinitely. After the 3-month treatment period, a contrast-enhanced electrocardiogram-gated cardiac computed tomography will be performed to identify hypo-attenuated leaflet thickening of the bioprosthetic valve. The primary objective of the study is to assess the impact of apixaban on the prevention of hypo-attenuated leaflet thickening at 3 months. The secondary and exploratory endpoints will be clinical outcomes and safety profiles of the two strategies. DISCUSSION: Antithrombotic therapy after aortic valve replacement is used to prevent valve thrombosis and systemic thromboembolism. Latent bioprosthetic valve thrombosis is a precursor of clinically significant prosthetic valve dysfunction or thromboembolic events. The hallmark feature of latent bioprosthetic valve thrombosis is hypo-attenuated leaflet thickening on cardiac computed tomography. Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. There is no evidence on the effect of direct oral anticoagulants on the incidence of hypo-attenuated leaflet thickening after surgical aortic valve replacement with rapid deployment bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov NCT06184113. Registered on December 28, 2023.

Efficacy and Safety of High PEEP NIV in COVID-19 Patients.

OBJECTIVE: To investigate the efficacy and safety of non-invasive ventilation (NIV) with high PEEP levels application in patients with COVID-19-related acute respiratory distress syndrome (ARDS). METHODS: This is a retrospective cohort study with data collected from 95 patients who were administered NIV as part of their treatment in the COVID-19 intensive care unit (ICU) at University Hospital Centre Zagreb between October 2021 and February 2022. The definite outcome was NIV failure. RESULTS: High PEEP NIV was applied in all 95 patients; 54 (56.84%) patients could be kept solely on NIV, while 41 (43.16%) patients required intubation. ICU mortality of patients solely on NIV was 3.70%, while total ICU mortality was 35.79%. The most significant difference in the dynamic of respiratory parameters between 2 patient groups was visible on Day 3 of ICU stay: By that day, patients kept solely on NIV required significantly lower PEEP levels and had better improvement in PaO2, P/F ratio, and HACOR score. CONCLUSION: High PEEP applied by NIV was a safe option for the initial respiratory treatment of all patients, despite the severity of ARDS. For some patients, it was also shown to be the only necessary form of oxygen supplementation.