ArticleSAGE open medicine2021
Safety of apixaban in Indian patients undergoing elective total knee replacement or total hip replacement surgery: A multi-center, phase-IV study.
Article in SAGE open medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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5 authors at 4 institutions in 1 country.
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Abstract
backgroundVenous thromboembolism is a significant source of morbidity and mortality following total hip replacement and total knee replacement. Apixaban has been proven to be efficacious without increased risk of bleeding in phase-III trials in patients undergoing total knee replacement and total hip replacement. Due to paucity of data on safety of apixaban in Indian patients, this phase-IV study was conducted to evaluate safety of apixaban in patients undergoing total knee replacement and total hip replacement.
methodsIn this non-comparative phase-IV clinical trial, patients undergoing elective total knee replacement or total hip replacement surgery, or a revision of at least one component of total knee replacement or total hip replacement, were enrolled. The eligible patients were given the approved dosage of apixaban 12 to 24 h after completing the skin wound closure. The primary safety outcome was the composite of the International Society on Thrombosis and Haemostasis-defined major bleeding and clinically relevant non-major bleeding events at the end of the treatment. The secondary efficacy endpoint was the composite of venous thromboembolism/all-cause death at the end of the treatment.
resultsA total of 498 patients received apixaban prophylaxis therapy. Six (1.2%) bleeding adverse events were observed during the treatment period. Only one bleeding event was adjudicated as an International Society on Thrombosis and Haemostasis-defined clinically relevant non-major bleeding event (moderate severity). There were no fatal bleeding events and no deaths following the treatment. One venous thromboembolism event, that is, symptomatic distal left leg DVT, was reported in a total knee replacement patient and was adjudicated during the treatment period.
conclusionApixaban demonstrated a favorable safety profile for venous thromboembolism prevention in Indian patients undergoing total knee replacement or total hip replacement.
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