ArticleInterdisciplinary cardiovascular and thoracic surgery2025
Major Bleeding and Thromboembolic Events with the On-X Mechanical Aortic Valve Prosthesis: A SWEDEHEART Study.
Article in Interdisciplinary cardiovascular and thoracic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Lower International Normalized Ratio Anticoagulation in Patients with Mechanical Valves Needs Robust Evaluation.Interdisciplinary cardiovascular and thoracic surgery · 2025Article
- Reply to Xu et al.Interdisciplinary cardiovascular and thoracic surgery · 2025Article
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Authors and funding
5 authors.
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Abstract
objectivesLifelong anticoagulation therapy is mandatory in patients with mechanical heart valves. The On-X aortic valve is currently the only mechanical heart valve approved for a lower (1.5-2.0) target international normalized ratio (INR) compared to the standard INR target 2.0-3.0. There is limited evidence demonstrating clinical benefits of the On-X valve over other mechanical aortic valves. We therefore investigated the risk of bleeding and thromboembolic events in patients with the On-X aortic valve.
methodsThis nationwide, population-based cohort study, using the target trial emulation framework, included all adults who underwent primary mechanical aortic valve replacement in Sweden 2014-2022 from the SWEDEHEART register. The rates of major bleeding and thromboembolic events were obtained from national registers. Confounding was addressed by weighting.
resultsOf the 3047 patients, 656 patients (22%) received an On-X aortic valve and 2391 patients (78%) received other mechanical aortic valves. The mean age was 54 years and 23% were women. After 8 years, the weighted major bleeding cumulative incidence was 7.2% (95% CI: 4.8%-10.7%) in the On-X valve group vs 7.0% (95% CI: 5.5%-8.8%) in the other mechanical valves group, and the weighted cumulative incidence of thromboembolic events was 7.3% (95% CI: 5.3%-10.2%) in the On-X valve group vs 6.4% (95% CI: 5.0%-7.9%) in the other mechanical valves group.
conclusionsWe found no clinically relevant difference in major bleeding or thromboembolic events in patients with the On-X aortic valve compared to patients with other mechanical aortic valves.
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