Safety of low intensity oral anticoagulant therapy in patients with bileaflet mechanical aortic valve prosthesis: A propensity weighted study. (15th October 2020)

• Record Type: Journal Article
• Authors: Rubino, Antonino S.; Torella, Michele; Della Ratta, Ester E.; Galbiati, Denise; Della Corte, Alessandro; Bancone, Ciro; De Santo, Luca S.; De Feo, Marisa
• Is Part Of: International journal of cardiology. Volume 317(2020)
• Page Start: 139
• Page End: 143
• Publication Date: 2020-10-15
• Subjects: Anticoagulation -- Mechanical valve -- Aortic valve replacement; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2020.05.094
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: Scarce data are available on the long-term outcomes of different regimens of oral anticoagulation in an all comer population of patients undergoing aortic valve replacement with a bileaflet mechanical heart valve. Methods: Outcomes of 88 patients discharged with a target INR of 2.0 (LOW-INR) were compared to 147 contemporary patients who have been recommended a target INR of 2.5 (CONV). Primary outcome was the composite of any thromboembolic or haemorrhagic events. Secondary outcomes were the individual components of the primary outcome, cardiovascular mortality and stroke. To reduce selection bias, a propensity weighted analysis was performed. Results: After inverse probability of treatment weighting, the primary endpoint occurred in 0.7% of patient in the LOW-INR group and in 7.0% in the CONV group ( p = .0255). Linearized event rate were significantly lower in the LOW-INR group (primary endpoint: rate difference − 12.0 per 1000 patient/years, p = .0052; haemorrhage: −5.8 per 1000 patient/years, p = .0330; neurological events: −7.6 per 1000 patient/years, p = .0140). Conventional target INR was associated with an increased hazard of the composite endpoint (HR 11.193, 95% CI 1.424–88.003, p = .0217). Conclusions: Lowering the intensity of oral anticoagulation resulted in a relevant clinical benefit of reduced rates of haemorrhagic and neurological adverse events in the mid-term follow-up. This report confirms the safety profile of the low INR regimen in an all comer population undergoing aortic valve replacement with an Abbott mechanical valve. Graphical abstract: Unlabelled Image Highlights: Unknown long term outcomes with different anticoagulation regimens after valve replacement. We performed a retrospective analysis of prospectively collected data. Target INR 2 is associated to less hemorrhagic and neurological events. Target INR 2.5: hazard ratio 8.3 of thromboembolic and hemorrhagic events. We confirm the safety profile of reduced INR regimen in the long term follow-up.