Abstract

Abstract Introduction Good quality of anticoagulation in patients with valvular heart disease (VHD) is needed to reduce ischaemic complications. There is limited evidence on factors affecting anticoagulation control in patients implanted with mechanical or tissue prosthetic valve(s). Objective To examine quality, factors affecting anticoagulation control and all-cause death in VHD patients with and without atrial fibrillation (AF) receiving a vitamin K antagonist (VKA) oral anticoagulant. The relationship between INR control with all-cause death and ≥1 adverse clinical events (ACE) [thromboembolism, bleeding, cardiovascular hospitalisation and all-cause death] were explored. Methods Anticoagulation control of 456 VHD patients [164 (36%) with AF and 290 (64%) without AF] referred to a hospital-based anticoagulation clinic were assessed retrospectively by time in therapeutic range (TTR) (Rosendaal) and percentage of INRs in range (PINRR) for a median of (IQR) 6.2 years (3.3–8.5). VHD was defined by the presence of mechanical or tissue prosthetic valve at either the mitral or aortic site or both. Results Mean (SD) age 51 (14.7), 64.5% male, mean (SD) CHA2DS2-VASc score 2.0 (1.4), 96.1% mechanical prosthesis and 64% aortic valve replacement. VHD patients with AF had lower mean TTR and PINRR, lower proportion of optimal TTR (i.e.≥70%) despite similar number of INR tests compared to VHD patients without AF [Table 1]. Predictors of poor TTR on multivariate logistic regression analysis were female sex, AF and anaemia/bleeding history. Significantly higher proportions of VHD patients with AF died [Table 1]. More deaths (13.1% vs. 4.1%; p=0.011) and ≥1 ACE (42.7% vs. 27.6%; p=0.006) were seen in VHD patients with TTR <70% vs. TTR≥70%, respectively. Table 1 N (%) Total (N=456) AF (N=164) No AF (N=290) p-value Mean (SD) TTR 58.5 (14.6) 55.7 (14.2) 60.1 (14.6) 0.002 TTR ≥70% 98 (21.5) 23 (14.0) 75 (25.7) 0.004 Mean (SD) PINRR 50.1 (13.8) 47.4 (13.5) 51.6 (13.7) 0.002 Mean (SD) INR tests 96.2 (55.3) 100.7 (58.8) 93.7 (53.1) 0.19 All-cause death 51 (11.2) 34 (20.7) 17 (5.8) <0.001 AF: Atrial fibrillation; IQR: interquartile range; PINRR: percentage of INRs in range; SD: standard deviation; TTR: Time in therapeutic range. Conclusion The quality of anticoagulation in VHD patients with AF was low. The presence of AF, anaemia/bleeding history and female sex independently predicted poor TTR. All-cause death was more common in VHD patients with AF and poor TTR. Closer INR monitoring is needed especially in VHD patients with AF to improve anticoagulation control and prevent adverse clinical outcomes. Acknowledgement/Funding Kementerian Pendidikan Malaysia and Universiti Teknologi MARA for PhD study but not directly for work under consideration

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