Abstract
OBJECTIVES: Patient self-testing (PST) for warfarin management is well-established in developed countries but remains underused in developing regions. This study compared the safety and effectiveness of PST with usual care (UC) in China. DESIGN: A multicentre, open-label, randomised, controlled trial. SETTING: A total of five centres participated in this study, including one provincial tertiary hospital, two municipal tertiary hospitals and two primary hospitals. PARTICIPANTS: Patients undergoing mechanical heart valve (MHV) replacement at five centres were prospectively enrolled. Patients were trained and stratified according to time on warfarin at enrolment and were randomly assigned to the PST or UC group. INTERVENTIONS: The PST group used a point-of-care testing device for at-home international normalised ratio (INR) monitoring with pharmacist-guided warfarin dosing, while the UC group attended outpatient clinics for INR monitoring and dosing. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the difference in time in therapeutic range (TTR). The secondary outcomes were incidences of major bleeding, thromboembolism and all-cause deaths in 12 months. RESULTS: From March 2021 to March 2023, a total of 556 patients were enrolled, with a mean age of 47.5 years, 45.1% being male. 342 were newly initiating warfarin therapy, while 214 had been on warfarin for over 6 months. Baseline characteristics were similar between the PST and UC groups. The PST group showed significantly higher TTR (67.2% vs 55.1%, p<0.001) and lower incidences of major bleeding (0.7% vs 7.9%, p<0.001) and thromboembolism (0.4% vs 6.8%, p<0.001), with no difference in all-cause mortality (0.4% vs 1.8%, p=0.22). Logistic regression identified that using PST and younger age were independent factors associated with fewer warfarin-related adverse events. CONCLUSIONS: A pharmacist-led PST intervention with ongoing education and counselling led to improved TTR and clinical outcomes in patients with MHV in China. TRIAL REGISTRATION NUMBER: China Clinical Trial Registry (ChiCTR2000038984).