February 11, 2026Open Access

Evaluation of a pharmacist-led patient-self-testing model for warfarin management in patients undergoing mechanical heart valve replacement in China: a multicentre, open-label, randomised, controlled trial

Q: What does this research mean for the field?

Patient self-testing for warfarin management significantly improves time in therapeutic range and reduces major bleeding compared to usual care in patients undergoing mechanical heart valve replacement in China. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Key Result

Pharmacist-led patient self-testing increased TTR to 67.2% vs 55.1% and reduced major bleeding (0.7% vs 7.9%) and thromboembolism (0.4% vs 6.8%) in MHV patients.

Key Points

This research aims to evaluate the effectiveness and safety of pharmacist-led patient self-testing for warfarin management compared to usual care in patients with mechanical heart valves.
Multicentre, open-label, randomized, controlled trial design.
Participants were patients with mechanical heart valve replacement in China, enrolled and stratified by warfarin use duration.
The PST group used at-home INR monitoring devices, while the UC group received standard outpatient care.
Primary outcome measured was time in therapeutic range (TTR); secondary outcomes included major bleeding, thromboembolism, and mortality.
The PST group achieved a significantly higher TTR of 67.2% compared to 55.1% in the UC group (p<0.001).
Incidence of major bleeding was lower in PST (0.7%) versus UC (7.9%) (p<0.001).
Thromboembolism events were also lower in PST (0.4%) than UC (6.8%) (p<0.001).
No significant difference in all-cause mortality between groups (0.4% for PST and 1.8% for UC, p=0.22).
Logistic regression indicated that PST use and younger age were linked to fewer warfarin-related adverse events.

Structured PICO

Does a pharmacist-led patient-self-testing model for warfarin management improve time in therapeutic range and clinical outcomes compared to usual care in patients undergoing mechanical heart valve replacement?

Population

556 patients undergoing mechanical heart valve (MHV) replacement in China, mean age 47.5 years, 45.1% male. 342 newly initiating warfarin therapy, 214 on warfarin for over 6 months.

Intervention

Patient self-testing (PST) using a point-of-care testing device for at-home international normalised ratio (INR) monitoring with pharmacist-guided warfarin dosing

Comparator

Usual care (UC) attending outpatient clinics for INR monitoring and dosing

Outcome

Difference in time in therapeutic range (TTR)surrogate

Pharmacist-led patient self-testing for warfarin management significantly improved time in therapeutic range and reduced major bleeding and thromboembolism compared to usual care in patients with mechanical heart valves.

Main Result

Absolute Event Rate: 0% vs 0%

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).