Highlights
- Pharmacist-led patient self-testing (PST) achieved a significantly higher Time in Therapeutic Range (TTR) of 67.2% compared to 55.1% in usual care (p<0.001).
- The PST model reduced the incidence of major bleeding from 7.9% to 0.7% and thromboembolic events from 6.8% to 0.4%.
- Younger age and the use of the PST model were identified as independent protective factors against warfarin-related adverse events.
- The study demonstrates the feasibility and safety of decentralizing anticoagulation management in developing healthcare regions through pharmacist-led interventions.
Background: The Challenge of Warfarin Management in China
Warfarin remains the primary anticoagulant for patients undergoing mechanical heart valve (MHV) replacement due to its proven efficacy and cost-effectiveness. However, its narrow therapeutic index and significant inter-individual variability necessitate frequent monitoring of the International Normalised Ratio (INR). In many developing regions, including parts of China, the traditional ‘usual care’ (UC) model—where patients travel to hospital clinics for venous blood sampling and physician-led dose adjustments—presents significant barriers. These include geographic distance, long wait times, and the associated economic burden, often leading to poor adherence and suboptimal anticoagulation control.
Patient self-testing (PST), utilizing point-of-care (POC) devices, has been widely adopted in developed nations to address these challenges. However, its implementation in China has been limited by a lack of structured management frameworks and concerns regarding patient competency. This multicentre trial sought to evaluate whether a pharmacist-led PST model could bridge this gap, providing a safer and more effective alternative for MHV patients.
Study Design and Methodology
This study was a multicentre, open-label, randomised, controlled trial conducted across five distinct healthcare settings in China: one provincial tertiary hospital, two municipal tertiary hospitals, and two primary hospitals. This diverse setting ensured a broad representation of the patient population, from urban centers to more rural environments.
Participant Stratification
A total of 556 patients undergoing MHV replacement were enrolled. Participants were stratified based on their duration of warfarin therapy at the time of enrollment: those newly initiating therapy (n=342) and those who had been on warfarin for more than six months (n=214). This stratification allowed researchers to assess the intervention’s impact on both the volatile stabilization phase and the long-term maintenance phase of anticoagulation.
The Pharmacist-Led Intervention
Patients in the PST group were provided with POC testing devices for at-home INR monitoring. Crucially, this was not merely a technical provision; it was a comprehensive care model. Pharmacists provided intensive initial training and ongoing education. Patients reported their INR results to the pharmacist, who then guided warfarin dosing based on standardized protocols. In contrast, the UC group followed the standard of care, attending outpatient clinics for INR monitoring and physician-led management.
Primary and Secondary Endpoints
The primary outcome was the difference in Time in Therapeutic Range (TTR), calculated via the Rosendaal method, representing the quality of anticoagulation control. Secondary outcomes included clinical safety events over a 12-month follow-up period: major bleeding, thromboembolism, and all-cause mortality.
Key Findings: Efficacy and Safety Data
The results of the trial, conducted between March 2021 and March 2023, provide compelling evidence for the pharmacist-led PST model.
Anticoagulation Quality (TTR)
The PST group demonstrated a markedly superior TTR compared to the UC group (67.2% vs 55.1%, p<0.001). A TTR above 60% is generally considered the threshold for effective and safe anticoagulation; the PST group comfortably exceeded this, while the UC group fell short. This 12.1% difference highlights the enhanced stability provided by more frequent testing and specialized pharmacist oversight.
Clinical Outcomes and Safety
The improvement in TTR translated directly into better clinical outcomes. The incidence of major bleeding was dramatically lower in the PST group (0.7%) compared to the UC group (7.9%, p<0.001). Similarly, thromboembolic events—one of the most feared complications of MHV replacement—occurred in only 0.4% of the PST group, compared to 6.8% in the UC group (p<0.001). While all-cause mortality showed a downward trend in the PST group (0.4% vs 1.8%), the difference did not reach statistical significance (p=0.22), likely due to the relatively low overall mortality rate in the study period.
Predictors of Success
Logistic regression analysis revealed that the PST model was a strong independent factor associated with a reduction in warfarin-related adverse events. Interestingly, younger age was also associated with fewer events, possibly reflecting better health literacy or technical proficiency with POC devices, though the pharmacist-led education aimed to mitigate these disparities across all age groups.
Expert Commentary: Transforming Anticoagulation Care
The success of this trial underscores a critical shift in the management of chronic conditions: the transition from physician-centric models to multidisciplinary, patient-engaged care. Pharmacists, as medication experts, are uniquely positioned to manage the complexities of warfarin therapy. Their involvement ensures that dose adjustments are not only data-driven but also accompanied by patient counseling that addresses diet, drug interactions, and lifestyle factors.
The significant reduction in both bleeding and clotting events suggests that PST, when managed by pharmacists, offers a ‘double benefit’—improving both safety and efficacy. In the context of the Chinese healthcare system, where tertiary hospitals are often overburdened, this model provides a scalable solution to decentralize care without compromising quality. By empowering patients with POC technology and supporting them with professional expertise, the PST model overcomes the logistical barriers that have historically hindered anticoagulation management in developing regions.
However, it is important to acknowledge that the success of PST relies heavily on the quality of the pharmacist-patient relationship and the robustness of the education provided. The multicentre nature of this trial suggests that the model is generalizable, but its implementation requires institutional support for pharmacist-led clinics and reimbursement for POC supplies.
Conclusion
The evaluation of this pharmacist-led PST model in China demonstrates that it is not only feasible but superior to the current standard of care for patients with mechanical heart valves. By significantly improving TTR and reducing the risk of life-threatening complications like major bleeding and stroke, this model sets a new benchmark for anticoagulation management. Future efforts should focus on integrating this model into national healthcare policies to ensure that more patients can benefit from high-quality, accessible, and safe warfarin therapy.
Funding and Trial Registration
This study was registered with the China Clinical Trial Registry (ChiCTR2000038984). Funding was provided by regional health research grants and institutional support from the participating hospitals.
References
Wang C, Luo J, Zhou X, Guo Y, Cao W, Zhang D, Song L, Tan S. 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. BMJ Open. 2026 Feb 9;16(2):e105575. doi: 10.1136/bmjopen-2025-105575. PMID: 41663175; PMCID: PMC12887516.