ObjectiveTo evaluate the reasonableness of anticoagulation management strategy in patients after mechanical heart valve replacement. MethodsAll patients were followed and registered continually at outpatient clinic from July 2011 to February 2013, with a minimum of 6 months after surgery. Targeted international normalized rate (INR) 1.60 to 2.20 and warfarin weekly dosage adjustment were used as the strategy of anticoagulation management. Except bleeding, thrombogenesis and thromboembolism, time in therapeutic range (TTR) and fraction of TTR (FTTR) were adopted to evaluate the quality of anticoagulation management. ResultsA total 1 442 patients and 6 461 INR values were included for data analysis. The patients had a mean age of 48.2±10.6 years (14-80 years) and the following up time were 6 to 180 months (39.2±37.4 months) after surgery. Of these patients, 1 043 (72.3%) was female and 399 (27.7%) was male. INR values varied from 0.90-8.39 (1.85±0.49) and required weekly doses of warfarin were 2.50-61.25 (20.89±6.93 mg). TTR of target INR and acceptable INR were 51.1% (156 640.5 days/306 415.0 days), 64.9% (198 856.0 days/306 415.0 days), respectively. FTTR of target INR and acceptable INR were 49.4% (3 193 times/6 461 times), 62.6% (4 047 times/6 461 times). There were 8 major bleeding events, 7 mild bleeding events, 2 thromboembolism events, and 2 thrombogenesis in the left atrium. ConclusionIt is reasonable to use target INR 1.60-2.20 and warfarin weekly dosage adjustment for patients after mechanical heart valve replacement.
ObjectiveTo assess the health effectiveness, cost and cost effectiveness of different oral anticoagulation (OAT) therapies in China, including warfarin plus international normalized ratio (INR) test in hospital labs (Lab test), warfarin plus patient self-management (PSM) with point of care device, and novel anticoagulant (Dabigatran) alone. MethodsA Markov model containing four states (no complication, hemorrhagic event, thrombotic event and death) was developed to account for long-term cost and outcomes of warfarin/novel anticoagulant users including atrial fibrillation patients and deep venous thrombosis patients. Direct medical cost was taken into consideration, covering expenses of drugs, OAT monitoring and complication management. Both clinical and cost parameters were mainly derived from literatures. ResultsCompared with hospital lab test, the PSM pattern obtained a prolonged 8.48 years and 5.08 QALYs with the larger amount of cost, CNY 47 482. The incremental cost-effectiveness ratio (ICER) of PSM versus hospital lab test came to CNY 19 240 per QALY gained, lower than GDP China per capita in 2014 (CNY 46 628). And the novel anticoagulant pattern was dominated by PSM pattern due to shortened QALYs while increased cost. The sensitivity analysis demonstrated the results were not sensitive to main indicators, including utility in different health status, complication probability, and disease management cost. ConclusionPSM can generate more QALYs by reducing the risk of major thrombotic and bleeding events with acceptable incremental cost, which turns to be the most cost effective way among the 3 patterns and demonstrates promising future in OAT management.