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PURPOSE: The DELIVER trial demonstrated the efficacy of dapagliflozin in reducing primary endpoint (cardiovascular (CV) mortality or worsening heart failure) for heart failure with mid-range ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF). This study assessed the economic and clinical effects of incorporating dapagliflozin into a standard treatment regimen for HFpEF and HFmrEF cases in China. METHODS: A multistate Markov model was used to assess the clinical and economic effects of adding dapagliflozin to the usual treatment regimen for HFpEF and HFmrEF. A log-logistic formula was used to represent the cumulative incidence of hospitalization, readmission, and CV mortality. A 5% annual discount was applied to all costs. The health outcome was the incremental cost-effectiveness ratio (ICER), measured using quality-adjusted life years (QALYs) and life years (LYs). The findings were examined using sensitivity and scenario analyses to assess robustness. RESULTS: In the HFpEF or HFmrEF population, the 11.2-year incremental QALYs was 0.15 and LYs was 0.2, yielding an ICER of $10,615.87 per QALY and $7,763.08 per LY. These ICER values are lower than China's per capita gross domestic product (GDP) of $12,752 in 2022. The one-way sensitivity analysis revealed that non-hospital CV death was the most influential parameter. Furthermore, there was a 68% chance that dapagliflozin was cost-effective as an additional treatment, given a willingness-to-pay limit of three times the GDP ($38,256). CONCLUSIONS: Dapagliflozin adjunctive therapy was cost-effective in patients with HFpEF or HFmrEF from the perspective of Chinese national insurance.
RESUMO
BACKGROUND: Current guidelines recommend oral anticoagulation (OAC) following transcatheter aortic valve replacement (TAVR) in patients with clinical indication, but the optimal antithrombotic regimen remains uncertain. We aimed to compare the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in patients undergoing TAVR with concomitant indication of OAC. HYPOTHESIS: Comparing with VKAs therapy, NOACs are similar in reducing the all-cause mortality and major bleeding in post-TAVR patients requiring OAC medication. METHODS: We searched the databases of PubMed, Embase, and Cochrane library databases to identify studies that investigated NOACs versus VKAs after TAVR in patients with another indication of OAC, which were published before 28th September 28, 2021. The effectiveness of outcomes was all-cause mortality and stroke or systemic embolism, while the main safety outcome was major and/or life-threatening bleeding. The hazard ratio (HR) with 95% confidence interval (CI) was used as a measure of treatment effect. RESULTS: Our search identified eight studies. We included 4947 post-TAVR patients with another indication of OAC allocated to the NOAC (n = 2146) or VKA groups (n = 2801). There were no significant differences in the all-cause mortality (HR: 0.91, 95% CI: 0.77-1.08, p = .29, I2 = 47%), stroke or systemic embolism (HR: 0.96, 95% CI: 0.68-1.37, p = .84, I2 = 0%), and major and/or life-threatening bleeding (HR: 1.09, 95% CI: 0.89-1.32, p = .40, I2 = 30%) in both groups. CONCLUSION: Among post-TAVR patients who required OAC therapy, NOACs therapy compared to VKAs is similar in reducing the all-cause mortality, stroke or systemic embolism, and major and/or life-threatening bleeding events.
