Gender differences in added benefit of catheter-based renal denervation for resistant hypertension: model-based estimation of unadjusted and quality-adjusted life year gains in males and females

Abstract

Purpose: Our goal was to estimate, stratified by gender, the impact of catheter-based renal denervation plus standard of care (RDN) versus standard of care alone (SoC) on life year (LY) and quality-adjusted life year (QALY) gain in simulated European resistant hypertension cohorts of different cardiovascular (CV) risk. Methods: A recently published simulation model based on multivariate risk equations for CHD, MI, stroke, CHF, and ESRD was populated with CV risk factors and life tables for Germany. LY and QALY gain was estimated for male and female cohorts of age 58 defined by combinations of 1) pre-treatment SBP of 165 mmHg vs. 190 mmHg; and 2) low vs. high cardiovascular risk profile from the JNC 7 guidelines. All other input parameters, including the treatment effect based on a previously published linear regression model, were derived from the Symplicity HTN-2 randomized controlled trial. No discounting was applied. Results: Renal denervation was estimated to reduce a pre-treatment SBP of 165 by 30 mm Hg, and a SBP of 190 by 40 mm Hg, respectively. The projected lifetime gains in LYs and QALYs for RDN vs. SoC were projected as follows for male/ female cohorts: 1) Low CV risk profile at 165 mmHg: 1.37/ 1.88 LYs, 1.13/ 1.54 QALYs; 2) Low CV risk profile at 190 mmHg: 1.21/ 1.70 LYs, 1.03/ 1.41 QALYs; 3) High CV risk profile at 165 mmHg: 1.93/ 2.29 LYs, 1.53/ 1.90 QALYs; 3) High CV risk profile at 190 mmHg: 1.55/ 1.83 LYs, 1.25/ 1.49 QALYs. Conclusions: Our results suggest gender is an important factor influencing patient-relevant outcomes in patients treated with catheter-based renal denervation. While renal denervation was associated with clinically meaningful gains in life expectancy and quality-adjusted life expectancy across cardiovascular risk profiles and pre-treatment systolic blood pressure in both genders, females were projected to experience consistently higher gains than males. These model-based findings need to be confirmed in clinical trials.