A study published in the Journal of the American College of Cardiology, based on data from the Symplicity HTN-2 trial, suggests that renal denervation may be a cost-effective method of managing resistant hypertension and may result in a reduction in cardiovascular morbidity and mortality in the long term.
Benjamin Geisler (Wing Tech Inc, Menlo Park, California, USA) and others reported that although the Symplicity HTN-2 trial showed that the Symplicity renal denervation system (Medtronic) reduced systolic blood pressure in patients with resistant hypertension compared with standard of care (three or more antihypertensive medications), neither the effect of the system on cardiovascular events nor its cost-effectiveness has been previously evaluated. They wrote: “Our aim, therefore, was to develop a decision-analytic model to predict long-term cardiovascular consequences and to ultimately assess the cost-effectiveness based on the long-term clinical effectiveness of this novel treatment compared to standard of care alone.”
Geisler et al used a Markov (state-transition) model to compare the impact of renal denervation plus standard of care for resistant hypertension with standard of care alone. Based on data from the Symplicity HTN-2 trial, the model predicted that renal denervation would reduce cardiovascular mortality by 30% and all-cause mortality by 15% over 10 years. The authors wrote: “The discounted lifetime incremental cost-effectiveness ratios (ICER) for renal denervation were US$2,715 per life-gained and US$3,071 per quality adjusted life year (QALY).”
They added that the ICER only exceeded US$50,000 per QALY “willingness-to-pay” threshold if renal denervation reduced systolic blood pressure by 11.1mmHg or less, which the authors commented would be “substantially less than what has been observed in clinical trials (99% confidence interval: 22.8 to 40.5mmHg reduction).” They commented: “Under the hypothetical assumption that the treatment effect would decrease by 1mmHg annually, the projected ICER increased to approximately US$13,30 per QALY. Threshold analysis revealed that systolic blood pressure reduction would need to decrease by >3mmHg per year for ICER to exceed the US$50,000 per QALY willingness-to-pay threshold.”
Jan B Pietzsch (Wing Tech Inc, Menlo Park, California, USA), senior author and study director, said: “Our reliance on widely established multivariate risk equations, such as those from the Framingham Heart Study, allowed us to comprehensively assess and confirm the robustness of the model’s projections across a wide range of cardiovascular risk profiles.” Brent Egan (Department of Medicine, Medical University of South Carolina, Charlestown, USA), a co-author of the study, added: “These results suggest that renal denervation with the Symplicity system is a cost-effective treatment strategy for resistant hypertension at a value substantially lower than the commonly accepted threshold. Moreover, this health-economic model indicates that renal denervation with the Symplicity system may decrease mortality and reduce cardiovascular events in treatment-resistant patients, which would offer a major advancement in our approach to addressing this growing and costly disease.”
