Geisler BP, Egan BM, Cohen JT, et al.
J Am Coll Cardiol. 2012;():. doi:10.1016/j.jacc.2012.07.029

Background

Resistant hypertension is an elevated blood pressure despite optimal treatment with full doses of 3 antihypertensive agents, including a diuretic. Hypertension is the most common risk factor for the development of cardiovascular disease (CVD) (1,2) with long-term cardiovascular and renal consequences with a substantial burden to health care systems (2).
Resistant hypertension affects 12% of hypertensive persons. In the Symplicity HTN-2 randomized controlled trial, catheterbased renal denervation (RDN) lowered systolic blood pressure by 32±23 mm Hg from 178± 18 mm Hg at baseline ). This treatment has been shown to be a viable therapeutic approach for resistant hypertension (7).
Aim of this study was to develop a decision-analytic model to predict long-term cardiovascular consequences and to assess the cost-effectiveness based on the long-term clinical effectiveness of this treatment compared to standard of care.

Main results

• Renal denervation reduced cardiovascular mortality by 30% and all-cause mortality by 15% compared with standard therapy over 10 years
• Median survival was increased from 17.07 to 18.37 years
• Quality-adjusted life expectancy increased from 12.07 to 13.17 quality-adjusted life-years, resulting in a discounted incremental cost-effectiveness ratio of $3,071/QALY.

Long-term relative risk of adverse events with renal denervation vs standard of care

Event	10-y relative risk	Lifetime relative risk
Stroke	0.70	0.83
MI	0.68	0.85
All coronary disease	0.78	0.90
Heart failure	0.79	0.92
End-stage renal disease	0.72	0.81

Conclusion

Renal denervation (RDN) for resistant hypertension may be cost-effective and may provide long-term clinical benefits (lower cardiovascular morbidity and mortality).

References

1. Fryar CD, Hirsch R, Eberhardt MS, et al. Hypertension, High Serum Total Cholesterol, and Diabetes: Racial and Ethnic Prevalence Differences in U.S. Adults, 1999–2006. NCHS Data Brief. Hyattsville, MD: National Center for Health Statistics, 2010.
2. World Health Organization. Global Health Risks: Mortality and Burden of Disease Attributable to Selected Major Risks. Geneva, Switzerland: World Health Organization, 2009.
3. Persell SD. Prevalence of resistant hypertension in the United States, 2003–2008. Hypertension 2011;57:1076–80.
4. Schlaich MP, Sobotka PA, Krum H, et al. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med 2009;361:932– 4.
5. Krum H, Schlaich M, Whitbourn R, et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 2009;373:1275– 81.
6. Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension 2011;57:911–7.
7. Symplicity HTN-2 Investigators, Esler MD, Krum H, Sobotka PA,et al. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 2010;376:1903–9.

Abstract

Objectives
The purpose of this study was to assess cost-effectiveness and long-term clinical benefits of renal denervation in resistant hypertensive patients.

Background
Resistant hypertension affects 12% of hypertensive persons. In the Symplicity HTN-2 randomized controlled trial, catheterbased renal denervation (RDN) lowered systolic blood pressure by 32 23 mm Hg from 178 18 mm Hg at baseline.

Methods
A state-transition model was used to predict the effect of RDN and standard of care on 10-year and lifetime probabilities of stroke, myocardial infarction, all coronary heart disease, heart failure, end-stage renal disease, and median survival. We adopted a societal perspective and estimated an incremental cost-effectiveness ratio in U.S. dollars per quality-adjusted life-year, both discounted at 3% per year. Robustness and uncertainty were evaluated using deterministic and probabilistic sensitivity analyses.

Results
Renal denervation substantially reduced event probabilities (10-year/lifetime relative risks: stroke 0.70/0.83; myocardial infarction 0.68/0.85; all coronary heart disease 0.78/0.90; heart failure 0.79/0.92; end-stage renal disease 0.72/0.81). Median survival was 18.4 years for RDN versus 17.1 years for standard of care. The discounted lifetime incremental cost-effectiveness ratio was $3,071 per quality-adjusted life-year. Findings were relatively insensitive to variations in input parameters except for systolic blood pressure reduction, baseline systolic blood pressure, and effect duration. The 95% credible interval for incremental cost-effectiveness ratio was cost-saving to $31,460 per quality-adjusted life-year.

Conclusions
The model suggests that catheter-based renal denervation, over a wide range of assumptions, is a cost-effective strategy for resistant hypertension that might result in lower cardiovascular morbidity and mortality.