Renal denervation (RDN) for resistant hypertension may be cost-effective and may provide long-term clinical benefits, according to a new analysis published in the Journal of the American College of Cardiology.
Benjamin Geisler and colleagues developed a model to predict the impact of the Medtronic Symplicity RDN system in patients with resistant hypertension. Over 10 years, according to the model, RDN treatment resulted in large differences in outcomes, though the benefits were less pronounced when projected over a lifetime.
Projected 10 year Relative Risk:
- Stroke: 0.70 (reduced from 11.6% in the control group to 8.2% in the RDN group)
- MI: 0.68 (reduced from 9.6% to 6.5%)
- CHD: 0.78 (reduced from 24.8% to 19.4%)
- HF: 0.79 (reduced from 5.4% to 4.3%)
- ESRD: 0.72 (reduced from 2.9% to 2.1%
- CV mortality: 0.70 (reduced from 12.5% to 8.7%)
- All-cause mortality: 0.85 (reduced from 23.0% to 19.5%)
Median survival was lengthened from 17.07 years to 18.37 years. The authors calculated an increase in quality-adjusted life-years (QALY) from 12.07 to 13.17 years, resulting in a discounted incremental cost-effectiveness ratio of $3,071/QALY. Cost-effectiveness was “markedly below the commonly accepted threshold of $50,000 per QALY [quality-adjusted life-year],” and might even be cost-saving, according to the authors.
The model assumes that RDN causes a long term reduction in blood pressure, though current data from the Symplicity HTN-2 trial only extends to 36 months. However, the authors reported that RDN remained “cost-effective across a wide range of assumptions.”
Republished with permission from CardioExchange, a NEJM group publication.
As an interventionalist I really hope that the renal deneveration (RDN) works. That being said, until it is shown to improve hard clinical events in a major study (Not 52 patients SIMPLICITY2) it is too premature to reach any conclusions. At best it is fortune telling and at worst it is marketing spin by industry seeking to hype the therapy.
I will ask the same question I asked in the session at #ESC2012, “if we had a completely new class of hypertension drugs, what would we need before we approve it?” Regardless of spin a 106 patients study is a Phase-I study. I would like to see appropriate powered Phase III study with clinical end points before passing judgment. It is too premature to do complex analysis from 52 patients to show “cost-effectivenes.” The gold standard in hypertension therapy is not just the lowering of a number but preventing death, heart attacks and strokes over the life time of therapy.
While FDA maybe too restrictive at least it protects US patients and consumers to a certain extent. At least 2 companies (more to follow) are now actively selling and promoting RDN outside of USA. Soon I predict newspapers ads extolling Cure for Hypertension next to the cure for baldness ads.