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Adequately powered randomized clinical trials are urgently needed to establish the long-term safety, efficacy, and cardiovascular outcomes of renal denervation for treatment-resistant hypertension.
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Widespread use of renal denervation for resistant hypertension should be restrained until adequately powered randomized clinical trials establish its long-term efficacy and safety.
The Symplicity studies suggest that intravascular renal sympathetic nervous denervation improves blood pressure in patients with resistant hypertension, thus potentially opening a market for devices to be used when conventional drug therapy fails to restore blood pressure control. However, the size and durability of the antihypertensive, renal and sympatholytic effects of renal denervation, the long-term safety, improvement of quality of life, the possibility to relax antihypertensive drug treatment, the cost-effectiveness, and long-term hard cardiovascular-renal outcomes still remain to be firmly established. Most ongoing studies are small, industry-driven and purely observational with objectives to test new catheters and source of energy for renal nerve ablation or to search for ancillary benefits and new indications of the technique. The most urgent need, that is adequately powered randomized clinical trials testing renal denervation versus usual medical therapy delivered according to the state-of-the-art are under-represented and seldom funded by industry. The authors make a plea for a coordinated research effort in Europe. With this objective, they established collaboration with leading European experts and started the European Network for Coordinating Research on Renal Denervation. In the meantime, renal denervation should remain the ultima ratio in adherent and truly resistant patients with severe hypertension, confirmed by ambulatory monitoring, in whom secondary hypertension has been excluded and in whom all other efforts to reduce blood pressure have failed.
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Persu et al. (2013) conducted an editorial in treatment-resistant hypertension. Renal denervation was evaluated. Adequately powered randomized clinical trials are urgently needed to establish the long-term safety, efficacy, and cardiovascular outcomes of renal denervation for treatment-resistant hypertension.
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