Why the study?
Does percutaneous renal artery denervation reduce blood pressure compared to a sham procedure in patients with resistant hypertension?
Does percutaneous renal artery denervation reduce blood pressure compared to a sham procedure in patients with resistant hypertension?
The failure of the Symplicity HTN-3 trial to meet its primary efficacy endpoint highlights the need to better understand intraprocedural efficacy control and predictors of blood pressure response for renal denervation.
Commentary on : Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med 2014;370:1393–401.[OpenUrl][1][CrossRef][2][PubMed][3][Web of Science][4] Percutaneous renal artery denervation (RDN) has recently been developed as an invasive technique to reduce blood pressure (BP) in patients with resistant hypertension. It is based on the principle of interrupting sympathetic renal afferent and efferent nerves, thereby reducing sympathetic activity. Several studies and registries documented a significant reduction in office and ambulatory BP after RDN and a persisting BP response during long-term follow-up.1 ,2 However, the recently published Symplicity HTN-3 study failed to meet its primary efficacy end point, while the primary safety end point was met. HTN-3 was a prospective, 2:1 randomised, single-blinded trial comparing the safety and efficacy of RDN to an invasive sham procedure (renal artery angiography with sedation) using the Symplicity Flex System. Only 535 of 1441 initially evaluated patients could satisfy the inclusion criteria of office systolic BP (SBP) ≥160 mm Hg and ambulatory SBP ≥135 mm Hg after … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D370%26rft.spage%253D1393%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1402670%26rft_id%253Dinfo%253Apmid%252F24678939%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1056/NEJMoa1402670&link_type=DOI [3]: /lookup/external-ref?access_num=24678939&link_type=MED&atom=%2Febmed%2F19%2F6%2F227.atom [4]: /lookup/external-ref?access_num=000334095200007&link_type=ISI
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Donazzan et al. (2014) studied this question.
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