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Renal denervation for resistant hypertension—the Symplicity HTN-1 study

2014; Elsevier BV; Volume: 383; Issue: 9932 Linguagem: Inglês

10.1016/s0140-6736(14)60911-9

1474-547X

Rahman Shah,

Potassium and Related Disorders

Henry Krum and colleagues1Krum H Schlaich MP Böhm M et al.Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study.Lancet. 2014; 383: 622-629Summary Full Text Full Text PDF PubMed Scopus (483) Google Scholar reported that the improvement in blood pressure control resulting from renal denervation persisted during 36 months of follow-up. However, because this was an open label study, several confounding factors could have affected the results.2Barton S Which clinical studies provide the best evidence?.BMJ. 2000; 321: 255-256Crossref PubMed Scopus (269) Google Scholar A few factors were mentioned by the authors, but they failed to mention that the mean number of medications taken by patients was higher at 36 months than at 6 months. Similarly, more patients were receiving aldosterone antagonists at 36 months compared to baseline, and this treatment has been very effective in resistant hypertension.3Chapman N Dobson J Wilson S et al.Effect of spironolactone on blood pressure in subjects with resistant hypertension.Hypertension. 2007; 49: 839Crossref PubMed Scopus (508) Google Scholar Furthermore, whether there were any differences in medication dosage at follow-up was not clear, which could have affected the result.4Brunner HR Nussberger J Waeber B Dose-response relationships of ACE inhibitors and angiotensin II blockers.Eur Heart J. 1994; 15S: 123-128Crossref Google Scholar Additionally, the progressive improvement in blood pressure control during the follow-up period is suggestive of a so-called healthy adherer effect resulting from participation in a clinical study.5Chewning B The healthy adherer and the placebo effect.BMJ. 2006; 333: 18-19Crossref PubMed Google Scholar Therefore, it would have been helpful if the authors could have provided some data on changes in patient weight during the follow-up. Finally, placebo-controlled, randomised clinical trials provide the best clinical evidence,2Barton S Which clinical studies provide the best evidence?.BMJ. 2000; 321: 255-256Crossref PubMed Scopus (269) Google Scholar and the recently completed Symplicity HTN-3 study showed that renal denervation is no better than a sham procedure for reducing office blood pressure through 6 months. Thus, the apparent early and persistent improvement in blood pressure in the open label study by Krum and colleagues1Krum H Schlaich MP Böhm M et al.Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study.Lancet. 2014; 383: 622-629Summary Full Text Full Text PDF PubMed Scopus (483) Google Scholar is most likely due to the above-mentioned factors rather than renal denervation. I declare no competing interests. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 studyChanges in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety. Full-Text PDF Renal denervation for resistant hypertension—the Symplicity HTN-1 study – Authors' replyFirst, we take this opportunity to clarify the purpose of our safety and proof-of-principle study published in 2009,1 as there seems to be some misunderstanding of its aims. We did this initial 45 patients, 12 month uncontrolled assessment focused primarily on safety of the renal denervation procedure (both peri-procedural and longer-term) as well as to establish whether systemic sympathetic abrogation was actually being achieved, using both precise (noradrenaline kinetics, micro-neurography2) and crude (office blood pressure) clinical measures. Full-Text PDF