Portal de Periódicos da CAPES

‘SYMPLICITY: not all that simple’ is, in fact, simple

2014; Elsevier BV; Volume: 86; Issue: 5 Linguagem: Inglês

10.1038/ki.2014.257

1523-1755

Jay I. Meltzer, Juan Oliver,

Cardiovascular Syncope and Autonomic Disorders

The editorial ‘SYMPLICITY: not all that simple’1Luft F. SYMPLICITY: not all that simple.Kidney Int. 2014; 85: 999-1001Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar states that Medtronic’s suspension of catheter-based renal denervation (CRDN) following the SYMPLICITY HTN-3 trial2Bhatt D.L. Kandzari D.E. O’Neill W.W. et al.A controlled trial of renal denervation for resistant hypertension.N Engl J Med. 2014; 370: 1393-1401Crossref PubMed Scopus (1604) Google Scholar came as a complete surprise. The editorial also suggests that CRDN may ‘not be better’ than medical therapy but in fact CRDN had no blood pressure (BP) effect at all. A recent New England Journal of Medicine editorial3Messerli F.H. Bangalore S. Renal denervation for resistant hypertension?.N Engl J Med. 2014; 370: 15Crossref Scopus (56) Google Scholar also appeared surprised of the trial’s results. Implicit in both editorials is the belief that the BP falls in SYMPLICITY 1 and 2 trials were both proof of CRDN success and, proof of concept. However, there has been no proof that CRDN persistently decreases renal sympathetic nerve activity. Despite SYMPLICITY-3 elegant design and execution, criticism has been relentless. At the recent meeting of the American Society of Hypertension, Murray Elser’s Keynote speech mocked it as ‘FDA branding’ and criticized its results by claiming that CRDN was perhaps technically incompetent. There has also been a choir clamoring for additional studies, including testing other devices. Unfortunately, no one has suggested that the observations in these trials proves once more how large the placebo effect in hypertensives can be, disregarding a number of old studies, some carried out by giants in the field.4Goldring W. Chasis H. Schreiner G.E. et al.Reassurance in the management of benign hypertensive disease.Circulation. 1956; 14: 260-264Crossref PubMed Google Scholar Furthermore, absent proof that CRDN works, there appears to be no serious discussion as to what now should be done; i.e., stop all CRDN until a reliable and accurate measure of the renal sympathetic response to it is available. Only then physicians will have the right to recruit subjects for further studies.