Noticias

Noticias

  • Título: Final 3-Year Report Published From the SYMPLICITY HTN-1 Study
  • Fecha: 07-11-2013

  • November 7, 2013—The final 3-year report of the SYMPLICITY HTN-1 study of percutaneous renal denervation in patients with treatment-resistant hypertension renal denervation (RDN) were published by Professor Henry Krum, MD, et al online ahead of print in The Lancet.

    The investigators assessed the long-term antihypertensive effects and safety of renal denervation with radiofrequency ablation, which has been shown to substantially reduce blood pressure in patients with treatment-resistant hypertension. This study, which specifically evaluated the Symplicity (Medtronic, Inc., Minneapolis, MN) device, is registered with the US Food and Drug Administration’sClinicalTrials.gov by identifier numbers: NCT00483808, NCT00664638, and NCT00753285.

    As summarized in The Lancet, SYMPLICITY HTN-1 is an open-label study that enrolled 153 patients, of whom 111 consented to follow-up for 36 months. Eligible patients had a systolic blood pressure of at least 160 mm Hg and were taking at least three antihypertensive drugs, including a diuretic, at the optimum doses. Investigators assessed changes in office systolic blood pressure and safety every 6 months and reported every 12 months.

    The investigators reported that 88 patients had complete data at 36 months. At baseline the mean age was 57 years (standard deviation [SD], 11); 37 (42%) patients were women; 25 (28%) had type 2 diabetes mellitus; the mean estimated glomerular filtration rate was 85 (SD, 19) mL/min per 1.73 m2; and mean blood pressure was 175/98 (SD, 16/14) mm Hg.

    At 36 months, significant changes were seen in systolic (−32 mm Hg, 95% confidence interval [CI], −35.7 to −28.2) and diastolic blood pressure (−14.4 mm Hg, −16.9 to −11.9). Decreases of 10 mm Hg or more in systolic blood pressure were seen in 69% of patients at 1 month, 81% at 6 months, 85% at 12 months, 83% at 24 months, and 93% at 36 months. One new renal artery stenosis requiring stenting and three deaths unrelated to RDN occurred during follow-up.

    Changes in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety, concluded the SYMPLICITY HTN-1 investigators in The Lancet.



  • Fuente: endovascular.es