Noticias

Noticias

  • Título: Randomized Sham-Controlled Trial Examines Blood Pressure Effects of Renal Denervation in Patients with Mild Refractory Hypertension
  • Fecha: 16-09-2014

  • Results of Symplicity Flex TrialReported at TCT 2014

    WASHINGTON, DC – According to a newsmall-to-modest sized but sham-controlled study, renal sympathetic denervation(RSD) used to treat mild refractory hypertension was associated with reductionsin blood pressure in secondary analyses, but missed its primary endpoint.Findings from the Symplicity Flex trial were reported today at the 26th annualTranscatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsoredby the Cardiovascular Research Foundation (CRF), TCT is the world’s premiereducational meeting specializing in interventional cardiovascular medicine.

    According to the Centers for DiseaseControl, 67 million American adults (31 percent) have high blood pressure andonly about half (47 percent) have their condition under control. RSD is aminimally invasive catheter based procedure that uses radiofrequency ablationto treat resistant hypertension. There is little data with regard to theeffectiveness of RSD in patients with refractory hypertension yet only mildlyelevated blood pressure.

    The Simplicity Flex trial randomized atotal of 71 patients with refractory hypertension and mildly elevated bloodpressure (daytime systolic BP of 135-149 and/or diastolic blood pressure of90-94 mmHG on ambulatory BP measurement). One group received catheter-based RSDwhile the second group received an invasive sham procedure. All patients had astable antihypertensive drug regimen of three or more agents including adiuretic, except when not tolerated or contraindicated. The primary endpointwas the change in 24 hour systolic blood pressure at six months.

    The mean change in 24 hour systolic BPin the intention to treat (ITT) cohort at six months was -7.0 ± 10.6 mmHg forpatients undergoing RSD and -3.5 ± 9.4 mmHg in the sham group (p=0.15). In theper protocol population, the change in 24 hour systolic blood pressure (BP) atsix months was -8.3 ± 8.9 mmHG in the RSD group compared to -3.5 ± 9.5 mmHG inthe sham group (p= 0.042). There was also a significant reduction in daytimesystolic BP in RSD patients in the per protocol analysis (-9.9 ± 9.0 vs. -3.7 ±9.9, p=0.012). No significant changes in the 24 hour diastolic, mean BP or anymeasures of nighttime BP were recorded and there were no serious adverseevents.

    “In patients with mild refractoryhypertension, renal sympathetic denervation showed a significant reduction of24 hour systolic BP in the per protocol cohort at six months, however in theintention to treat population the results were not significant,” said leadinvestigator Steffen Desch, MD University of Schleswig-Holstein, Campus Lübeck,in Germany.

    “Findings indicate that this procedurecould supplement current therapies and help reduce the number of patients withuncontrolled high blood pressure.”

    The Symplicity Flex trial was funded bythe Heart Center at the University of Leipzig. Dr. Desch reported nodisclosures.



  • Fuente: endovascular.es