Results from SPYRAL HTN-ON MED Study of Symplicity Spyral RDN shows blood pressure reductions in uncontrolled hypertension.- Medtronic.
Medtronic announced first-ever-data from the SPYRAL HTN-ON MED Study in hypertensive patients prescribed anti-hypertension medications treated with the Symplicity Spyral renal denervation (RDN) system. Initial study results found statistically significant and clinically important blood pressure reductions with no major adverse safety events out to six months. At six months, patients randomized to the renal denervation procedure experienced an average 9 mm Hg drop in 24-hour mean systolic ambulatory blood pressure (ABPM), resulting in a 7.4 mm Hg difference compared to patients in the sham control arm (p=0.005).
For RDN patients, 24-hour mean diastolic ABPM also declined 6 mm Hg, which is 4.1 mm Hg lower than the sham control arm (p=0.029). Likewise, average office systolic blood pressure (OBP) in patients in the RDN arm declined 9.4 mm Hg - a 6.8 mm Hg difference from the sham control arm (p=0.021), and the diastolic OBP declined 5.2 mm Hg, a 3.5 mm Hg difference from the sham control arm (p=0.048).
Additional analysis of the cyclical hourly changes in blood pressure demonstrated that the blood pressure lowering effects of renal denervation were distributed throughout the day and, importantly, throughout the nighttime period when blood pressure control is even more critical due to higher risks of adverse events like heart attack and stroke caused by hypertension. Blood pressure during sleep is the most significant predictive marker of cardiovascular disease morbidity and mortality, and reduction in asleep blood pressure is associated with highly significant reduction of cardiovascular disease risk.
The Late-Breaking Trial data, presented at the 2018 EuroPCR Annual Meeting in Paris, was published simultaneously in The Lancet. The Symplicity Spyral system is investigational in the United States and Japan.
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