Late-breaking SPYRAL HTN-ON MED study at EuroPCR indicates renal denervation lowers blood pressure in hypertensive patients in presence of blood pressure medication.
Medtronic has announced first-ever-data from the SPYRAL HTN-ON MED study. Initial results found statistically significant and clinically important blood pressure reductions in hypertensive patients prescribed antihypertension medications treated with the Symplicity Spyral renal denervation system with no major adverse safety events out to six months. 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 USA and Japan.
At six months, patients randomised to the renal denervation procedure experienced an average 9mmHg drop in 24-hour mean systolic ambulatory blood pressure (ABPM), resulting in a 7.4mmHg difference compared to patients in the sham control arm (p=0.005). For renal denervation patients, 24-hour mean diastolic ABPM also declined 6mmHg, which is 4.1mmHg lower than the sham control arm (p=0.029).
Likewise, average office systolic blood pressure (OBP) in patients in the renal denervation arm declined 9.4mmHg – a 6.8mmHg difference from the sham control arm (p=0.021), and the diastolic OBP declined 5.2mm Hg, a 3.5mmHg difference from the sham control arm (p=0.048).
“Data from the SPYRAL HTN-ON MED study is important for the clinical community and for patients with hypertension as it represents a typical scenario of managing uncontrolled hypertension patients, prescribed up to three blood pressure medications,” said David Kandzari, director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta, USA, co-principal investigator in the SPYRAL HTN-ON MED study, and member of the Medtronic Executive Committee that designed and oversees the SPYRAL HTN Global Clinical Program. “With these new results, mirroring those of the parallel SPYRAL HTN-OFF MED trial, we have convincing evidence at six months showing the continued safety and efficacy of renal denervation in both the presence and absence of blood
The SPYRAL HTN-ON MED patients were prescribed a stable regimen of up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE /ARB inhibitors or beta blockers. Similar to recent studies of uncontrolled hypertension, drug testing indicated that adherence to prescribed antihypertensive medication was inadequate as only about 60% of patients were found to be taking medications as prescribed. Medication adherence remains a challenge in controlling hypertension in patients resulting in intermittent blood pressure control that can lead to an increased risk for cardiovascular events.
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 night-time 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.
“We are encouraged by these data showing the procedure may enable a blood pressure lowering effect 24 hours a day. Renal denervation is essentially ‘always on’ even when the effect of medications may be subsiding between doses” said Raymond Townsend, director of the Hypertension Program at the Hospital of the University of Pennsylvania, a professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania, and co-principal investigator in the trial. Townsend is a member of the Medtronic Executive Committee that designed and oversees the SPYRAL HTN Global Clinical Program.”