Effectiveness of Radiofrequency Renal Denervation in the United States: Six-Month Primary End Point Results From the SPYRAL AFFIRM Study
David E. Kandzari, Kazuomi Kario, Michael A. Weber, Raymond R. Townsend, Roland E. Schmieder, Michael Böhm, Kostantinos Tsioufis, Robert Stoler, David P. Lee, Frank Navetta, Barry Bertolet, Srinivasa Potluri, Shukri David, Debbie L. Cohen, Te-Hsin Lung, Kelsey Anderson, Julie Carvelli, Felix Mahfoud,BACKGROUND:
Radiofrequency renal denervation (RDN) is a guideline-recommended therapy for uncontrolled hypertension. SPYRAL AFFIRM is a single-arm, postapproval study assessing the efficacy and safety of radiofrequency RDN using the Symplicity Spyral catheter. We report the 6-month primary end point results in the SPYRAL AFFIRM US population.
METHODS:
Enrolled patients had an office systolic/diastolic blood pressure (BP) ≥140/90 mm Hg and a home systolic BP ≥135 mm Hg. Patients with type 1 diabetes, poorly controlled type 2 diabetes (HbA1c >8.0%), or an estimated glomerular filtration rate <45 mL/min per 1.73 m 2 were excluded. The primary end point was the 6-month change in office systolic BP from baseline compared with a prespecified performance goal (−6.0 mm Hg).
RESULTS:
Among 594 patients treated in the AFFIRM study from 73 US clinical sites, baseline clinical characteristics included: mean (±SD) age, 57±12 years; female, 45%; African American, 27%; Hispanic, 11%; type 2 diabetes, 19%; and mean estimated glomerular filtration rate, 79±20 mL/min per 1.73m
2
. Baseline systolic/diastolic office, home, and 24-hour ambulatory BP (mm Hg) were 169±21/106±13, 158±17/101±13, and 151±18/96±13, respectively. Patients were prescribed an average of 3.6±2.0 antihypertensive medications at baseline that remained unchanged through 6 months. Six months after RDN, the change in systolic BP (mm Hg) was −18.2±22.0, −9.4±13.8, and −9.7±16.8 for office, home, and 24-hour ambulatory measures, respectively (
CONCLUSIONS:
In this US postapproval study, the primary end point was met with significant BP reductions following radiofrequency RDN consistent across different measures. In a broader patient population with uncontrolled hypertension, these results reaffirm the safety and efficacy of radiofrequency RDN.
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