SAN DIEGO, CA\u2014Renal denervation is a safe and effective treatment for reducing blood pressure in a population of real-world patients with uncontrolled hypertension, the SPYRAL-AFFIRM postapproval study shows.<\/p>\n\n\n\n
Office systolic and diastolic blood pressure was reduced by 18.2 and 10.2 mmHg, respectively, six months after treatment with the Symplicity Spyral renal denervation system (Medtronic). The treatment was effective across multiple predefined subgroups, including Black and Hispanic patients, older patients, and those with type 2 diabetes and chronic kidney disease.<\/p>\n\n\n\n
David Kandzari, MD (Piedmont Heart Institute, Atlanta, GA), who presented the results at TCT 2026, acknowledged that the reduction in blood pressure may seem “exceptionally high” compared with the sham-controlled, randomized clinical trials, but the US postapproval study was intended to be representative of a less-selected patient population. For example, 25% had an office systolic blood pressure exceeding 180 mmHg, which was the upper boundary for inclusion in the sham-controlled trials. Additionally, more than half of the SPYRAL-AFFIRM patients were prescribed four or more antihypertensive medications.<\/p>\n\n\n\n
“We know that the higher severity of blood pressure is associated with a greater reduction in blood pressure following renal denervation,” said Kandzari.<\/p>\n\n\n\n
The Symplicity Spyral renal denervation system was greenlit by the Food and Drug Administration in 2023, although the path to approval had been rocky. Early enthusiasm for renal denervation faltered after SYMPLICITY HTN-3<\/a>, the first sham-controlled trial, failed to replicate the results of the earlier single-arm studies. The SPYRAL HTN-ON MED<\/a> trial, which was hampered by the COVID-19 pandemic, also missed its primary endpoint. The SPYRAL HTN-OFF MED<\/a> did show that renal denervation effectively lowered blood pressure compared with a sham procedure in patients not on medication for uncontrolled hypertension.<\/p>\n\n\n\n “It has indeed been a long journey traveled, in part because of developing the evidence that demonstrates the safety and efficacy of this therapy,” said Kandzari.<\/p>\n\n\n\n To Cardiology Now News<\/em>, Kandzari noted that while the postapproval study includes just 6-month follow-up, other data show that renal denervation is durable. Longer-term follow-up, out to 3 years<\/a> and beyond, shows sustained, if not amplified, reductions in blood pressure, said Kandzari. There is also data in select patients showing that the blood-pressure reductions are sustained a decade out<\/a> from the procedure, he said.<\/p>\n\n\n\n Continued Evidence Development<\/strong><\/p>\n\n\n\n SPYRAL-AFFIRM, the single-arm, postapproval study required by the FDA, enrolled 987 international patients with uncontrolled hypertension, defined as office blood pressure \u2265 140\/90 mmHg and home blood pressure 135 mmHg or greater. The new analysis focused on the 594 patients treated at 73 US sites (mean age 56.5 years; 45.3% female).<\/p>\n\n\n\n At baseline, the mean office, home, and 24-hour blood pressures were 169\/106, 158\/101, and 151\/96 mmHg, respectively.<\/p>\n\n\n\n At 6 months, the reduction in office systolic blood pressure met the prespecified performance goal, which was set at a 6.0-mmHg reduction from baseline (P<\/em> < 0.001). Home and 24-hour systolic blood pressure was reduced by 9.4 and 9.7 mmHg, respectively. Home and office diastolic blood pressure was reduced by 6.3 and 6.4 mmHg, respectively. In all, 86.1% experienced a more than 10-mmHg reduction in office blood pressure and\/or a more than 5-mmHg reduction in home blood pressure (and\/or a reduction of more than one antihypertensive medication).<\/p>\n\n\n\n As noted, the reduction in office and home systolic blood pressure was consistent across multiple subgroups. Treatment was also safe, with vascular complications occurring in 1% of treatment patients, renal artery reintervention in 0.2%, and hospitalization for hypertensive crisis\/emergency in 0.9% at 6 months. <\/p>\n\n\n\n Clyde Yancy, MD (Northwestern University Feinberg School of Medicine, Chicago, IL), the discussant following the late-breaking presentation, noted that while the postapproval study lacks a sham-control comparator, “what makes this interesting beyond just curious is the inclusion of a more complex patient profile.”<\/p>\n\n\n\n Yancy noted that patients were treated with a mean of 3.6 antihypertensive medications, and that SPYRAL-AFFIRM includes a population that physicians are frequently seeing in clinical practice, including those with diabetes, renal insufficiency, and obesity.<\/p>\n\n\n\n “We have to remember that hypertension is the leading cardiovascular condition worldwide,” said Yancy. “It is causal for cardiac dysfunction, heart failure, and it is an important risk factor for ischemic heart disease. It is imperative that we understand how to best treat hypertension.”<\/p>\n\n\n\n