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Published on: May 26, 2022
Long-term clinical benefit after radiofrequency renal denervation: pooled 36-month results from the SPYRAL Clinical
David E Kandzari1, Michael Böhm2, Roland E Schmieder3
1Piedmont Heart Institute, Atlanta, GA, USA.
Insights
Radiofrequency renal denervation (RF-RDN) significantly lowered blood pressure (BP) in uncontrolled hypertension patients over 36 months. Nearly 90% of patients experienced clinical benefit, demonstrating long-term efficacy and safety.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Nephrology
Background:
- Catheter-based renal denervation (RDN) is a guideline-recommended therapy for uncontrolled hypertension.
- Long-term follow-up is crucial to assess the durability of RDN efficacy.
- Further studies are needed to determine the proportion of patients benefiting clinically from RDN.
Purpose of the Study:
- To evaluate 36-month blood pressure (BP) changes following radiofrequency (RF)-RDN.
- To determine the proportion of patients achieving a clinical benefit after RF-RDN.
- Pooled data from four SPYRAL programme studies were analyzed.
Main Methods:
- Data from 2,137 patients treated with RF-RDN (Symplicity Spyral) were pooled.
- Office and 24-hour ambulatory BP, and antihypertensive medication use were assessed up to 36 months.
- Adverse events were monitored throughout the study period.
Main Results:
- Significant reductions in office systolic BP (-18.1±23.4 mmHg) and 24-hour ambulatory systolic BP (-13.3±17.6 mmHg) were observed at 36 months (p<0.0001).
- Antihypertensive medication use decreased slightly from 3.8±2.1 to 3.5±1.9.
- 88% of patients achieved a clinical benefit, defined as a reduction in office systolic BP ≥10 mmHg, ambulatory systolic BP ≥5 mmHg, and/or ≥1 medication.
Conclusions:
- Radiofrequency RDN demonstrated significant and durable BP reductions up to 36 months in a broad patient population.
- The procedure was associated with a low rate of adverse events, indicating a favorable safety profile.
- Nearly 90% of patients experienced a clinical benefit, supporting the long-term efficacy of RF-RDN for uncontrolled hypertension.
Background:
Catheter-based renal denervation (RDN) is a guideline-recommended therapy for uncontrolled hypertension. Late-term follow-up among RDN trials is essential to characterise the durability of its efficacy, and further study is needed to ascertain the proportion of patients experiencing a clinical benefit.
Aims:
We aimed to evaluate 36-month blood pressure (BP) changes after radiofrequency (RF)-RDN across four clinical studies from the SPYRAL programme and to determine the proportion of patients who experienced a clinical benefit.
Methods:
Data were pooled from the Global SYMPLICITY Registry DEFINE, SPYRAL First-In-Human, and SPYRAL HTN-OFF MED and -ON MED trials. All patients were treated with RF-RDN (Symplicity Spyral). Medications, BP changes, and adverse events were evaluated through 36 months.
Results:
A total of 2,137 patients treated with RF-RDN using the Spyral device were included in the analysis. Baseline office systolic (OS)BP was 163±23 mmHg, baseline 24-hour ambulatory systolic (AS)BP was 152±17 mmHg, and the baseline number of antihypertensive medications was 3.8±2.1. At 36 months, the number of medications was 3.5±1.9, and reductions in OSBP and ASBP were significant (-18.1±23.4 mmHg and -13.3±17.6 mmHg, respectively; p<0.0001). Overall, adverse event rates were low. The proportion of patients who experienced a reduction in OSBP ≥10 mmHg, ASBP ≥5 mmHg, and/or ≥1 medication was 88% at 36 months.
Conclusions:
In this large, pooled cohort of Spyral RF-RDN patients, there were significant BP reductions through 36 months with few adverse events. Additionally, nearly 9 out of 10 patients experienced a clinical benefit. These findings suggest the long-term efficacy and safety of RF-RDN across a broad spectrum of patients with uncontrolled hypertension.
