Skip to main content
  • Editorial: Meta-Analysis in Renal Denervation – Or How to Compare Apples With Oranges?

    Hypertension is the most prevalent cardiovascular risk factor worldwide and represents a leading cause of premature death and disability  . Despite the availability of effective lifestyle interventions and antihypertensive drugs, more than half of individuals with hypertension in the United States (almost 30 million individuals) are estimated to have blood pressure above guideline-recommended targets  . Against this background, several device-based hypertension therapies have been developed and studied lately, of which renal denervation (RDN) has emerged to the most advanced and favorable technology  . To date, various studies investigating the safety and efficacy of catheter-based RDN in uncontrolled hypertension have been published, ranging from large international registries to observational, non-randomized, feasibility studies and randomized, blinded, sham-controlled, pivotal trials. The early proof-of-concept studies (SYMPLICITY HTN-1  and SYMPLICITY HTN-2  ) showed exuberant blood pressure reductions in patients with apparent resistant hypertension on multiple antihypertensive drugs. The results of the first randomized, sham-controlled trial - SYMPLICITY HTN-3 - in patients with severely uncontrolled hypertension, however, caused abrupt disillusionment after the lack of demonstrable efficacy of first-generation radio-frequency RDN compared with invasive placebo treatment alone  . On closer inspection, several methodological shortcomings were identified, which have extensively been described elsewhere  , in particular the lack of circumferential ablation of the renal arteries and, for example, fluctuations in adherence to antihypertensive medication during the study. These confounding factors were systematically analyzed and addressed by international expert consensus groups, which provided recommendations for the design and conduct of new studies in RDN, the so-called second-generation studies. This has finally led to the publication of the randomized, sham-controlled SPYRAL HTN-OFF MED pivotal trial  . Here, 331 patients with known hypertension but without antihypertensive therapy were included, of whom 165 patients were assigned to radio-frequency RDN and 166 patients to an invasive placebo (sham procedure). The primary endpoint of the trial was met with a difference of −4.0 mmHg in 24-h ambulatory systolic blood pressure between groups (95% confidence interval [CI] −6.1 to −1.8 mmHg, p < 0.001)  . This pivotal trial is one of four randomized, sham-controlled studies demonstrating that radio-frequency (SPYRAL HTN-ON MED  ) and ultrasound-based (RADIANCE-HTN SOLO  and TRIO  ) RDN can safely and significantly reduce BP in patients without concomitant antihypertensive agents but also in combination with 1, 2, or 3 antihypertensive drugs. Given the availability of multiple scientific studies addressing the same question, with each individual study reporting measurements that are expected to have some degree of error, a meta-analysis appears reasonable to achieve a more precise estimate of the treatment efficacy and safety of RDN  .

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details