Publications

OBJECTIVES

The authors performed an updated meta-analysis of randomized placebo-controlled trials of renal denervation and specifically compared the effect of renal denervation in patients taking medications and in those not taking medications.

BACKGROUND

Renal denervation has now undergone several blinded placebo-controlled trials, covering the spectrum from patients with drug-resistant hypertension to those not yet taking antihypertensive medications.

METHODS

All blinded placebo-controlled randomized trials of catheter-based renal sympathetic denervation for hypertension were systematically identified, and a random-effects meta-analysis was performed. The primary efficacy outcome was the change in ambulatory systolic blood pressure beyond the effect of the placebo procedure. Analysis was stratified by whether there was background antihypertensive medication use.

RESULTS

There were 7 eligible trials, totaling 1,368 patients. Denervation significantly reduced ambulatory systolic (mean difference -3.61 mm Hg; 95% CI: -4.89 to -2.33 mm Hg; P < 0.0001), ambulatory diastolic (-1.85 mm Hg; 95% CI: -2.78 to -0.92 mm Hg; P < 0.0001), office systolic (-5.86 mm Hg; 95% CI: -7.77 to -3.94 mm Hg; P < 0.0001), and office diastolic (-3.63 mm Hg; 95% CI: -4.77 to -2.50; P < 0.0001) blood pressure. There was no evidence that the use of concomitant antihypertensive medication had a significant impact on the effect of denervation on any of these endpoints (P = NS for each comparison).

CONCLUSIONS

The randomized placebo-controlled trials show consistently that renal denervation provides significant reduction in ambulatory and office blood pressure. Although the magnitude of benefit, about 4/2 mm Hg, is modest, it is similar between patients on background antihypertensive medications and those who are not. Denervation could therefore be a useful strategy at various points for patients who are not willing to add antihypertensive agents. Whether the effect changes with time is currently unknown.

The present study aims to estimate a pooled hazard ratio (HR) comparing overall survival (OS) for salvage surgery compared to nonsurgical management of recurrent head and neck squamous cell carcinoma (HNSCC). PubMed/MEDLINE and Embase-Ovid were searched on March 5, 2020, for English-language articles reporting survival for salvage surgery and nonsurgical management of recurrent HNSCC. Meta-analysis of HR estimates using random effects model was performed. Fifteen studies reported survival for salvage surgery and nonsurgical management of recurrence. Five-year OS ranged from 26% to 67% for the salvage surgery groups, compared to 0% to 32% for the nonsurgical management groups. Six studies reported HRs comparing salvage surgery to nonsurgical management; the pooled HR was 0.25 (95% CI [0.16, 0.38]; p < 0.0001). Selection for salvage surgery was associated with one quarter of the mortality rate associated with nonsurgical management in light of confounding factors including subsite and treatment intent.