Size of blood pressure reduction from renal denervation: insights from meta-analysis of antihypertensive drug trials of 4121 patients with focus on trial design: the CONVERGE report

Howard, James P.; Nowbar, Alexandra N.; Francis, Dárrel P.

doi:10.1136/heartjnl-2013-304238

Cited by 80 publications

(70 citation statements)

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“…identical to the reduction in 24-hour ambulatory blood pressure. If these results are transferred to the non-randomized/non-controlled denervation studies [10,17], one could thus expect a blood pressure reduction of approximately 13 mmHg in a randomized and controlled denervation study [18]. This is highly consistent with the results of a subgroup analysis of the Symplicity HTN-2 involving 20 patients who also underwent subsequent 24-hour ambulatory blood pressure monitoring.…”

Section: Discussionsupporting

confidence: 74%

“…A meta-analysis conducted by Howard et al [18] examined this discrepancy between blood pressure reduction according to office-based measurement and 24-hour monitoring in both pharmacological studies and renal denervation studies. In pharmacological studies, the reduction in blood pressure according to office measurements and according to 24-hour ambulatory monitoring became more similar as blinding and randomization increased (so-called regression-to-the-mean effect).…”

Section: Discussionmentioning

confidence: 99%

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Renal Denervation: Results of a Single-Center Cohort Study

Luetkens

Wilhelm

Düsing

et al. 2014

Fortschr Röntgenstr

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Purpose: To investigate the effect of renal denervation on office-based and 24-h ambulatory blood pressure measurements (ABPM) in a highly selective patient population with drug-resistant hypertension. Materials and Methods: Patients with drug resistant hypertension eligible for renal denervation were included in the study population. Office blood pressure and ABPM were assessed prior to and after renal denervation. To detect procedure related renal or renal artery damage, magnetic resonance imaging (MRI) and angiography (MRA) were performed pre-interventional, one day post-interventional, and one month after renal denervation. Results: Mean follow-up time between renal denervation and blood pressure re-assessment was 9.5???3.9 months. Between August 2011 and March 2013, 17 patients prospectively underwent renal denervation. Pre-interventional mean office blood pressure and ABPM were 177.3???20.3/103.8???20.4?mmHg and 155.2???20.5/93.7???14.5?mmHg, respectively. Post-interventional, office blood pressure was significantly reduced to 144.7???14.9/89.5???12.1 (p??0.05). The number of prescribed antihypertensive drugs was unchanged after renal denervation (4.7???2.0 vs. 4.2???1.2, p?=?0.18). No renovascular complications were detected in follow-up MRI. Conclusion: After renal denervation, no significant decrease in ABPM was observed. These results may indicate a limited impact of renal denervation for drug resistant hypertension. Key Points: ??Renal denervation showed no significant effects on 24-h ambulatory blood pressure measurements. ??A significant decrease in office blood pressure measurements may be explained by a potential detection bias. ??Renal artery alterations were not observed on follow-up MRI scans. Citation Format: ??Luetkens J. A., Wilhelm K., D?sing R. et?al. Renal Denervation: Results of a Single-Center Cohort Study. Fortschr R?ntgenstr 2015; 187: 36???41

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Section: Discussionsupporting

confidence: 74%

Section: Discussionmentioning

confidence: 99%

Renal Denervation: Results of a Single-Center Cohort Study

Luetkens

Wilhelm

Düsing

et al. 2014

Fortschr Röntgenstr

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“…A current meta-analysis was able to show that the office blood pressure was significantly lower (by 5.6 mmHg) than ambulatory blood pressure measurements in unblinded/ non-randomized pharmacological studies. This difference can no longer be detected after blinding and randomization [46]. The authors therefore predict that the blood pressure reduction due to renal denervation could be in the order of magnitude of 10 -15 mmHg [46].…”

Section: Blood Pressure Reductionmentioning

confidence: 98%

“…This difference can no longer be detected after blinding and randomization [46]. The authors therefore predict that the blood pressure reduction due to renal denervation could be in the order of magnitude of 10 -15 mmHg [46]. In a first analysis of the scarce data, no statistically significant difference regarding the frequency of cardiovascular events could be shown between patients treated by renal denervation and the control group treated with medication [33].…”

Section: Blood Pressure Reductionmentioning

confidence: 99%

Renal Denervation: Unde Venis et Quo Vadis?

Nähle

Düsing²,

Schild

2015

Fortschr Röntgenstr

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!Objective and Methods: Renal denervation is a minimally invasive, catheter-based option for the treatment of refractory hypertension. Indications and contraindications for renal denervation have been defined in an interdisciplinary manner. The efficacy and safety of the procedure were evaluated. Results: Currently, indication for renal denervation is limited to patients with primary hypertension and a systolic blood pressure of ≥ 160 mm Hg (or ≥ 150 mm Hg in diabetes type 2) despite optimal medical therapy with ≥ 3 different antihypertensive drugs. In this specific patient population, an average blood pressure reduction of 32/14 mmHg was observed in non-randomized/-controlled trials after renal denervation. These results were not confirmed in the first randomized controlled trial with a non-significantly superior blood pressure reduction of 14.1 ± 23.9 mm Hg compared to controls (−11.74 ± 25.94 mm Hg, difference −2.39 mm Hg p = 0.26 for superiority with a margin of 5 mm Hg) who underwent a sham procedure. Conclusion: The efficacy and long-term effects of renal denervation need to be re-evaluated in light of the HTN3 study results. To date, renal denervation should not be performed outside of clinical trials. Future trials should also assess if renal denervation can be performed with sufficient safety and efficacy in patients with hypertension-associated diseases. The use of renal denervation as an alternative therapy (e. g. in patients with drug intolerance) can currently not be advocated. Key points:▶ The indication for renal denervation should be assessed in an interdisciplinary fashion and according to current guidelines with a special focus on ruling out secondary causes for arterial hypertension.▶ 5 -10 % of patients with hypertension suffer from refractory hypertension, but only about 1 % of patients meet the criteria for a renal denervation.▶ Renal denervation leads to a significant decrease in office blood pressure; however, the impact on 24-hour blood pressure measurements remains unclear.▶ In the first randomized controlled trial on renal denervation with a control group undergoing a sham procedure, blood pressure reduction failed to reach the anticipated level of superiority over best medical treatment.▶ Periprocedural complications are rare, but long-term safety can currently not be appraised due to the limited data available. Review 237Nähle CP et al.

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“…Although the discrepancy in office and ambulatory BP reduction may be the result of a failure to exclude white coat hypertension, similar discrepancies in antihypertensive drug trials have been because of a lack of blinding and lack of placebo control. 84 As a result, institution of blinding and placebo control in trial design has attenuated office BP reductions and has left ambulatory BP reductions unchanged in antihypertensive drug trials.…”

Section: Interventional Therapy: Device Based Sympathetic Modulationmentioning

confidence: 99%

Apparent Treatment-Resistant Hypertension and Chronic Kidney Disease: Another Cardiovascular-Renal Syndrome?

Vemulapalli

Tyson

Svetkey

2014

Advances in Chronic Kidney Disease

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To identify patients at increased risk of cardiovascular (CV) outcomes, apparent treatment-resistant hypertension (aTRH) is defined as having a blood pressure above goal despite the use of 3 or more antihypertensive therapies of different classes at maximally tolerated doses, ideally including a diuretic. Recent epidemiologic studies in selected populations estimated the prevalence of aTRH as 10% to 15% among patients with hypertension and that aTRH is associated with elevated risk of CV and renal outcomes. Additionally, aTRH and CKD are associated. Although the pathogenesis of aTRH is multifactorial, the kidney is believed to play a significant role. Increased volume expansion, aldosterone concentration, mineralocorticoid receptor activity, arterial stiffness, and sympathetic nervous system activity are central to the pathogenesis of aTRH and are targets of therapies. Although diuretics form the basis of therapy in aTRH, pathophysiologic and clinical data suggest an important role for aldosterone antagonism. Interventional techniques, such as renal denervation and carotid baroreceptor activation, modulate the sympathetic nervous system and are currently in phase III trials for the treatment of aTRH. These technologies are as yet unproven and have not been investigated in relationship to CV outcomes or in patients with CKD.

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Size of blood pressure reduction from renal denervation: insights from meta-analysis of antihypertensive drug trials of 4121 patients with focus on trial design: the CONVERGE report

Cited by 80 publications

References 71 publications

Renal Denervation: Results of a Single-Center Cohort Study

Renal Denervation: Results of a Single-Center Cohort Study

Renal Denervation: Unde Venis et Quo Vadis?

Apparent Treatment-Resistant Hypertension and Chronic Kidney Disease: Another Cardiovascular-Renal Syndrome?

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