Abstract P154: Win Ratio Methodology Demonstrates Consistency Of Benefit Across Different Blood Pressure Reduction Thresholds Following Renal Denervation In The Spyral Htn-on Med Pilot Study

Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
David E Kandzari ◽  
Stuart Pocock ◽  
Michael A Weber ◽  
Michael Boehm ◽  
Martin Fahy ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Pilot Study ◽  
Renal Denervation ◽  
Blood Pressure Reduction ◽  
Ratio Analysis ◽  
Statistical Methodology ◽  
Sham Control ◽  
Antihypertensive Medications ◽  
Trial Outcomes ◽  
Opposing Group

Objective: The win ratio is a statistical methodology to evaluate clinical trial outcomes using multiple hierarchical endpoints. We applied the win ratio to patients in SPYRAL HTN-ON MED pilot study to quantify potential differences in renal denervation (RDN) efficacy utilizing different blood pressure (BP) reduction thresholds. Methods: In the SPYRAL HTN-ON MED pilot study, patients were enrolled with office systolic BP (OSBP) ≥150 mmHg and <180 mmHg, office diastolic BP ≥90 mmHg, and mean 24-hour ambulatory systolic BP (ASBP) ≥140 mmHg and <170 mmHg despite 1 to 3 antihypertensive medications. Patients were randomized 1:1 to RDN or sham procedure. For the win ratio analysis, each RDN patient was compared with every sham control patient in the opposing group first according to ASBP to determine “win”, “lose” or “tie” with a threshold of 5 mmHg. Then, ties from the ASBP comparison underwent the comparison using OSBP with a threshold of 10 mmHg. Any tie for a pair comparing OSBP resulted in comparison of any reduction in anti-hypertensive medication burden. The win ratio analysis was repeated using thresholds of 3.5 mmHg for ASBP change, 5 mmHg for OSBP change and any net change in medication burden. Results: The calculated win ratio favored RDN: 2.78 (95% CI: 1.58, 5.48, p<0.001), using thresholds of 5 mmHg for ASBP change, 10 mmHg for OSBP change, and any net change in medication burden, all at 6 months. To test the sensitivity of the analysis, the BP thresholds were changed to 3.5 mmHg for ASBP and 5 mmHg for OSBP, and the win ratio analysis was repeated, resulting in a win ratio again in favor of RDN of 2.68 [1.58, 5.00], p<0.001. Conclusions: Win ratio methodology applied to the SPYRAL HTN-ON MED pilot study demonstrated that RDN was associated with a 2.6-2.8 times greater likelihood of BP or drug reduction compared with sham patients when evaluated across different BP reduction thresholds at 6 months.

scholarly journals Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial

2021 ◽  
Author(s):  
Kazuomi Kario ◽  
Yoshiaki Yokoi ◽  
Keisuke Okamura ◽  
Masahiko Fujihara ◽  
Yukako Ogoyama ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Blood Pressure Reduction ◽  
Control Group ◽  
Pressure Reduction ◽  
Sham Control ◽  
Sham Procedure ◽  
Significant Difference

Abstract Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (−6.6 mmHg) and sham control (−6.5 mmHg) groups (difference: −0.1, 95% confidence interval −5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: –1.8 mmHg [p = 0.488] and −2.0 mmHg [p = 0.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial. Clinical trial registration NCT02918305 (http://www.clinicaltrials.gov).

Abstract 65: Effects of Immediate Blood Pressure Reduction on Two-Year Mortality and Major Disability in Patients With Acute Ischemic Stroke

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jiang He ◽  
Yonghong Zhang ◽  
Tan Xu ◽  
Dali Wang ◽  
Chung-Shiuan Chen ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Ischemic Stroke ◽  
Treatment Group ◽  
Acute Ischemic Stroke ◽  
Antihypertensive Treatment ◽  
Blood Pressure Reduction ◽  
Control Group ◽  
Antihypertensive Medications ◽  
Vascular Events

Although elevated blood pressure (BP) is very common in patients with acute ischemic stroke, the management of hypertension among them remains controversial. We tested the effect of immediate BP reduction on two-year mortality and major disability in acute ischemic stroke patients. The China Antihypertensive Trial in Acute Ischemic Stroke, a randomized, single-blind, blinded end-points trial, was conducted in 4,071 patients with ischemic stroke within 48 hours of onset and elevated systolic BP (SBP). Patients were randomly assigned to receive antihypertensive treatment (n=2,038) or to discontinue all antihypertensive medications (n=2,033) during hospitalization. Post-treatment follow-ups were conducted at 3, 12, and 24 months after hospital discharge. The primary outcome was a composite of death and major disability at the two-year follow-up visit. Mean SBP was reduced by 21.8 in the treatment group and 12.7 mm Hg in the control group within 24 hours after randomization (P<0.001). Mean SBP was 137.3 mm Hg in the treatment group and 146.5 in the control group at day 7 after randomization (P<0.001). At two-year follow-up, study outcomes were obtained in 1945 (95.4%) participants in the treatment group and 1925 (94.7%) in the control group. 78.8% of the patients in the treatment group and 72.6% in the control group reported the use of antihypertensive medications (p<0.001). SBP was 138.8 mmHg in the antihypertensive treatment group and 139.7 in the control group (p=0.02). Among patients in the antihypertensive treatment group, 24.5% (476/1945) died or had a major disability, compared with 22.1% (425/1925) in the control group (odds ratio 1.14 [95% CI 0.99 to 1.33], p=0.078). Hazard ratios for all-cause mortality (1.01 [0.81, 1.25], p=0.95), recurrent stroke (0.91 [0.73, 1.13], p=0.40), and vascular events (0.97 [0.79, 1.19], p=0.76) were not statistically significant comparing the antihypertensive treatment group to the control group. The effect of antihypertensive treatment did not differ by pre-defined subgroups. In conclusion, among patients with acute ischemic stroke, BP reduction with antihypertensive medications during hospitalization did not reduce or increase the composite outcome of death and major disability over two years.

scholarly journals TIME COURSE OF BLOOD PRESSURE REDUCTION AFTER RENAL DENERVATION

2013 ◽  
Vol 61 (10) ◽  
pp. E1378
Author(s):  
Willemien Verloop ◽  
Eva E. Vink ◽  
Peter J. Blankestijn ◽  
Evert-Jan Vonken ◽  
Pieter A. Doevendans ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Renal Denervation ◽  
Time Course ◽  
Blood Pressure Reduction ◽  
Pressure Reduction

scholarly journals Long-term benefit of renal denervation on blood pressure control in a patient with hemorrhagic stroke

2019 ◽  
Vol 7 ◽  
pp. 2050313X1987097
Author(s):  
Francesco Versaci ◽  
Giuseppe Andò ◽  
Marcello Chiocchi ◽  
Francesco Romeo
Keyword(s):  
Blood Pressure ◽  
Renal Denervation ◽  
Hemorrhagic Stroke ◽  
Blood Pressure Reduction ◽  
Pressure Control ◽  
Refractory Hypertension ◽  
Sustained Efficacy ◽  
Term Benefit

A 49-year-old man with malignant hypertension had been admitted with hemorrhagic stroke. Refractory hypertension had been observed during hospitalization and the decision had been made to perform renal denervation. A significant blood pressure reduction was obtained immediately after renal denervation and persists at 2-year follow-up. This case demonstrates the long-term sustained efficacy of renal denervation performed in the acute phase of hemorrhagic stroke. In addition, it supports the notion that renal denervation–induced normalization of blood pressure may contribute to better outcomes in a challenging setting such as intracranial bleeding.

scholarly journals THE EFFECTS OF TRANSCATHETER RENAL DENERVATION ON BLOOD PRESSURE AND BRAIN STRUCTURAL CHANGES IN RESISTANT HYPERTENSION

2013 ◽  
Vol 19 (3) ◽  
pp. 256-262 ◽  
Author(s):  
N. L. Afanasieva ◽  
S. E. Pekarskiy ◽  
V. F. Mordovin ◽  
G. V. Semke ◽  
T. M. Ripp ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Magnetic Resonance ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Single Case ◽  
Blood Pressure Reduction ◽  
Magnetic Resonance Tomography ◽  
Lateral Ventricles ◽  
The Brain

Objective.To study the changes of 24-hour blood pressure parameters and brain structure at follow-up after transcatheter renal denervation in resistant hypertension.Design and methods.We enrolled patients with verified resistant hypertension undergoing an intervention that included 4–8 applications of radiofrequency discharge in both renal arteries using a standard catheter5 F under the controlled temperature regimen (60 С0, 8 Watt, 2-minute application). The efficiency of the intervention was assessed by the office and 24-hour blood pressure decrease within 6 months after intervention. All subjects underwent magnetic resonance tomography («Magnetom-OPEN», «Siemens AG», Germany).Results.By the time of statistical analysis 45 subjects underwent renal denervation, there was not a single case of renal artery damage. At six-month follow-up a significant reduction of office blood pressure (-34,8/-17,2 mmHg; p < 0,00001/0,00001), and mean 24-hour blood pressure (-11,1/-7,1 mmHg; p < 0,001/0,001) was found. No increase of encephalopathy signs by magnetic resonance tomography was found. At the same time there was a reduction of the linear size of lateral ventricles of the brain, subarachnoid space, III ventricle of the brain, liquor volume in the lateral ventricles of the brain.Conclusions.Renal denervation is a safe method resulting in effective blood pressure reduction in resistant hypertension. It is associated with the positive changes of encephalopathy and liquor dynamics according to the magnetic resonance tomography. 

Abstract P013: Meta-analysis of Poor Outcomes and Permissive Hypertension after Acute Ischemic Stroke

Hypertension ◽  
2015 ◽  
Vol 66 (suppl_1) ◽  
Author(s):  
Alexander Ivanov ◽  
Ambreen Mohamed ◽  
Alex Korniyenko
Keyword(s):  
Blood Pressure ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Meta Analysis ◽  
Blood Pressure Reduction ◽  
Random Effect ◽  
Random Effect Model ◽  
Pressure Reduction ◽  
Antihypertensive Medications ◽  
All Cause Mortality

Background: Stroke is the leading cause of long term disability and second leading cause of death worldwide. The effectiveness of primary and secondary prevention of stroke by antihypertensive medications is well validated, however, support for permissive hypertension in the early course of acute ischemic stroke (AIS) has been questioned. Materials and methods: We searched Pubmed, Embase, and Cochrane databases to identify RCTs comparing different blood pressure reduction regimens with placebo in AIS patients within 48 hours after symptom onset and sample size of 100 or more patients. We excluded studies that do not report mortality or functional outcomes at the end of follow up. The main outcomes were all-cause mortality and death or severe morbidity which was defined as: modified Rankin Score >2 or Bartel ADL index<60, Glasgow outcome scale3, Mathew Impairment Scale <14. Relative risks (RR) and corresponding 95% confidence intervals (CI) were calculated using random-effect model. Results: In our analysis we included 20 trials involving 17,209 patients. There was no difference in all-cause mortality RR 1.04 (95% CI 0.95-1.13), p=0.4 nor in mortality or severe disability RR 1.03 (95% CI 0.99-1.08), p=0.16 between active blood pressure reduction and permissive hypertension strategy. There was no evidence of heterogeneity between studies for both outcomes I 2 =2.6% and I 2 =14.1% , p for heterogeneity =0.42 and =0.27, respectively. Conclusion: Use of antihypertensive therapy in acute period of ischemic stroke does not have an effect on disability or all-cause mortality.

Sign in / Sign up

Export Citation Format

Share Document