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).
A 37-year-old woman was transferred with hypotension after sudden chest oppression associated with emotional stress. The electrocardiogram showed ST-segment elevation in the whole lead except aV R , and troponin T was positive. Therefore, she received emergent catheterization for acute coronary syndrome. Initial coronary angiography revealed severe vessel spasm in all coronaries (A, Online Videos 1 and 2). After intracoronary nitroglycerin administration, all coronary arteries normalized (B, Online Videos 3 and 4), and STsegment elevation also returned to baseline. However, typical apical ballooning and midventricular wall motion abnormality in end-systolic phase of left ventriculography remained (C and D, Online Video 5). Echocardiography 6 months later demonstrated normalization of left ventricular wall motion. The clinical features of the apical ballooning syndrome (Takotsubo cardiomyopathy) is acute heart failure, sometimes critical, but the etiology has not been clarified. The current typical case was able to document global coronary spasm, which might explain the cause of this syndrome.
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