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IMPORTANCE: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment. OBJECTIVE: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension. DESIGN, SETTING, AND PARTICIPANTS: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms. INTERVENTIONS: Ultrasound renal denervation vs a sham procedure. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months. RESULTS: Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P

Supplemental material, sj-pdf-1-vmj-10.1177_1358863X231174052 for Patient and limb outcomes 10 years after endovascular revascularization of the superficial femoral artery for peripheral artery disease: The Boston Femoral Artery Endovascular Revascularization Outcomes (Boston FAROUT) study by Scott Kinlay, Piotr Sobieszczyk, Andrew C Eisenhauer, Simon Ostrowski and Thomas M Todoran in Vascular Medicine

OBJECTIVES This study sought to evaluate the image quality and diagnostic accuracy of noncontrast quiescent-interval single-shot (QISS) magnetic resonance angiography (MRA) versus iodine-contrast computed tomography angiography (CTA) in patients with peripheral artery disease (PAD), with invasive digital subtraction angiography (DSA) as the reference standard. BACKGROUND QISS is a recently introduced noncontrast MRA technique. Although the diagnostic accuracy of QISS is reportedly similar to that of contrast-enhanced MRA, its performance compared with contrast-enhanced CTA, the most frequently used noninvasive modality for evaluation of PAD, is unknown. METHODS Thirty patients (66 +/- 7 years of age) with PAD underwent lower extremity CTA with third-generation dual-source dual-energy CT and 1.5-T MRA using a prototype noncontrast QISS sequence. DSA was performed within 50 days. The abdominal aorta and lower extremity run-off were imaged. Eighteen arterial segments were analyzed. Subjective image quality (3-point Likert scale) and stenosis (5-point grading) were evaluated by 2 observers and compared using the Mann-Whitney U and chi-square tests, respectively. Sensitivity and specificity of MRA and CTA for > 50% stenosis detection were compared using the McNemar-test. RESULTS Of 540 segments, 15 (2.8%) and 42 (7.8%) inconclusive segments were excluded from MRA and CTA analysis, respectively (p = 0.0006). The DSA results were available for 410 of the remaining segments. Overall subjective image quality was rated similarly with QISS-MRA (2.52 [95% confidence interval: 2.46 to 2.57]) and CTA (2.49 [95% confidence interval: 2.43 to 2.55]; p = 0.5062). The sensitivity and specificity of MRA for > 50% stenosis were 84.9% and 97.2%, respectively, similar to those of CTA (87.3% and 95.4%, respectively). Interobserver agreement for stenosis detection was excellent for MRA (kappa > 0.81) and CTA (kappa > 0.81). CONCLUSIONS Noncontrast QISS-MRA provides high diagnostic accuracy compared with DSA, while being less prone to image artifacts than CTA. QISS better visualizes heavily calcified segments with impaired flow. QISS-MRA obviates the need for contrast administration in PAD patients. (C) 2017 by the American College of Cardiology Foundation.

Objectives This study sought to evaluate the image quality and diagnostic accuracy of noncontrast quiescent-interval single-shot (QISS) magnetic resonance angiography (MRA) versus iodine-contrast computed tomography angiography (CTA) in patients with peripheral artery disease (PAD), with invasive digital subtraction angiography (DSA) as the reference standard. Background QISS is a recently introduced noncontrast MRA technique. Although the diagnostic accuracy of QISS is reportedly similar to that of contrast-enhanced MRA, its performance compared with contrast-enhanced CTA, the most frequently used noninvasive modality for evaluation of PAD, is unknown. Methods Thirty patients (66 ± 7 years of age) with PAD underwent lower extremity CTA with third-generation dual-source dual-energy CT and 1.5-T MRA using a prototype noncontrast QISS sequence. DSA was performed within 50 days. The abdominal aorta and lower extremity run-off were imaged. Eighteen arterial segments were analyzed. Subjective image quality (3-point Likert scale) and stenosis (5-point grading) were evaluated by 2 observers and compared using the Mann–Whitney U and chi-square tests, respectively. Sensitivity and specificity of MRA and CTA for >50% stenosis detection were compared using the McNemar-test. Results Of 540 segments, 15 (2.8%) and 42 (7.8%) inconclusive segments were excluded from MRA and CTA analysis, respectively (p = 0.0006). The DSA results were available for 410 of the remaining segments. Overall subjective image quality was rated similarly with QISS-MRA (2.52 [95% confidence interval: 2.46 to 2.57]) and CTA (2.49 [95% confidence interval: 2.43 to 2.55]; p = 0.5062). The sensitivity and specificity of MRA for >50% stenosis were 84.9% and 97.2%, respectively, similar to those of CTA (87.3% and 95.4%, respectively). Interobserver agreement for stenosis detection was excellent for MRA (κ > 0.81) and CTA (κ > 0.81). Conclusions Noncontrast QISS-MRA provides high diagnostic accuracy compared with DSA, while being less prone to image artifacts than CTA. QISS better visualizes heavily calcified segments with impaired flow. QISS-MRA obviates the need for contrast administration in PAD patients.