用于治疗难治性高血压的髂内动静脉吻合术：ROX CONTROL HTN试验的一年结果
Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial.
作者信息
Lobo Melvin D, Ott Christian, Sobotka Paul A, Saxena Manish, Stanton Alice, Cockcroft John R, Sulke Neil, Dolan Eamon, van der Giet Markus, Hoyer Joachim, Furniss Stephen S, Foran John P, Witkowski Adam, Januszewicz Andrzej, Schoors Danny, Tsioufis Konstantinos, Rensing Benno J, Scott Benjamin, Ng G André, Schmieder Roland E
机构信息
From the NIHR Biomedical Research Centre at Barts, William Harvey Research Institute, London, United Kingdom (M.D.L., M.S.); Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany (C.O.); Cardiovascular Medicine, Ohio State University, Columbus (P.A.S.); ROX Medical, Inc, San Clemente, CA (P.A.S.); Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland Medical School, Dublin (A.S.); Department of Cardiology, Columbia Presbyterian Hospital, New York, NY (J.R.C.); Cardiology Department, Eastbourne District General Hospital, East Sussex, United Kingdom (N.S.); Department of Medicine for the Elderly, Connolly Hospital, Dublin, Ireland (E.D.); Department of Endocinrology and Nephrology, Universitätsmedizin Berlin, Germany (M.v.d.G.); Department of Internal Medicine and Nephrology, Universitätsklinikum Marburg, Germany (J.H.); Department of Cardiology, East Sussex Healthcare NHS Trust, United Kingdom (S.S.F.); Cardiac Department, Royal Brompton Hospital, London, United Kingdom (J.P.F.); Cardiology Department, St Helier Hospital, Surrey, United Kingdom (J.P.F.); Department of Interventional Cardiology and Angiology (A.W.) and Department of Hypertension (A.J.), Institute of Cardiology, Warsaw, Poland; Department of Cardiology, Universitair Ziekenhuis Brussel, Belgium (D.S.); Department of Cardiology, Hippokration General Hospital of Athens, Greece (K.T.); Department of Cardiology, St Antonius Ziekenhuis, Nieuwegein, The Netherlands (B.J.R.); Department of Cardiology, ZNA-Cardio Middelheim, Antwerp, Belgium (B.S.); Department of Cardiovascular Sciences, NIHR Leicester Cardiovascular Biomedical Research Unit, University of Leicester, Glenfield Hospital, United Kingdom (G.A.N.); and Department of Nephrology and Hypertension, Universitätsklinikum Erlangen, Germany (R.E.S.).
出版信息
Hypertension. 2017 Dec;70(6):1099-1105. doi: 10.1161/HYPERTENSIONAHA.117.10142. Epub 2017 Oct 23.
UNLABELLED
Creation of a central iliac arteriovenous anastomosis using a novel nitinol coupler device results in an immediate, significant reduction of blood pressure (BP). We present efficacy and safety findings at 12 months post-coupler insertion. This open-label, multicenter, prospective, randomized trial enrolled patients with a baseline office systolic BP ≥140 mm Hg and average daytime ambulatory BP ≥135/85 mm Hg. Subjects were randomly allocated to coupler implantation and continuing previous pharmacotherapy or to maintain previous treatment alone. At 12 months, 39 patients who had coupler therapy were included in the intention-to-treat analysis. Office-based systolic BP reduced by 25.1±23.3 mm Hg (baseline, 174±18 mm Hg; <0.0001) post-coupler placement, and office diastolic BP reduced by 20.8±13.3 mm Hg (baseline, 100±13 mm Hg; <0.0001). Mean 24-hour ambulatory BP reduced by 12.6±17.4/15.3±9.7 mm Hg (<0.0001 for both). In a prespecified subset of patients who failed to respond adequately to prior renal denervation, coupler therapy led to highly significant reduction in office systolic/diastolic BP (30.7/24.1 mm Hg) and significant reduction in 24-hour ambulatory systolic/diastolic BP (12.4/14.4 mm Hg) at 12 months (n=9). After coupler therapy, 14 patients (33%) developed ipsilateral venous stenosis; all were treated successfully with venous stenting. These findings confirm the importance of arterial mechanics in the pathophysiology of hypertension and support the clinical use of a central iliac arteriovenous anastomosis.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.
未标注
使用新型镍钛诺耦合器装置创建髂总动静脉吻合术可立即显著降低血压（BP）。我们展示了耦合器植入后12个月的疗效和安全性结果。这项开放标签、多中心、前瞻性、随机试验纳入了基线诊室收缩压≥140 mmHg且平均日间动态血压≥135/85 mmHg的患者。受试者被随机分配接受耦合器植入并继续之前的药物治疗，或仅维持之前的治疗。12个月时，39例接受耦合器治疗的患者纳入意向性分析。耦合器放置后，诊室收缩压降低了25.1±23.3 mmHg（基线值为174±18 mmHg；<0.0001），诊室舒张压降低了20.8±13.3 mmHg（基线值为100±13 mmHg；<0.0001）。平均24小时动态血压降低了12.6±17.4/15.3±9.7 mmHg（两者均<0.0001）。在预先指定的对先前肾去神经支配反应不足的患者亚组中，耦合器治疗在12个月时导致诊室收缩压/舒张压显著降低（30.7/24.1 mmHg），24小时动态收缩压/舒张压显著降低（12.4/14.4 mmHg）（n = 9）。耦合器治疗后，14例患者（33%）出现同侧静脉狭窄；所有患者均通过静脉支架置入成功治疗。这些发现证实了动脉力学在高血压病理生理学中的重要性，并支持髂总动静脉吻合术的临床应用。
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