This article is more than 5 years old. Information may no longer be current.
CONTROL-HTN: Mechanical device improved BP in patients with resistant arterial hypertension
Click Here to Manage Email Alerts
Patients with treatment-resistant arterial hypertension had significant reductions in office-measured and ambulatory BP following arteriovenous anastomosis with a mechanical device, according to results from the CONTROL-HTN study presented at VIVA 14.
Researchers for the prospective, controlled, blinded, multicenter study evaluated 83 patients with treatment-resistant hypertension. The patients were randomly assigned to undergo arteriovenous anastomosis with the Rox Coupler (Rox Medical), a mechanical device designed for the treatment of arterial hypertension, or a control procedure. During treatment, the nitinol Rox Coupler is placed to create a fixed arteriovenous anastomosis between the artery and external iliac vein to improve arterial compliance and decrease vascular resistance.
Eamon Dolan, MD, from Connolly Hospital in Dublin, reported 6-month data from an intent-to-treat analysis of 43 patients in the device group and 35 in the control group at VIVA 14.
The device was successfully implanted in 97.7% of patients. The device group exhibited a significant reduction in office-measured BP compared with the control group. The researchers observed a similar reduction in 24-hour ambulatory BP, with significantly greater improvement in both systolic (P=.0041) and diastolic BP (P<.0001) in the device group from baseline to 6 months.
Compared with baseline, maximum BP values at 6 months were significantly lower in the device group at all evaluated time points, including daytime (192.6 mm Hg systolic and 120.1 mm Hg diastolic BP at baseline vs. 174.3 mm Hg and 99.1 mm Hg at 6 months), night (161.8 mm Hg systolic and 96 mm Hg diastolic at baseline vs. 151.1 mm Hg and 85.8 mm Hg at 6 months) and 24-hour assessments (194.2 mm Hg systolic and 120.9 mm Hg diastolic at baseline vs. 176.5 mm Hg and 100.3 mm Hg at 6 months; P<.05 for all).
Researchers also noted a decrease in the variability of systolic and diastolic BP, particularly during the daytime, which may reduce potential damage caused by BP extremes, according to a press release.
The Rox Coupler is not available for commercial use in the United States, but has received CE mark approval in Europe.
For more information:
Dolan E. Late-Breaking Clinical Trials. Presented at: VIVA 2014; Nov. 4-7, 2014; Las Vegas.
Disclosure: Cardiology Today could not confirm relevant financial disclosures.
Perspective
Back to Top
Michael R. Jaff, DO
Despite the recent pall that has fallen over the field of renal denervation for resistant hypertension, the Rox Coupler is an incredibly novel approach to the treatment of these complex patients. Using a deliberate communication between the iliac artery and vein, [the device causes an] immediate and reproducible BP reduction. However, the experience in this first presentation is limited, and there are concerns regarding the long-term safety of this procedure, both locally in the vein and systemically, [related to] high-output congestive HF. Further evaluation in multiple centers over a longer term is required.
Click Here to Manage Email Alerts