De Novo Atherosclerotic Renal Artery Stenosis Covered Stent Treatment for Resistant Hypertension (ARTISAN) Results.

Authors

Douglas E. Drachman
D Christopher Metzger
Ashit Jain
Ravish Sachar
Amr El-Sayed Abbas, Corewell Health
Kenneth Rosenfield
Gary M. Ansel

Document Type

Article

Publication Date

10-18-2024

Publication Title

Journal of the Society for Cardiovascular Angiography & Interventions

Abstract

BACKGROUND: Atherosclerotic renal artery stenosis (ARAS) may provoke hypertension and/or impaired kidney function. Some patients develop uncontrolled hypertension and deteriorating kidney function despite optimal medical therapy. In these patients, endovascular treatment is an important therapeutic option. ARTISAN was a prospective, open-label, single-arm, multicenter clinical trial to evaluate the safety and effectiveness of the iCast RX covered stent both functionally for reestablishing renal artery flow, and clinically for controlling resistant hypertension.

METHODS: Patients considered for enrollment had average systolic blood pressure (SBP) ≥155 mm Hg despite taking 3 antihypertensive medications. Prior to enrollment and covered stent placement, angiographic confirmation of ARAS ≥80% with physiologic significance was required. Clinical assessments were performed at 30 days, 9 months, and annually through 36 months. Covered stent safety and efficacy were based on 9-month coprimary end points, including primary vessel patency and SBP improvement at 9 months. Secondary outcomes included target lesion revascularization, major adverse events, and secondary patency.

RESULTS: Sixty-eight of the planned 138 subjects were enrolled. Primary patency was seen in 94.3% of subject lesions; the mean SBP reduction was 15.7 mm Hg. The functional and clinical end points met prespecified performance goals of 70% primary patency (

CONCLUSIONS: The high primary patency and improvement in SBP, persisting through 36 months, suggest that the iCast RX covered stent is safe and effective for the treatment of appropriately selected patients with ARAS.

Volume

3

Issue

12

First Page

102400

Recommended Citation

Drachman DE, Metzger DC, Jain A, Sachar R, Abbas AE, Rosenfield K, et al. De novo atherosclerotic renal artery stenosis covered stent treatment for resistant hypertension (ARTISAN) results. J Soc Cardiovasc Angiogr Interv. 2024 Oct 18;3(12):102400. doi: 10.1016/j.jscai.2024.102400. PMID: 39807237.

DOI

10.1016/j.jscai.2024.102400

ISSN

2772-9303

PubMed ID

39807237