Multicenter Prospective, Randomized, Sham-Controlled Study of Genicular Artery Embolization

Presented During:

Sat, 6/13/2020: 12:50 PM  - 12:59 PM 
Webinar  
Room: Webinar  

Final ID:

Authors:

S Bagla1, R Piechowiak1, T Hartman2, J Orlando1, M Lipscomb2, T Benefield2, A Isaacson3

Institutions:

1Vascular Institute of Virginia, Woodbridge, VA, 2UNC Chapel Hill, Chapel Hill, NC, 3UNC Dept of Radiology, Chapel Hill, NC

First Author:

Sandeep Bagla, MD  
Vascular Institute of Virginia
Woodbridge, VA

Co-Author(s):

Rachel L. Piechowiak, DO  
Vascular Institute of Virginia
Woodbridge, VA
Terry S Hartman  
UNC Chapel Hill
Chapel Hill, NC
Julie C. Orlando, RT  
Vascular Institute of Virginia
Woodbridge, VA
Markeela Lipscomb  
UNC Chapel Hill
Chapel Hill, NC
Thad Benefield  
UNC Chapel Hill
Chapel Hill, NC
Ari J. Isaacson, MD  
UNC Dept of Radiology
Chapel Hill, NC

Presenting Author:

Sandeep Bagla, MD  
Vascular Institute of Virginia
Mc Lean, VA

Purpose:

To determine if genicular artery embolization (GAE) is more effective than a sham procedure in reducing pain and disability secondary to knee osteoarthritis (OA)

Materials:

Twenty-one subjects (3 Male, 18 Female, mean age 64 years, BMI 31.4) were blinded and randomized (2:1 allocation) to GAE (Group A) or a sham procedure of lower extremity angiography without embolization (Group B) in a U.S. Investigational Device Exemption study (NCT0336295). Subjects were included who had knee pain greater than 50/100 mm Visual Analog Scale (VAS), refractory to at least 3 months of conservative therapy and a Kellgren-Lawrence (KL) grade of 1, 2 or 3. Subjects were assessed with MRI, VAS and Global Western Ontario and McMaster University Osteoarthritis Index (WOMAC), before and after the procedure. At 1 month, if there was no improvement, subjects were allowed crossover to an unblinded treatment arm. Adverse events were recorded at all time points. Analysis was performed using mixed effects linear regression models comparing the groups.

Results:

There were 14 subjects in group A and 7 subjects in group B. Embolization with resorbable microspheres was technically successful in 100% (Group A). One subject from Group A was lost to follow-up before the 1-month visit. All subjects in group B crossed over to treatment after 1 month. Baseline mean VAS for Groups A and B were 80.3 and 83.0 respectively. The reduction in VAS from baseline to 1-month(m) was 49.82 (SE=6.65) for Group A, 4.64 (SE=9.06) for Group B. The estimate for the difference in reduction for treatment compared to sham for VAS was 45.17 (SE=11.24, 95% CI: [22.22, 68.12], p=0.00036). The reduction in Global WOMAC from baseline to 1-m for Group A was 27.15 (SE=6.24), 6.43 (SE=8.51) for the Group B. The estimate for the difference in reduction for treatment compared to sham for Global WOMAC was 20.73 (SE=10.55, 95% CI: [-0.82, 42.27], p=0.059). There were no major adverse events.

Conclusions:

GAE is significantly more effective in reducing knee pain in osteoarthritis than a sham procedure.

Abstract Categories:

Arterial Interventions: Embolization

Keywords:

Geniculate artery embolization
Knee