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 LB3. Relay™ Thoracic Stent‐Graft Phase II PMA Submission Results

Mark A. Farber MD1, W. Anthony Lee MD2, Patrick Vaccaro MD3, Christopher Kwolek MD4, Gustavo Oderich MD5, Matthew Eagleton MD6, and Phillip Hess MD7, on behalf of the Bolton Relay Investigators
1University of North Carolina, Chapel Hill, NC; 2Christine E. Lynn Heart and Vascular Institute, Boca Raton FL; 3Ohio State University, Columbus, OH; 4Massachusetts General Hospital, Boston, MA; 5Mayo Clinic, Saint Mary’s Hospital, Rochester, MN; 6Cleveland Clinic Foundation, Cleveland, OH; and 7University of Florida, Gainsville, FL.

OBJECTIVES: To evaluate the safety and efficacy of the Relay™ Stent‐Graft to treat thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU).

METHODS: Between January 23, 2007 and April 25, 2011, 180 patients were enrolled at 29 sites in a nonrandomized trial. The study consisted of two cohorts: a control group (S) of prospective and retrospective surgical subjects (N=60) and a prospective endovascular (EV) treatment arm (N=120). Safety was evaluated by analyzing major adverse events at 30 days and through one year. Aneurysm and device‐related adverse events were tabulated following implant such that efficacy implications could be conducted.

RESULTS: Mean age for the cohort was 71.9 years with a significant portion of the patients > 80 years (18.3%) which differed statistically between cohorts (EV: 26.7%, S: 1.7%, p<0.001). The sex distribution (M:F) in the EV group was nearly equal (51.7%:48.3%) and co‐morbid conditions paralleled prior trials. Successful endovascular repair was accomplished in 96.7% with no conversions. The mean number of devices implanted was 1.6 with 30.2% being in inserted proximal to the left subclavian artery. Endovascular allcause mortality at 30 days was 5.8% while the surgical arm mortality was 10%. Procedural neurologic events occurred in 7.8% of patients and was predominantly stroke related in both groups. Surgical cohort complications were mainly comprised of procedural bleeding and respiratory failure in 28.3% and 18.3% respectively. Clinical utility measures favored TEVAR (p< 0.001) with respect to procedural duration, transfusions, EBL, ICU time, and hospital stay. Subjects treated with the Relay device experienced statistically significantly fewer major AE post‐procedure than subjects who underwent surgical repair (p< 0.001).

CONCLUSIONS: Endovascular outcomes compare favorably with respect to the surgical arm and mirror previously approved FDA devices for TEVAR despite having slightly older patients in this cohort.

AUTHOR DISCLOSURES: M. Farber MD, Consulting Fees or Other Remuneration (Payment): W.L. Gore, Cook, Bolton; W. Lee MD, Scientific Advisory Committee: Bolton; Consulting Fees or Other Remuneration (Payment): Bolton; P. Vaccaro MD, Nothing to disclose; C. Kwolek MD, Scientific Advisory Committee: Bolton; Consulting Fees or Other Remuneration (Payment): Bolton; G. Oderich MD, Other: National Principal Investigator – T-Branch Clinical Trial: Cook; M. Eagleton MD, Consulting Fees or Other Remuneration (Payment): Cook, Bolton, P. Hess MD, Speakers Bureau: Terumo

Updated May 2012

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