December 12, 2008

5 YEAR FOLLOW UP OF THE TALENT eLPS ABDOMINAL STENT GRAFT PIVOTAL TRIAL: EARLY AND LONG TERM SAFETY AND EFFICACY

Irene C. Turnbull, MD, Mikel Sadek, MD, Honesto Poblete, MD, Jonathan Bowman, MD, Rajesh Malik, MD, Alexander Salloum, MD, Ageliki G. Youhouka, MD, Sharif H. Ellozy, MD, Michael L. Marin, MD, Peter L. Faries, MD.
Mount Sinai School of Medicine, New York, NY, USA.

OBJECTIVES:
This study evaluated the acute and long-term safety and efficacy of the Talent eLPS stent-graft based on the United States multicenter trial through 5 years.
METHODS:
This pivotal trial was a prospective, nonrandomized, multicenter study conducted at thirteen sites from February 2002 to April 2003. The study group (N=166) underwent endovascular aortic aneurysm repair (EVAR) using the Talent eLPS stent-graft (eLPS group). The control group (N=243) underwent surgical abdominal aortic aneurysm (AAA) repair, data for this group were obtained from the Society for Vascular Surgery Endovascular AAA Surgical Controls Project. Outcomes were compared at 30-days and 12-months. Additional 5-year follow-up data was obtained for the eLPS group. A confirmatory, single-center study (N=137) was used to evaluate the modified CoilTrac delivery system in medically high-risk patients, and outcomes were evaluated at 30-days.
RESULTS:
The technical success rate for the eLPS group was 97.6%. Primary efficacy, defined as successful aneurysm treatment at 12-months, was achieved in 90.2%. Twelve-month outcomes included: freedom from aneurysm expansion (95.0%), freedom from endoleak (93.2%), freedom from stent-graft migration (99.2%), freedom from secondary endovascular procedures (96.7%), and stent-graft patency (100%). The eLPS group exhibited significantly improved freedom from major adverse events (MAE) at 30-days and 12-months (Table I). Five-year outcomes for the eLPS group included: freedom from all-cause mortality (72.9%), freedom from aneurysm-related mortality (96.4%), and freedom from conversion to surgery (99.1%). For the CoilTrac confirmatory group, the technical success rate was 100%. There were no occurrences of aneurysm rupture or conversion to open repair at 30-days. Two mortality events were reported, which were unrelated to the aneurysm, procedure or device.
CONCLUSIONS:
This study demonstrates satisfactory safety and efficacy profiles for EVAR using the Talent eLPS stent-graft and the CoilTrac delivery system up to 5 years follow up.

Table I. Talent eLPS Abdominal Stent Graft: Safety and Efficacy
Safety and efficacy endpoints	eLPS group	Surgical group	P Value
Freedom from MAE (30d)	89.2%	44.0%	<.001
Freedom from MAE (12mo)	80.4%	44.0%	<.001
Freedom from all-cause mortality (30d)	98.2%	97.1%	NS
Freedom from all-cause mortality (12mo)	93.7%	92.4%	NS
Freedom from aneurysm related mortality (12mo)	98.2%	96.7%	NS

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