Update on the Talent aortic stent-graft: a preliminary report from United States phase I and II trials.
OBJECTIVE
Phase I and phase II trials were conducted to determine the safety and efficacy of the Talent aortic stent-graft (Medtronic World Medical, Sunrise, Fla) in the treatment of infrarenal abdominal aortic aneurysms (AAA). This is a preliminary report of the technical results and 30-day clinical outcome of these trials.


METHODS
Multicenter prospective trials were conducted to test the Talent stent-graft in high-risk and low-risk patient populations with AAA, including phase I feasibility and phase II clinical trials. The low-risk study included concurrent surgical controls.


RESULTS
In the phase I trial, deployment success was achieved in 92% (23/25 patients), and initial technical success was 78% (18/23 implants without endoleak). The 30-day technical success rate was 96%, with six endoleaks that resolved spontaneously (without need for further intervention); and the 30-day mortality rate was 12% (3/25 patients). The phase II high-risk trial demonstrated a deployment success of 94% (119/127 patients) and an initial technical success of 86% (102/119 implants). The 30-day technical success rate was 96%, and the 30-day mortality rate was 1.5% (2/127 patients). The phase II low-risk trial included a first-generation and a second-generation Talent stent-graft. Deployment success rates were 97% and 99%, respectively, and technical success rates at 30 days were 97% and 96%, respectively. The 30-day mortality rate was 2% in the phase II low-risk first-generation device trial, and the adverse-event rate was 20%. Corresponding figures for the second-generation device were 0% and 1.8%, respectively.


CONCLUSIONS
The Talent stent-graft can be deployed successfully and achieves endovascular exclusion in a large proportion of patients with AAA. Morbidity and mortality rates are acceptable. One-year clinical results and the comparison with concurrent surgical control subjects remain to be evaluated.
Criado
F J
FJ
Center for Vascular Intervention, Division of Vascular Surgery, Union Memorial Hospital/MedStar Health, USA.
Wilson
E P
EP
Fairman
R M
RM
Abul-Khoudoud
O
O
Wellons
E
E
D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods* / Q000401:mortality; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods* / Q000401:mortality; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012307:Risk Factors; D012449:Safety; D015607:Stents / Q000009:adverse effects / Q000592:standards; D016896:Treatment Outcome; D014481:United States