Full article reprinted from "The Gray Sheet" - September 8, 2008
Find out how the results of Medtronic's VALOR trial show that the firm's recently launched Talent endovascular thoracic stent may lower mortality rates for patients undergoing open surgery to repair thoracic aortic aneurysms.
Full article reprinted from "The Gray Sheet" - September 8, 2008
Results of Medtronic's VALOR trial show that 30-day all-cause mortality with the firm's recently launched Talent endovascular thoracic stent graft was 2% versus 8% for patients undergoing open surgery to repair thoracic aortic aneurysms.
The rates even out somewhat at one year, but the results still favor Talent (16.1%) over surgery (20.6%), according to the study, published in the September issue of the Journal of Vascular Surgery.
The prospective, nonrandomized, 38-center pivotal trial was the main study used to support the June PMA approval of Talent for treatment of descending thoracic aortic aneurysms (1"The Gray Sheet" June 9, 2008, In Brief).
The device is indicated for treatment of descending TAAs in patients with non-aneurysmal aortic diameters in the range of 18 mm-42 mm; non-aneurysmal aortic proximal and distal neck lengths ≥20 mm; and iliac/femoral access vessel morphology compatible with vascular techniques, devices and/or accessories.
For the study, investigators compared data from 195 Talent patients who otherwise would have been considered candidates for open surgical repair at "low to moderate" surgical risk, with retrospective surgery data from 189 patients at three centers - Cleveland Clinic, Massachusetts General Hospital and the Hospital of the University of Pennsylvania.
Vessel access and device deployment were successful in 194 subjects, Ronald Fairman, Hospital of the University of Pennsylvania, et al. write.
Four Talent patients (2.1%) died ≤30 days after implantation due to causes including atheroembolic multisystem failure, stroke, periprocedural cardiac arrest and complications from a myocardial infarction and perforated ulcer.
Six Talent patients (3.1%) died of an aneurysm-related cause through 12 months of follow-up, including the four ≤30 days post-implantation. That compares with 22 patients (11.6%) in the open surgery group at 12 months.
One or more major adverse events occurred in 41% of Talent patients ≤30 days after implantation, compared with 84.4% in the open surgery group. However, vascular complications were higher in the Talent group (21%) compared with open surgery patients (12.3%).
In terms of Talent's effectiveness, seven patients (4%) were identified with a "type I" endoleak at the time of 30-day follow-up, although of the 45 patients (25.9%) with endoleaks, most were "type II," Fairman et al. note. Fourteen procedures were performed to resolve the endoleaks. There were also four stent migrations, although only one patient required an intervention related to the event.
Overall, the data demonstrate that Talent "results in lower peri-operative death, 12-month aneurysm-related death and lower rates of morbidity than open surgery," the researchers conclude.
Benefits "Clearly Outweigh The Risks," Study Finds
The higher rate of vascular complications with Talent "demonstrates the need for further refinement of endovascular thoracic delivery systems," the study notes. However, the benefits "clearly outweigh the risks" based on the "clinically significant results."
Talent has been approved in Europe for TAAs since 1998, and interest in thoracic stent grafts has increased since the first endovascular devices debuted for abdominal aortic aneurysms, according to the study article. Medtronic's Talent AAA graft was approved in April (2"The Gray Sheet" April 21, 2008, In Brief).
In March 2005, FDA approved a competing device, W.L. Gore's TAG thoracic endoprosthesis, leading to "rapid dissemination" of the technology, according to Fairman et al.
According to the investigators, a review of recent literature has shown Talent and TAG to be comparable in terms of all-cause and aneurysm-related mortality and safety. Talent, however, sized from 22 mm to 46 mm, offers a wider range of diameter options. "Of the patients implanted with diameters <26 mm or >40 mm, 25% would not have been eligible for endovascular repair using commercially available devices owing to diameter sizing constraints," the researchers state.
In addition to the Gore device, Talent competitors include Cook's Zenith TX2 thoracic aortic aneurysm graft, approved in May (3"The Gray Sheet" May 26, 2008, In Brief).
- Brooke McManus
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