BALTIMORE — An endovascular graft for repairing thoracic aortic aneurysms appeared to be superior to open surgical repair in preliminary results from the device's pivotal trial.
“Major morbidity, severe morbidity, and clinical utility” were better with TEVAR (thoracic endovascular aortic repair), and “there was similar overall and interim-term survival following TEVAR and open repair,” Dr. Jon S. Matsumura said at the Vascular Annual Meeting.
“Most surgeons feel that TEVAR is the first-line treatment for patients with suitable anatomy, but we can't make any conclusions about superiority based on our current data,” Dr. Matsumura said in an interview. The study was designed to assess outcomes at 1 year after treatment, but at the time of the report this duration of follow-up was not available for all patients in the study.
“We'll make a comparison when we have all the patients followed for 1 year, and the results are audited,” said Dr. Matsumura, a vascular surgeon at Northwestern University, Chicago. Because of the limitations of the current data, statistically significant differences between the control and intervention groups have not yet been evaluated, he added.
The STARZ-TX2 (Study of Thoracic Aortic Aneurysm [TAA] Repair with the Zenith-TX2 TAA Endovascular Graft) was sponsored by Cook Medical Inc., which is developing the device. Dr. Matsumura is a consultant to Cook and receives research support from the company.
This was a nonrandomized study that enrolled 160 patients to treatment using the endovascular graft and 70 patients to conventional, open repair. Treatment was at 42 international centers in March 2004-July 2006. The patients who underwent endovascular repair were significantly younger, with an average age of 72 years, compared with an average age of 68 in the open-repair group. The open-repair patients also had significantly more comorbidities at the time of surgery.
At 1 year after surgery, the overall survival rate was 92% in patients who had endovascular repair, and 87% in the open-repair group. The endovascular-repair group also had better results for several measures, such as posttreatment morbidity scores, aneurysm-related deaths, and duration of hospitalization (see box).
The incidence of strokes during follow-up was 2.5% in the endovascular-repair group and 8.6% in the open-surgery group. Paraplegia appeared in 1.3% and 5.7%, respectively. Paraparesis occurred in 3.8% of the endovascular patients and in none of the control patients.
The patients who underwent endovascular repair had no stent fractures or barb separations. They did not need to undergo any conversion operations, and had no aneurysm ruptures. After 1 year, there was one type III endoleak. And at 1 year, only 7% of the aneurysms had grown, whereas 50% had become smaller, and 43% did not change in size.
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