Initial Results Presented for Cook's STABLE Clinical Trial

January 3, 2011—Cook Medical (Bloomington, IN) announced the initial results from the STABLE trial, which studied the company's proximal endograft and distal uncovered stent for the endovascular treatment of type B aortic dissection. The Cook stent graft system comprises two main components: an endograft that seals the torn aortic section and a second uncovered stent that helps support the true lumen of the aorta and promote apposition of the dissected vessel wall. Principal investigator Joseph Lombardi, MD, presented the findings in November at the VEITH Symposium in New York City.

“The initial data for the STABLE clinical trial show promise,” commented Dr. Lombardi. “Aortic dissection can be a life-threatening condition, and surgical intervention is a highly invasive procedure. If confirmed, these initial results are a positive step toward proving the safety and efficacy of a minimally invasive treatment for aortic dissection.”

According to Dr. Lombardi, for this prospective, single-arm, international study, patients with complicated type B aortic dissection were treated with a combination of proximal endovascular thoracic grafts and distal bare endovascular stents. Indications for enrollment were malperfusion of visceral organs, impending rupture, aortic diameter > 4 cm, rapid aortic expansion, persistent uncontrollable pain, or hypertension despite maximum medical therapy. The study endpoint was mortality at 30 days. Clinical and radiographic (computed tomography and x-ray) follow-up were performed at 1 year.

The investigators enrolled 40 patients at 10 centers from December 2007 to September 2009. The majority of patients were men (70%), and the mean age was 58 years. All patients had multiple, specific indications for treatment (77.5% with impending rupture/malperfusion), and the mean time from presentation to treatment was 20 days (range, 0–78).

Dr. Lombardi reported that all devices were successfully deployed and patent. The 30-day mortality rate was 5%. Thirty-day morbidity included stroke (10%), paraplegia (2.5%), aortic rupture (2.5%), and renal failure (12.5%). None of the patients became dialysis dependent. No conversions to open surgery, issues with device integrity, or stent migration have been observed.

The investigators concluded that the initial data with this composite thoracic endovascular aortic repair construct have shown favorable clinical and anatomic results and that the overall effectiveness of this treatment strategy will be assessed with continued enrollment and long-term data.