Advertisement

October 14, 2019

Five-Year STABLE I Results Reported for Cook Medical's Zenith System to Treat Complicated Type B Aortic Dissections

October 15, 2019—The final 5-year results from STABLE I were published by Joseph V. Lombardi, MD, et al in Journal of Vascular Surgery (2019;70:1072–1081).

STABLE I is a prospective, single-arm, multicenter evaluation of the Zenith dissection endovascular system (Cook Medical). The investigators noted that the Zenith is a pathology-specific device composed of a proximal stent graft with barbs and a distal bare stainless-steel stent for the treatment of patients with complicated type B aortic dissection.

In February 2019, Cook announced FDA approval of the device; in March, the company announced its launch in the United States. Dr. Lombardi is the global principal investigator of the STABLE I and STABLE II clinical trials that evaluated the device.

As summarized in Journal of Vascular Surgery, the study prospectively enrolled 86 patients (mean age, 59 years; 73% men) at sites in the United States (STABLE I in United States), Europe, and Australia (STABLE 1 outside the United States) from 2007 to 2012. Treatment occurred during the acute phase (≤ 14 days after symptom onset) in 55 patients and during the nonacute phase (> 14 days; all treated ≤ 90 days) in 31 patients.

At 30 days, the all-cause mortality rate was 5.5% (3/55) for acute patients and 3.2% (1/31) for nonacute patients (P > .99).

In the 5-year clinical and imaging data from STABLE I, which were available for 88.5% of eligible patients, investigators found that the acute and nonacute cohorts appeared to respond similarly to treatment involving use of the stent grafts and bare-metal stents, demonstrating similar clinical outcomes and favorable improvement in aortic remodeling in the thoracic and abdominal aortas.

The specific 5-year findings in acute versus nonacute patients included:

  • Freedom from all-cause mortality (79.9% ± 6.2% vs 70.1% ± 8.4%; log-rank test, P = .4)
  • Freedom from dissection-related mortality—including deaths of indeterminate relatedness to dissection repair (83.9% ± 5.9% vs 90.1% ± 5.9%; log-rank test, P = .55)
  • Complete false lumen thrombosis in the thoracic aorta, which increased over time (74.1% vs 58.8%)
  • Overall increase in true lumen diameter from preprocedure and a concomitant decrease in false lumen diameter was seen in both groups of patients at the level of the largest diameter in both the thoracic and abdominal aortas
  • Stable or shrinking transaortic diameter in the thoracic aorta (65.5% vs 81.3%)
  • Stable or shrinking transaortic diameter in the abdominal aorta (48.3% vs 76.5%)
  • Freedom from secondary intervention (65.5% ± 7.5% vs 71.2% ± 9%; log-rank test, P = .71)

Endovascular repair of complicated type B aortic dissection with this composite device design demonstrated low all-cause mortality at 30 days, as well as low dissection-related mortality throughout follow-up, concluded the STABLE I investigators in Journal of Vascular Surgery.

Advertisement


October 15, 2019

SIR Launches Public Awareness Campaign Aimed at Patients and Referring Physicians

October 15, 2019

SIR Launches Public Awareness Campaign Aimed at Patients and Referring Physicians