Comparison between covered and bare Cheatham-Platinum stents for endovascular treatment of patients with native post-ductal aortic coarctation: immediate and intermediate-term results.

OBJECTIVES: This study sought to evaluate the outcomes of endovascular treatment with covered versus bare Cheatham-platinum stents (NuMed, Hopkinton, New York) in coarctation of aorta (CoA) patients.

BACKGROUND: Covered stenting has been newly recognized as a useful therapeutic method for patients with native CoA, but there has been no study comparing the use of covered stents with bare stents for treating CoA.

METHODS: In this randomized clinical trial, 120 patients with a mean age of 23.60 ± 10.99 years (range 12 to 58 years, 79 men), with post-ductal, short-segment, severe native CoA underwent implantation of bare Cheatham-Platinum (bCP) (n = 60) or covered Cheatham-Platinum (cCP) (n = 60) stents. Patients were followed clinically at 1, 3, 6, and 12 months after the stenting and yearly thereafter. During follow-up, multislice computed tomography (64 slices) was scheduled to assess any complications.

RESULTS: The procedural success rate was 100% in both groups. Patients were followed for 31.1 ± 19.2 months. Although recoarctation was seen only in the bCP group during follow-up, the difference between groups did not reach statistical significance (6.7% vs. 0%; p = NS). Two cases of pseudoaneurysm (3.3%) occurred in the cCP group, but none was observed in the bCP group (p = NS). Normotensive status significantly increased during follow-up in both groups (from 15% to 73.3% in the bCP group and 16.7% to 78.3% in the cCP group, p < 0.001 for each group and not significant between groups).

CONCLUSIONS: Implanting bCP and cCP stents have very high success rates with remarkable hemodynamic effects in severe native CoA patients. Patients undergoing cCP stent implantation experienced a nonsignificantly lower recoarctation rate and a higher occurrence of pseudoaneurysm formation with respect to bCP stenting during follow-up. These findings indicate that CoA stenting is a safe procedure. (Endovascular Stenting With Covered CP Stent Compared With Bare CP Stent for Adult Patients With Coarctation: The Initial and Intermediate-Term Follow-Up Results; IRCT201012045311N1).