Balloon-expandable cheatham-platinum stents versus self-expandable nitinol stents in coarctation of aorta: 3-year outcome of a randomized clinical trial

Abstract

Abstract Introduction Although stenting showed early promising results in the treatment of patients with coarctation of aorta (CoA), its long-term benefit it is scarcely studied. Previously, we have shown, balloon-expandable stents (BES) and self-expandable (SES) stents were both effective and safe during 12-month follow up in the treatment of native CoA. Purpose To report the 3-year outcomes of BES versus SES stents in patients with native CoA. Methods Adult patients with de novo native CoA were randomized into Cheatham-platinum BES and uncovered nitinol SES groups in this parallel-group, open-label, blinded endpoint randomized clinical trial. All randomized patients were assigned to the 3-year structural follow up, consisted of clinical examination (including blood pressure measurement), exercise test for detecting masked hypertension, aortic CT angiography and transthoracic echocardiography. The 3-year incidence of recoarctation of aorta, thoracic aortic aneurysm formation, and residual hypertension were reported as the main long-term outcomes. Results Of the 92 patients initially randomized, 71 patients were participated in 3-year structural follow-up (Figure 1). Residual hypertension, defined as a persistent need for antihypertensive drugs at 3-year were significantly higher in BES (25 (71.4%) versus 17 (47.2%) patients (risk ratio (RR), 1.51, 95% confidence interval (CI), [1.00 to 2.26], p= 0.03) (Figure 2). Apart from five patients diagnosed with recoarctation during the first year of follow-up, no new cases of recoarctation were detected between 1 to 3-year follow up. Of note 2 of 3 patients with recorctation in the BES group, needed a second reintervention during the long-term follow up. Thoracic aortic aneurysm formation was not different in both stent types (4 (11.4%) versus 2 (5.6%) patients (RR, 2.06, 95% CI, [0.40 to 10.52], p= 0.37). Three-year median differences of ascending aorta and aortic arch were not different between the two groups. Conclusion Overall, both BES and SES were safe and effective in the long-term follow up. The rate of recoarctation was low even in the long-term follow up, which were safely reintervene. A hypothesis-generating difference were detected between two types of stents on residual hypertension which needs to be verified in larger studies.Baseline Characteristics and Study Flow3-year Outcomes