Comparison between cheatham-platinum stent and self-expandable uncovered nitinol stent in patients with coarctation of aorta – a randomized controlled trial

Abstract

Abstract Background Endovascular treatment is considered the main therapeutic approach for native coarctation of aorta (CoA) in adult patients. Balloon-expandable stents (BE) have been introduced as the primary choice for coarctoplasty. However during the recent years, self-expandable (SE) stents with acceptable radial force have been suggested as an alternative. Still, no randomized controlled (RCT) trials have compared the efficacy and safety of both strategies. Methods The present study is a prospective, single center, parallel-group, open-label RCT on patients with native CoA (Figure). Patients were randomized into Bare Cheatham-Platinum Stents and Uncovered Nitinol Stent (SE). All patients were scheduled to be followed in 1-, 6-, 12-month and 36-month intervals. The present report, focuses on the one-year outcome of the study. Results Of 101 patients with native CoA referred to our center, 93 patients have been randomized into BE- (47 patients) and SE-arm (46 patients). One year follow up is scheduled to be completed on March 2020. In the preliminary analysis of 62 patients, 1 intraprocedural stent migration has occurred in each group. No aortic perforation was detected in the study. Vascular access site complications were similar between the two groups (3 (6.3%) in BE versus 1 (2.1%) in SE, p value= 0.432). One nonfatal stroke occurred in BE group. No mortality or bailout surgical repair happened in one year study in the two groups. One patient with re-coarctations were detected during one year follow up in each of the groups (p value=0.210). No aortic pseudoaneurysm or aneurysmal formation were observed in 12-month follow up aortic CT angiography. Conclusion The preliminary results showed no significant difference in efficacy and safety of both treatment modalities. The final result is pending. Study Flow Chart Funding Acknowledgement Type of funding source: None