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Balloon-Expandable Cheatham-Platinum Stents Versus Self-Expandable Nitinol Stents in Coarctation of Aorta: A Randomized Controlled Trial Publisher Pubmed



Sadeghipour P1 ; Mohebbi B1 ; Firouzi A1 ; Khajali Z2 ; Saedi S2 ; Shafe O1 ; Pouraliakbar HR2 ; Alemzadehansari MJ1 ; Shahdi S2 ; Samiei N3 ; Sadeghpour A3 ; Babaei M4 ; Ghadrdoost B1 ; Afrooghe A4 Show All Authors
Authors
  1. Sadeghipour P1
  2. Mohebbi B1
  3. Firouzi A1
  4. Khajali Z2
  5. Saedi S2
  6. Shafe O1
  7. Pouraliakbar HR2
  8. Alemzadehansari MJ1
  9. Shahdi S2
  10. Samiei N3
  11. Sadeghpour A3
  12. Babaei M4
  13. Ghadrdoost B1
  14. Afrooghe A4
  15. Rokni M1
  16. Dabbagh Ohadi MA5
  17. Hosseini Z1
  18. Abdi S1
  19. Maleki M3
  20. Bassiri HA1
  21. Haulon S6
  22. Moosavi J1
Show Affiliations
Authors Affiliations
  1. 1. Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
  2. 2. Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
  3. 3. Echocardiography Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
  4. 4. School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Students’ Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran
  6. 6. Aortic Centre, Hopital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Universite Paris-Saclay, Paris, France

Source: JACC: Cardiovascular Interventions Published:2022


Abstract

Objectives: This study sought to compare the safety and efficacy of the balloon-expandable stent (BES) and the self-expandable stent (SES) in the endovascular treatment of coarctation of aorta. Background: Coarctoplasty with stents has conferred promising results. Although several nonrandomized studies have approved the safety and efficacy of the BES and the SES, no high-quality evidence exists for this comparison. Methods: In the present open-label, parallel-group, blinded endpoint randomized pilot clinical trial, adult patients with de novo native aortic coarctation were randomized into Cheatham-platinum BES and uncovered nitinol SES groups. The primary outcome of the study was a composite of procedural and vascular complications. The secondary outcomes of the study consisted of the incidence of aortic recoarctation, thoracic aortic aneurysm/pseudoaneurysm formation, and residual hypertension at a 12-month follow-up. Results: Among 105 patients who were screened between January 2017 and December 2019, 92 eligible patients (32 women [34.8%]) with a median age of 30 years (IQR: 20-36 years) were randomized equally into the BES and SES groups. The composite of procedural and vascular complications occurred in 10.9% of the BES group and 2.2% of the SES group (odds ratio: 0.18; 95% CI: 0.02-1.62; P = 0.20). Aortic recoarctation occurred in 5 patients (5.4%), 3 patients (6.5%) in the BES group and 2 patients (4.3%) in the SES group (odds ratio: 0.65; 95% CI: 0.10-4.09; P = 0.64). Only 1 patient (1.1%) was complicated by aortic pseudoaneurysm. Hypertension control was achieved in 50% of the study population, with an equal distribution in the 2 study groups at the 12-month follow-up. Conclusions: Both the BES and the SES were safe and effective in the treatment of native coarctation. © 2022 American College of Cardiology Foundation
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1. Midterm to Long-Term Safety and Efficacy of Self-Expandable Nitinol Stent Implantation for Coarctation of Aorta in Adults, Catheterization and Cardiovascular Interventions (2017)
2. Dislodgement of Balloon Expandable Stent Graft in Aortic Coarctoplasty, Protector or Proctor Fault?: A Case Report, International Journal of Surgery Case Reports (2025)
3. The Effect of Coarctation Degrees on Wall Shear Stress Indices, Scientific Reports (2021)
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