Bahram Sohrabi1, Peiman Jamshidi2, Alireza Yaghoubi1, Afshin Habibzadeh1, Yashar Hashemi-Aghdam3, Araz Moin3, Babak Kazemi1, Samad Ghaffari1, Mohammad Reza Abdolahzadeh Baghayi1, Khalil Mahmoody4. 1. Department of Cardiology, Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 2. Department of Cardiology, Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Cardiology, Kantonsspital Lucerne, Lucerne, Switzerland. 3. Young Researchers Club, Tabriz Islamic Azad University of Medical Sciences, Tabriz, Iran. 4. Department of Cardiology, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address: khalil_mahmoodi@yahoo.com.
Abstract
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 ofbare 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).
RCT Entities:
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).