Department of Cardiology, Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Cardiology, Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Cardiology, Kantonsspital Lucerne, Lucerne, Switzerland.
JACC Cardiovasc Interv. 2014 Apr;7(4):416-23. doi: 10.1016/j.jcin.2013.11.018. Epub 2014 Mar 14.
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.
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.
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.
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).
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).
本研究旨在评估带膜与裸 Cheatham-platinum 支架(NuMed,Hopkinton,纽约)在主动脉缩窄(CoA)患者中的血管内治疗效果。
带膜支架治疗已被新认为是治疗先天性 CoA 的有效治疗方法,但尚无比较带膜支架与裸支架治疗 CoA 的研究。
在这项随机临床试验中,120 名平均年龄为 23.60±10.99 岁(12 至 58 岁,79 名男性)的、有导管后、短节段、严重的先天性 CoA 患者接受了裸 Cheatham-Platinum(bCP)(n=60)或带膜 Cheatham-Platinum(cCP)(n=60)支架植入。患者在支架置入后 1、3、6 和 12 个月以及此后每年进行临床随访。在随访期间,计划进行多层螺旋 CT(64 层)评估任何并发症。
两组的手术成功率均为 100%。患者随访 31.1±19.2 个月。尽管在随访期间仅在 bCP 组观察到再狭窄,但两组之间的差异无统计学意义(6.7%对 0%;p=NS)。cCP 组发生 2 例假性动脉瘤(3.3%),而 bCP 组未观察到(p=NS)。两组的血压正常状态在随访期间均显著增加(bCP 组从 15%增加到 73.3%,cCP 组从 16.7%增加到 78.3%,每组 p<0.001,组间无显著差异)。
在严重先天性 CoA 患者中,植入 bCP 和 cCP 支架具有非常高的成功率,并具有显著的血流动力学效果。与 bCP 支架植入相比,接受 cCP 支架植入的患者在随访期间再狭窄发生率略低,假性动脉瘤形成发生率略高。这些发现表明 CoA 支架植入是一种安全的手术。