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The evidence regarding the mid- and long-term follow-up of transcatheter intervention for coarctation of aorta (CoA) is limited, with the majority of the relevant studies being retrospective in design with small study populations123. Previously, we reported the 1-year results of a randomised controlled trial comparing balloon-expandable stents (BES) and self-expanding stents (SES) in patients with de novo native CoA4. Herein, we have summarised the 3-year follow-up results (IRCT20181022041406N3).
Adult patients with de novo native CoA and no prior history of surgical or endovascular coarctoplasty were included (Central illustration). A structural follow-up, encompassing transthoracic echocardiography and aortic computed tomography angiography was performed at 1- and 3-year follow-up. A supervised exercise test to detect masked hypertension was added to the 3-year follow-up. The main outcomes assessed were the 3-year rates of recoarctation, aortic injuries, and residual hypertension. A detailed description of the eligibility criteria, randomisation, procedural details, and study outcomes has been published previously4 and is summarised in Supplementary Appendix 1, Supplementary Appendix 2 and Supplementary Appendix 3.
Of 92 patients initially randomised, 71 patients (25 women [32.2%]), with a median age of 30 years (interquartile range 20-35), participated in the 3-year structural follow-up (2 patients passed away [1 COVID-19 infection and 1 car accident] and the others did not participate in the follow-up). Patient flow, baseline, and 3-year clinical and imaging characteristics are depicted in Supplementary Figure 1, Supplementary Table 1, Supplementary Table 2 and Supplementary Table 3.
No new recoarctation was detected between the 1- and 3-year follow-up, and only 5 patients (with recoartation previously detected during the first year of follow-up) were identified as having recoarctation. Among those patients, 2 cases, both initially randomised into the BES group and treated for recoarctation during the first year, needed reballooning due to significant restenosis during the 3-year follow-up (Table 1). Aortic wall injuries were detected in 6 patients (8.5%), all treated conservatively with no further endovascular/surgical intervention needed (Supplementary Figure 2). The stenting procedure did not significantly impact aortic remodelling insofar as no substantial changes were noted in the diameter of the ascending and diaphragmatic aorta (Table 1). A total of 42 out of the 71 patients (59.1%) had residual hypertension, detected more frequently in the BES group, with a trend existing towards a higher median number of antihypertensive drugs during the 3-year follow-up (Table 1, Supplementary Figure 3, Supplementary Table 4). A detailed report of the 3-year results is presented in Supplementary Appendix 2.
A few prospective studies have elaborated the mid- to long-term outcomes of the endovascular treatment of CoA; however, most of these investigations had no integrated imaging protocol2, or only a small proportion of their baseline population was finally monitored by approved imaging tests3. We followed up 77.1% (71 of 92) of our randomised population with the structural imaging protocol, and recoarctation occurred in 7.0% of the population with no new cases between the 1- and 3-year follow-up periods. This finding is in contrast with the major investigations focusing on long-term outcomes, in which a higher rate (~20%) of reintervention has been reported23. The inclusion of paediatric patients in the mentioned studies might explain the higher rates of reintervention. Recoarctation rates below 10% were reported when limiting their population to adult patients.
The rate of post-stenting aortic pathologies/injuries during the long-term follow-up was poorly reported with no clear consensus on their management; however, our data showed a low incidence and benign features with no need to intervene during the 3-year follow-up (Supplementary Figure 2). Intrastent filling defect was detected in 25% of patients treated with SES (Supplementary Figure 4). Although the clinical significance of the observed filling defects was not elaborated in the current study, it might challenge the short-term discontinuation of the antithrombotic regimen. Filling defects could not be analysed in patients with BES due to considerable artefacts.
Even though transcatheter intervention exerts a positive impact on reducing blood pressure, a considerable proportion of patients might still suffer from residual hypertension, which predisposes patients to many acquired heart conditions, including coronary artery disease, persistent arrhythmia, stroke, and heart failure234. Holzer et al3 and Eriksson et al2 reported a downward trend in prolonged hypertension prevalence (42% and 34%, respectively) in patients treated endovascularly. The higher incidence of residual hypertension in the current study might result again from their inclusion of a paediatric population and better blood pressure response in this younger population. Additionally, we observed a higher residual hypertension in patients treated with BES. Although several explanations for this, such as less haemodynamic disturbance due to better flexibility of nitinol stents, could be suggested5, the current finding is explanatory and hypothesis-generating and needs confirmation by future large-scale studies.
The small sample size, a 23% attrition rate, and the lack of ambulatory blood pressure monitoring for residual hypertension are among the major limitations of this study, which have been fully discussed in Supplementary Appendix 3, Supplementary Table 5 and Supplementary Table 6.
In this 3-year follow-up, both BES and SES exhibited low rates of recoarctation, aortic wall injuries and remodelling, but still, more than half of the studied population suffered from residual hypertension. Larger-scale investigations are warranted to substantiate and validate these findings.
Table 1. Three-year outcomes of the study patients.
| Balloon-expandable stents (n=35) | Self-expandingstents (n=36) | p-value | Risk ratio (95% CI) | |
|---|---|---|---|---|
| Main outcomes | ||||
| Recoarctation of the aortaa | 3 (8.5) | 2 (5.5) | 0.64 | 1.50 (0.26-8.68) |
| Thoracic aortic aneurysmal formationb | 4 (11.4) | 2 (5.6) | 0.37 | 2.06 (0.40-10.52) |
| Residual hypertensionc | 25 (71.4) | 17 (47.2) | 0.03 | 1.51 (1.00-2.26) |
| Other outcomes | ||||
| Number of antihypertensive medications | 2.0 (1.0 to 2.0) | 1 (0.0 to 2.0) | 0.06 | |
| Difference in antihypertensive medicationsd | 0.0 (0.0 to 1.0) | 0.0 (0.0 to 0.75) | 0.39 | |
| Difference in the ascending aorta diametere, mm | 0.3 (−1 to 1.6) | 0.4 (−1.4 to 1) | 0.60 | |
| Difference in the diaphragmatic aorta diametere, mm | −1.1 (−2 to 0.4) | −0.85 (−2.1 to 0.4) | 0.76 | |
| Sizeable intrastent filling defect | N/Af | 9 (25.0) | ||
| Stent protrusion | 0 (0) | 1g (2.7) | ||
| Data are presented as n (%) or median (interquartile range). a All the cases of recoarctation of the aorta were detected during the first year of follow-up, and no new cases were detected between the 1- and 3-year follow-up periods. b Detailed types of aortic injuries are summarised in Supplementary Figure 4; all were treated conservatively with no further endovascular/surgical therapies. c Residual hypertension was defined as a persistent need for antihypertensive drugs. d Median difference in the number of antihypertensive medications between the 1- and 3-year follow-up periods. e Changes in the aortic diameter between baseline and 3-year follow-up were analysed by the same operator with a similar methodology. f Due to considerable artefacts imposed by balloon-expandable stents, evaluation for the presence of filling defects was not feasible (Supplementary Figure 4). g The protrusion was minimal, with no apparent additional aortic injuries; it was treated conservatively. CI: confidence interval; N/A: not applicable | ||||
Acknowledgements
The authors thank Farshad Shakerian, MD, Ali Zahedmehr, MD, Reza Kiani, MD, Mohammad Javad Alemzadeh-Ansari, MD, Alireza Rashidinejad, MD, Shabnam Shahdi, MD, Ebrahim Hajizadeh, MD, Maryam Zarinsadaf, and Sara Tayyebi, MS, from Rajaie Cardiovascular, Medical and Research Center, Tehran, Iran, for their valuable contributions to data gathering. The Central illustration and the CONSORT diagram were designed using “Biorender.com”.
Funding
The study was financially supported by Rajaie Cardiovascular, Medical and Research Center.
Conflict of interest statement
The authors have no conflicts of interest to declare.
Supplementary data
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