Preemptive TEVAR after type I aortic dissection repair: the ERADICARE trial on aortic remodeling and one-year outcomes

Abstract

Background

A persistent distal false lumen after surgery for DeBakey type I acute aortic dissection (AAD) is associated with increased risk of adverse aortic events (AAEs). This pilot randomized controlled trial aimed to evaluate whether elective thoracic endovascular aortic repair (TEVAR), performed 1–3 months after type I AAD surgery in selected high-risk patients, promotes aortic remodeling and improves clinical outcomes.

Methods

Thirty-two patients who underwent surgical repair for type I AAD were randomized to either elective TEVAR (n = 15) or standard conservative management (n = 17). CT angiography–based inclusion criteria were: (a) a re-entry tear in Ishimaru zones 3 or 4, and (b) a maximum descending thoracic aorta (DTA) diameter > 40 mm and/or a false lumen diameter > 20 mm. One-year follow-up included clinical assessment and CT angiography.

Results

The TEVAR group exhibited significantly more favorable aortic remodeling than the conservative group, as demonstrated by greater reductions in total aortic diameter (zones 2–9), greater increases in true lumen diameter (zones 3–8), and greater reductions in false lumen diameter (zones 2–8). Complete false lumen thrombosis was also more frequent in the TEVAR group (zones 2–6). Clinically, the TEVAR group had significantly lower rates of dissection extension (0% vs. 29.4%; p = 0.050), rehospitalization due to complications (0% vs. 58.8%; p < 0.001), and long-term AAEs (20.0% vs. 58.8%; p = 0.026).

Conclusions

In selected high-risk patients, performing TEVAR 1–3 months after surgical repair of type I AAD may promote favorable aortic remodeling and be associated with improved one-year clinical outcomes.

Clinical registration number

This study is registered with ISRCTN under the title “Endovascular Repair After Aortic Dissection Type I or Conservative – Aortic Remodeling Enhancement (ERADICARE Trial),” registration number ISRCTN 11,964,494 (10.1186/ISRCTN11964494).

Supplementary Information

The online version contains supplementary material available at 10.1186/s13019-026-03843-1.

Background

Operative mortality rates for patients undergoing urgent repair of DeBakey type I acute aortic dissection (AAD) have significantly declined, from 25.0% in 1995 to 18.4% in 2013, according to data from the International Registry of Aortic Dissection (IRAD) [1]. This improvement is largely attributed to advances in diagnostic imaging, surgical techniques, and organ protection strategies, as well as enhanced perioperative care—particularly in high-volume centers with experienced multidisciplinary teams. Despite the reduction in operative mortality, late adverse aortic events (AAEs) remain a major concern in these patients. A study with a mean follow-up of 20.4 months reported an AAE risk of 46.1%, with 17.3% of patients requiring late distal reintervention [2]. Following standard ascending aorta and hemiarch repair, residual false lumen (FL) flow due to a preexisting distal tear or a distal anastomotic new entry (DANE) tear is common. A persistently patent FL is not only linked to organ malperfusion and dissection extension [3] but also serves as a predictor of progressive distal aortic dilation [4, 5]. Consequently, there is growing interest in strategies to prevent or manage residual patent FL, particularly in younger patients. Notably, patients under 50 years old—even when excluding those with genetic aortopathies—have both a longer life expectancy and a significantly higher risk of adverse aortic remodeling [6].

In patients not undergoing aortic arch replacement or a frozen elephant trunk procedure, concomitant antegrade thoracic endovascular aortic repair (TEVAR) of the descending aorta under direct visualization during initial surgery has been utilized in some centers [7, 8]. We recently reviewed the limited evidence on the role of TEVAR in the context of type I AAD [9]. These data suggest that although TEVAR is primarily employed in the acute phase to address malperfusion, it may also promote favorable remodeling by reducing FL pressurization.

Based on this evidence, we hypothesized that elective TEVAR, performed shortly after type I AAD surgery in patients with high-risk features for AAEs, could significantly enhance aortic remodeling and improve clinical outcomes. Although extensive literature exists on preemptive TEVAR in high-risk patients with uncomplicated DeBakey type III AAD, [10], data on the management of the dissected distal aorta following initial type I AAD repair remain scarce. To investigate this hypothesis, we designed the Endovascular Repair after Aortic Dissection type I or Conservative – Aortic Remodeling Enhancement (ERADICARE) trial, a pilot randomized controlled trial registered in the ISRCTN registry (ISRCTN11964494). If successful, this approach may reshape the mid- and long-term treatment paradigm for type I AAD. To that end, our inclusion criteria were tailored to identify patients with established high-risk anatomical features, such as a maximum descending thoracic aorta diameter > 40 mm or a false lumen diameter > 20 mm.

Methods

Thirty-two patients who survived at least 30 days following ascending aorta and hemiarch replacement, including root reconstruction or a modified Bentall procedure, for type I AAD between March 1, 2021, and September 1, 2023, and who met the inclusion and exclusion criteria (detailed below), were randomly assigned to two groups using computer-generated software. In the TEVAR group, patients underwent TEVAR 1 to 3 months post-surgery. The precise timing of TEVAR was determined by a combination of clinical and logistical factors. Medical considerations included the patient’s recovery and overall postoperative condition. Logistical factors included the patient’s ability and willingness to be readmitted shortly after major surgery (particularly in cases involving long-distance travel), attending physician and stent-graft availability, and departmental scheduling constraints. The control group received standard medical management without any further intervention after the initial procedure. Follow-up assessments included clinical examinations and computed tomography angiography (CTA) at 1, 6, and 12 months post-surgery.

Inclusion criteria were as follows: (a) a re-entry tear in Ishimaru zone 3 or 4; (b) a maximum descending thoracic aorta (DTA) diameter > 40 mm and/or a maximum false lumen (FL) diameter > 20 mm; (c) provision of informed consent for TEVAR and randomization. Patients who underwent an initial frozen elephant trunk (FET) procedure or total arch replacement were excluded. Additional exclusion criteria included: (a) a residual tear in the aortic arch, (b) major postoperative complications that could affect long-term outcomes, such as stroke, renal failure with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m², spinal cord injury-related complications, prolonged intubation requiring tracheostomy, or severe septic complications, (c) history of previous open or endovascular aortic surgery, and (d) technical infeasibility of TEVAR, as determined by the operating surgeon.

The primary endpoint of the study was positive aortic remodeling, based on widely accepted criteria, and defined as an increase in true lumen (TL) diameter, a reduction in false lumen (FL) diameter, a decrease in total aortic (TA) diameter, and progression toward complete FL thrombosis. The extent of FL thrombosis was classified as fully patent, partially thrombosed, or completely thrombosed. All remodeling parameters were assessed across Ishimaru zones 2–9.

Secondary endpoints included: (a) one-year survival rate; (b) freedom from crossover to TEVAR in the control group; (c) total days of hospitalization; (d) incidence of long-term AAEs, including dissection extension, stent graft-induced new entry tears (SINE), clinical or angiographic malperfusion, aortic rupture, stroke, spinal cord ischemia, renal insufficiency, and vascular complications; (e) rehospitalization due to AAEs or any other cause.

The trial protocol was approved by the Ethics Committee of Evangelismos General Hospital, Athens, Greece (protocol number 96/31-3-2021). All participants provided written informed consent, also approved by the ethics committee. The study was conducted in accordance with the Declaration of Helsinki and relevant Greek bioethics legislation, with the protection of personal data and rights ensured in accordance with applicable laws.

Statistical analysis

Continuous variables were reported as mean ± standard deviation (SD) or median with interquartile range (IQR), depending on data distribution. Normality was assessed using the Kolmogorov-Smirnov test. Student’s t-test was applied to normally distributed variables, while the Mann-Whitney U test was used for non-normally distributed variables. Categorical variables were expressed as absolute numbers and percentages, with comparisons performed using the chi-squared test or Fisher’s exact test, as appropriate.

To evaluate changes in TL, FL, and TA diameters over time between groups, repeated measures analysis of variance (ANOVA) was performed. When needed, log transformations were applied to address non-normal distributions. Cochran’s Q test was used to analyze changes in the proportions of FL patency, partial thrombosis, and complete thrombosis within each group during follow-up.

All P-values were two-tailed, with statistical significance set at p < 0.05. Analyses were conducted using SPSS statistical software (version 26.0).

Results

Fifteen patients were assigned to the TEVAR group and 17 to the conservative group. Data collection and follow-up were completed for all participants. Baseline characteristics at presentation with type I AAD are summarized in Table 1. Demographics, preoperative variables, and initial surgical procedures were comparable between groups, except for preoperative acidosis, which was more frequent in the TEVAR group (66.7% vs. 17.6%; p = 0.005). Preoperative CTA measurements were also similar (Supplement Table 1).

Table 1.

Patients’ characteristics and clinical status preoperatively. The type of surgery for each group

		Conservative group (n = 17; 53.1%)	TEVAR group (n = 15; 46.9%)	P
		n (%)	n (%)
Gender
Males		15 (88.2)	10 (66.7)	0.141+
Females		2 (11.8)	5 (33.3)
Age, mean (SD)		57.4 (13.3)	61.4 (12)	0.377‡
Body Mass Index (BMI), mean (SD)		28.5 (3.2)	28.4 (4.4)	0.969‡
Familial history of aortic disease
No		13 (76.5)	12 (80)	0.810+
Yes		4 (23.5)	3 (20)
Aneurysm presence before dissection
No		8 (47.1)	7 (46.7)	> 0.999++
Yes		5 (29.4)	4 (26.7)
Unknown		4 (23.5)	4 (26.7)
If yes, Diameter (mm), mean (SD)		43.6 (1.3)	44.5 (2.4)	0.494‡
Presence of syndromic disease		2 (11.8)	1 (6.7)	> 0.999++
Hypertension		12 (70.6)	10 (66.7)	> 0.999++
Dyslipidemia		5 (29.4)	6 (40)	0.529+
Heart failure		0 (0)	0 (0)	-
COPD		2 (11.8)	4 (26.7)	0.383++
Peripheral artery disease		0 (0)	2 (13.3)	0.212++
Chronic renal failure		0 (0)	2 (13.3)	0.212++
Diabetes Mellitus		5 (29.4)	6 (40)	0.529+
CAD		5 (29.4)	3 (20)	0.691++
Smoking		12 (70.6)	9 (60)	0.529+
Other		5 (29.4)	3 (20)	0.691++
Pre-operative clinical condition
Hemodynamic stability		3 (17.6)	3 (20)	> 0.999++
Cardiac tamponade		0 (0)	2 (13.3)	0.212++
Malperfusion presence		1 (5.9)	4 (26.7)	0.161++
Lower extremity malperfusion		1 (5.9)	2 (13.3)	0.589++
Renal failure due to malperfusion		1 (5.9)	6 (40)	0.033++
Splanchnic organ malperfusion		0 (0)	0 (0)	-
Cerebral complications		0 (0)	0 (0)	-
Spinal cord ischemia		1 (5.9)	2 (13.3)	0.021++
Paraparesis		1 (5.9)	2 (13.3)	0.021++
Intubation		1 (5.9)	2 (13.3)	0.589++
Resistant pain		13 (76.5)	7 (50)	0.153++
Unresponsive to treatment hypertension		11 (64.7)	10 (66.7)	0.907+
Mental status problematic		1 (5.9)	3 (20)	0.319++
Preoperative galactic acid elevated (Higher than 2.2mmol/L)		10 (58.8)	12 (80)	0.265++
Presence of acidosis (Ph < 35)		3 (17.6)	10 (66.7)	0.005+
Type of surgery
Ascending Aorta (AA) + Hemiarch Replacement		11 (64,7)	13 (86,7)	0.302++
Bentall + AA + Hemiarch replacement		5 (29.4)	2 (13.3)
Bentall + AA + Hemiarch replacement + CABG X 1		1 (5.9)	0 (0)

+Pearson’s chi-square test; ++Fisher’s exact test; ‡Student’s t-test

In the TEVAR group, endograft access was achieved via the right common femoral artery in all but one patient, who underwent implantation through the left side. Various endograft types were used, including the Cook Zenith Alpha, Jotec Evita, and Medtronic Valiant Freeflo (in both straight and tapered configurations). In all cases, zone 3 served as the proximal landing zone, with distal extension to zone 4. In one patient with a Medtronic Valiant Freeflo tapered stent graft, partial coverage of zone 5 occurred due to the deployment of an additional straight graft at the distal end to address initial suboptimal apposition. Graft oversizing was consistently maintained below 10% of the true lumen diameter. The mean graft diameter was 31.7 ± 4.8 mm, and the mean graft length was 150.5 ± 5.6 mm (Supplement Table 2).

At follow-up, the TEVAR group demonstrated significantly more favorable aortic remodeling than the control group, as reflected by changes in TL, FL, and TA diameters across all Ishimaru zones. Both groups showed increases in maximum TL diameter in zones 1–8; however, this increase was significantly greater in the TEVAR group for zones 3–8 (Supplement Table 3). TL diameter changes over time in zones 2, 3, 5, and 8 are shown in Fig. 1. For illustrative purposes, these zones were selected to represent key anatomical regions: the aortic arch (zone 2), proximal DTA and TEVAR landing zone (zone 3), thoracoabdominal junction (zone 5), and abdominal aorta (zone 8).

Fig. 1.

Representation of TL diameter fluctuation for both groups in comparison for aortic zones 2,3,5,8

Maximum FL diameter decreased in both groups across zones 1–8, but reductions were significantly greater in the TEVAR group for zones 2–8 (Supplement Table 4). FL diameter changes are illustrated in Fig. 2. TA diameter decreased significantly in zones 1, 2, 5, and 7 in both groups; however, the TEVAR group exhibited greater reductions across zones 2–9 (Fig. 3, Supplement Table 5). No differences in remodeling outcomes were observed within the TEVAR group based on the timing of the procedure.

Fig. 2.

Representation of FL diameter fluctuation for both groups in comparison for aortic zones 2,3,5,8

Fig. 3.

Representation of TA diameter fluctuation for both groups in comparison for aortic zones 2,3,5,8

FL thrombosis patterns also favored the TEVAR group. At presentation, FL patency rates were similar between groups, but after surgery, FL patency significantly declined in both cohorts (Supplement Table 6). The proportion of partially thrombosed FL significantly decreased in zones 3–7 in both groups, with the TEVAR group also showing a significant reduction in zones 2 and 8 (Supplement Table 7). While both groups demonstrated significant increases in completely FL thrombosis in zones 7–9, the TEVAR group had higher complete thrombosis rates in zones 2–6 (Supplement Table 8). Changes in FL thrombosis in zone 5 over time are shown in Fig. 4.

Fig. 4.

Diagram depicting the percentages of patent FL, partially thrombosed FL and complete thrombosis of FL for zone 5 over the study period

Regarding secondary endpoints, the one-year survival rate was 100% in both groups. However, two patients in the conservative group required crossover to TEVAR due to dissection extension. One experienced persistent, medically refractory pain; the other had progressive aortic enlargement (maximum DTA diameter of 60 mm), raising concern for AAEs. In both cases, the decision to intervene was based on the attending surgeon’s clinical judgment.

The TEVAR group experienced significantly fewer AAEs than the conservative group (20% vs. 58.8%; p = 0.026), including a lower rate of dissection extension (0% vs. 29.4%; p = 0.050). Additionally, rehospitalization rates were markedly lower in the TEVAR group (0% vs. 58.8%; p < 0.001). All AAE-related outcomes are presented in Table 2, with key clinical events depicted in Fig. 5.

Table 2.

Patients’ operative, postoperative and clinical outcomes, by group

	Control group (n = 17; 53.1%)	Intervention group (n = 15; 46.9%)	P
	n (%)	n (%)
Type of surgery
Ascending Aorta (AA) + Hemiarch Replacement	11 (64,7)	13 (86,7)	0.302++
Bentall + AA + Hemiarch replacement	5 (29.4)	2 (13.3)
Bentall + AA + Hemiarch replacement + CABG X 1	1 (5.9)	0 (0)
Mortality	0 (0)	0 (0)	-
Stroke	0 (0)	0 (0)	-
Paraparesis	0 (0)	0 (0)	-
Renal insufficiency	1 (5.9)	2 (11.8)	0.021++
Malperfusion	1 (5.9)	0 (0)	> 0.999++
Rupture	0 (0)	0 (0)	-
Crossover	2 (11.8)	0 (0)	0.486++
Reinterventions	6 (35.3)	1 (6.7)	0.088++
Hospitalization (Days), mean (SD)	10.4 (2.3)	12.1 (4.5)	0.178‡
Extension of dissection	5 (29.4)	0 (0)	0.050++
Re-hospitalization due to complication	10 (58.8)	0 (0)	< 0.001++
Vascular complications	1 (5.9)	3 (21.4)	0.304++
30-day mortality	0 (0)	0 (0)	-
Spinal cord ischemia	0 (0)	0 (0)	-
Splachnic malperfusion	0 (0)	0 (0)	-
Pericardial / Pleural effusion	1 (5.9)	0 (0)	> 0.999++
Recurrent pain	1 (5.9)	0 (0)	> 0.999++
Deep sternal wound infection	1 (5.9)	0 (0)	> 0.999++
Dynamic obstruction of celiac artery	1 (5.9)	0 (0)	> 0.999++
Complications	10 (58.8)	3 (20)	0.026+
Days of hospitalization, median (IQR)	3 (0 ─ 6)	2 (2 ─ 2)	0.260‡‡
If yes, duration (days), median (IQR)	8 (5 ─ 9)	3 (0 ─ 6)	0.259‡‡

+Pearson’s chi-square test; ++Fisher’s exact test; ‡Student’s t-test; ‡‡Mann-Whitney test

Fig. 5.

Comparative clinical outcomes between conservative and TEVAR group

Exploratory analysis within both groups did not identify additional predictors of aortic remodeling beyond the predefined anatomical risk factors used for inclusion.

Discussion

The ERADICARE trial evaluated aortic remodeling and clinical outcomes following elective TEVAR for residual dissection in the DTA, performed 1–3 months after hemiarch repair for type I AAD in high-risk patients. Compared with standard conservative management, preemptive TEVAR in patients with a zone 3 or 4 re-entry tear, a maximum DTA diameter > 40 mm, and/or a maximum FL diameter > 20 mm led to significantly more favorable aortic remodeling at one year. This was reflected by greater reductions in TA and FL diameters and a greater increase in TL diameter across much of the descending thoracic and abdominal aorta. Additionally, the TEVAR group demonstrated a higher rate of complete FL thrombosis in Ishimaru zones 2–6. Favorable aortic remodeling was also observed in segments distal to the covered region in several cases, indicating a positive remodeling effect beyond the stent-graft itself. These anatomical benefits were associated with fewer AAEs and rehospitalizations compared to conservative treatment.

Unlike type III AAD, the role of preemptive TEVAR in improving long-term outcomes after type I AAD surgery remains underexplored. In a tear-oriented approach, type I AAD surgery in the absence of arch re-entries typically involves proximal aortic and hemiarch replacement. While this strategy prioritizes early survival by minimizing operative risk, it does not address potential re-entry tears in the DTA that may lead to early or late AAEs, including organ malperfusion and FL expansion. A more aggressive approach, such as total arch replacement with FET, may improve long-term survival and reduce the need for reoperation [11] but is technically demanding, not universally feasible, and carries a higher early mortality risk, particularly in lower-volume or non-specialized aortic centers [12].

TEVAR for residual dissection in type I AAD has been previously reported. In a recent systematic review, we identified 157 patients across nine studies undergoing TEVAR for type I AAD [9]. Most commonly (84.7%), the stent graft was implanted intraoperatively, typically via an antegrade approach, at the discretion of the surgeon. Indications for TEVAR included preoperative malperfusion [7, 8], TL diameter restriction to < 50% [13], proximal DTA aneurysm [7], or—in the pre-FET era—a tear in the arch or proximal DTA not addressable by hemiarch repair [14, 15]. Di Tommaso et al. reported postoperative TEVAR for residual dissection, although not in a preemptive manner. Their study described transfemoral stent implantation in the aortic arch at a median of 4.7 years post-AAD surgery, typically in response to aortic enlargement (> 5 mm/year) or impending rupture [16].

To our knowledge, only one study (published in abstract format) has evaluated early preemptive TEVAR for residual dissection after proximal type I AAD repair in high-risk patients [17]. Morishita et al. identified age < 60 years, aortic diameter > 46 mm, and patent FL as predictors of late reintervention. Based on these criteria, 11 patients underwent TEVAR 50–297 days post-surgery (median: 122), using a proximal covered and distal bare-metal stent. Subclavian revascularization was performed in four patients and supra-aortic debranching in two. In line with our results, they reported 100% one-year survival with no procedural conversions or early mortality. At one year, CT angiography showed complete FL thrombosis in 8 patients and partial thrombosis in 3. Notably, all seven patients treated within three months achieved complete FL thrombosis. TL area increased by 203 mm², while FL area decreased by 276 mm² at the point of maximum aortic diameter.

Given the limited experience with preemptive TEVAR in residual type I AAD, we based the timing and indications for TEVAR in our patients on the findings of Morishita et al.,¹⁷ studies on predictors of progressive DTA dilation and AAEs after type I AAD surgery, and data on preemptive TEVAR in uncomplicated type III AAD.

We selected a therapeutic window of 1 to 3 months. Acute-phase TEVAR has been associated with higher complication rates, increased reinterventions, and greater one-year mortality compared to subacute-phase TEVAR, likely due to the thinner, more fragile intimal flap [18]. Additionally, patients recovering from type I AAD surgery require at least one month to recuperate and undergo thorough evaluation for postoperative complications that may affect long-term prognosis or endovascular suitability. Conversely, delaying TEVAR beyond three months results in thickening and reduced mobility of the dissection flap, making chronic-phase TEVAR more prone to perioperative endoleaks, reinterventions, limb malperfusion, and less favorable aortic remodeling [19–21].

Our aortic diameter thresholds were based on established predictors of aneurysmal progression. An FL diameter ≥ 22 mm and a maximal aortic diameter ≥ 40 mm are independent predictors of aneurysmal growth and late intervention in uncomplicated type III AAD [22]. Similarly, a postoperative DTA diameter > 40 mm and a patent FL predict progressive DTA dilation in patients after type I AAD surgery [5].

A key consideration in our strategy was the inclusion of patients with a dissected aortic arch but without identifiable primary or re-entry tears within the arch. These patients underwent ascending aorta and hemiarch replacement, leaving the dissected—but tear-free—arch segment unresected. In the TEVAR group, the stent graft was deployed proximally in zone 3, carrying a theoretical risk of SINE. To mitigate this risk, TEVAR was delayed to the subacute phase to allow intimal fibrosis and structural stabilization, and stent graft oversizing was restricted to < 10% of TL diameter. No SINE events were observed, supporting the hypothesis that this tailored approach is technically feasible and safe in selected high-risk patients, despite theoretical concerns and limited broader adoption.

As regards the technical aspects of TEVAR, we have some comments to make based on our experience. First, we recommend surgical cutdown in all cases in order to avoid extra manipulations and to ensure the access point. Additionally, we suggest that maintaining the graft oversizing below 10% is a safe approach with satisfactory outcomes. The mean graft diameter was 31.7 ± 4.8 mm, and the mean graft length was 150.5 ± 5.6 mm, while both straight and tapered covered grafts were used. No intraoperative complications occurred intraoperatively regardless of the TEVAR device implemented. During the study period, viz. the first year of follow up, no complications related to graft type were detected. Therefore, according to ERADICARE trial all the graft types used for TEVAR (Cook Zenith Alpha, Jotec Evita, and Medtronic Valiant Freeflo) were safe and effective. New devices and grafts types are developing constantly from several companies with promising outcomes according to studies and clinical practice, as graft stents with Nitilol stent full covered with ePTFE (expanded polytetrafluoroethylene). Although, various types of polyester grafts are effective enough, grafts stents with Nitilol stent covered with ePTFE may be proved equally or even more effective in the near future.

Although aortic remodeling lacks a universally accepted definition [23], we used widely recognized parameters, including an increase in TL diameter, reduction in FL diameter, decrease in TA diameter, and complete FL thrombosis [24, 25]. While some investigators assess TL, FL, and TA volumes, we excluded volumetric analysis due to concerns regarding heterogeneity and bias [26]. Based on these parameters, the TEVAR group demonstrated significantly more favorable aortic remodeling than the conservative group, with greater FL diameter reductions, TL diameter increases, and higher rates of complete FL thrombosis across multiple aortic zones. Specifically, TL diameter increased more in zones 3–8, and FL diameter decreased more in zones 2–8. While zones 3 and 4 were expected to show improvement due to direct TEVAR coverage, TEVAR also positively influenced proximal and distal aortic remodeling. The higher degree of FL thrombosis further suggests that negative remodeling was mitigated in the arch, descending thoracic, and abdominal aorta.

A previous observational study reached different conclusions from those of the ERADICARE trial. Reed et al. examined patients with both Type A and Type B aortic dissections. [27]. Among 43 DeBakey Type I cases, five underwent TEVAR early post-repair—one for aortic growth > 5 mm in one month, three for resistant hypertension, and one for dissection propagation. Half of the conservatively treated patients showed no aortic growth, leading the authors to suggest that preemptive TEVAR may not be necessary. However, the study lacked predefined criteria and provided no detailed TEVAR subgroup outcomes, limiting interpretability. More recently, Hasami et al. described 25 patients who underwent zone 2 arch replacement and debranching during acute type A dissection repair, with 11 subsequently receiving preemptive TEVAR due to early DTA dilation > 4 cm— also used as a high-risk criterion in our study [28]. All TEVAR procedures were technically successful, and early imaging showed stable or reduced aortic diameters. However, no aortic growth was observed in the conservatively treated patients, and group differences were not statistically significant. In contrast, the ERADICARE trial, through a randomized controlled design and clearly defined inclusion criteria, demonstrates that elective preemptive TEVAR in high-risk type I AAD patients yields more favorable aortic remodeling than conservative management.

Finally, in our study, the TEVAR group was associated with improved clinical outcomes, with lower rates of dissection extension, rehospitalization, and long-term AAEs compared to the control group. While these outcomes were statistically significant, we acknowledge that composite endpoints may limit interpretability. Nonetheless, the consistency across multiple clinical parameters supports the hypothesis that favorable anatomical remodeling may contribute to improved early post-discharge outcomes.

Despite its rigorous methodology, the ERADICARE trial has limitations. Conducted at a single center with a relatively small sample size, its findings may not be fully generalizable to other settings with different patient characteristics or resource availability. Further research, particularly multicenter randomized trials, is warranted to validate these results and inform clinical decision-making.

In conclusion, the ERADICARE trial suggests that in selected high-risk patients, performing TEVAR 1–3 months after initial repair for Type I AAD may promote favorable aortic remodeling and be associated with improved one-year clinical outcomes. These findings support the need for further validation in larger, multicenter studies with longer follow-up.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

AEE

Adverse aortic events

AAD

Acute Aortic Dissection

DANE

Distal anastomotic new entry tear

SINE

Stent graft-induced new entry tear

IRAD

International Registry of Acute Aortic Dissection

FL

False Lumen

TL

True Lumen

TA

Total Aortic

TEVAR

Thoracic Endovascular Aortic Repair

ERADICARE

Endovascular Repair after Aortic Dissection type I or Conservative – Aortic Remodeling Enhancement

ISRCTN

International Standard Randomized Controlled Trial Number

CTA

Computed Tomography Angiography

DTA

Descending Thoracic Aorta

SD

standard deviation

IQR

interquartile range

ePTFE

expanded polytetrafluoroethylene

Author contributions

N.S.: conceptualization, data curation, investigation, methodology, writing original draft M.A.: methodology, project administration, investigation, data curation T.K.: project administration, resources, data curation, methodology P.D.: data curation, resources, investigation G.N.: Data curation, investigation, methodology I.A.: resources, writing review – editing I.T.: formal analysis, writing review – editing, software, validation I.K.: conceptualization, data curation, validation, writing review-editing D. C. A.: conceptualization, investigation, validation, supervision, writing review - editing.

Funding

None.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval

Informed consent was obtained from all participants. The study was conducted in accordance with bioethics regulations and Greek legislation. Personal data were protected in compliance with applicable laws.

Clinical Registration

This study is registered in ISRCTN under the title Endovascular Repair After Aortic Dissection Type I or Conservative – Aortic Remodeling Enhancement (ERADICARE) Trial (Registration No. ISRCTN11964494).

Competing interests

The authors declare no competing interests.