Proximal stent graft combined with distal bare stent vs. conventional thoracic endovascular aortic repair in the treatment of complicated Stanford type B aortic dissection: a systematic review and meta-analysis

Introduction

Acute aortic dissection (AD) is a catastrophic cardiovascular emergency (1). Thoracic endovascular aortic repair (TEVAR) is currently the primary intervention for the treatment of Stanford type B AD (TBAD) (2,3). TEVAR facilitates aortic remodeling through thrombosis of the false lumen (FL), and helps maintain the size of the true lumen (TL) by deploying a covered stent graft to occlude the primary intimal tear (4). Current evidence indicates that significant remodeling of the aorta is typically observed in segments covered by stents (5). AD is defined as complicated if patients show symptoms of impending rupture, end-organ malperfusion, resistant hypertension, or uncontrolled pain (6). In cases of complicated dissections, standard TEVAR often fails to achieve satisfactory therapeutic outcomes (7). The FL can be perfused by blood flow through the distal intimal tear, leading to persistent blood flow in the FL, which subsequently causes TL collapse, aortic enlargement, and suboptimal aortic remodeling (8).

Several techniques have been employed by surgeons to improve aortic remodeling, such as the provisional extension to induce complete attachment (PETTICOAT) technique, restrictive bare stents, and other augmented techniques with adjunctive distal bare stents (DBSs). The PETTICOAT technique uses bare metal stents for standard stent grafting to prevent the collapse of the distal TL. Restrictive BSs are used prior to thoracic stent grafting to restrict the distal edge and mitigate the risk of excessive oversizing at its distal end (9). These approaches have gained widespread application in clinical practice over the past decade. However, debate continues as to their efficacy in enhancing aortic remodeling and minimizing postoperative complications. Due to insufficient high-quality two-arm studies, previous meta-analyses have found no significant difference in aortic remodeling between patients treated with a proximal stent graft (PSG) combined with a DBS (BS groups), and those treated with standard TEVAR (non-BS groups) (10). To facilitate the acquisition of evidence and provide informed recommendations for clinical decision making and future research, a comprehensive meta-analysis and systematic review incorporating the most recent studies was conducted to gain quantitative insights into the efficacy of these techniques in the treatment of complicated TBAD. We present this article in accordance with the MOOSE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1697/rc).

Methods

Literature review

The Cochrane Library, Embase, Web of Science, and PubMed databases were searched to retrieve relevant studies on this topic published from 2012 to 2024 using the following key terms: “provisional extension to induce complete attachment technique”, “petticoat”, “restrictive stent”, “protective stent”, “bare stent”, and “aortic dissection”. After completing the first round of the search process, the abstracts and full texts of any potentially eligible studies were evaluated. A manual search of the bibliographic references and other important publications was conducted to identify whether there is any article relevant to our study.

Inclusion and exclusion criteria

Studies that compared the use of the PSG with and without a DBS for the treatment of complicated TBAD were selected for inclusion in the meta-analysis. The following five types of studies were excluded: (I) studies that did not include both BS and non-BS groups; (II) systematic reviews, narrative reviews, letters, case reports, commentaries, and editorials; however, these articles were examined to identify any other potentially relevant studies; (III) studies that did not involve TBAD, but other arterial diseases such as aneurysms, intramural aortic hematoma, aortic coarctation, aortoarteritis, and arterial injuries; (IV) studies with data obtained only from abstracts, personal correspondence, websites, or meeting proceedings; and/or (V) different studies with the same patient sample.

Data extraction

Two authors independently reviewed all the studies retrieved from the database searches. If any disagreements arose, a third reviewer was consulted, and the issue was resolved by consensus. To ensure the comprehensiveness of the obtained data, the following study and patient characteristic data were collected: number of patients, gender, age, start and end years, follow-up time, cases of chronic and acute dissections, preoperative general condition, postoperative complications, morbidity rate, mortality rate, and aortic remodeling in the postoperative phase. According to the temporal distribution of aortic-related mortality (ARM), the non-survivors were categorized into the following two groups: the early death group (30 days after surgery); and the late death group (>30 days after surgery). Morbidity was defined as adverse events during the postoperative phase, including endoleak (any type), retrograde dissection, aortic rupture, paraplegia or paraparesis, stroke, reintervention, conversion to open repair, renal failure, or stent graft-induced new entry (SINE). Remodeling of the aorta was assessed according to the stabilization of the overall aortic diameter, as well as FL thrombosis at 6–12 months post-surgery.

Statistical analysis

Review Manager 5.2 (https://revman.cochrane.org/info; Cochrane Information Management System) was employed for the statistical analyses. Dichotomous variables were estimated on the basis of the risk ratio (RR) and 95% confidence interval (CI). The random-effects model was used for data pooling. Heterogeneity was measured using the I² index, which is a parameter used to evaluate variance when the number of studies is small. I² values of <25% and >75% indicated low and significant heterogeneity, respectively (11). Sensitivity analyses were performed by comparing the output of both fixed- and random-effects models. Visual analyses of funnel plots and Egger regression tests were performed to evaluate publication bias. Statistical significance was defined as a P value of <0.05 with a two-sided CI.

Results

Selection of relevant studies and their characteristics

Initially, 511 articles were retrieved, of which 89 duplicate articles were excluded. The remaining 422 articles were screened to determine their relevance. After reviewing the abstracts and titles of these 422 articles, 378 additional articles were excluded. Of the remaining 44 articles, 29 articles were excluded after reading their full texts. Ultimately, 15 articles with BS and non-BS groups containing 635 and 827 patients, respectively, were included in the meta-analysis. Citation searching was performed by reviewing reference lists of key publications; however, no additional studies eligible for inclusion were identified through this method. A flow diagram of the article selection process is shown in Figure 1. Subsequently, the data from these studies were compiled. Tables 1,2 set out the study characteristics and patients’ baseline information.

Figure 1 Study flow chart.

Study quality

The Newcastle-Ottawa Scale (NOS) was used to assess the methodological quality of the studies (26). Based on the NOS score, an overall low-to-moderate risk of bias was observed. Of the 15 cohort studies, nine and six studies had a low and moderate risk of bias, respectively, but no study had a high risk of bias. The same issue affected the quality of these studies; that is, poor cohort comparability due to a lack of statistical-based controlling of the critical confounding variables (n=2). Other issues included the follow-up period (n=3) and follow-up adequacy/completeness (n=1). Two investigators independently performed the assessment, and any disagreements were resolved by discussion. The results of the risk of bias assessment and study quality assessment are summarized in Table 3.

Mortality

There was no significant difference in the 30-day ARM rate (RR: 0.59; 95% CI: 0.26–1.34; P=0.21) between the BS group and the non-BS group. However, the BS group had a significantly lower >30-day ARM rate (RR: 0.58; 95% CI: 0.34–0.98; P=0.048) and overall ARM rate (RR: 0.58; 95% CI: 0.38–0.88; P=0.01) than the non-BS group. The 30-day ARM rate, >30-day ARM rate, and overall ARM rate results are illustrated in Figure 2.

Figure 2 Forest plots comparing (A) 30-day ARM rate, (B) >30-day ARM rate, and (C) overall ARM rate between the BS group and the non-BS group. ARM, aortic-related mortality; BS, bare stent; CI, confidence interval; M-H, Mantel-Haenszel.

Morbidity

The fixed-effects model analysis results showed that the BS group had significantly lower rates of SINE (RR: 0.14; 95% CI: 0.06–0.32; P<0.001), conversion to open repair (RR: 0.28; 95% CI: 0.08–0.99; P=0.052), and reintervention (RR: 0.40; 95% CI: 0.26–0.61; P<0.001) than the non-BS group. However, the two groups did not differ significantly in terms of the rates of endoleak (RR: 0.87; 95% CI: 0.49–1.53; P=0.62), aortic rupture (RR: 0.65; 95% CI: 0.22–1.94; P=0.44), paraplegia or paraparesis (RR: 0.54; 95% CI: 0.22–1.32; P=0.17), stroke (RR: 0.91; 95% CI: 0.38–2.15; P=0.83), retrograde dissection (RR: 1.06; 95% CI: 0.33–3.40; P=0.92), and renal failure (RR: 2.35; 95% CI: 0.75–7.43; P=0.14). The perioperative complication results for both groups are illustrated in Figure 3.

Figure 3 Forest plots comparing (A) aortic rupture, (B) endoleak, (C) stroke, (D) paraplegia or paraparesis, (E) retrograde dissection, (F) renal failure, (G) reintervention, (H) conversion to open repair, and (I) SINE between the BS group and the non-BS group. BS, bare stent; CI, confidence interval; M-H, Mantel-Haenszel; SINE, stent graft-induced new entry.

Aortic remodeling

The random-effects model analysis results did not reveal any statistically significant difference between the two groups in terms of complete thoracic FL thrombosis (RR: 1.20; 95% CI: 0.95–1.52; P=0.13). However, complete abdominal FL thrombosis was significantly lower in the BS group than the non-BS group (RR: 2.49; 95% CI: 1.37–4.53; P=0.003) (Figure 4).

Figure 4 Forest plots comparing (A) complete thoracic FL thrombosis and (B) complete abdominal FL thrombosis between the BS group and the non-BS group. BS, bare stent; CI, confidence interval; FL, false lumen; M-H, Mantel-Haenszel.

Publication bias

In terms of the funnel plot and Egger testing, the visual analysis results did not reveal any indications of publication bias in either the BS or non-BS groups (Figure 5).

Figure 5 Funnel plot assessment of publication bias for each outcome: (A) >30-day ARM rate, (B) overall ARM rate, (C) reintervention, (D) conversion to open repair, (E) SINE, (F) complete abdominal FL thrombosis, (G) 30-day ARM rate, (H) aortic rupture, (I) endoleak, (J) stroke, (K) paraplegia or paraparesis, (L) retrograde dissection, (M) renal failure, and (N) complete thoracic FL thrombosis. ARM, aortic-related mortality; FL, false lumen; RR, risk ratio; SE, standard error; SINE, stent graft-induced new entry.

Discussion

TEVAR is currently the standard therapeutic intervention for the endovascular management of patients with Stanford TBAD (27,28). Compared to open surgery, TEVAR has reduced invasiveness, a lower in-hospital mortality rate, and superior mid- and long-term aortic remodeling outcomes (29-31). However, conventional TEVAR is limited to sealing the proximal intimal tear, which often only results in complete FL thrombosis of the proximal portion of the lesion. In the distal segments, particularly the abdominal aorta, partial FL persists without complete thrombosis (32,33). For patients with complicated TBAD, characterized by impending rupture, malperfusion of terminal organs, refractory hypertension, or uncontrollable pain, this limitation of conventional TEVAR may have a more detrimental effect on patient prognosis. These complications include incomplete FL thrombosis, persistent FL perfusion, and distal TL collapse, which in turn can contribute to the continuous dilation of the aorta, promote the formation of dissecting aneurysms, and elevate the risk of aortic rupture (33-35).

To address these challenges, several innovative solutions have been proposed. In 2005, Mossop et al. (36) introduced the PETTICOAT technique. Subsequently, in 2006, a case series of 12 patients who underwent DBS implantation reported that the PETTICOAT technique led to improved aortic remodeling and prognosis, particularly in the distal thoracic and abdominal aortic segments for complicated TBAD (37). In 2013, Feng et al. (24) proposed a modified technique incorporating a distal uncovered stent, wherein a constrained uncovered stent was positioned external to the stent graft. This modification was designed to mitigate the risk of SINE and promote TL dilation. Such techniques aim to mitigate the mid- and long-term adverse outcomes associated with complicated TBAD and have yielded satisfactory results.

PSG combined with DBS has primarily been used for complicated TBAD, and several reports have documented its application. Sobocinski et al. (25) showed that compared to standard TEVAR, the addition of a DBS significantly enhances postoperative TL remodeling and FL reduction in the abdominal aortic segment. In their 1-year postoperative follow-up period, Nienaber et al. (18) observed that the rate of FL thrombosis in the abdominal region was significantly higher in the PETTICOAT technique group than the conventional TEVAR group (53.8% vs. 17.9%). Building on these findings, several meta-analyses and systematic reviews have been conducted to evaluate the efficacy of PSG combined with DBS for the treatment of complicated TBAD. Bertoglio et al. (38) undertook a systematic review of 11 studies, and concluded that the PETTICOAT technique is safe and feasible, and improves TL dilation in the distal thoracoabdominal aorta. However, the review did not examine differences in short-term and mid-term survival rates. Qiu et al. (10) conducted another meta-analysis that showed the combination of the PSG and DBS reduces some postoperative complications, but no significant differences were observed in ARM and TL remodeling after surgery.

The outcomes of earlier systematic reviews and meta-analyses (10,38-40) have been inconsistent and unreliable due to the small sample sizes and low-quality of the studies. Currently, there is a lack of objective and reasonable assessments of the efficacy of the combined PSG and DBS. In this study, the NOS results indicated that all of the included studies were of moderate to high quality. We also analyzed the outcomes of the two groups included in the studies. Based on the follow-up time, we classified the patients into two categories based on their mortality rate: 30-day mortality and >30-day mortality. No significant difference was found in the 30-day mortality rate between the BS and non-BS groups; however, the BS group had a lower >30-day mortality rate than the non-BS group.

There are three potential pathological mechanisms by which the bare stents may improve the prognosis of TBAD patients. Firstly, the bare stents may improve SINE, which is a serious complication unique to TEVAR (41). Secondly, the bare stents may maintain blood flow at the distal artery (42). Thirdly, as dissection-related mortality in standard TEVAR is significantly associated with FL thrombosis, techniques or devices that promote FL formation and TL recovery may be critical for mid- and long-term prognosis (43). Thus, while we found that deploying the DBS involved more endovascular intervention, the patients who received a DBS had a better mid- and long-term survival rate than those who received standard TEVAR.

The comparison between the two groups mainly focused on aortic remodeling. Substantial remodeling of the aorta is usually restricted to the stent-covered thoracic segment, and there are very few observations about the abdominal aorta (19). As stated above, aortic remodeling is directly associated with alterations in the diameter or volume of the TL. Among the 15 included studies, 13 (9,12-18,21-24,44) reported changes in TL diameter, and three (14,16,25) reported changes in TL volume. These studies showed that the DBS improves remodeling of the aorta in the treatment of complicated TBAD.

Because the included studies applied various statistical methods to calculate the diameter or volume of the TL, a direct comparison could not be conducted. Thus, we compared complete FL thrombosis at the abdominal and thoracic levels. The groups did not differ significantly in terms of complete thoracic FL thrombosis. However, the BS group had a higher incidence of complete abdominal FL thrombosis, which indicates that there were variations in remodeling in the abdominal and distal thoracic aortas covered by bare metal stents. The main objective of these new technologies is to improve aortic remodeling. It is generally thought that the BS improves alignment and re-apposition, and the uniform radial force of the stent on the arterial wall better expands the TL (45,46). Additionally, Lin et al. found that the C-reactive protein level was lower in the BS group, which indicated that the BS group had lower levels of inflammation (20). Thus, inflammation may be an important factor influencing aortic remodeling.

The BS group had a longer stent length; however, the two groups exhibited no differences in stent-associated complications such as endoleak, aortic rupture, paraparesis or paraplegia, stroke, retrograde dissection, and renal failure. The BS group also showed favorable results in terms of the lower rate of conversion to open repair, reintervention, and SINE, with significant differences compared to the non-BS group. It may be that the DBS improves the aorta’s anatomical structure, promotes aorta formation, reverses TL collapse, ensures TL flow, and minimizes reintervention risk and various adverse events in the postoperative phase (47). We also found that the occurrence of SINE was rare in the BS group. Several factors contribute to the occurrence of SINE. The distal edge of the thoracic stent graft and the adjacent native intima of the thoracic aortae can be aligned with the BS (48). Correct alignment can effectively disperse and mitigate the effects of radial force, thus avoiding the damage to aortic intima by the edge of the stent graft (49). A large stent graft size may also increase the risk of SINE in the non-BS group (50). These results support our analysis. Moreover, a distinct advantage of applying a bare metal stent in acute situations is the minimization of spinal cord ischemia development, which might occur in patients with endografts with coverage up to the celiac artery level (51).

Therefore, the combined PSG and DBS is considered a superior option for the management of complex TBAD. Further, to prevent unfavorable outcomes, surgeons must possess proficient skills in performing this technique and thoroughly evaluate the condition of each patient.

Limitations

This study had several limitations. First, the included studies were non-randomized; consequently, selection bias and reporting bias were present in the analyzed results. Second, due to the limited number of studies in this meta-analysis, it is challenging to draw definitive conclusions regarding these patients. Additional research on changes in the diameter or volume of the aorta preoperatively and postoperatively needs to be conducted to accurately assess whether the combined PSG and DBS is more effective in promoting aortic remodeling. Finally, further research is to be conducted to validate the performance of DBSs in terms of postoperative event rates, particularly at different stages of TBAD.

Conclusions

The combination of PSG and DBS enhances aortic remodeling by promoting complete thrombosis in the abdominal FL, leading to improved patient outcomes through reduced rates of complications related to ARM, conversion to open repair, reintervention, and SINE. Consequently, this technique represents a favorable approach for the treatment of complicated TBAD.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the MOOSE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1697/rc

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1697/prf

Funding: This study was supported by the National Science Foundation of China (No. 81970412), the Shanghai Municipal Science and Technology Commission Innovation Fund (No. 22S31904800), the Fujian Province Health Science and Technology Fund (No. 2021GGB030), the Shanghai Municipal Science and Technology Commission Innovation Fund (No. 18441902400), the National Clinical Research Center for Interventional Medicine Fund (No. 2021-004), the Shanghai Municipal Health Commission (No. 20214Y0474), the Xiamen Municipal Health Science and Technology Program Fund (No. 3502Z20194034), the Fudan Zhangjiang Clinical Medicine Innovation Fund (No. KP7202115), and the Zhongshan Hospital’s Talents Supporting Plan (No. 2019ZSGG11).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1697/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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(English Language Editor: L. Huleatt)