Efficacy and safety of self-expandable metallic stent on benign tracheobronchial stenosis: a systematic review and meta-analysis

Introduction

Benign tracheobronchial stenosis (TBS), commonly caused by endotracheal intubation, tracheotomy, pulmonary tuberculosis and airway anastomosis (1), as well as non-infectious etiologies such as vasculitis or external compression, could lead to severe dyspnea or even respiratory failure. Surgical resection and airway reconstruction might currently have limitation in treating a subset of patients with benign airway stenosis, which is largely due to unresectable long length lesion, intolerance to surgery, as well as the complications in terms of surgical trauma and postoperative restenosis (2). Accumulating evidence suggests that bronchoscopic technique has emerged as the indispensable treatment for benign TBS, particularly of tracheobronchial stent for rapidly alleviating airway obstruction (3). Whereas, the safety and efficacy of airway stent in the management of benign TBS remain elusive.

Dumon silicone airway stent is reportedly preferred to surgery as the first option for the treatment of benign TBS (4). Despite presenting with favorable elasticity, high strength and toughness, as well as good histocompatibility, silicone airway stent still has challenge for the high risk of displacement and deployment limitation in some cases with severe airway obstruction (5). In this scenario, self-expandable metallic stents (SEMS) could be implemented to rapidly relieve dyspnea and maintain airway lumen, with lower risk of stent migration, less bacterial colonization and favorable mucociliar clearance (6). SEMS can be classified as “covered” (a membrane covers the stent mesh to reduce tissue ingrowth) or “uncovered” (bare metal mesh), which may influence both complication profiles and removability.

Nevertheless, the application of metallic stent in benign TBS is still a matter of debate due to its related complications in terms of stent fracture, adjacent structure involvement, granulation tissue hyperplasia, and eventually, airway restenosis. The United States Food and Drug Administration (FDA) warning has been given that SEMS would generate a high risk of difficulty in removal and stent-related complications in benign TBS (7). However, there has been accumulating experience from several studies that the short-term use of SEMS under the intensive observation could conduce to alleviating dyspnea without severe adverse events (8). In this regard, we conducted a meta-analysis in an attempt to elucidate the safety and efficacy of the SEMS in benign TBS. Furthermore, a subgroup analysis was performed to evaluate the differences between covered and uncovered metallic stent in the treatment of benign TBS. The study design was conducted following the Cochrane Handbook (9). And we present this article in accordance with the PRISMA reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1007/rc) (10).

Methods

Registration information

We registered the study protocol in PROSPERO (CRD42022367621) prior to data extraction to minimize reporting bias. The registration details include the search strategy, inclusion criteria, and planned statistical methods.

Patient and public involvement

Patients were not involved in the design or execution of this study.

Inclusion criteria

Researches that meeting the following criteria were included in our study: (I) patients diagnosed of benign TBS; (II) patients received metallic airway stenting treatment; (III) studies that included data on airway stent removal, stent effectiveness, airway restenosis, and/or stent-related complications.

Exclusion criteria

The following researches were excluded from this study: (I) patients diagnosed of malignant airway stenosis; (II) availability of the full text or relevant data; (III) book chapters, abstract articles only, conference papers, reviews, thesis, letters; (IV) in vitro or animal study; (V) articles written in non-English languages.

Data collection and extraction

The following terms were combined to generate search keywords: metal and stent and (airway or tracheal or bronchial or tracheobronchial) and (stenosis or obstruction or constriction or narrow) and (benign or “tracheal intubation” or tracheotomy or tuberculosis or “tracheobronchial anastomosis”) and “English” [Language] and “humans” [MeSH Terms]. All data were independently retrieved by two investigators (M.S. and Z.S.). Disagreements were resolved by discussions between the two reviewers and an independent expert (S.L.).

Assessment of risk of bias

The risk of bias was evaluated by using the methodological index for non-randomized studies (MINORS) on the basis of previous report (11): (I) a clearly stated aim; (II) inclusion of consecutive patients; (III) prospective collection of data; (IV) endpoints appropriate to the aim of the study; (V) unbiased assessment of the study endpoint; (VI) follow-up period appropriate to the aim of the study; (VII) loss to follow-up less than 5%; and (VIII) prospective calculation of the study size. Each item was scored on a scale of 0, 1 and 2: “0” denoted unreported, “1” denoted underreported, while “2” denoted adequately reported, respectively.

Data synthesis and analysis

All included studies were divided into two subgroups: covered stents and uncovered stents groups based on the type of SEMS, for the sake of assessing the association between stenting safety and SEMS type. Moreover, the effective rates defined as the percentage of patients who had their stents successfully removed without symptomatic restenosis, or patients had a stability of the metallic stent support (12), was implemented to evaluate the efficacy of SEMS for benign TBS. While the stent-related complication and stent removal rate were analyzed to evaluate the safety of SEMS treatment.

Meta-analysis was performed to elucidate the incidence of each outcome event using a generalized linear mixed model (GLMM) with logit transformation in R (version 4.3.1, meta package). This approach accounts for within-study variability via random effects, handles extreme proportions (0% or 100%) through logit transformation, and applies continuity correction for studies with zero events. Pooled results were reported as proportions with 95% confidence intervals (CIs) bounded between 0 and 1. Heterogeneity was quantified using the I² statistic (≥50% considered substantial), τ² (estimated using the restricted maximum-likelihood estimator), and Cochran’s Q test (P<0.10 indicating significance). Subgroup differences were assessed using mixed-effects models. To address incomplete outcome reporting or missing data, all available data from each study were included without imputation, and sensitivity analyses were performed by excluding studies with incomplete reporting. Publication bias was evaluated visually using funnel plots and quantitatively with Egger’s linear regression test. And we note that Egger’s test has limited power when fewer than 10 studies are available for an outcome, and “non-significant” results do not rule out potential bias.

Results

Study characteristics

We identified a total of 729 records from literatures, 693 were excluded based upon the criteria of the study (Figure 1). In total, 36 studies comprising 797 benign TBS participants, treated with 1,236 SEMS, were recruited during 26.0±13.5 months of follow-up period. The mean age of enrolled patients was 47.5±14.4 years. Furthermore, the included single-arm studies and controlled studies were analyzed by using MINORS, indicating a moderate quality of included studies (Table 1).

Figure 1 Flow diagram for study inclusion. SCI, Science Citation Index.

Efficacy of SEMS

The study showed that the effective rate was 56.4% (95% CI: 40.3–71.3%) using a random-effects GLMM model with logit transformation, with 82.9% of patients had airway stents successfully removal without restenosis, and 17.1% had a long-term stent placement (Figure 2). The effective rates according to the etiology of benign TBS were respectively analyzed: iatrogenic injury (tracheotomy, intubation, anastomotic stenosis after transplantation or lobectomy) 41.5%, infectious (tuberculous) 83.3%, non-infectious (polychondritis, Wegener’s granuloma) 46.2%, and external compression 75.0%. The average time of stent placement was 6.59±4.96 months. After 3.97±3.14 months, stents were removed in 25.7% due to stent-related complications. 74.3% of patients underwent elective stent removal after 1.90±1.91 months. Some stents were still in place in a subset of patients at the end of follow-up period, due to the high risk of airway restenosis or being not at the scheduled time for stent removal. The total success rate of stent extraction was 98.7%.

Figure 2 Forest plot for meta-analysis on efficacy. CI, confidence interval.

Safety of SEMS

The incidence of stent-related complications was 45.0% (95% CI: 32.0–59.0%) in the overall pooled analysis (Figure 3), including symptomatic airway restenosis 18.7% (95% CI: 9.8–32.6%), granulation tissue hyperplasia 24.6% (95% CI: 18.9–31.3%), mucus retention 27.3% (95% CI: 10.2–55.7%), stent migration 12.4% (95% CI: 8.5–17.8%), and stent rupture 4.7% (95% CI: 2.5–8.6%). Airway stent-related death was rarely reported (Table 2).

Figure 3 Forest plot for subgroup meta-analysis on complications based upon stent type. CI, confidence interval.

Subgroup analysis

Subgroup analysis for stent types was conducted using complication indexes. Uncovered stents had a lower incidence of complication than covered stents (UC vs. C: 31.5%, 15.8–53.2% vs. 52.3%, 39.2–65.1%) (Figure 3). Whereas, quantitative assessment of heterogeneity was performed by I² (I²>50%), suggesting a heterogeneity among the included studies. Hence, we classified various complications and conducted subgroup analysis based on the influencing factors, indicating that covered stents were associated with higher incidences of granulation tissue formation, sputum retention, migration compared with uncovered stents (granulation: 28.2% vs. 27.7%; sputum retention: 19.2% vs. 18.1%; migration: 23.8% vs. 8.1%). When further stratified by stent type, stenosis location, and etiology, the pooled incidence of complications was 42.3% (Figure 4), which represents a restricted subset of the overall analysis rather than a discrepancy with the main estimate. In sum, the incidence of complications varied from the cause and location of the stenotic lesion, tracheal stenosis (70%) and anastomotic stenosis after lung transplantation or lobectomy (96%) might associated with higher prevalence of stent-related complications (Table 2 and Figure 4).

Figure 4 Forest plot for multiple aspects of subgroup meta-analysis on complications. CI, confidence interval.

Publication bias

The P value for Egger linear test was 0.826, showing no publication bias in our meta-analysis. Consistent with the result of Egger linear test, a symmetrical funnel plot was obtained (Figure 5).

Figure 5 Funnel plot of studies included in the meta-analysis. s.e., standard error.

Discussion

To the best of our knowledge, this is the first meta-analysis providing comprehensive insights into the efficacy and safety of SEMS in treating benign TBS. The pooled results of the previous studies demonstrated that SEMS had 56.4% effective rate and 45% incidence of modest complications (restenosis, granulation, mucus retention and migration) during 26.0±13.5 months of follow-up period, indicating that SEMS presents favorable efficacy and safety in the management of benign TBS under intensive bronchoscopic observation. However, considering that benign airway stenosis may have a longer natural course, this follow-up period, while relatively substantial, might not fully capture long-term complications. Therefore, the results should be interpreted with caution, and SEMS remains most appropriate for temporary symptomatic relief or as a bridge to removable stents.

Patients with airway stenosis experience aggravating dyspnea and decreased oxygen saturation, which might even lead to life-threatening respiratory failure. Tracheobronchial stent placement is emerged as one of the important methods for treating airway stenosis, which could achieve dyspnea alleviation and physical ability improvement. Silicone stents is currently served as the “standard treatment” for benign BTS, Dumon stent have reportedly 75.5% effective rate in the treatment of benign BTS (11). However, silicone stents might have limitation in treating a subset of patients, as follow: (I) rigid bronchoscopic manipulation could not be exerted in patient with excessive or limited cervical joint motion; (II) silicone stents could not be fully unfolded in severe narrowing airways, even with balloon dilatation treatment; (III) patients who could not tolerate general anesthesia and the following silicone stent placement. In this scenario, the application of metallic airway stent could be taken in to consideration.

Since metallic stents might bring complications in terms of granulation tissue hyperplasia, stent displacement and stent fracture, patients with benign TBS would take on risks of airway restenosis and difficulty in stent removal (49). In 2005, the United States Food and Drug Administration (FDA) issued a public health regulation advising physicians to exercise caution when using metallic stents. The guidance emphasized that stents should only be considered as a last resort in cases where no alternative solutions exist for benign airway stenosis (7). Whereas, SEMS has an advantage in adhering to the airway wall which makes it possible to be adjusted according to the anatomical structure with a lower rate of stent displacement compared with silicone scaffold. Moreover, the airway epithelium could grow through the stent mesh to maintain mucosal clearance (50). On this account, accumulating studies have been recently dedicating to explore and elucidate the efficacy and safety of metallic stents in the treatment of benign airway stenosis. Despite the fact that most of the clinical practice was reported with small sample sizes, the pooled data in our study showed that metallic stent presented 62.6% of effective rate in treating benign TBS, while the success rate of stent extraction was 98.7%. The total incidence of stent-related complications was 42.3%, all of these complications were modest and easily treated.

In this study, we found 74.3% patients had airway stents removal without restenosis during the follow-up period, only 25.7% needed to replace the stent for long-term treatment, indicating that SEMS had a considerable efficacy in the management of benign TBS. The subgroup analysis based on etiology showed that SEMS had a higher effective rate in tuberculosis infection and external compression related stenosis, rather than injury-induced and systemic immune diseases. This might be in part due to the pathogenic mechanisms of injured and immunogenic airway strictures are more diverse and complex, which bring a great challenge for SEMS to achieve a favorable therapeutic effect (51).

In the current analysis, we found a significant difference in the incidence of complications (range, 11.1–88.9%) from various researches, which might be attributed to the differences in the follow-up period and bronchoscopic management (43). Granulation tissue hyperplasia is considered as the most common complication in SEMS treatment. The previous study showed that time-to-granulation tissue formation of covered and uncovered stents was about 20 days (45). This might be conducive to the early bronchoscopic detection of granulation tissue hyperplasia after stent placement. We performed a subgroup analysis based on the airway stent type, revealing a notable correlation between complication rates and stent type. It should be noted that many of the stents labeled as “covered” in the included studies were not truly fully covered, with the extremities often left bare. This partial coverage may confound the comparison of granulation tissue formation between covered and uncovered stents. Consequently, the observed similarity in granulation rates should be interpreted with caution. Future studies should focus on clearly defined fully-covered stent designs to provide more reliable estimates of complication rates. Although our results report the success rate of metallic stent removal, it is important to emphasize that in benign TBS, removability is a crucial clinical consideration. Granulation tissue formation, particularly around bare-metal stents, can complicate extraction, and the ultimate therapeutic goal is to restore airway patency without long-term stent dependence. The subgroup analysis demonstrated a lower complication rates in uncovered SEMS compared with covered stent (sputum retention and migration), which was currently deemed as controversial from different studies (52). This disagreement might due to the patient selection and improvement of metallic material. Otherwise, Rodriguez et al. have pointed out that uncovered SEMS present the advantage of in-scaffold neoepithelialization, which is beneficial to reduce mucus retention (53).

The high heterogeneity (I²>50%) across studies, likely due to differences in study design, patient selection, follow-up duration, and definitions of complications, limits the generalizability of the pooled estimates. Minor differences in granulation tissue formation and sputum retention between covered and uncovered SEMS should be interpreted cautiously, whereas the trend toward higher migration rates in covered stents warrants further investigation in larger, standardized studies. While restenosis is primarily a stent-related complication, progression of underlying airway pathology may also contribute in some cases. Clinicians should consider these factors when planning SEMS placement and interpret complication rates in the context of individual patient characteristics.

We further performed subgroup analysis based on the location and causes of benign TBS, indicating that patients with tracheal stenosis, post-anastomosis and post-tuberculous stenosis might have higher incidence of stent related complications. The studies that SEMS for treating upper tracheal and subglottic stenosis were included in our meta-analysis. Due to the stent shifting and repeated stimulation in the airway, the rigid upper/subglottic airway and the expansive trachea generated shear forces at the stent-mucosal interface would lead to persistent mucosal damage and excessive granulation tissue hyperplasia (50). Therefore, SEMS might be more suitable to serve as a temporary treatment or a transitional plan for further procedures rather than long-term placement in subglottic tracheal stenosis. Moreover, temporary SEMS implantation could be also used as a means of transition to silicone stents or surgical procedures in patients with severe airway stenosis, especially when rigid bronchoscopy or silicone stents cannot be advanced to the stenotic airway even after bronchoscopic treatment (e.g., thermal ablation, balloon dilatation). The temporary SEMS can continuously dilate and reshape the airway lumen, thereby re-establishing airway patency. This capability facilitates the implantation of silicone stents in patients suffering from severe airway stenosis (6).

Funnel-plot and Egger’s tests did not reveal significant small-study asymmetry, but these methods have limited power with few studies and low event rates. Beyond statistical bias, contextual factors likely affect this literature: (I) operator/center preference—centers with limited rigid bronchoscopy access may favor SEMS; (II) selective reporting and time-lag—short-term favorable outcomes are more frequently published; and (III) device classification uncertainty—many included studies did not clearly distinguish fully covered from partially covered stents, which may obscure differences in complication rates and contribute to heterogeneity. These factors may inflate perceived efficacy and safety. Caution is warranted, and future preregistered studies with standardized outcomes across centers are needed.

Nevertheless, there were some undeniable limitations to this study. First, all the included studies were not RCT studies, which would limit the generalizability of the results. There exists some differences in inclusion and exclusion criteria from the included studies (lesion location, severity, course of disease, etc.), which would bias the results of the study. Second, the current studies did not investigate and analyze the non-surgical treatment (such as balloon-dilation, laser ablation, etc.) in pre- and post-operative care, which might affect the prognosis of stenting treatment. Third, the optimal duration of SEMS placement remains controversial, the included researches in our meta-analysis rarely reported the placement time, or stenting treatment with a large time span, hence, the stent duration and follow-up interval should be continuously highlighted in the further prospective studies. Additionally, most included studies were small, with sample sizes ranging from 3 to 112 patients. Small studies increase the risk of wide confidence intervals, imprecise estimates, and potential publication bias, particularly for rare events such as stent rupture. Therefore, readers should interpret these pooled incidence rates with caution regarding their generalizability and precision.

Conclusions

SEMS could be relatively effective and safe in treating benign TBS with intensive observation and follow-up, it might also be implemented as a transition procedure for further treatment in patients with severe benign TBS.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1007/rc

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1007/prf

Funding: The study was supported by the Guangzhou Science and Technology Bureau project (No. 202102010362) and the Foundation of the State Key Laboratory of Respiratory Diseases (No. SKLRD-Z-202314) to Z.S.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1007/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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