Published online Mar 18, 2025. doi: 10.13105/wjma.v13.i1.100176
Revised: January 11, 2025
Accepted: January 21, 2025
Published online: March 18, 2025
Processing time: 217 Days and 2.5 Hours
Current United States Food and Drug Administration (FDA) guidelines estab
To compare the efficacy and safety of covered SEMS against uncovered SEMS, and thereafter propose more direct trials comparing covered SEMS against silicone stents for consideration of revision of current FDA guidelines.
A comprehensive literature review of MEDLINE and EMBASE was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Of 3002 articles, 64 publications met the eligibility criteria with a total of 900 patients (468 covered SEMS, 432 uncovered SEMS). The collected data were analyzed using Statistical Package for the Social Sciences version 11.5.
Covered SEMS showed a higher success rate of insertion (98.6% vs 88.2%) and lower complication rates of infection (1.3% vs 13.2%), restenosis (1.5% vs 10.6%), stent fracture (2.6% vs 7.4%), bleeding (0% vs 5.8%), and pneumothorax (0% vs 2.8%) compared to uncovered SEMS. However, covered SEMS compared to uncovered SEMS showed higher complication rates of stent migration (12.4% vs 6.9%) and granulation tissue formation (26.5% vs 20.1%).
Our study suggests that covered SEMS are an effective, safe, and viable option in the treatment of BAS. Thus, further consideration regarding the utilization of covered SEMS over other forms of stent types is appropriate.
Core Tip: Covered self-expanding metal stents (SEMS) are viable alternatives to uncovered SEMS and silicone stents, with higher stenting success rates and less complication risks. This is a systematic review evaluating the safety and efficacy of SEMS in benign airway stenosis treatment. Our results challenge the existing guidelines that favor silicone stents and point to contemporary covered SEMS as a viable alternative in view of its increased insertion success and lower complication rates, compared to uncovered SEMS.
- Citation: Han L, Peck EW, Teo E, See KC. Systematic review comparing the efficacy and safety of covered and uncovered self-expanding metal stents in benign airway stenosis. World J Meta-Anal 2025; 13(1): 100176
- URL: https://www.wjgnet.com/2308-3840/full/v13/i1/100176.htm
- DOI: https://dx.doi.org/10.13105/wjma.v13.i1.100176
Benign airway stenosis (BAS) causes significant morbidity and mortality. Patients with tracheal stenosis present clinically with dyspnea, stridor, or wheezing with symptoms persisting for several years[1]. Causes of BAS can be broadly divided into mechanical causes and inflammatory diseases. A large proportion of mechanical causes include those of iatrogenic etiology such as post-tracheostomy tracheal stenosis and post-intubation tracheal stenosis. Other mechanical causes involve extramural compression due to trauma, aneurysm, and goiter. Inflammatory causes include tuberculosis of the lung, tracheobronchomalacia, granulomatosis with polyangiitis, sarcoidosis, amyloidosis, and relapsing polychondritis[2].
Airway stenting of benign tracheal stenosis is an effective approach that has been employed widely in clinical practice[3]. Silicone stents have been available since the mid-1980s and have traditionally been the mainstay treatment for BAS. In the 1980s, modified vascular metal stents (Gianturco) were used in airways, however this was eventually disfavored due to the unacceptable complication rates with over 30% of cases experiencing migration and/or rupture of the metallic mesh[4]. Subsequently in the 1990s, the introduction of self-expanding metal stents (SEMS) proved better clinical effectiveness and lower complication rates[5]. SEMS can be broadly categorized into two groups of covered and uncovered.
Among respiratory interventionists, there has been controversy regarding the advantages of SEMS vs silicone stents. Proponents of SEMS cite several advantages they have over silicon stents: (1) Their deployment via flexible bronchoscopy, which requires only topical airway anesthesia and moderate sedation compared to the use of rigid bronchoscopy needed in silicone stents[6-8]; (2) How SEMS have excellent adherence properties to the airway wall therefore decreasing risk of migration; and (3) The radio-opaque properties of SEMS, thereby being easily appreciated on radiography scans. However, others cite protocols and guidelines like the 2005 United States Food and Drug Administration (FDA) public health notification which favor the use of silicone stents over uncovered SEMS, due to the adverse complications faced during the insertion and removal of uncovered metal stents[9].
With the accumulation of almost two decades of evidence on newer covered SEMS since the conception of the FDA notification, this guideline requires reviewing as evident by the multiple advantages SEMS offer compared to silicone stents. There remains currently no literature on the comparison of SEMS and silicone stenting in the context of BAS.
Therefore, this paper provides a systematic review comparing the efficacy and safety of covered SEMS against uncovered SEMS, and thereafter proposes more direct trials comparing covered SEMS against silicone stents for consideration of revision of current FDA guidelines should there be resounding evidence for the use of covered SEMS in BAS.
The literature search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The search terms of “Metal”, “Stent”, “Benign airway obstruction”, “Stenosis”, “Airway”, “Trachea”, “Tracheol”, “Bronchus”, “Bronchial”, “Self-expanding metal stents”, “Self Expandable Metallic Stents”, “Montgomery T tube”, “Dumon stent”, “Polyflex stent”, “SEMS” were searched on Medline and EMBASE. Additionally, bibliographies of included citations were hand searched. The protocol for this study was registered in PROSPERO (No. CRD42022333088).
The search was conducted on publications from database inception until December 31, 2021. A systematic review of literature was conducted for all existing cohort studies, case series, and case reports containing data on efficacy and safety of metal stent usage. Studies involving malignant airway diseases, non-pulmonary stenting, bronchoscopy procedures without the use of stents and pediatric patients (less than 16 years of age) were excluded. The search was limited to English and human studies. Systematic reviews, review articles, editorials, letters, and studies with no results were also excluded.
The primary outcome of this study was to evaluate the efficacy and safety of SEMS in the treatment of BAS. The assessment of efficacy was based on the success of the procedure defined by declared correct placement of stents at the desired location to relieve airway stenosis with subsequent clinical, radiological, or functional improvement. A procedure was deemed effective if it reported success or postoperative improvements in any of these three domains.
Separately, the assessment of safety was evaluated throughout the course of treatment–stent insertion, stent-induced complications, stent removal, and stent-related death. The definitions of key terms summarizing the primary outcomes of efficacy and safety are shown in Table 1.
| TS | TS was defined as the number of successful insertion procedures of a balloon catheter through a stenosis followed by appropriate positioning of the stent across the diseased segment and increase in tracheal diameter of the stenotic segment |
| CS | CS was defined as the number of patients with improved clinical symptoms pertaining to the tracheal pathology post-stent insertion |
| RS | RS was defined as the number of patients with a lack of abnormal pathological findings on chest X-ray investigation post-stent insertion |
| FS | FS was defined as the number of patients with an improved FEV1/forced vital capacity ratio or FEV1 post-stent insertion as compared to pre-stent insertion |
| Successful insertions1 | Successful insertion of airway stent was defined as the number of insertion procedures where the stent was placed at the desired location to relieve airway stenosis |
| Unsuccessful insertions | Unsuccessful insertion of airway stent was defined as the number of insertion procedures where the stent could not be placed at the desired location to relieve airway stenosis |
| Removal success | Successful removal was defined as the number of removal procedures where airway stents were removed from tracheal lumen without immediate deterioration of patient’s clinical symptoms or restenosis of airway |
| Unsuccessful removal | Unsuccessful removal of airway stent was defined as the number of removal procedures where the stent could not be removed and remained lodged in the patient’s airway |
| Complications | Complications were defined as the number of a particular adverse stent-related clinical event occurring after insertion |
| Uncovered SEMS | Uncovered SEMS were defined as SEMS without any polymer coverage over the body of the stent |
| Covered SEMS | Covered SEMS were defined as SEMS covered with a complete polymer coverage across the entire body of the stent |
| Metal stent death | Metal stent death was defined as the number of patients whose death was directly caused by the insertion or removal of a SEMS |
Relevant studies were identified by two independent authors through title and abstract screening. Further selection for inclusion was based on the full text according to PRISMA guidelines, summarized in Figure 1. Then data were extracted independently by the authors. Data from individual articles included study design, types of stents (covered and uncovered), stent brand, demographic presentation of patients, stent insertion indication, number of successful stent insertions, stent induced complications, stent removal indication, number of successful stent removals, and number of deaths caused by stent intervention. A summary of stent indications and complications can be found in Supplementary Table 1[6,10-73]. Any discrepancies related to data extraction and synthesis were resolved by the senior author after further discussion.
The Joanna Briggs Institute (JBI) Critical Appraisal tool is a validated tool used to assess the methodological quality of studies and to determine the extent of possible bias in terms of its design, conduct and analysis. For this study, the appraisal tools for cohort studies, case reports, and case series were utilized. The JBI critical appraisal tables can be found in Supplementary Table 2[10,28], Supplementary Table 3[6,11,13-16,18-23,25,26,29,31-34,36,37,39-41,43-45,47,49-52,54-58,60,62,63,65-69,71,73-79] and Supplementary Table 4[12,17,24,27,30,35,38,42,46,48,53,58,59,61,64,70,80-82].
The collected data were analyzed using Statistical Package for the Social Sciences version 11.5 (SPSS Inc., Chicago, IL, United States). Patient characteristics were described using proportions, means, and standard deviations. Comparison of proportions was done using Fisher’s Exact Test.
From a pool of 3002 studies, 64 publications describing 900 patients cases met the inclusion criteria for final analysis in this systematic review. Of the 900 cases, 468 involved the utilization of covered SEMS, while the other 432 cases were on uncovered SEMS.
Of the 1082 stents inserted in 900 patients, we saw a promising rate of 93.6% (1013/1082) of metal stents successfully inserted. The 98.6% (511/518) of covered SEMS were successfully inserted, which was significantly better compared to the 88.2% (462/524) of uncovered SEMS (P < 0.001).
Overall, 95.2% (435/457) of metal stents were successfully removed. The 95.0% (305/321) of covered SEMS and 93.8% (90/96) of uncovered SEMS were successfully removed. This difference however was not statistically significant (P = 0.607).
A range of complications in SEMS were observed, most common being infection, restenosis, stent fracture, bleeding, pneumothorax, stent migration, and granulation tissue formation. For infection, restenosis, stent fracture, bleeding, and pneumothorax, patients with covered SEMS showed statistically significantly lower complication rates. The 1.3% (6/468) of patients with covered SEMS developed infection compared to 13.2% (57/432) of patients with uncovered SEMS (P < 0.001). The 1.5% (7/468) of patients with covered SEMS developed restenosis compared to 10.6% (46/432) of patients with uncovered SEMS (P < 0.001). The 2.6% (12/468) of patients with covered SEMS developed stent fracture compared to 7.4% (32/432) of patients with uncovered SEMS (P = 0.001). No (0/468) patient with covered SEMS developed bleeding or pneumothorax, compared to 5.8% (25/432) (P < 0.001) and 2.8% (12/432) (P < 0.001) respectively of patients with uncovered SEMS.
By contrast, for stent migration and granulation tissue formation, the results reflected a significantly higher com
Stent-related death was rarely reported: 0% for covered SEMS vs 0.2% (1/432) for uncovered SEMS, the difference being found to be not statistically significant (P = 0.480). A summary of the results can be found in Table 2.
| All patients with SEMS | Patients with covered SEMS (n = 468) | Patients with uncovered SEMS (n = 432) | P value (fisher's exact test)7 | |
| Successful insertions | 1013 (93.6)1 | 511 (98.6)2 | 462 (88.2)3 | < 0.001 |
| Successful removals | 435 (95.2)4 | 305 (95.0)5 | 90 (93.8)6 | 0.607 |
| Stent-related deaths | 1 (0.1) | 0 (0.0) | 1 (0.2) | 0.480 |
| Complication rate | ||||
| Stent migration | 88 (9.8) | 58 (12.4) | 30 (6.9) | 0.007 |
| Granulation tissue formation | 211 (23.0) | 124 (26.5) | 87 (20.1) | 0.027 |
| Infection | 63 (7.0) | 6 (1.3) | 57 (13.2) | < 0.001 |
| Restenosis | 53 (5.9) | 7 (1.5) | 46 (10.6) | < 0.001 |
| Stent fracture | 44 (4.9) | 12 (2.6) | 32 (7.4) | 0.001 |
| Bleeding | 25 (2.8) | 0 (0.0) | 25 (5.8) | < 0.001 |
| Pneumothorax | 12 (1.3) | 0 (0.0) | 12 (2.8) | < 0.001 |
| Mucus plugging | 11 (1.2) | 7 (1.5) | 4 (0.9) | 0.550 |
| Others8 | 63 (7.0) | 48 (10.3) | 15 (3.5) | < 0.001 |
Determining the type of airway stents to employ in the treatment of BAS is a crucial decision with consideration of both patient and disease factors. Understanding the efficacy and safety of each airway stent is of paramount importance. An ideal stent should be easy to insert and remove, effective in relieving airway stenosis, and have minimal complications–it should not fracture, migrate nor pose any life-threatening risks to a patient[83]. The results of this systematic review argue for the use of covered SEMS over uncovered SEMS due to its higher rate of success in both stent insertions, and the lower prevalence of complications such as infection, restenosis, stent fracture, bleeding, and pneumothorax. Additionally, stent-related death was not reported for covered SEMS.
Despite SEMS being traditionally regarded as inferior to silicone stenting in BAS, an argument on the contrary can be made. SEMS have a thinner wall thickness compared to silicone stents and their ability to wrap the inner surface of the airway lumen provides an added benefit and advantage in the effective relief of airway stenosis. It is noteworthy that SEMS also overcome several intrinsic limitations of silicone stents such as customization for wider lumen sizes which is otherwise not possible in a fixed silicone stent[84]. Another practical advantage of SEMS is its ease of insertion via flexible bronchoscopy under topical anesthesia[85]. This bypasses the need for general anesthesia used in the insertion of silicone stents via rigid bronchoscopy which poses significant risks of cardiovascular and respiratory complications especially in patients with multiple comorbid medical conditions[86].
This paper acknowledges prior literature as reviewed by Rodriguez et al[87] in 2000 which highlights the difficulty of removal and high incidence of complications such as stent fracture associated with the use of uncovered SEMS in BAS, which amongst many, have supported the 2005 FDA discommendation of the use of uncovered SEMS in BAS.
However, it is important to acknowledge and recognize technological advancement and improvement of covered SEMS since the 2005 FDA advisory. Notably, this has led to a reduction in the stent fracture rate amongst covered SEMS to a level comparable to that of silicone stents[9]. An example of a recent study on such covered SEMS is one published by Salguero et al[88] on the safety of covered metal stents in airway diseases. Although it covers both malignant and benign airway pathologies, the paper concluded that in an era of contemporary stents and surveillance bronchoscopies, covered metal stents is a safe and applicable option, with multiple pragmatic advantages. Hence, it is evident that the practice of metal stenting is widely adopted internationally, and this study challenges the traditional and obsolete association of metal stents with high complication rates in airway diseases.
The results of this paper show significantly lower complications rates of covered SEMS compared to uncovered SEMS in the domains of infection, restenosis, stent fracture, bleeding, pneumothorax, and other miscellaneous complications. However, we acknowledge the increased risks of granulation tissue formation and stent migration.
A study conducted by Xiong et al[72] in 2019 supports the findings of our study where there was a statistically significant increased complication rate of minor granulation of covered SEMS (22/59, 37.29%) compared to uncovered SEMS (8/72, 11.11%) in BAS, while major granulation (requiring stent replacement) complication rate was likewise higher although not statistically significant.
By contrast, a study by Li et al[89] in 2021 comparing covered SEMS with uncovered SEMS among 45 patients (36 covered SEMS, 9 uncovered SEMS), showed a significantly lower complication rate of granulation tissue formation in covered SEMS (15/36, 41%) compared to uncovered SEMS (9/9, 100%). This finding aligns with conventional pathophysiological understanding that granulation tissue regrowth is lower in covered SEMS compared to uncovered counterparts because they prevent the proliferation of tissue through stent interstices[90].
Evidently, there are differing data and reviews regarding complication rates of granulation tissue formation between covered and uncovered SEMS. There are two plausible explanations for this discrepancy. First, the degree of granulation tissue formation is not always quantified or defined as seen in Xiong et al's review, and the extent of granulation tissue defined and assessed between studies could be inconsistent[72]. Second, the exact pathogenesis of granulation is multifactorial and still unclear. Multiple studies have surmised that the degree of granulation tissue hyperplasia is most likely due to an array of factors such as friction of the airway wall, pressure of stent on wall, site of stent implantation and the presence of ongoing airway infection, which confounds the evaluation of granulation tissue formation being definitively attributed to the type of SEMS[72,91]. Ultimately, this complication can be successfully managed and resolved using argon plasma coagulation[92], which can be performed without the use of a laser, reducing the chance of airway fire[93].
As aforementioned, the complication rate of stent migration was significantly higher in covered SEMS compared to uncovered SEMS. This could be attributed to the allowance of stent ingrowth and epithelialization in uncovered SEMS which provides a lower risk of stent migration compared to covered SEMS.
Although there is a paucity of head-to-head comparative studies between covered SEMS and silicone stents in the existing literature, when comparison is made between covered SEMS and silicone stents, it is interesting to note that covered SEMS still provide a lower risk of stent migration compared to silicone stents (Table 3)[94-97]. According to a study published by Chen et al[94], based on a 7-year experience with silicone Dumon stents, covered SEMS appear to have a relatively low stent migration rate of 12.4% compared to silicone stents with stent migration rates ranging from 17.2% to 51.0%. A possible explanation for less frequent stent migration in metallic stents is the self-expanding nature of metal stents that promotes better wall adherence[68,80,98]. Additionally, it is noteworthy that only 69.0% of silicone stents were successfully inserted while 54.7% of them were successfully removed[99] which pales in comparison with the high success rate of insertion of covered SEMS as seen from this study, where covered SEMS had a relatively high success of stent insertion of 98.6%, and of stent removal of 95.0%.
| Patients with covered SEMS (n = 468) | Patients with uncovered SEMS (n = 432) | Silicone stent study (No. 1) (n = 263) | Silicone stent study (No. 2) (n = 63) | Silicone stent study (No. 3) (n = 58) | Silicone stent study (No. 4) (n = 75) | |
| Successful insertions | 511 (98.6)1 | 462 (88.2)2 | 181 (69.0) | - | - | 70 (93.3) |
| Successful removals | 305 (95.0)3 | 90 (93.8)4 | 117 (54.7) | - | - | 49 (65.0) |
| Stent-related deaths | 0 (0.0) | 1 (0.2) | 2 (0.8) | - | - | - |
| Stent complication rate | ||||||
| Stent migration | 58 (12.4) | 30 (6.9) | 78 (18.6)5 | 62 (28.0)5 | 10 (17.2) | 38 (51.0) |
| Granulation tissue formation | 124 (26.5) | 87 (20.1) | 72 (17.2)5 | - | - | - |
| Infection | 6 (1.3) | 57 (13.2) | - | - | 14 (24.1) | - |
| Restenosis | 7 (1.5) | 46 (10.6) | 24 (5.7)5 | - | - | 30 (40.0) |
| Stent fracture | 12 (2.6) | 32 (7.4) | - | - | 1 (1.7) | - |
| Bleeding | 0 (0.0) | 25 (5.8) | - | - | - | 1 (1.3) |
| Pneumothorax | 0 (0.0) | 12 (2.8) | - | - | - | 5 (6.67) |
| Mucus plugging | 7 (1.5) | 4 (0.9) | - | 131 (60.0)5 | 21 (36.2) | 14 (19.0) |
| Others6 | 48 (10.3) | 15 (3.5) | - | 18 (8.0)5 | 6 (10.3) | - |
Limitations of our study include the following. Firstly, although the total number of patients (n = 900) was substantial, there were 11 papers consisting of 204 patients that were excluded as these papers did not specify if covered or uncovered SEMS were used.
Second, due to the lack of comparative studies primarily comparing covered SEMS with silicone stents, evaluation regarding silicone stents could not be conducted in this systematic review. Therefore, further comparative studies with long-term follow up would be beneficial in directly addressing the advantages and disadvantages of SEMS against silicone stents.
Third, a main finding of the paper was the rate of restenosis whereby the data reflected a significant difference between covered and uncovered SEMS hence supporting that covered SEMS are of superior efficacy. It is noteworthy to consider factors which could confound this result such as experience and competence of the physician conducting the stent insertion, which are impossible to ascertain from the reports.
Lastly, given that the pooled data are from case reports, series and cohort studies with a diversity of patient population, in terms of ethnicity, age, and comorbidities, there is increased likelihood of heterogeneity within this study. Furthermore, we acknowledge that different airway pathologies are classically managed differently. For example, post-transplant stenosis/dehiscence are typically managed internationally with uncovered SEMS while benign tracheoesophageal fistulas are managed with fully covered SEMS due to the different and unique set of challenges each complex pathology poses. Given the aforementioned heterogeneity of the population of this study, this highlights the necessity for further subgroup analyses on this topic.
With these considerations, firm recommendations against FDA's advisory cannot be made solely based on the results of this study. However, it is evident that covered SEMS are likely superior to uncovered SEMS in view of significantly reduced complications and increased insertion and removal rates. Therefore, we propose and recommend for further direct trials and head-to-head comparative studies between covered SEMS and silicone stents. This would allow further subgroup analyses (i.e. post-transplant stenosis/dehiscence patients, benign tracheoesophageal fistula, tracheal/bronchial/Lobar stenosis, etc.) to be conducted and provide an avenue for more accurate representative data and definitive conclusion on the efficacy and safety of covered SEMS in BAS. We feel that these are necessary and urgently required to ascertain the relevance of the FDA guideline in the context of advanced medical technology, with improved covered SEMS treatment in BAS.
To conclude, in our review of the efficacy and safety of SEMS, contemporary covered SEMS show higher success rates of stent insertion compared to uncovered SEMS making them a viable option for the treatment of BAS. Coupled with lower complication risks of infection, restenosis, stent fracture, bleeding, and pneumothorax the benefits of covered SEMS over uncovered SEMS warrant a re-evaluation of the 2005 FDA advisory against SEMS use in BAS[9].
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