Comparative Study of Two Drug Eluting Stent in the

Central Annals of Otolaryngology and Rhinology

Cite this article: Catalano P, Tallab H, Wijewickrama R, Ghaderi M, Pritikin J (2018) Comparative Study of Two Drug Eluting Stent in the Treatment of Chronic Sinusitis with Nasal Polyp. Ann Otolaryngol Rhinol 5(4): 1220.

*Corresponding author

Peter Catalano, Department of Otolaryngology, St. Elizabeth’s Medical Center ,736 Cambridge Street , Brighton, MA 02135, USA, Tel: 617-779-6440; Email:

Submitted: 07 November 2018

Accepted: 26 November 2018

Published: 28 November 2018

ISSN: 2379-948X

Copyright© 2018 Catalano et al.

OPEN ACCESS

Keywords•Nasal dressing; Nasal polyp; Chronic sinusitis

Abstract

Background: The delivery of topical steroids via a drug elution vehicle is effective in the control of the local immune response in patients with chronic sinusitis with nasal polyps. This study evaluates the clinical outcomes and costs between two resorbable drug-eluting devices.

Prospective, multi-center (3 sites, 4 surgeons)

Methods: 40 consecutive patients with CRSwNP and undergoing endoscopic sinus surgery were enrolled. 20 patients (group A) received the mometasone device (Propel Standard), and 20 patients (group B) received the triamcinolone device (PosiSep). Baseline, 3 week, and 3 month SNOT-22, and peri-operative endoscopy scores (POSE) were compared. Lund-Mackay (LM) scores were obtained at baseline. No other steroids were permitted.

Results: Demographics, baseline SNOT-22, LM, and POSE scores were similar between groups. T-tests showed significant reduction in SNOT-22 and POSE scores at 3 weeks (p<.006) and 3 months (p<.0001) for each group. ANOVA analysis showed no difference between group A and B at 3 weeks, however, POSE ethmoid for group B was superior to group A at 3 months (p=.007). Device cost per case in group A ($1450) was 10-fold higher than group B ($140).

Summary: Group A and B were similar cohorts. Each showed statistically significant improvement in SNOT-22 and POSE scores, with POSE ethmoid in group B superior to group A at 3 months. Device cost per case in group A greatly exceeded that of group B. Drug elution devices used during ESS provide excellent control of local inflammation and marked reduction in patient symptoms over a 3 month period.

INTRODUCTION The management of patients with chronic sinusitis with nasal

polyps (CRSwNP) requires a combination of endoscopic sinus surgery (ESS) and medical control of the underlying immune process. In the past, the latter mainly consisted of either pulsed or continuous oral steroids. Many such patients have been rendered steroid dependent. The addition of leukotriene inhibitors [1], topical nasal steroids [2], immunotherapy [3], and improved nasal hygiene via the use of nasal saline irrigations, has all contributed to improved outcomes, and often reduce the overall requirement for systemic steroids. However, systemic medications can produce a multitude of side effects themselves. Targeted topical drug delivery devices can avoid systemic side effects of a medication, drug-drug interactions between medications, and also concerns over patient compliance. These advantages are even more compelling in chronic disease states where long-term medical management is required, however, the main potential drawback of targeted topical therapies is often their cost due to the significant capital requirements of research, development, and regulatory approval, leading to commercialization.

In this study, we evaluate the clinical performance and cost of two resorbable drug-eluting concepts currently available

for peri-operative use in patients undergoing ESS for CRSwNP. Standard Propel is an FDA-approved device composed of a polyethylene glycol (PEG) skeleton formed into the shape of a crown and coated with 370ug of mometasone furonate [4]. The device dissolves over a 30-day period and when placed into the middle meatus at the completion of ESS will elute drug onto the surrounding nasal and sinus mucosa while in place. Several studies [5,6] have shown the clinical benefit of Propel in reducing intra-nasal synechia, early polyp regrowth, peri-operative infection, middle turbinate lateralization, and the need for systemic steroids to manage the local inflammatory process of the disease. The current drawbacks of this device are its cost ($1450 per case), and its inability to provide local hemostasis, often prompting surgeons to simultaneously combine Propel with some other space-occupying hemostatic nasal dressing.

The other drug eluting system is a self-dissolving chitosan-based nasal dressing called PosiSep with a readily available steroid medication called triamcinolone. Chitosan-based dressings have been shown to enhance wound healing, provide hemostasis, and are biologically inert [7]. PosiSep has also been shown to reduce middle meatal synechia, control peri-operative bleeding, dissolve within a 5-7 day period, and greatly minimize

Research Article

Comparative Study of Two Drug Eluting Stent in the Treatment of Chronic Sinusitis with Nasal PolypPeter Catalano*, Hussam Tallab, Rohan Wijewickrama, Max

Ghaderi, and Jordan Pritikin

Department of Otolaryngology, St. Elizabeth’s Medical Center, USA

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Catalano et al. (2018)Email: [email protected]

Ann Otolaryngol Rhinol 5(4): 1220 (2018) 2/7

middle meatal crusting. Otolaryngologists have successfully used resorbable nasal dressings hydrated with steroids, antibiotics, or some combination to reduce peri-operative morbidity after ESS for the past several years [8- 11]. The advantages of this approach is that the patient derives the combined benefit of the nasal dressing (hemostasis, synechiae reduction, middle turbinate stabilization) with the targeted drug elution (reduction in local mucosal inflammation), at an affordable price. The cost of a 2x4 cm PosiSep is $125, and the cost of triamcinolone is $12 per 40mg vial. Lastly, the surgeon has the advantage to combine drugs and also vary drug dose depending upon the clinical indications.

MATERIALS AND METHODSPatients>18 years of age were recruited in subspecialized

rhinology centers among patients with CRSwNP refractory to medical treatment and requiring bilateral sinus surgery. Patients requiring revision surgery were included. Patients were excluded if they were<18 years old, ineligible for informed consent, unable to comply with the postoperative visits necessary for data collection, were diabetic, or had previous history of a serious surgical complication such as orbital entry, CSF leak, or nasal hemorrhage. Ethics approval was obtained from the local institutional ethics committees.

40 consecutive patients with CRSwNP requiring ESS were enrolled and followed prospectively for 90 days. There were 3 treatment sites (Boston, Philadelphia, and Chicago) and 4 participating rhinologists. The Standard Propel device was used exclusively by the Philadelphia and Chicago locations, and the 2 surgeons in Boston used only PosiSep (PS). This was determined by insurance reimbursement for each product, and the surgeons experience with it. Patient demographics were collected (Table 1), along with baseline Lund-Mackay (LM), SNOT-22, and peri-operative sinus endoscopy scores (POSE). SNOT-22 and POSE ethmoid and total scores were also collected 3 weeks and 3 months following surgery. All POSE scores were obtained by an independent observer at each site to avoid scoring bias. Surgical complications were reported if present, and no other oral or topical steroid medication was permitted 1 month before, and 3 months after ESS. Revision and primary cases were included. ESS techniques were very consistent among the four surgeons involved in this study to minimize the effect such differences might have on outcomes.

Patients were treated bilaterally after ESS, with group A patients receiving the Propel device, and group B receiving the PS device. Mometasone 370 ug is used in each Propel implant, and 2 ml of triamcinolone solution at a concentration of 20mg/ml was used to hydrate each half of the PS dressing. Each PS dressing is 20 x 40 x 1.5 mm, and one-half (i.e. 2x2 cm) was placed in each middle meatus, therefore 20mg/ml per side. Patients in group B were instructed to begin daily nasal saline irrigations 72 hours after ESS to avoid further dilution of the triamcinolone. Group A patients began daily nasal saline irrigations the day after ESS. Surgical complications, including post-operative sinusitis and epistaxis, were collected at each site. Surgical site debridement, if needed, was performed at the 3 week post-op visit. General anesthesia was preferred for the procedure. The POSE scores were obtained in Boston by an independent rhinologist by

direct endoscopic examination. This person could not be blinded as some portion of the product (Posisep or Propel) was often present during the 3 week exam.

RESULTS 20 patients were enrolled in each group. Patient demographics

were not statistically different between groups with the exception of revision cases (Table 1). There were 13 males and 7 females in group A, and 14 males and 6 females in group B. Average patient age in groups A and B was 39.2and 43.2 years, respectively. There were 6 revision cases in group A, and 9 in group B. Samter’s Triad was diagnosed in 2 patients in group A, and 2 patients in group B.

Baseline Lund-Mckay staging scores averaged 15.1 in group A, and 14.8 in group B. LM polyp grade was 1.8 for group A, and 1.7 for group B. Sino-Nasal Outcome Test (SNOT-22) scores averaged 43in group A (range 10-66), and 36.8 in group B (range 13-66). Perioperative Sinus Endoscopy(POSE) score for ethmoid sinuses were 12.4 in group A, and 12.2 in group B. POSE total scores were 22.2 and 21.3 for groups A and B, respectively (Table 2, Figure 1). None of these differences was statistically significant (p>.05).

SNOT-22 scores at three weeks postoperative assessment were 16.6 for group A, and 15.2 for group B. POSE ethmoid scores

Table 1: Patients demographics in each group.

group A (Propel) group B (PosiSep)

min age 20 28

max age 62 83

average age 39.2 43

males 13 14

females 7 6

primary ESS 17 11

revision ESS 6 9

atopy 10 12

Table 2: Baseline disease-specific characteristics in each group.

Lund-Makay score group A (Propel) group B (PosiSep)

min 9 8

max 24 24

average score 15.1 14.8

Lund-Makay polyp grade

min 0 1

max 3 3

Average grade 1.8 1.7

SNOT 22 score

min 10 7

max 68 60

average score 43 36.8

POSE average score

POSE Ethmoid 12.4 12.2

POSE total 22.2 21.3

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Lund-Makay score Lund-Makay polyp grade SNOT 22 score POSE ethmoid

score POSE total score

group A (Propel) 15.1 1.8 43 12.4 22.2

group B (PosiSep) 14.8 1.7 36.8 12.2 21.3

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50


Figure 1 Baseline parameters scores average in each group.

were 5.9 for group A, and 3 for group B (p<.006) . POSE total scores were 7.7 for group A, and 4.5 for group B (Figure 2). At 3 months SNOT-22 scores were 9.3 for group A, and 8.7 for group B. POSE ethmoid was 1.8 in group A, and 0.85 in group B. POSE total was 2.7 for group A, and 0.95 for group B (p<.017) (Figure 3).

Statistical analysis was performed using T-tests to evaluate changes in metrics at various time points within each group. Therefore, there are T-test derived p-values for SNOT-20 and POSE scores in the PosiSep group between baseline and 3 weeks post-op and baseline and 3 months post-op. The same analysis was done for patients in the Propel group. A separate analysis was performed using one-way ANOVA to assess if there was also a difference in post-operative outcome at 3 weeks and 3 months between the two groups, i.e. was the improvement seen in the PS group over time significantly different than the improvement seen in the Propel group over the same time period.

T-test for SNOT-22within group A revealed difference between baseline, 3 weeks and 3 months with high statistical significance (p<.00001). POSE ethmoid between baseline, 3 weeks and 3 months shows high statistical significance (p<.00001). Figure 4 represent POSE total between baseline, 3 weeks and 3 months shows high statistical significance (p<.00001).Analysis within group B revealed SNOT-22 difference between baseline, 3 weeks and 3 months with high statistical significance (p<.006) between each time point. POSE ethmoid between baseline, 3 weeks and 3 months shows high statistical significance (p<.00001) between each time point. POSE total between baseline, 3 weeks and 3 months shows high statistical significance (p<.00001) between each time point (Figure 5).

A one way ANOVA tested between groups A and B shows that POSE ethmoid scores at 3 months were statistically better in group B compared to group A (p=.007) (Figure 6). Device cost per patient in group A ($1450) was 10-fold higher than in group B ($140).

DISCUSSION Dissolving targeted drug-eluting products have become

a significant adjunct to ESS for patients with CRSwNP. The advantages of local control of the inflammatory process and improved wound healing without the concerns for systemic side

effects of medications, drug-drug interactions, and medication compliance, cannot be overstated. Use of these products represents a paradigm change in rhinology and has its origins in the Stratus device introduced in 2010 by Acclarent. Stratus was the first drug-eluting technology in Otolaryngology, was non-resorbable, and received CE Mark approval as such in 2011. Stratus did not receive FDA clearance as a drug-eluting device and was therefore used off-label for this purpose. In a landmark study by Levine and Kuhn [12], Stratus loaded with 0.2ml of triamcinolone (40mg/ml) was placed in the ethmoid sinus for 28 days and serum levels obtained from patients at various time points from hours to days post implantation. This study showed serum levels were detectable in humans at picogram concentrations at all time points over the 28 days. There were no complications, nor any side-effects from the treatment. The picogram concentrations of drug detected in the patient’s serum are subclinical in terms of pharmacologic their effect, but prove that drug can move from a device reservoir into the local sinus mucosa simply due to diffusion gradients. The problem with Stratus was two-fold; it did not dissolve and therefore required extraction in the surgeon’s office, and it was expensive at approximately $1600 per unit.

Based on this model, Catalano et al [13], performed a study whereby pieces of a resorbable polyurethane sponge-like nasal dressing called Nasopore was placed into the ethmoid sinus of guinea pigs and hydrated with either saline, triamcinolone at concentration of 20mg/ml or 40 mg/ml, or gentamycin 80mg/ml. The animals were sacrificed at certain time points over a 30 day period and their serum evaluated for the presence of drug. Their data was similar to Kuhn and Levine’s, and showed the presence of gentamycin and triamcinolone in picogram concentrations at each time point over the 30 day period. This study confirmed that a dissolving nasal dressing can also be used as a drug carrier/elution vehicle in the sinuses.

The Propel device has been also shown to be significantly reduce the inflammatory reaction in the middle meatus after ESS and reduce synechia formation, middle turbinate lateralization, and crusting [5,6]. These results have been durable over 90 days and the device has been easy to place and comfortable for patients. As shown in this study, the beneficial effects of topical drug elution are durable and can easily last 90 days. However, as demonstrated by patients in Group B, topical medications act

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SNOT 22 score POSE ethmoid score POSE total score

group A (Propel) 16.6 5.9 7.7

group B (PosiSep) 15.2 3 4.5

0

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12

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16

18


Figure 2 3-weeks parameters scores average in each group.

SNOT 22 score POSE ethmoid score POSE total score

group A (Propel) 9.3 1.8 2.7

group B (PosiSep) 8.7 0.85 0.95

0

1

2

3

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9

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Figure 3 3-months parameters scores average in each group.

baseline 3-weeks 3-months

POSE total score 22.2 7.7 2.7

POSE ethmoid score 12.4 5.9 1.8

SNOT 22 score 43 16.6 9.3

05

101520253035404550

POSE total score POSE ethmoid score SNOT 22 score

Figure 4 Parameters scores average timeline within group A.

quickly as the PosiSep dressing was irrigated with saline twice daily beginning 72 hours after placement. This irrigation not only diluted the concentration of medication in the dressing, but also began to help dissolve the dressing from the middle meatus. This observation is further supported in a study by Moore, et

al [14] where Triamcinolone was shown to be very effective in reducing recurrent middle meatal polyps after prior ESS. In their study, 2 groups of patients with prior ESS and recurrent nasal polyps were treated with either a nasal dressing hydrated with Triamcinolone at concentration of 20mg/ml, or 1 week of oral

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methylprednisolone. POSE and SNAQ-11 (Sino-Nasal Assessment Questionnaire 11) scores at baseline and at 1 and 2 month follow-up time points were not statistically different. Therefore, topical drug elution has been shown to be as effective as oral steroids for the control of early middle meatal polyp regrowth after ESS. The dose of Triamcinolone in their study, and in ours, is extremely low at 40mg/patient, thus showing that a low dose of medication for a short duration can results in clinical resolution of early nasal polyps.

Patients in Group B were treated with an off-label combination of a nasal dressing hydrated with a steroid medication. The “off-label” use of nasal dressings for this purpose is conceptually similar to the common practice of using of topical budesonide irrigations as a maintenance treatment to prevent the recurrence of polyps in patients with CRSwNP. In fact, the use of any steroid for the treatment of nasal inflammation, allergic rhinitis, tonsil swelling associated with acute, mononucleosis, CRSwNP, and CRSsNP is also “off-label”. The use of most antibiotics for acute sinusitis is “off-label”, as are medications such as methotrexate

for rheumatoid arthritis. Physicians have used medications in an off-label manner for decades, namely because it is cost-prohibitive for pharmaceutical companies to perform adequate clinical trials for every possible application of a given medication. Furthermore, the duration of use for most antibiotics is “off-label” as none of them are “indicated” for use beyond 10 days, yet our Academy has determined by consensus that the threshold for considering ESS in patients with CRS is the persistence of sinusitis and its symptoms after 6 weeks of antibiotic treatment. This is certainly an “off-label” recommendation of the use of a medication.

The advantages of using PosiSep nasal dressing to deliver medications to the middle meatus are several. Posisep is comprised of chitosan obtained from the exoskeleton of crustaceans, which has been shown to enhance wound healing and aide in hemostasis. PosiSep can be hydrated with any liquid, including saline, antibiotics, anti-inflammatory medications, or some combination thereof. In addition, the type and dose of medication can be tailored to the clinical needs of the patient.

baseline 3-weeks 3-months

POSE total score 21.3 4.5 0.95

POSE ethmoid score 12.2 3 0.85

SNOT score 36.8 15.2 8.7

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35

40

POSE total score POSE ethmoid score SNOT score

Figure 5 Parameters scores average timeline within group B.

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SNOT 22 baseline

POSE ethmoid baseline

Pose total baseline

3-w SNOT 22

3-w POSE ethmoid

3-w POSE total

3-m SNOT 22

3-m POSE ethmoid

3-m POSE total

group A group B

Figure 6 Parameters average scores changes in both groups over time.

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There are numerous antibiotics available in liquid form, and the dose of steroid can easily be varied based on the severity of the inflammatory process. Pletker et al [15] performed a study similar to More et al [14], where they used a carboxycellulose middle meatal gel to deliver topical steroids to the middle meatus in patients who developed recurrent middle meatal polyps after ESS. The dose of topical steroid in their study is quite high in comparison to the dose used in our study or by More, yet they had similar outcomes and no reported side effects from this treatment choice. This flexibility to customize treatment for the clinical needs of the patient has been the mainstay of medical treatment for decades, whether it be medications for hypertension, diabetes, asthma, migraine, congestive heart failure, etc. As we have come to learn, there is no such thing as “one size fits all” in medicine. There are guidelines for safe use of medications, but beyond that, dose and duration of treatment has always been the physician’s decision and the range of dose and duration can vary widely by practitioner.

As with the Propel implant, PosiSep is easy to place endoscopically. Both products have a streamlined profile that allows maximum visualization of the MM during placement. As the Propel implant deploys, the cage springs open to help retain the device in the MM. The Propel lattice then comes into contact with the MM mucosa and the drug elution process begins via a concentration gradient. The same phenomenon occurs with PosiSep, which is placed in the MM as a thin compressed polymer that expands into a sponge-like material when hydrated. The PosSep sponge provides more direct contact with the MM mucosa than the lattice of Propel, and perhaps this has some advantage and helps explain why only a short exposure time is required to achieve excellent control over local inflammation. Propel is recommended for use over 30 days whereas PosiSep is typically irrigated out of the MM within 1 week of surgery.

Another major issue is the economic impact of these products on the cost of care. Most phenotypes of CRSwNP are associated with a risk of polyp recurrence within weeks to years after surgery. Thus, the need for adjunctive medical management is critical. Steroids are by far the most effective medication for this purpose, however, the systemic route has significant long and short-term adverse physiologic effects. Hence, the quest to develop a topical drug-eluting model for this disease has been significant. However, it is important to keep in mind that the recidivistic nature of CRSwNP often requires repeated applications of a targeted topical steroid every 2 to 6 months depending upon the biology in a given patient. Thus, it is imperative that practitioners have access to a cost effective option that be easily and safely used with such frequency in an office setting after its initial use after ESS. This was the rationale behind the recurrent polyposis/drug-elution studies by More [14] and Pletker [15]. In our study, the cost for using bilateral Propel implants was $1450 per patient, whereas the cost per patient using bilateral PosiSep dressings hydrated with Traimcinalone (20 mg/ml) was $140. Based on the clinical outcomes in this study, how does one rationalize the use of Propel at a cost 10-fold higher than PosiSep? If the outcomes of the Propel group had been shown to be far superior to those of the PosiSep group, one might be able to make a cogent argument.

However, that is not the case, and if we posit that the study

cohort may require additional topical steroid treatment over the ensuing 12 months, we can easily see how the cost of using Propel implants becomes prohibitive. In today’s climate where the cost of care is equally important to effectiveness of care, our results do not allow us to sanction the routine use of Propel is patients with CRSwNP.

The limitations of the study include the inability to have unbiased observers evaluate the pre and post-op surgical sites in the Philadelphia and Chicago locations. This potential observer bias would only make the results of this study more compelling. Use of validated subjective QoL and endoscopic grading systems is less than optimal, however, there are no purely objective validated metrics for this purpose. One might argue that two different topical steroids were evaluated in addition to two different delivery mechanisms. While this is clearly true, our rationale was to load each device with the topical steroid that it is most commonly used with. Propel only comes with mometasone, and most physicians are using triamcinolone with PosiSep. Our study design using 2 groups of patients as opposed to an intra-patient matched control studywas purposeful to allow SNOT-20 scores to be used as a metric. In the latter design, SNOT-20 scores would not be able to distinguish between left and right sides of the nose. Furthermore, as stated earlier, Propel was not available for use in the Boston facility.

Based on the findings in this study, middle meatal drug elution devices are very effective in reducing patient symptoms and helping to normalize sino-nasal mucosa after primary or revision ESS in patients > 18 years of age with CRSwNP. Contraindications might include patients < 18 years, those with diabetes, previous orbital entry during ESS, and those unwilling to follow-up to make sure that any device remnants are removed from the nasal cavity.

CONCLUSION In patients with CRSwNP undergoing ESS, both the Chitosan-

based polymer nasal dressing (PosiSep) and the Propel drug-eluting implant showed highly statistically significant improvement in SNOT-22 and POSE endoscopy scores at all time points during the 3 month post-op period. One-way ANOVA analysis showed superiority of the POSE ethmoid scores at 3 months for the PosiSep group versus the Propel group. The per patient cost of Propel was 10-fold higher than that for PosiSep with triamcinolone.

Editor’s note: This work was presented in the American Rhinology Society meeting in Chicago in 09/09 2017.

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Catalano P, Tallab H, Wijewickrama R, Ghaderi M, Pritikin J (2018) Comparative Study of Two Drug Eluting Stent in the Treatment of Chronic Sinusitis with Nasal Polyp. Ann Otolaryngol Rhinol 5(4): 1220.

Cite this article

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