RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study
Background Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer‐term outcomes. Methods A ra...
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| Veröffentlicht in: | International forum of allergy & rhinology 2016-06, Vol.6 (6), p.573-581 |
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| creator | Forwith, Keith D. Han, Joseph K. Stolovitzky, J. Pablo Yen, David M. Chandra, Rakesh K. Karanfilov, Boris Matheny, Keith E. Stambaugh, James W. Gawlicka, Anna K. |
| description | Background
Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer‐term outcomes.
Methods
A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in‐office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six‐month follow‐up included endoscopic grading and patient‐reported outcomes.
Results
At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2‐fold improvement in mean nasal obstruction/congestion score (−1.06 ± 1.4 vs −0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2‐fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients.
Conclusion
The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid‐eluting implant for in‐office treatment of CRSwNP after ESS. These longer‐term 6‐month study results demonstrate that the steroid‐eluting implant represents a durable, safe, and effective treatment strategy for this patient population. |
| doi_str_mv | 10.1002/alr.21741 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1799560289</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4099840731</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4611-893ed6e131226c70ab548eeb223c1a37d0ae0594566002daac1cf334d20321103</originalsourceid><addsrcrecordid>eNp1kctu1DAUhiMEotXQBS-ALLGhUtP6kjiT7qphGJBGVGrLRWwsxz4pLk4c7FglvB1vhqcznQUS3vhY-s7no_Nn2UuCTwnG9Exaf0pJVZAn2SHFBc15PS-e7uuKH2RHIdzhdEpSlqR6nh1QXteUkPIw-3O1vL5cf16eo8Y42QTnG9lYQGEE74zOwcbR9LcomD4GZLrByn4MqHUemT53bWsUoNGDHDvoR-Ra5EFF7zeP1ON6GaRFg7PT4IIJSLZJvLOF6G_BT-eI553rx-_IxVG5DpLeuw5J5GWvXWd-gz5BKhHeWbupG2t6DToNGfX0InvWShvgaHfPsk_vljeL9_n6cvVhcbHOVcEJyec1A82BMEIpVxWWTVnMARpKmSKSVRpLwGVdlJynrWopFVEtY4WmmKVVYTbL3my9g3c_I4RRdCYosGkh4GIQpKrrkmOaPpplr_9B71z0fZrugWKM8apK1PGWUt6F4KEVgzed9JMgWGyiFSla8RBtYl_tjLHpQO_JxyATcLYF7o2F6f8mcbG-elTm2w6Tsv6175D-h-AVq0rx5eNKcHazePt1dS2-sb91VL-K</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1799333677</pqid></control><display><type>article</type><title>RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Forwith, Keith D. ; Han, Joseph K. ; Stolovitzky, J. Pablo ; Yen, David M. ; Chandra, Rakesh K. ; Karanfilov, Boris ; Matheny, Keith E. ; Stambaugh, James W. ; Gawlicka, Anna K.</creator><creatorcontrib>Forwith, Keith D. ; Han, Joseph K. ; Stolovitzky, J. Pablo ; Yen, David M. ; Chandra, Rakesh K. ; Karanfilov, Boris ; Matheny, Keith E. ; Stambaugh, James W. ; Gawlicka, Anna K.</creatorcontrib><description>Background
Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer‐term outcomes.
Methods
A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in‐office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six‐month follow‐up included endoscopic grading and patient‐reported outcomes.
Results
At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2‐fold improvement in mean nasal obstruction/congestion score (−1.06 ± 1.4 vs −0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2‐fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients.
Conclusion
The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid‐eluting implant for in‐office treatment of CRSwNP after ESS. These longer‐term 6‐month study results demonstrate that the steroid‐eluting implant represents a durable, safe, and effective treatment strategy for this patient population.</description><identifier>ISSN: 2042-6976</identifier><identifier>EISSN: 2042-6984</identifier><identifier>DOI: 10.1002/alr.21741</identifier><identifier>PMID: 26992115</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Absorbable Implants ; Ambulatory Care ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - therapeutic use ; bioabsorbable ; Chronic Disease ; chronic sinusitis ; corticosteroid ; CRSwNP ; Endoscopy ; Humans ; implant ; inflammation ; Mometasone Furoate - administration & dosage ; Mometasone Furoate - therapeutic use ; nasal polyps ; Nasal Polyps - drug therapy ; Nasal Polyps - surgery ; Nose ; Paranasal Sinuses - surgery ; Patient Reported Outcome Measures ; Recurrence ; refractory ; Reoperation ; revision ESS ; Rhinitis - drug therapy ; Rhinitis - surgery ; Sinuses ; Sinusitis - drug therapy ; Sinusitis - surgery ; stent ; Transplants & implants ; Treatment Outcome</subject><ispartof>International forum of allergy & rhinology, 2016-06, Vol.6 (6), p.573-581</ispartof><rights>2016 ARS‐AAOA, LLC</rights><rights>2016 ARS-AAOA, LLC.</rights><rights>2016 ARS-AAOA, LLC</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4611-893ed6e131226c70ab548eeb223c1a37d0ae0594566002daac1cf334d20321103</citedby><cites>FETCH-LOGICAL-c4611-893ed6e131226c70ab548eeb223c1a37d0ae0594566002daac1cf334d20321103</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Falr.21741$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Falr.21741$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27915,27916,45565,45566</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26992115$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Forwith, Keith D.</creatorcontrib><creatorcontrib>Han, Joseph K.</creatorcontrib><creatorcontrib>Stolovitzky, J. Pablo</creatorcontrib><creatorcontrib>Yen, David M.</creatorcontrib><creatorcontrib>Chandra, Rakesh K.</creatorcontrib><creatorcontrib>Karanfilov, Boris</creatorcontrib><creatorcontrib>Matheny, Keith E.</creatorcontrib><creatorcontrib>Stambaugh, James W.</creatorcontrib><creatorcontrib>Gawlicka, Anna K.</creatorcontrib><title>RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study</title><title>International forum of allergy & rhinology</title><addtitle>Int Forum Allergy Rhinol</addtitle><description>Background
Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer‐term outcomes.
Methods
A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in‐office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six‐month follow‐up included endoscopic grading and patient‐reported outcomes.
Results
At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2‐fold improvement in mean nasal obstruction/congestion score (−1.06 ± 1.4 vs −0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2‐fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients.
Conclusion
The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid‐eluting implant for in‐office treatment of CRSwNP after ESS. These longer‐term 6‐month study results demonstrate that the steroid‐eluting implant represents a durable, safe, and effective treatment strategy for this patient population.</description><subject>Absorbable Implants</subject><subject>Ambulatory Care</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - therapeutic use</subject><subject>bioabsorbable</subject><subject>Chronic Disease</subject><subject>chronic sinusitis</subject><subject>corticosteroid</subject><subject>CRSwNP</subject><subject>Endoscopy</subject><subject>Humans</subject><subject>implant</subject><subject>inflammation</subject><subject>Mometasone Furoate - administration & dosage</subject><subject>Mometasone Furoate - therapeutic use</subject><subject>nasal polyps</subject><subject>Nasal Polyps - drug therapy</subject><subject>Nasal Polyps - surgery</subject><subject>Nose</subject><subject>Paranasal Sinuses - surgery</subject><subject>Patient Reported Outcome Measures</subject><subject>Recurrence</subject><subject>refractory</subject><subject>Reoperation</subject><subject>revision ESS</subject><subject>Rhinitis - drug therapy</subject><subject>Rhinitis - surgery</subject><subject>Sinuses</subject><subject>Sinusitis - drug therapy</subject><subject>Sinusitis - surgery</subject><subject>stent</subject><subject>Transplants & implants</subject><subject>Treatment Outcome</subject><issn>2042-6976</issn><issn>2042-6984</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kctu1DAUhiMEotXQBS-ALLGhUtP6kjiT7qphGJBGVGrLRWwsxz4pLk4c7FglvB1vhqcznQUS3vhY-s7no_Nn2UuCTwnG9Exaf0pJVZAn2SHFBc15PS-e7uuKH2RHIdzhdEpSlqR6nh1QXteUkPIw-3O1vL5cf16eo8Y42QTnG9lYQGEE74zOwcbR9LcomD4GZLrByn4MqHUemT53bWsUoNGDHDvoR-Ra5EFF7zeP1ON6GaRFg7PT4IIJSLZJvLOF6G_BT-eI553rx-_IxVG5DpLeuw5J5GWvXWd-gz5BKhHeWbupG2t6DToNGfX0InvWShvgaHfPsk_vljeL9_n6cvVhcbHOVcEJyec1A82BMEIpVxWWTVnMARpKmSKSVRpLwGVdlJynrWopFVEtY4WmmKVVYTbL3my9g3c_I4RRdCYosGkh4GIQpKrrkmOaPpplr_9B71z0fZrugWKM8apK1PGWUt6F4KEVgzed9JMgWGyiFSla8RBtYl_tjLHpQO_JxyATcLYF7o2F6f8mcbG-elTm2w6Tsv6175D-h-AVq0rx5eNKcHazePt1dS2-sb91VL-K</recordid><startdate>201606</startdate><enddate>201606</enddate><creator>Forwith, Keith D.</creator><creator>Han, Joseph K.</creator><creator>Stolovitzky, J. Pablo</creator><creator>Yen, David M.</creator><creator>Chandra, Rakesh K.</creator><creator>Karanfilov, Boris</creator><creator>Matheny, Keith E.</creator><creator>Stambaugh, James W.</creator><creator>Gawlicka, Anna K.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201606</creationdate><title>RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study</title><author>Forwith, Keith D. ; Han, Joseph K. ; Stolovitzky, J. Pablo ; Yen, David M. ; Chandra, Rakesh K. ; Karanfilov, Boris ; Matheny, Keith E. ; Stambaugh, James W. ; Gawlicka, Anna K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4611-893ed6e131226c70ab548eeb223c1a37d0ae0594566002daac1cf334d20321103</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Absorbable Implants</topic><topic>Ambulatory Care</topic><topic>Anti-Inflammatory Agents - administration & dosage</topic><topic>Anti-Inflammatory Agents - therapeutic use</topic><topic>bioabsorbable</topic><topic>Chronic Disease</topic><topic>chronic sinusitis</topic><topic>corticosteroid</topic><topic>CRSwNP</topic><topic>Endoscopy</topic><topic>Humans</topic><topic>implant</topic><topic>inflammation</topic><topic>Mometasone Furoate - administration & dosage</topic><topic>Mometasone Furoate - therapeutic use</topic><topic>nasal polyps</topic><topic>Nasal Polyps - drug therapy</topic><topic>Nasal Polyps - surgery</topic><topic>Nose</topic><topic>Paranasal Sinuses - surgery</topic><topic>Patient Reported Outcome Measures</topic><topic>Recurrence</topic><topic>refractory</topic><topic>Reoperation</topic><topic>revision ESS</topic><topic>Rhinitis - drug therapy</topic><topic>Rhinitis - surgery</topic><topic>Sinuses</topic><topic>Sinusitis - drug therapy</topic><topic>Sinusitis - surgery</topic><topic>stent</topic><topic>Transplants & implants</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Forwith, Keith D.</creatorcontrib><creatorcontrib>Han, Joseph K.</creatorcontrib><creatorcontrib>Stolovitzky, J. Pablo</creatorcontrib><creatorcontrib>Yen, David M.</creatorcontrib><creatorcontrib>Chandra, Rakesh K.</creatorcontrib><creatorcontrib>Karanfilov, Boris</creatorcontrib><creatorcontrib>Matheny, Keith E.</creatorcontrib><creatorcontrib>Stambaugh, James W.</creatorcontrib><creatorcontrib>Gawlicka, Anna K.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>International forum of allergy & rhinology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Forwith, Keith D.</au><au>Han, Joseph K.</au><au>Stolovitzky, J. Pablo</au><au>Yen, David M.</au><au>Chandra, Rakesh K.</au><au>Karanfilov, Boris</au><au>Matheny, Keith E.</au><au>Stambaugh, James W.</au><au>Gawlicka, Anna K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study</atitle><jtitle>International forum of allergy & rhinology</jtitle><addtitle>Int Forum Allergy Rhinol</addtitle><date>2016-06</date><risdate>2016</risdate><volume>6</volume><issue>6</issue><spage>573</spage><epage>581</epage><pages>573-581</pages><issn>2042-6976</issn><eissn>2042-6984</eissn><abstract>Background
Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer‐term outcomes.
Methods
A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in‐office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six‐month follow‐up included endoscopic grading and patient‐reported outcomes.
Results
At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2‐fold improvement in mean nasal obstruction/congestion score (−1.06 ± 1.4 vs −0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2‐fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients.
Conclusion
The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid‐eluting implant for in‐office treatment of CRSwNP after ESS. These longer‐term 6‐month study results demonstrate that the steroid‐eluting implant represents a durable, safe, and effective treatment strategy for this patient population.</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>26992115</pmid><doi>10.1002/alr.21741</doi><tpages>9</tpages></addata></record> |
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| subjects | Absorbable Implants Ambulatory Care Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - therapeutic use bioabsorbable Chronic Disease chronic sinusitis corticosteroid CRSwNP Endoscopy Humans implant inflammation Mometasone Furoate - administration & dosage Mometasone Furoate - therapeutic use nasal polyps Nasal Polyps - drug therapy Nasal Polyps - surgery Nose Paranasal Sinuses - surgery Patient Reported Outcome Measures Recurrence refractory Reoperation revision ESS Rhinitis - drug therapy Rhinitis - surgery Sinuses Sinusitis - drug therapy Sinusitis - surgery stent Transplants & implants Treatment Outcome |
| title | RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study |
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