Silver Nitrate-Coated Versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial

Joseph B Shrager; Rahul Bhatnagar; Christine T Kearney; Nathan P Retzlaff; Evan Cohen; Andrew E Stanton; Colleen Keyes; Momen M Wahidi; Colin Gillespie; Najib Rahman; Anthony L Kerry; David Feller-Kopman; Daniel Nader; Jason Akulian; Alex Chen; Mark Berry; Adnan Majid; Chakravarthy Reddy; Alain Tremblay; Nick A Maskell

doi:10.1513/AnnalsATS.202111-1301OC

Silver Nitrate-Coated Versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial

Joseph B Shrager^*, Rahul Bhatnagar, Christine T Kearney, Nathan P Retzlaff, Evan Cohen, Andrew E Stanton, Colleen Keyes, Momen M Wahidi, Colin Gillespie, Najib Rahman, Anthony L Kerry, David Feller-Kopman, Daniel Nader, Jason Akulian, Alex Chen, Mark Berry, Adnan Majid, Chakravarthy Reddy, Alain Tremblay, Nick A Maskell

^*Corresponding author for this work

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Abstract

RATIONALE: Tunneled, indwelling pleural catheters (IPC) have been demonstrated to be an effective method of managing malignant pleural effusions. However, they allow pleurodesis and can therefore be removed in only a subset of patients. A novel, silver-nitrate coated IPC was developed with the intention of creating a rapid, effective chemical pleurodesis to allow more frequent and earlier catheter removal. This study represent the pivotal clinical trial evaluating that catheter vs the standard IPC.

OBJECTIVES: To compare the efficacy of a novel silver nitrate-eluting indwelling pleural catheter (SNCIPC) with that of a standard, uncoated catheter.

METHODS: The SWIFT trial was a multicentre, parallel-group, randomised, controlled, patient-blind trial. Central randomisation occurred following a computer-generated schedule, stratified by site. Recruitment was from 17 secondary or tertiary-care hospitals in the USA and 3 in the UK and included adult patients with malignant pleural effusion needing drainage, without evidence of lung entrapment or significant loculation. The intervention group underwent insertion of a SNCIPC with maximal fluid drainage, followed by a tapering drainage schedule. The control group received a standard, uncoated catheter. Follow up was until 90 days. The primary outcome measure was pleurodesis efficacy, measured by fluid drainage, at 30 days.

RESULTS: 119 patients were randomised. 5 withdrew before receiving treatment, leaving 114 (77 SNCIPC, 37 standard IPC) for intention-to-treat analysis. Mean age was 66 years (SD 11). More patients in the SNCIPC group were in-patients (39% vs 14%, p=0.009). For the primary outcome, pleurodesis rates were 12/37 (32%) in the control group and 17/77 (22%) in the SNCIPC group (rate difference -0.10, 95% CI -0.30-0.09). Median time to pleurodesis was 11 days (IQR 9-23) in the control group and 4 days (IQR 2-15) in the SNCIPC group. No significant difference in treatment-related adverse event rates was noted between groups.

CONCLUSIONS: The SNCIPC did not improve pleurodesis efficacy compared to a standard indwelling pleural catheter. This study does not support the wider use of the SNCIPC device. Clinical trial registered with ClinicalTrials.gov (NCT02649894).

Original language	English
Pages (from-to)	1722–1729
Number of pages	8
Journal	Annals of the American Thoracic Society
Volume	19
Issue number	10
Early online date	1 Apr 2022
DOIs	https://doi.org/10.1513/AnnalsATS.202111-1301OC
Publication status	Published - 1 Oct 2022

Bibliographical note

Funding Information:
Supported by Becton, Dickinson and Company.

Funding Information:
The authors acknowledge all involved in the development and execution of this complex trial: the investigators and coordinators at all 20 sites; the data safety monitoring board (Drs. Richard Chiacchierini, Saeid Khansarinia, and Bert O'Neil); Chiltern International, Inc., for trial oversight; and the cross-functional new product development team at Becton, Dickinson and Co.

Publisher Copyright:
© 2022 by the American Thoracic Society.

Research Groups and Themes

Academic Respiratory Unit

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10.1513/AnnalsATS.202111-1301OC

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Shrager, J. B., Bhatnagar, R., Kearney, C. T., Retzlaff, N. P., Cohen, E., Stanton, A. E., Keyes, C., Wahidi, M. M., Gillespie, C., Rahman, N., Kerry, A. L., Feller-Kopman, D., Nader, D., Akulian, J., Chen, A., Berry, M., Majid, A., Reddy, C., Tremblay, A., & Maskell, N. A. (2022). Silver Nitrate-Coated Versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial. Annals of the American Thoracic Society, 19(10), 1722–1729. https://doi.org/10.1513/AnnalsATS.202111-1301OC

@article{35165445adff4dd3b8e033803a33e33c,

title = "Silver Nitrate-Coated Versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial",

abstract = "RATIONALE: Tunneled, indwelling pleural catheters (IPC) have been demonstrated to be an effective method of managing malignant pleural effusions. However, they allow pleurodesis and can therefore be removed in only a subset of patients. A novel, silver-nitrate coated IPC was developed with the intention of creating a rapid, effective chemical pleurodesis to allow more frequent and earlier catheter removal. This study represent the pivotal clinical trial evaluating that catheter vs the standard IPC.OBJECTIVES: To compare the efficacy of a novel silver nitrate-eluting indwelling pleural catheter (SNCIPC) with that of a standard, uncoated catheter.METHODS: The SWIFT trial was a multicentre, parallel-group, randomised, controlled, patient-blind trial. Central randomisation occurred following a computer-generated schedule, stratified by site. Recruitment was from 17 secondary or tertiary-care hospitals in the USA and 3 in the UK and included adult patients with malignant pleural effusion needing drainage, without evidence of lung entrapment or significant loculation. The intervention group underwent insertion of a SNCIPC with maximal fluid drainage, followed by a tapering drainage schedule. The control group received a standard, uncoated catheter. Follow up was until 90 days. The primary outcome measure was pleurodesis efficacy, measured by fluid drainage, at 30 days.RESULTS: 119 patients were randomised. 5 withdrew before receiving treatment, leaving 114 (77 SNCIPC, 37 standard IPC) for intention-to-treat analysis. Mean age was 66 years (SD 11). More patients in the SNCIPC group were in-patients (39\% vs 14\%, p=0.009). For the primary outcome, pleurodesis rates were 12/37 (32\%) in the control group and 17/77 (22\%) in the SNCIPC group (rate difference -0.10, 95\% CI -0.30-0.09). Median time to pleurodesis was 11 days (IQR 9-23) in the control group and 4 days (IQR 2-15) in the SNCIPC group. No significant difference in treatment-related adverse event rates was noted between groups.CONCLUSIONS: The SNCIPC did not improve pleurodesis efficacy compared to a standard indwelling pleural catheter. This study does not support the wider use of the SNCIPC device. Clinical trial registered with ClinicalTrials.gov (NCT02649894).",

author = "Shrager, \{Joseph B\} and Rahul Bhatnagar and Kearney, \{Christine T\} and Retzlaff, \{Nathan P\} and Evan Cohen and Stanton, \{Andrew E\} and Colleen Keyes and Wahidi, \{Momen M\} and Colin Gillespie and Najib Rahman and Kerry, \{Anthony L\} and David Feller-Kopman and Daniel Nader and Jason Akulian and Alex Chen and Mark Berry and Adnan Majid and Chakravarthy Reddy and Alain Tremblay and Maskell, \{Nick A\}",

note = "Funding Information: Supported by Becton, Dickinson and Company. Funding Information: The authors acknowledge all involved in the development and execution of this complex trial: the investigators and coordinators at all 20 sites; the data safety monitoring board (Drs. Richard Chiacchierini, Saeid Khansarinia, and Bert O'Neil); Chiltern International, Inc., for trial oversight; and the cross-functional new product development team at Becton, Dickinson and Co. Publisher Copyright: {\textcopyright} 2022 by the American Thoracic Society.",

year = "2022",

month = oct,

day = "1",

doi = "10.1513/AnnalsATS.202111-1301OC",

language = "English",

volume = "19",

pages = "1722–1729",

journal = "Annals of the American Thoracic Society",

issn = "2329-6933",

publisher = "American Thoracic Society",

number = "10",

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Shrager, JB, Bhatnagar, R, Kearney, CT, Retzlaff, NP, Cohen, E, Stanton, AE, Keyes, C, Wahidi, MM, Gillespie, C, Rahman, N, Kerry, AL, Feller-Kopman, D, Nader, D, Akulian, J, Chen, A, Berry, M, Majid, A, Reddy, C, Tremblay, A & Maskell, NA 2022, 'Silver Nitrate-Coated Versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial', Annals of the American Thoracic Society, vol. 19, no. 10, pp. 1722–1729. https://doi.org/10.1513/AnnalsATS.202111-1301OC

TY - JOUR

T1 - Silver Nitrate-Coated Versus Standard Indwelling Pleural Catheter for Malignant Effusions

T2 - The SWIFT Randomized Trial

AU - Shrager, Joseph B

AU - Bhatnagar, Rahul

AU - Kearney, Christine T

AU - Retzlaff, Nathan P

AU - Cohen, Evan

AU - Stanton, Andrew E

AU - Keyes, Colleen

AU - Wahidi, Momen M

AU - Gillespie, Colin

AU - Rahman, Najib

AU - Kerry, Anthony L

AU - Feller-Kopman, David

AU - Nader, Daniel

AU - Akulian, Jason

AU - Chen, Alex

AU - Berry, Mark

AU - Majid, Adnan

AU - Reddy, Chakravarthy

AU - Tremblay, Alain

AU - Maskell, Nick A

N1 - Funding Information: Supported by Becton, Dickinson and Company. Funding Information: The authors acknowledge all involved in the development and execution of this complex trial: the investigators and coordinators at all 20 sites; the data safety monitoring board (Drs. Richard Chiacchierini, Saeid Khansarinia, and Bert O'Neil); Chiltern International, Inc., for trial oversight; and the cross-functional new product development team at Becton, Dickinson and Co. Publisher Copyright: © 2022 by the American Thoracic Society.

PY - 2022/10/1

Y1 - 2022/10/1

N2 - RATIONALE: Tunneled, indwelling pleural catheters (IPC) have been demonstrated to be an effective method of managing malignant pleural effusions. However, they allow pleurodesis and can therefore be removed in only a subset of patients. A novel, silver-nitrate coated IPC was developed with the intention of creating a rapid, effective chemical pleurodesis to allow more frequent and earlier catheter removal. This study represent the pivotal clinical trial evaluating that catheter vs the standard IPC.OBJECTIVES: To compare the efficacy of a novel silver nitrate-eluting indwelling pleural catheter (SNCIPC) with that of a standard, uncoated catheter.METHODS: The SWIFT trial was a multicentre, parallel-group, randomised, controlled, patient-blind trial. Central randomisation occurred following a computer-generated schedule, stratified by site. Recruitment was from 17 secondary or tertiary-care hospitals in the USA and 3 in the UK and included adult patients with malignant pleural effusion needing drainage, without evidence of lung entrapment or significant loculation. The intervention group underwent insertion of a SNCIPC with maximal fluid drainage, followed by a tapering drainage schedule. The control group received a standard, uncoated catheter. Follow up was until 90 days. The primary outcome measure was pleurodesis efficacy, measured by fluid drainage, at 30 days.RESULTS: 119 patients were randomised. 5 withdrew before receiving treatment, leaving 114 (77 SNCIPC, 37 standard IPC) for intention-to-treat analysis. Mean age was 66 years (SD 11). More patients in the SNCIPC group were in-patients (39% vs 14%, p=0.009). For the primary outcome, pleurodesis rates were 12/37 (32%) in the control group and 17/77 (22%) in the SNCIPC group (rate difference -0.10, 95% CI -0.30-0.09). Median time to pleurodesis was 11 days (IQR 9-23) in the control group and 4 days (IQR 2-15) in the SNCIPC group. No significant difference in treatment-related adverse event rates was noted between groups.CONCLUSIONS: The SNCIPC did not improve pleurodesis efficacy compared to a standard indwelling pleural catheter. This study does not support the wider use of the SNCIPC device. Clinical trial registered with ClinicalTrials.gov (NCT02649894).

AB - RATIONALE: Tunneled, indwelling pleural catheters (IPC) have been demonstrated to be an effective method of managing malignant pleural effusions. However, they allow pleurodesis and can therefore be removed in only a subset of patients. A novel, silver-nitrate coated IPC was developed with the intention of creating a rapid, effective chemical pleurodesis to allow more frequent and earlier catheter removal. This study represent the pivotal clinical trial evaluating that catheter vs the standard IPC.OBJECTIVES: To compare the efficacy of a novel silver nitrate-eluting indwelling pleural catheter (SNCIPC) with that of a standard, uncoated catheter.METHODS: The SWIFT trial was a multicentre, parallel-group, randomised, controlled, patient-blind trial. Central randomisation occurred following a computer-generated schedule, stratified by site. Recruitment was from 17 secondary or tertiary-care hospitals in the USA and 3 in the UK and included adult patients with malignant pleural effusion needing drainage, without evidence of lung entrapment or significant loculation. The intervention group underwent insertion of a SNCIPC with maximal fluid drainage, followed by a tapering drainage schedule. The control group received a standard, uncoated catheter. Follow up was until 90 days. The primary outcome measure was pleurodesis efficacy, measured by fluid drainage, at 30 days.RESULTS: 119 patients were randomised. 5 withdrew before receiving treatment, leaving 114 (77 SNCIPC, 37 standard IPC) for intention-to-treat analysis. Mean age was 66 years (SD 11). More patients in the SNCIPC group were in-patients (39% vs 14%, p=0.009). For the primary outcome, pleurodesis rates were 12/37 (32%) in the control group and 17/77 (22%) in the SNCIPC group (rate difference -0.10, 95% CI -0.30-0.09). Median time to pleurodesis was 11 days (IQR 9-23) in the control group and 4 days (IQR 2-15) in the SNCIPC group. No significant difference in treatment-related adverse event rates was noted between groups.CONCLUSIONS: The SNCIPC did not improve pleurodesis efficacy compared to a standard indwelling pleural catheter. This study does not support the wider use of the SNCIPC device. Clinical trial registered with ClinicalTrials.gov (NCT02649894).

U2 - 10.1513/AnnalsATS.202111-1301OC

DO - 10.1513/AnnalsATS.202111-1301OC

M3 - Article (Academic Journal)

C2 - 35363591

SN - 2329-6933

VL - 19

SP - 1722

EP - 1729

JO - Annals of the American Thoracic Society

JF - Annals of the American Thoracic Society

IS - 10

ER -

Silver Nitrate-Coated Versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial

Abstract

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