Rationale: Tunneled, indwelling pleural
catheters (IPCs) 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 represents the pivotal clinical trial evaluating that
catheter versus 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 [A Pivotal Multi-Center, Randomized, Controlled, Single-Blinded Study Comparing the
Silver Nitrate-Coated Indwelling Pleural
Catheter (SNCIPC) to the Uncoated PleurX® Pleural
Catheter for the Management of Symptomatic, Recurrent,
Malignant Pleural Effusions] trial was a multicenter, parallel-group, randomized, controlled, patient-blind trial. Central randomization occurred according to a computer-generated schedule, stratified by site. Recruitment was from 17 secondary or tertiary care hospitals in the United States and 3 in the United Kingdom and included adult patients with
malignant pleural effusion needing drainage, without evidence of lung entrapment or significant loculation. The intervention group underwent insertion of an SNCIPC with maximal fluid drainage, followed by a tapering drainage schedule. The control group received a standard, uncoated
catheter. Follow-up was conducted until 90 days. The primary outcome measure was
pleurodesis efficacy, measured by fluid drainage, at 30 days. Results: A total of 119 patients were randomized. Five withdrew before receiving treatment, leaving 114 (77 SNCIPC, 37 standard IPC) for analysis. The mean age was 66 years (standard deviation, 11). More patients in the SNCIPC group were inpatients (39% vs. 14%; P = 0.009). For the primary outcome,
pleurodesis rates were 12 (32%) of 37 in the control group and 17 (22%) of 77 in the SNCIPC group (rate difference, -0.10; 95% confidence interval, -0.30 to 0.09). Median time to
pleurodesis was 11 days (interquartile range, 9 to 23) in the control group and 4 days (interquartile range, 2 to 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 with a standard IPC. This study does not support the wider use of the SNCIPC device. Clinical trial registered with www.clinicaltrials.gov (NCT02649894).