LAUSR

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).