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    Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial

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    Authors
    Moss, J. G.
    Wu, O.
    Bodenham, A. R.
    Agarwal, R.
    Menne, T. F.
    Jones, B. L.
    Heggie, R.
    Hill, Steve
    Dixon-Hughes, J.
    Soulis, E.
    Germeni, E.
    Dillon, S.
    McCartney, E
    Grp, C. T.
    Show allShow less
    Affiliation
    Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Background: Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication rates and costs of the three devices to establish acceptability, clinical effectiveness, and cost-effectiveness of the devices for patients receiving SACT. Methods: We did an open-label, multicentre, randomised controlled trial (Cancer and Venous Access [CAVA]) of three central venous access devices: PICCs versus Hickman (non-inferiority; 10% margin); PORTs versus Hickman (superiority; 15% margin); and PORTs versus PICCs (superiority; 15% margin). Adults (aged ≥18 years) receiving SACT (≥12 weeks) for solid or haematological malignancy from 18 oncology units in the UK were included. Four randomisation options were available: Hickman versus PICCs versus PORTs (2:2:1), PICCs versus Hickman (1:1), PORTs versus Hickman (1:1), and PORTs versus PICCs (1:1). Randomisation was done using a minimisation algorithm stratifying by centre, body-mass index, type of cancer, device history, and treatment mode. The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other) assessed until device removal, withdrawal from study, or 1-year follow-up. This study is registered with ISRCTN, ISRCTN44504648. Findings: Between Nov 8, 2013, and Feb 28, 2018, of 2714 individuals screened for eligibility, 1061 were enrolled and randomly assigned, contributing to the relevant comparison or comparisons (PICC vs Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). Similar complication rates were observed for PICCs (110 [52%] of 212) and Hickman (103 [49%] of 212). Although the observed difference was less than 10%, non-inferiority of PICCs was not confirmed (odds ratio [OR] 1·15 [95% CI 0·78-1·71]) potentially due to inadequate power. PORTs were superior to Hickman with a complication rate of 29% (73 of 253) versus 43% (131 of 303; OR 0·54 [95% CI 0·37-0·77]). PORTs were superior to PICCs with a complication rate of 32% (47 of 147) versus 47% (93 of 199; OR 0·52 [0·33-0·83]). Interpretation: For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumours should receive a PORT within the UK National Health Service.
    Citation
    Moss JG, Wu O, Bodenham AR, Agarwal R, Menne TF, Jones BL, et al. Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial. The Lancet. 2021 Jul;398(10298):403–15.
    Journal
    Lancet
    URI
    http://hdl.handle.net/10541/624549
    DOI
    10.1016/s0140-6736(21)00766-2
    PubMed ID
    34297997
    Additional Links
    https://dx.doi.org/10.1016/s0140-6736(21)00766-2
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/s0140-6736(21)00766-2
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