Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial
Jonathan G Moss1, Olivia Wu2, Andrew R Bodenham3
1Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Insights
Totally implanted ports (PORTs) are safer and more effective for delivering systemic anticancer treatment (SACT) than Hickman-type tunnelled catheters (Hickman) and peripherally inserted central catheters (PICCs). These findings support the use of PORTs for SACT in UK patients.
Area of Science:
- Oncology
- Medical Devices
- Clinical Trials
Background:
- Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are central venous access devices used for systemic anticancer treatment (SACT).
- Comparing complication rates and costs of these devices is crucial for determining their clinical effectiveness and cost-effectiveness in SACT delivery.
Purpose of the Study:
- To compare complication rates and costs of Hickman, PICCs, and PORTs in patients receiving SACT.
- To establish the acceptability, clinical effectiveness, and cost-effectiveness of these three central venous access devices.
Main Methods:
- An open-label, multicentre, randomised controlled trial (CAVA) involving adults receiving SACT for malignancy across 18 UK oncology units.
- Three comparisons were made: PICCs vs. Hickman (non-inferiority), PORTs vs. Hickman (superiority), and PORTs vs. PICCs (superiority).
- The primary outcome was the composite complication rate, assessed until device removal, study withdrawal, or 1-year follow-up.
Main Results:
- Similar complication rates were observed between PICCs (52%) and Hickman (49%), with PICCs not confirmed as non-inferior.
- PORTs demonstrated superior safety and effectiveness compared to Hickman (29% vs. 43% complication rate).
- PORTs were also superior to PICCs, showing a lower complication rate (32% vs. 47%).
Conclusions:
- Totally implanted ports (PORTs) are more effective and safer than both Hickman and PICCs for the majority of patients receiving SACT.
- The findings strongly suggest that PORTs should be the preferred central venous access device for SACT delivery within the UK National Health Service.
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.
Funding:
UK National Institute for Health Research Health Technology Assessment Programme.
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