Randomised phase II trial evaluating the safety of peripherally inserted catheters versus implanted port catheters during adjuvant chemotherapy in patients with early breast cancer

Clatot, Florian; Fontanilles, Maxime; Lefebvre, L.; Lequesne, Justine; Veyret, Corinne; Alexandru, Cristina; Leheurteur, Marianne; Guillemet, Cécile; Gouerant, S.; Petrau, Camille; Théry, Jean-Christophe; Rigal, Olivier; Moldovan, Cristian; Tennevet, Isabelle; Rastelli, Olivier; Poullain, Amélie; Savary, L; Bubenheim, Michael; Georgescu, D.; Gouérant, Julien; Gilles-Baray, Marie; Fiore, Frédéric Di

doi:10.1016/j.ejca.2019.11.022

Cited by 28 publications

(26 citation statements)

References 21 publications

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“…Consistent with this observation, previous studies report higher thrombosis rates in PICCs when compared to tunneled/totally implanted catheters. 3,12,13,18,20–23 Thrombosis incidence in our study was relatively low compared to literature data, with PICC-related thromboses ranging from 1% to 25% 3–8,12–18,20,24–26 and tCVC-related thromboses ranging from 0 to 11.5% in other series. 10,12,13,15,27 Although the incidence of thrombosis in our study may have been underestimated in both arms, since Doppler evaluations of asymptomatic patients were not performed as per routine clinical practice and only symptomatic cases were evaluated, the low PICC thrombosis incidence in our series may have been positively affected by the systematic evaluation of the vein diameter by ultrasound guidance before PICC insertion.…”

Section: Discussioncontrasting

confidence: 69%

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Comparison of outcomes of central venous catheters in patients with solid and hematologic neoplasms: an Italian real-world analysis

Corti

Brambilla

Manglaviti

et al. 2020

Tumori

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Introduction: Although many reports have analyzed the outcomes of central venous catheters (CVCs) in oncologic and oncohematologic patients, current guidelines do not routinely recommend a specific type of CVC over the other. Methods: We retrospectively evaluated the outcomes of 178 patients with CVCs referred to an Italian specialized cancer center between January 2016 and December 2018. The analysis compares midterm peripherally inserted central venous catheters (PICCs) with long-term centrally inserted catheters, including totally implanted ports and tunneled catheters with central insertion (tCVCs). Results: A total of 130 PICCs (73%) and 48 tCVCs (27%) were analyzed. The overall complication rate was significantly increased in the PICC cohort compared to the tCVC cohort (43.1% vs 25%, respectively; p = 0.037), leading to complication-related device removal in 30.8% of PICCs vs 12.5% of tCVCs ( p = 0.013). No significant differences in terms of catheter-related thromboses ( p = 0.676) or catheter-related infections ( p = 0.140) were detected. Nonthrombotic obstructions were significantly higher in the PICC group compared to the tCVC cohort ( p = 0.006). Overall complication-free survival was significantly longer for tCVCs compared to PICCs (hazard ratio [HR], 0.262; 95% confidence interval [CI], 0.128–0.536; p < 0.0001), as well as obstruction-free survival (HR, 0.082; 95% CI, 0.018–0.372; p < 0.0001). In multivariable analysis, the type of CVC was independently correlated with the occurrence of any complication (HR, 0.273; 95% CI, 0.135–0.553; p < 0.0001). Conclusions: This Italian real-world experience suggests that PICCs are associated with a higher risk of overall complications compared with tCVCs. Catheter choice in oncologic patients should be guided by treatment type and duration, risk–benefit assessment, patient preferences, and compliance.

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Section: Discussioncontrasting

confidence: 69%

“…Both prospective and retrospective studies confirm the higher overall complication rates of PICCs (range, 15.9%–53.1%) when compared to tunneled/totally implantable devices (range, 2.2%–34.7%), 3–8,12–17 the observation being significantly supported by the results of three recent randomized controlled trials. 3,13,18…”

Section: Discussionmentioning

confidence: 99%

Comparison of outcomes of central venous catheters in patients with solid and hematologic neoplasms: an Italian real-world analysis

Corti

Brambilla

Manglaviti

et al. 2020

Tumori

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“…38 The other RCT was conducted in women with early breast cancers in France. 39 This trial reported a two-fold increased risk of catheter-related severe adverse events (grade ≥ III, or delay in chemotherapy administration or device removal) in the PICCs arm than in the PORTs arm.…”

Section: Discussionmentioning

confidence: 83%

“…Our findings are consistent with those from two recent RCTs, which also showed a significantly higher complication rate with PICCs than with PORTs. 38,39 One RCT was conducted in patients with solid cancers in Sweden; PICCs were shown to be associated with a 2.7-fold increase in complications (composite of catheter-related adverse events requiring intervention, thrombotic, occlusive, infections and mechanical). 38 The other RCT was conducted in women with early breast cancers in France.…”

Section: Discussionmentioning

confidence: 99%

Venous access devices for the delivery of long-term chemotherapy: the CAVA three-arm RCT

McCartney

Heggie

et al. 2021

Health Technol Assess

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Background Venous access devices are used for patients receiving long-term chemotherapy. These include centrally inserted tunnelled catheters or Hickman-type devices (Hickman), peripherally inserted central catheters (PICCs) and centrally inserted totally implantable venous access devices (PORTs). Objectives To evaluate the clinical effectiveness, safety, cost-effectiveness and acceptability of these devices for the central delivery of chemotherapy. Design An open, multicentre, randomised controlled trial to inform three comparisons: (1) peripherally inserted central catheters versus Hickman, (2) PORTs versus Hickman and (3) PORTs versus peripherally inserted central catheters. Pre-trial and post-trial qualitative research and economic evaluation were also conducted. Setting This took place in 18 UK oncology centres. Participants Adult patients (aged ≥ 18 years) receiving chemotherapy (≥ 12 weeks) for either a solid or a haematological malignancy were randomised via minimisation. Interventions Hickman, peripherally inserted central catheters and PORTs. Primary outcome A composite of infection (laboratory confirmed, suspected catheter related and exit site infection), mechanical failure, venous thrombosis, pulmonary embolism, inability to aspirate blood and other complications in the intention-to-treat population. Results Overall, 1061 participants were recruited to inform three comparisons. First, for the comparison of peripherally inserted central catheters (n = 212) with Hickman (n = 212), it could not be concluded that peripherally inserted central catheters were significantly non-inferior to Hickman in terms of complication rate (odds ratio 1.15, 95% confidence interval 0.78 to 1.71). The use of peripherally inserted central catheters compared with Hickman was associated with a substantially lower cost (–£1553) and a small decrement in quality-adjusted life-years gained (–0.009). Second, for the comparison of PORTs (n = 253) with Hickman (n = 303), PORTs were found to be statistically significantly superior to Hickman in terms of complication rate (odds ratio 0.54, 95% confidence interval 0.37 to 0.77). PORTs were found to dominate Hickman with lower costs (–£45) and greater quality-adjusted life-years gained (0.004). This was alongside a lower complications rate (difference of 14%); the incremental cost per complication averted was £1.36. Third, for the comparison of PORTs (n = 147) with peripherally inserted central catheters (n = 199), PORTs were found to be statistically significantly superior to peripherally inserted central catheters in terms of complication rate (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). PORTs were associated with an incremental cost of £2706 when compared with peripherally inserted central catheters and a decrement in quality-adjusted life-years gained (–0.018) PORTs are dominated by peripherally inserted central catheters: alongside a lower complications rate (difference of 15%), the incremental cost per complication averted was £104. The qualitative work showed that attitudes towards all three devices were positive, with patients viewing their central venous access device as part of their treatment and recovery. PORTs were perceived to offer unique psychological benefits, including a greater sense of freedom and less intrusion in the context of personal relationships. The main limitation was the lack of adequate power (54%) in the non-inferiority comparison between peripherally inserted central catheters and Hickman. Conclusions In the delivery of long-term chemotherapy, peripherally inserted central catheters should be considered a cost-effective option when compared with Hickman. There were significant clinical benefits when comparing PORTs with Hickman and with peripherally inserted central catheters. The health economic benefits were less clear from the perspective of incremental cost per quality-adjusted life-years gained. However, dependent on the willingness to pay, PORTs may be considered to be cost-effective from the perspective of complications averted. Future work The deliverability of a PORTs service merits further study to understand the barriers to and methods of improving the service. Trial registration This trial is registered as ISRCTN44504648. Funding This project was funded by the National Institute for Health Research (NHIR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 47. See the NIHR Journals Library website for further project information.

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“…For instance, in a global study examining patterns of peripheral intravenous catheter use, two-thirds of all surveyed devices were placed in a non-recommended site, had signs and symptoms of malfunction or were idle without a clear indication for continued use 3. Similarly, despite the risk of thrombosis associated with PICCs in patients with cancer,4 5 many such patients continue to receive chemotherapy through such devices when safer alternatives are available 6 7. And finally, while it is well known that patients with chronic kidney disease should not have devices inserted in arm veins to preserve these veins for dialysis,8 reports of this continue to permeate the literature 9.…”

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confidence: 99%

Making MAGIC: how to improve the use of peripherally inserted central catheters

Chopra

2020

BMJ Qual Saf

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Randomised phase II trial evaluating the safety of peripherally inserted catheters versus implanted port catheters during adjuvant chemotherapy in patients with early breast cancer

Cited by 28 publications

References 21 publications

Comparison of outcomes of central venous catheters in patients with solid and hematologic neoplasms: an Italian real-world analysis

Comparison of outcomes of central venous catheters in patients with solid and hematologic neoplasms: an Italian real-world analysis

Venous access devices for the delivery of long-term chemotherapy: the CAVA three-arm RCT

Making MAGIC: how to improve the use of peripherally inserted central catheters

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