PURPOSE:We conducted a national multi-center randomized controlled clinical trial comparing the efficacy of a novel anti-infective CVC coated with 5-FU (Angiotech Pharmaceuticals Inc., Vancouver, Canada) to a CVC externally coated with CH-SS, (ARROWgard Blue, Arrow International, Reading, Pennsylvania) on CC and CRBSI.
METHODS:Adult subjects initially admitted to an ICU requiring triple-lumen CVCs, were randomized (1:1) to the 5-FU or CH-SS CVC implanted ≤; 28 days using maximum barrier precautions. Explanted catheter tips were cultured using the roll plate method. Significant colonization was defined as growth > than 14 colony forming units (CFU), CRBSI was defined as isolation of identical species (antibiogram) from peripheral blood draw and CVC tip. CC, CRBSI and the effect of insertion site were tested using the χ2 or Fisher’s exact test. Post-hoc analyses were performed to determine CRBSI/1000-catheter days, differences in CC between jugular and subclavian sites for all catheters pooled, and a Kaplan-Meier analysis to determine the probability of remaining free from CC and CRBSI. A p-value of <0.05 was considered statistically significant.
RESULTS:Of 960 subjects randomized, 419 in the 5-FU and 398 in the CH-SS groups were evaluable. CRBSIs per 1000-catheter days were 0 for 5-FU and 0.56 for CH-SS (p=NS). The probabilities of being CRBSI-free were 100% and 88.5% respectively, for the 5-FU and CH-SS CVCs while the probabilities of remaining uncolonized were 59.6% and 65.8% for the 5-FU and CH-SS CVCs (p=NS). When both groups were pooled, the subclavian insertion site was less likely to result in CC (9/378) as compared to the internal jugular insertion site (22/412) (p=0.04) where the 5-FU CC rate was significantly lower (2.9% vs. 7.7%, CI –9.05%,–0.45%) than CH-SS.
CONCLUSION:CVCs with 5-FU external coatings are non-inferior compared to CVCs externally coated with CH-SS in preventing CRBSI and CC. Our data suggest the subclavian insertion site is associated with a lower risk of CC compared to the internal jugular site.
CLINICAL IMPLICATIONS:CVC coated with 5-FU are a suitable alternative to currently available antiinfective CVC.
DISCLOSURE:Jens Walz, No Financial Disclosure Information; No Product/Research Disclosure Information