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Abstract: TH-PO343

No Increase in All-Cause Mortality from Paclitaxel Coated Balloons (DCB) Used in an Arteriovenous Circuit in Dialysis Patients

Session Information

  • Vascular Access - I
    November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

  • 704 Dialysis: Vascular Access

Authors

  • Roy-Chaudhury, Prabir, University of North Carolina, Chapel Hill, North Carolina, United States
  • Saad, Theodore F., Nephrology Associates, PA, Newark, Delaware, United States
  • Trerotola, Scott O., University of Pennsylvania, Philadelphia, Pennsylvania, United States

Group or Team Name

  • on behalf of the Lutonix AV IDE investigators and the Medical Advisory Board
Background

Recent data have suggested an increased mortality in patients treated with paclitaxel balloons (DCB) in the femoropopliteal circulation. In order to assess this issue, in the setting of hemodialysis patients, a post-hoc analysis was performed to describe short (6 month), medium (12 month) and long term (24 month) mortality, in a randomized study on the use of DCB in failing arteriovenous fistulae (AVF).

Methods

285 patients were enrolled at 23 centers. Patients in both arms received vessel pre-dilatation followed by treatment with either a DCB or a control balloon of similar design to the DCB but without drug (PTA group). Endpoints included 3, 6, 9, 12, 18 and 24 month target lesion primary patency (TLPP), number of interventions required to maintain target lesion patency, and safety endpoints. A special focus of this presentation is a comparison of survival at 6, 12 and 24 months in the two arms of this study.

Results

The DCB and Control (PTA) groups were evenly matched with regard to age, sex, hypertension and smoking. 6 month post intervention primary patency was 71.4% for DCB and 63% in the control (p=NS). There were, however 31.3% fewer interventions at 6 months at the target lesion for the DCB group. A post-hoc analysis documented that there were no significant differences in all cause mortality (see Table) between the DCB and control (PTA) groups at 6 months (6.4% vs 4.2% mortality respectively), 12 months (12.8% vs 9% mortality) and 24 months (23.4% vs 18.1%). p = NS for all analyses.

Conclusion

These data (from the first large prospective randomized trial on the use of DCB in failing AVF) document that the use of DCB in the arteriovenous circuit (failing AVF) does not result in a statistically significant increase in mortality at the short (6 months), medium (1 year) and longer term (2 years ) endpoints.

Funding

  • Commercial Support