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Robert Lookstein (New York, USA; principal investigator) and Andrew Holden (Auckland, New Zealand; principal investigator) discuss the key six-month results and implications from the IN.PACT™ AV Access trial–recently published in the prestigious New England Journal of Medicine (NEJM)–which compared the safety and efficacy of the IN.PACT™ AV drug-coated balloon (Medtronic) with percutaneous transluminal angioplasty (PTA).
Lookstein discusses some of the data highlights from the trial’s secondary endpoints which, coupled with the primary outcomes, indicate an “incredible significant increase in the quality of care” that can be provided to patients who are on end-stage renal disease haemodialysis maintenance.
Holden outlines the key six-month findings which showed a “highly significant” difference in primary patency of the target lesion between the two groups (86.1% with the DCB arm vs. 68.0% in the standard PTA arm, Kaplan-Meier estimates). This was an “outstanding result”, says Holden, adding that the safety endpoint of adverse events up to 30 days, showed that there was “no difference at all” between the two treatment arms.
He also looks at the implication that the IN.PACT™ AV Access trial data has had on his own practice, noting that “given the power of these findings” his team have switched to an approach of primary high pressure balloon angioplasty followed by DCB angioplasty and that “all centres should now consider this as a standard of care”.
Lookstein explains the significance of the findings being published in the NEJM, before concluding that “one of the incredible surprises following the publication has been how well received the data set has been by medical colleagues in nephrology who really believe this technology is transformational and will only lead to improved outcomes and increases quality of life for their patients on haemodialysis.”
To learn more visit: www.medtronic.eu/avDCB
This video is sponsored by Medtronic.
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LEARN MORE:
IN.PACT™ AV Access trial shows improvement in patency “for the entire fistula”
‘Indisputable evidence’ that DCB is the “gold standard” for treating vascular access stenosis
