DCB remains superior to PTA at 1 year in treatment of arteriovenous fistula lesions
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A drug-coated balloon was superior to percutaneous transluminal angioplasty at 1 year for primary patency and clinically driven target lesion revascularization in patients with de novo or restenotic arteriovenous fistula lesions, according to new data from the IN.PACT AV Access study.
As Healio previously reported, the DCB (IN.PACT AV, Medtronic) was superior to PTA in the primary endpoint of 6-month primary patency. Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, director of interventional radiology at Auckland Hospital in New Zealand, presented the 1-year results at the Leipzig Interventional Course.
At 1 year, target lesion primary patency was 63.8% in the DCB group and 43.6% in the PTA group (difference, 20.3 percentage points; P < .001), whereas clinically driven TLR occurred in 35% of the DCB group and 54.3% of the PTA group (difference, –19.3 percentage points; P = .001), Holden said during a presentation, noting that Kaplan-Meier estimates of primary patency yielded similar results.
The groups did not significantly differ in access circuit thrombosis at 1 year (DCB, 2.9%; PTA, 6.2%; difference, –3.3 percentage points), he said.
Access circuit primary patency also favored the DCB group at 1 year (DCB, 53.8%; PTA, 32.4%; difference, 21.4 percentage points; P < .001), as did reintervention in the access circuit (DCB, 45.1%; PTA, 66.7%; difference, –21.5 percentage points; P < .001), according to the presentation.
Serious adverse events occurred in 46.9% of the DCB group compared with 69.2% of the PTA group at 1 year (difference, –22.3 percentage points; P < .001), Holden said.
The rates of all TLR were 40.1% in the DCB group and 62.4% in the PTA group at 1 year (difference, –22.3 percentage points; P < .001), according to the researchers.
There was no difference in the Kaplan-Meier estimate of freedom from all-cause death at 1 year (DCB, 90.6%; PTA, 90.4%; log-rank P = .931), Holden said.
“There was a sustained patency advantage for a DCB over PTA using quality vessel preparation with a high-pressure balloon over 12 months,” Holden said during the presentation. “There were fewer reinterventions to maintain target lesion primary patency in the DCB group compared to the PTA group.”
The DCB received FDA approval in November, as Healio previously reported.
The trial included 330 patients (mean age, 66 years; 65% men) who had a native arteriovenous fistula created at least 60 days before the procedure and had a de novo and/or nonstented restenotic lesion with at least 50% stenosis. – by Erik Swain
Reference:
Holden A, et al. New concepts for AV-shunt revascularization and central vein stenoses. Presented at: Leipzig Interventional Course; Jan. 28-31, 2020; Leipzig, Germany.
Disclosure: The study was funded by Medtronic. Holden reports he consults for Boston Scientific, Medtronic and W.L. Gore & Associates.