THURSDAY, Aug. 20, 2020 (HealthDay News) -- For the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas, drug-coated balloon angioplasty is superior to standard angioplasty during the six months after the procedure, according to a study published in the Aug. 20 issue of the New England Journal of Medicine.
Robert A. Lookstein, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a 1:1 randomized trial involving 330 participants at 29 international sites with new or restenotic lesions in native upper-extremity arteriovenous fistulas. Participants were randomly assigned to receive treatment with either a drug-coated balloon or a standard balloon (170 and 160, respectively) after successful high-pressure percutaneous transluminal angioplasty.
The researchers found that target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those treated with a standard balloon during the six months after the index procedure (82.2 versus 59.5 percent; difference in risk, 22.8 percentage points; 95 percent confidence interval, 12.8 to 32.8; P < 0.001). With respect to the primary safety end point of serious adverse events involving the arteriovenous access circuit within 30 days, drug-coated balloons were noninferior to standard balloons (4.2 versus 4.4 percent; difference in risk, −0.2 percentage points; 95 percent confidence interval, −5.5 to 5.0; P = 0.002 for noninferiority).
"We investigated lesions in arteriovenous fistulas; further studies will be required to evaluate the safety and effectiveness of drug-coated balloons for the treatment of central vein obstruction, in-stent restenosis, or arteriovenous graft stenosis," the authors write.
The study was funded by Medtronic.
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