Longer Patency, Fewer Repeat Procedures With Paclitaxel DCBs in Dialysis Patients

Compared with plain balloon angioplasty, treatment with a paclitaxel-coated balloon provides better patency and reduces the need for repeat procedures in dialysis patients with dysfunctional arteriovenous fistulas, the IN.PACT AV Access study shows.

Robert Lookstein, MD (Icahn School of Medicine at Mount Sinai, New York, NY), lead investigator of the study, said the drug-coated balloon (DCB) fills an unmet need for end-stage renal disease patients, giving them a better overall quality of life.

“From the perspective of a patient who is on hemodialysis several hours a day, multiple days a week, to have a 50% reduction in the number of procedures needed to maintain access patency just at 6-month follow-up, as we saw in this study, is a huge benefit,” he told TCTMD.

In November 2019, the US Food and Drug Administration approved the IN.PACT AV device (Medtronic) for use in AV dialysis fistula on the basis of IN.PACT AV Access. The full results of the trial were published this week in the New England Journal of Medicine.

Long-term Safety and Pandemic Implications

For IN.PACT AV Access, Lookstein and colleagues randomized 330 dialysis patients with new or nonstented restenotic arteriovenous fistulas up to 100 mm in length to treatment with the DCB or plain balloon angioplasty.

At 6 months, primary patency was 82.2% in the DCB group and 59.5% in the plain balloon group (P < 0.001). In addition to 56% fewer reinterventions, the DCB was noninferior to plain balloon for serious adverse events involving the arteriovenous access circuit within 30 days (4.2% vs 4.4%; P = 0.002 for noninferiority).

Lookstein said the DCB’s better patency has important implications given the current COVID-19 pandemic.

“[During the surge in New York] vascular specialists were committed to keeping patients with chronic medical illnesses out of the hospital, unless it was absolutely necessary,” he said. “That obviously still goes on to this day where we are really trying to minimize any elective or avoidable procedures due to the risks of exposure for these patients.”

The fact that there's no difference at 12 months is obviously very encouraging. Robert Lookstein

Paclitaxel DCBs have been a topic of considerable controversy since a meta-analysis published in late 2018 raised concern about a potential long-term mortality signal in patients with femoropopliteal artery disease. However, a similar meta-analysis published in 2019 showed no difference in rates of death between patients with arteriovenous fistula lesions treated with DCBs versus standard balloons. Nevertheless, the IN.PACT AV DCB does carry the FDA-mandated warning on its label regarding a possible late mortality signal with paclitaxel and the need to discuss this, along with options, risks, and benefits, with patients.

In the current trial, Lookstein and colleagues report that at 12-month follow-up, there was no significant difference in mortality between patients receiving the DCB compared with a plain balloon (9.4% vs 9.6%; P = 0.93).

To TCTMD, Lookstein said the study investigators are committed to following patients to 5 years, as the FDA has recommended.

“The fact that there's no difference at 12 months is obviously very encouraging,” he added. “We know that end-stage renal disease patients have a very different life expectancy than, for example, patients with intermittent claudication, which were the patient populations that have been routinely studied in the pivotal trials for DCBs in the superficial femoral artery. So, it is a very distinct, unique population with a different baseline mortality risk. That being said, we do plan on studying these patients for the long term.”

For the less than 20% of patients treated with a DCB who did not maintain primary patency, Lookstein said the study investigators would recommend repeat treatment with the DCB, turning to other options only when a decision had been made that the DCB has truly failed.

“The most common finding that we observed from the trial is that in those settings where it was deemed that the patient failed, it was really that the preparation of the vessel, the high-pressure balloon angioplasty, was the rate-limiting step,” he explained. “If you couldn't open up the vessel with a high-pressure balloon, it would likely be that the drug-coated balloon would not derive as much benefit to the patient. It just emphasized to us that vessel preparation prior to the use of a drug-coated balloon is absolutely critical to the success.”