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Drug-Coated Balloon and Drug-Eluting Stent Use in the Outpatient Setting

Currently in the United States, about 25% of all lower extremity arterial procedures are performed in an office-based setting, and about one-third of all endovascular procedures, which includes dialysis intervention and venous interventions—or about 448,000 of 1.3 million procedures—are done in a non-hospital setting. And this number is expected to increase by about 4.7% over the next 10 years.

“So, the office-based peripheral vascular procedure volume growth is outpacing the overall US procedural growth rate…,” said Bret N. Wiechmann, MD, from Vascular and Interventional Physicians in Gainesville, Florida, in his AMP 2020 Virtual talk on drug-eluting stent (DES) and drug-coated balloon (DCB) use in the office-based setting.

What’s driving DES and DCB use in outpatient environments? Mostly price and reimbursement, said Wiechmann, complicated by the mortality signal seen with paclitaxel.

When he conducted an informal survey of 15 colleagues—from around the country and in different practice settings—on their use of antiproliferative strategies, he found many reported not commonly using antiproliferatives, mostly because of cost and the “kind of looming paclitaxel issues we seem to be dealing with.”

For those that answered yes to the first question, their most common use of these devices was off-label use of coronary (DES) below-the-knee for tibial artery intervention and for repeat intervention of femoropopliteal restenosis.

“Drug-coated balloons have been around for several years now and really have contributed pretty substantially to the overall growth in the peripheral device market,” said Dr. Wiechmann. In 2015, CMS granted what's called a transitional pass through payment, as well as the new technology add-on payment for reimbursement in the office or in outpatient and inpatient settings. However, about two and a half years later those were both dropped, leaving the reimbursement for DCB the same as for angioplasty alone.

In the US, he said, only about 5% of DCB revenue is generated from the office-based setting, and added to the lack of reimbursement and the worries about a mortality signal with paclitaxel-coated devices, he suggested this market will grow in coming years, but at a slower rate. Their recent approval for AV access and potential approval in the infrapopliteal will likely drive revenue growth in the coming years.

In terms of atherectomy plus DCB procedures, Wiechmann noted that there was originally a lot of interest in combining these two that, in 2018, only about 30% of all the fem-pop atherectomy cases utilized DCBs. The rest of utilized either a plain balloon angioplasty or angioplasty and stenting.

“Again, the reasons for this revolve around reimbursement and the paclitaxel issues,” he said.

What about drug eluting stents? In 2018, about 24% of stents implanted in the femoropoliteal region were paclitaxel-eluting devices, the remainder being bare metal stents. “So, this is still a small, but not unsubstantial number,” he said. The minority are being used in the office-based environment and that number is expected to grow slowly.  

There is currently no DES or DCB with FDA approval for the infrapopliteal segment, but data on off-label use of coronary-limus-eluting devices is promising. That said, again looking at 2018 data, of the 9000 stents placed below-the-knee, more than 90% of those were coronary DES.

“And these numbers are projected to increase as we get closer, potentially, to an FDA approval and potential commercialization of [purpose-made] drug-eluting stents below the knee.”

Barriers to DES use in the office include a sense among some practitioners that they “don’t want to leave any kind of implant behind so they may favor a nonsense solution like a drug-coated balloon.” There are also those who simply don’t “believe” in drug-coated technology, so they might choose a nitinol stent or a biomimic-type stent. “And these companies have actually shown very competitive results without an antiproliferative strategy,” added Wiechmann.

Some question the cost-effectiveness of DES as initial use for patients with long segment chronic total occlusions (CTOs), “but certainly data does show improved freedom from revascularization.”

Wiechmann concluded that cost and reimbursement remain the biggest issues impacting DCB and DES use in the office-based lab. The paclitaxel discussion, he said, may have some lingering effects in terms of driving technological advance in non-drug strategies, naming specifically the vascular tack, the micromesh stent, biomimicry, and bioabsorbable stents.

“The trends away from the hospital and towards an office-based environment are likely going to put further [downward] pressure on industry in terms of an average sales price, because we know it's all about cost and reimbursement. But we await new delivery models, perhaps new devices, and approvals that may increase the adoption of DES and DCB in the future,” concluded Dr. Wiechmann.


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