DCBs for Femoropoliteal Disease: What’s Now and What’s Next?

NEW YORK, NY—After years of promising results, trials of drug-coated balloons (DCBs) showing greater retention of primary patency over conventional balloon angioplasty in patients with femoropopliteal disease have led to the approval of 2 devices in the United States. But where the field goes from here and how physicians should interpret the results of the various available and upcoming devices was the focus during a session at the VEITH Symposium yesterday.

In an overview of the current state of technology in the United States, Edward Woo, MD, of MedStar Health (Washington, DC), explained that DCBs have 3 key components: the drug itself, its carrier, and its mode of action. The FDA-approved Lutonix (Bard) and Admiral (Medtronic) balloons both elute paclitaxel but differ in the other 2 aspects, he summarized.

Thomas Zeller, MD, of the Universitäts-Herzzentrum Freiburg-Bad Krozingen (Bad Krozingen, Germany), briefly reviewed the most recent large trials that studied both devices—LEVANT 2 and IN.PACT SFA, respectively.

Device Performance, Tips, and Tricks

One-year results of LEVANT 2—published in the New England Journal of Medicine in July—confirmed greater primary patency in 316 patients randomized to the Lutonix DCB than the in 160 allotted conventional balloon angioplasty (65.2% vs 52.6%; P = .02). At 2 years, primary patency was still higher with the DCB, but the difference narrowed to 5.6% with controls (58.6% vs 53.0%; P = .05). Freedom from TLR was 82% at 2-years.

IN.PACT SFA—presented at TCT last month—randomized 331 patients with symptomatic femoropopliteal lesions up to 18 cm long to receive the Admiral balloon (n = 220) or standard angioplasty (n = 111). Two-year data showed more patients assigned to receive the DCB achieved primary patency (78.9% vs 50.1%; P < .001) and freedom from clinically-driven TLR (91% vs. 72.2%; P < .0001). There was no late catch-up after 1 year.

“Through these trials, we have learned some technical aspects of these procedures which are important,” Woo said. For example, “it’s very critical to obtain at least a 1:1 ratio of the DCB to the reference vessel diameter to optimize your patency. [Also], you have to have appropriate inflation pressure, [and] minimal transit time between opening the balloon and then getting it to the target lesion is critical.

Keeping the balloons “inflated for some period of time” is best, he added. “I think 2 minutes is ideal, even some people go a little bit longer. If you do 30 seconds, it’s really not going to achieve as good results.”

“If you [compare] of both trials at 1 year, we had a level 1 evidence of superior outcomes of DCB over [standard angioplasty],” Zeller said. But at 2 years, “there was only a marginal benefit” seen in LEVANT 2 and patency outcomes “favor the IN.PACT technology.” Because of this, he suggested the need for a trial directly comparing both devices “for evaluation of performance differences.”

The Future of DCBs

Until then, Woo said, “it’s hard to talk about the status of DCBs in the US without at least describing … reimbursement.” While balloons used in outpatient procedures are compensated by the Centers for Medicare & Medicaid services via a transitional pass through code, “on the inpatient level it’s a little bit different,” he noted, explaining that half of the balloons will be reimbursed up to $1,036 only if the “DRG is exceeded.”

Looking to the future, “there’s a lot of interest in the below-the-knee segment and in-stent restenosis, and there are ongoing trials to look at that,” Woo said. “Certainly you can imagine that things like hemodialysis access [and] carotid stenting … could all potentially benefit from DCB and the DCB platform.” Newer devices that have already achieved CE Mark in Europe—Boston Scientific’s Ranger and Spectranetics’ Stellarex balloons—will also change practice, he noted.

Discussion after the presentation turned to the potential for development of a DCB to specifically treat smaller vessels. “It’s clear” such a balloon is needed, said session moderator and symposium chair Frank J. Veith, MD, of the Cleveland Clinic (Cleveland, OH) and New York University (New York, NY). “Will we ever get such a balloon?” he asked.

Peter A. Schneider, MD, of Hawaii Permanente Medical Group (Honolulu), replied, “I think we will, but it will take a lot longer than what I was hoping for.” The “extremely positive signals” for DCBs in superficial femoral artery lesions and DES use below-the-knee “led me to believe that it would be a no brainer, but now we have 2 negative trials. And with every negative trial, there’s a blast effect of deterring other investigators with other ideas and companies from making investments in [new] big trials.”

“Failure always precedes success,” Veith observed, adding that with continued effort, creating new DCBs will “be doable.”