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DEFINITIVE AR: Atherectomy plus DCB may be beneficial in PAD

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Thomas Zeller

CHICAGO — In patients with peripheral artery disease, lumen gain achieved at 2 years after treatment with directional atherectomy followed by a drug-coated balloon may result in better outcomes, according to data from the DEFINITIVE AR pilot study.

In DEFINITIVE AR, Thomas Zeller, MD, from Universitaets-Herzzentrum Freiburg in Germany, and colleagues evaluated the effect of treating a lesion with directional atherectomy (SilverHawk/TurboHawk, Medtronic Endovascular) followed by DCB (Cotavance, Medrad) vs. DCB alone in 121 patients at 10 centers throughout Europe. If a patient’s lesion was not severely calcified as determined by angiography, they were randomly assigned to directional atherectomy plus DCB (n = 48) or DCB alone (n = 54), whereas patients with severely calcified lesions were enrolled in a prospective registry (n = 19).

The primary outcome was target lesion percent stenosis as determined by angiography at 1 year, and follow-up was later extended to 2 years.

At 1 year, target lesion percent restenosis was 33.6% in the atherectomy plus DCB group and 36.4% in the DCB alone group, with a mild trend favoring combination therapy, although this was not statistically significant.

Additionally, the researchers observed a trend toward better primary patency based on angiography with atherectomy plus DCB vs. DCB alone (82.4% vs. 71.8%) at 1 year, but the findings again were not statistically significant, according to the data.

“The question is: Does luminal gain result in benefits in terms of durability of the intervention? It seems to be of benefit even if there was no statistically significant difference in outcomes between study arms,” Zeller said during a presentation. “If you look at the duplex-derived patency and compare lesions that result in acute residual stenosis of less than 30% with those that have more than 30% residual stenosis, we see an absolute difference of 6.4%. When analyzing patency based on angiography, this difference was even more pronounced (19.4%).”

Although the difference was still not statistically significant, there was a clear trend favoring a residual stenosis of less than 30% acutely, Zeller said.

In the extension study, the researchers sought to assess longer-term effects of treating a lesion with directional atherectomy followed by DCB vs. DCB alone. Fifty-three patients were included in the 2-year follow-up.

Results showed that the overall outcome of freedom from major adverse events at 2 years favored the atherectomy plus DCB group vs. the DCB-alone group (73.7% vs. 71.7%), but the difference was not significant. Similarly, there was a mild trend favoring combination therapy vs. DCB alone in terms of freedom from target lesion revascularization (77% vs. 73.2%) that was again not significant.

At 2 years, lumen gain was associated with a trend toward lower TLR with residual stenosis of 30% or less after atherectomy plus DCB compared with DCB alone (83.3% vs. 55.2%), although the finding did not reach statistical significance.

“The study results suggest that achieving less than 30% residual stenosis following directional atherectomy leads to better outcomes, which were sustained through 2 years,” Zeller said. “The message behind this information is if you intend to perform atherectomy, you should aim for a residual stenosis of less than 30% in order to improve later use of DCB significantly over the plain use of DCB.”

He also noted that outcomes from the larger, statistically powered REALITY trial will evaluate this concept in the near future. – by Melissa Foster

Reference:

Zeller T. General Session 4: Aortic iliac and below: Where do we stand? Presented at: AMP: The Amputation Prevention Symposium; Aug. 9-12, 2017; Chicago.

Disclosures: The DEFINITIVE AR study was sponsored by Medtronic Endovascular. Zeller reports receiving honoraria and/or grant or research support from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharmaceuticals, Biotronik, Boston Scientific, Cardiovascular Systems Inc., Caveo Medical, Cordis, Contego Medical, Cook Medical, GLG, Intact Vascular, Innora, Medtronic, Mercator, Philips-Volcano, Pluristem, Spectranetics, Straub Medical, Terumo Medical, TriReme, Shockwave Medical, Veryan, VIVA Physicians and W.L. Gore & Associates.