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DISRUPT PAD: Lithoplasty system successfully treats calcified lesions in patients with PAD
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LAS VEGAS — A lithoplasty device was associated with positive 6-month outcomes in patients with symptomatic calcified femoropopliteal lesions, according to the results of the DISRUPT PAD study.
The device (Lithoplasty System, Shockwave Medical) uses lithotripsy pulses similar to those used for breaking up kidney stones to disrupt calcium in the vasculature with minimal disruption to the soft tissue and an integrated balloon to restore blood flow. The device was recently cleared by the FDA.
Thomas Zeller, MD, PhD, head physician in the department of angiology at Universitäts Herzzentrum, Bad Krozingen, Germany, and colleagues evaluated use of the device in 95 patients from eight centers with calcified femoropopliteal lesions 15 cm or less (mean, 7 cm). Results of the single-arm, two-phase study were presented by Zeller at VIVA 16.
“Calcium is the best-known enemy of any interventional procedure in the periphery and also in coronary interventions,” Zeller said during a press conference. “Dedicated treatment is still missing for this kind of lesion composition. By emitting shockwaves, the calcium inside the plaque should be disrupted into smaller pieces and the elasticity of the artery should be improved and the rigidity of calcium should be reduced, resulting in a better reaction to … balloon angioplasty.”
Outcomes of interest included improvement in percent diameter stenosis, acute lumen gain, 30-day and 6-month patency and 30-day and 6-month freedom from target lesion revascularization.
No safety issues emerged. Only one patient required a stent, which was to treat flow-limiting dissection present prior to the procedure, according to Zeller.
Additional pre- or post-dilatation was performed in 20% of cases.
At baseline, mean percent diameter stenosis was 78%, but after the procedure, that figure fell to approximately 24%, Zeller said.
“An important fact to note is that … reduction of percent diameter stenosis to less than 30% … could be shown in all kinds of lesions,” he said.
Mean net lumen gain was 3 mm, according to the results.
Primary patency was 100% at 30 days and 76.7% at 6 months, while freedom from TLR was 100% at 30 days and 96.8% at 6 months, according to Zeller.
“The DISRUPT program has successfully treated calcified PAD population with limited adjunctive therapies required,” Zeller said. “Eighty percent were single treatments with the Shockwave balloon. There were no safety issues seen acutely. There is consistent effectiveness across all subgroups.”
In Germany, the system is used in similar applications as atherectomy, and costs about the same as an atherectomy device, so usage usually depends on operator preference, he said. – by Erik Swain
Reference:
Zeller T, et al. Late-Breaking Clinical Trials. Presented at: VIVA 16; Sept. 18-22, 2016; Las Vegas.
Disclosure: The study was funded by Shockwave Medical. Zeller reports financial ties with 480 Biomedical, Abbott Vascular, AtheroMed, B. Braun Interventional, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, Daiichi Sankyo, Gerson Lehrman Group, Intact Vascular, Medtronic, Phillips, Shockwave Medical, Spectranetics, Straub Medical, Terumo, TriReme, Veryan/Novate and W.L. Gore & Associates.
Perspective
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Krishna J. Rocha-Singh, MD, FACC, FAHA, FSCAI, FSVM
These results appear to be fairly substantial. The question is whether this is going to elevate other therapies. Usually, we use angioplasty not as a standalone, but [rather] as an adjunct for vessel preparation. I think this device falls into a category, along with atherectomy, of use for vessel preparation prior to some type of drug therapy. What remains to be seen is whether CMS is going to value this and pay for it, and to what extent is it going to add cost to treating claudicants.
This is a step forward, for which we have been waiting a long time. However, calcium is the Achilles’ heel of all therapies for treatment of lesions in patients with PAD, and questions remain about whether this technology addresses deep-wall calcium, which was not proven in this study.
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