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DCB consistently effective in two cohorts of patients with PAD
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A drug-coated balloon showed strong, consistent efficacy in patients with peripheral artery disease at 1 year, according to new data from two cohorts in the IN.PACT Global Study.
At the Leipzig Interventional Course in Leipzig, Germany, researchers presented 1-year data from the Asian subset (n = 114; mean age, 68 years; 86% men) and the Belgian subset (n = 305; mean age, 70 years; 66% men) of the study.
Asian s ubset
In the Asian subset of patients from six sites in Singapore and South Korea, 26.8% had in-stent restenosis, 51.4% had total occlusions, 8% had severe calcification and mean lesion length was 17.43 cm.
Device success was 99.7%, procedure success was 99.1%, clinical success was 99.1% and the rate of provisional stenting was 19.3%, Donghoon Choi, MD, from the division of cardiology at Severance Cardiovascular Hospital in Seoul, South Korea, reported.
The rate of freedom from clinically driven target lesion revascularization at 12 months was 96.2%, and the 3.8% rate of clinically driven TLR was consistent with the rate of 7.5% in the overall population, Choi said.
The rate of major adverse events was 12.3%. Nine (8.5%) patients died, but no deaths were related to the device or procedure, and the rate of thrombosis was 0.9%, according to Choi. There were no cases of major target limb amputation.
Belgian s ubset
In the cohort of patients from seven sites in Belgium, the country with the most patients in the study, 26.4% had in-stent restenosis, 20.9% had total occlusions, 5.7% had severe calcification and the mean lesion length was 9.54 cm, according to Koen Deloose, MD, from the vascular surgery unit at AZ Sint Blasius in Dendermonde, Belgium.
Device success was 100%, procedure success was 99.3%, clinical success was 98.3% and the provisional stenting rate was 20.7%, he said.
The rate of freedom from clinically driven TLR at 12 months was 92.5%, similar to the overall study population, Deloose said.
The rate of key metrics was as follows: major adverse events, 12.8%; all-cause mortality, 3.5%; major target limb amputation, 0.7%; and thrombosis, 3.8%.
“These results demonstrate the consistency of the treatment effect with the IN.PACT Admiral DCB in the treatment of [superficial femoral artery] lesions, including in this geography-specific cohort,” Deloose said during the presentation. – by Erik Swain
References:
Choi D, et al.
Deloose K, et al. Deep Dive Session: Lower limb interventions (part II) – femoropopliteal, drug-eluting devices, and new technologies. Both presented at: Leipzig Interventional Course; Jan. 24-27, 2017; Leipzig, Germany.
Disclosure : The studies were funded by Medtronic. Choi reports no relevant financial disclosures. Deloose reports consulting for Abbott, Bard Peripheral Vascular, Bentley Biotronik, Cook Medical, Medtronic and Spectranetics.