LAS VEGAS — New 12-month data from an in-stent restenosis imaging cohort of the IN.PACT Global study demonstrate a primary patency rate of 88.7% and a clinically driven target lesion revascularization rate of 7.3% among real-world patients with femoropopliteal lesions, including de novo in-stent restenosis lesions, treated with a drug-coated balloon.
“The 12-month primary patency rate and 12-month clinically driven TLR rate are unmatched for this difficult-to-treat patient subgroup,” Marianne Brodmann, MD, of the Medical University of Graz, Austria, said during a press conference. “The results confirm the efficacy of the IN.PACT Admiral Drug-Coated Balloon (Medtronic) in the treatment of complex superficial femoral artery lesions, including challenging in-stent restenosis lesions.”
This cohort from the prospective, multicenter, single-arm IN.PACT Global study with independent core laboratory and clinical events committee adjudication included 131 patients with pure de novo in-stent restenosis (ISR) lesions. The mean age of the cohort was 68 years, 70% were men and 35% had diabetes. The mean lesion length was 17 cm, including 24% total occlusions and 59% calcified lesions, Brodmann said during a presentation.
“Complex lesion types including long lesions, chronic total occlusions and ISR remain unmet clinical needs, with no current treatment standard identified. ISR or occlusion is estimated to occur in 30 to 40% of all stents placed in the superficial femoral artery,” she said. “Treatment with standard percutaneous transluminal angioplasty techniques is associated with poor patency outcomes.”
According to other data from the cohort analysis, the primary safety outcome — a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target vessel revascularization within 12 months — was 91.1%. Examined separately, there were no cases of all-cause death or major target limb amputation during 12-month follow-up. The rate of thrombosis was low, Brodmann said, at 0.8%. Major adverse events occurred in 8.9% of patients.
“Treatment of patients with ISR remains a challenge,” Brodmann said. “… These results demonstrate remarkable efficacy and safety for ISR patients treated with the IN.PACT Admiral DCB with a mean lesion length of 17 cm.”
Treatment of ISR is not an approved indication in the United States. – by Katie Kalvaitis
Brodmann M. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.
Disclosure: Brodmann reports receiving honoraria from AstraZeneca, Bard Peripheral Vascular, Bayer, Biotronik, Boehringer Ingelheim, Bristol-Myers Squibb/Sanofi, Daiichi Sankyo, Medtronic, Novartis, Pfizer, Sanofi Aventis, Takeda and Terumo and consulting for Bard Peripheral Vascular and Covidien.