LAS VEGAS — A drug-coated balloon was safe and effective at 12 months in a real-world population of patients with symptomatic femoropopliteal peripheral artery disease, according to data presented at VIVA 16.
For the IN.PACT Global study, researchers evaluated 1,406 consecutive patients (mean age, 69 years; 68% men) with claudication and Rutherford class 2 to 4 femoropopliteal PAD. All had lesions treated with the DCB (IN.PACT Admiral, Medtronic).
Mean lesion length was 12.09 cm, 18% of patients had in-stent restenosis, 35.5% had chronic total occlusions and 68.7% had calcified lesions, the researchers reported. The population included patients from the IN.PACT Global study’s in-stent restenosis, long-lesion and CTO imaging cohorts.
“These patients could have bilateral disease or multiple sequential lesions involving the superficial femoral and popliteal artery,” Michael R. Jaff, DO, FSCAI, professor of medicine at Harvard Medical School, the Paul and Phyllis Fireman Endowed Chair in Vascular Medicine and medical director of the Fireman Vascular Center at Massachusetts General Hospital, said during a press conference. “All TASC lesions were included. Every single case was reviewed by an independent clinical events committee. The goal was to expand the evidence of the IN.PACT Admiral [DCB] in the treatment of a real-world patient population.”
Michael R. Jaff
The primary effectiveness endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was freedom from device- and procedure-related mortality at 30 days and freedom from major target limb amputation and clinically driven target vessel revascularization at 12 months.
The primary effectiveness endpoint was met in 92.6% of patients and the primary safety endpoint was met in 92.1% of patients, Jaff said.
Major adverse events occurred in 12% of patients, all-cause mortality in 3.5%, device- or procedure-related death in 0.2%, clinically driven TVR in 8.1%, target limb major amputation in 0.2% and thrombosis in 2.9%, according to the findings.
The bailout stenting rate was 24%, which is not unexpected in patients as complex and sick as these, and those who received provisional stenting did not differ in outcomes from those who did not, Jaff said.
The study “demonstrates consistent efficacy of the IN.PACT Admiral [DCB] in this clinical cohort across many prespecified imaging subgroups, confirming the positive outcomes seen in our other IN.PACT SFA experiences,” Jaff, a member of the Cardiology Today and Cardiology Today’s Intervention Editorial Boards, said during the press conference. “These 1-year worldwide data suggest reassurance to the vascular specialist that the IN.PACT Admiral [DCB] can and should be a first-line treatment for patients with SFA and popliteal disease in complex and broad patient populations.”
Future research should pinpoint “the pattern of failure of [DCBs] over time, and what we can be doing differently at the time of treatment that would give us better durability over time,” he said. “But I think the message is fairly consistent: [DCBs] are here to stay.” – by Erik Swain
Jaff MR, et al. Late-Breaking Clinical Trials. Presented at: VIVA 16; Sept. 18-22; Las Vegas.
The study was funded by Medtronic. Jaff reports consulting for Cardinal Health and Volcano, receiving research funding from Novella, and holding equity in AccessClosure, Embolitech, Janacare, Micell Technologies, Northpoint Domain, Northwind Medical, PQ Bypass, Primacea, Valiant and Vascular Therapies.