LAS VEGAS — A drug-coated balloon was linked to superior outcomes compared with percutaneous transluminal angioplasty in patients with femoropopliteal artery disease, according to 3-year results from the IN.PACT SFA study.
Researchers randomly assigned 331 patients (mean age, 68 years; 66% men) with superficial femoral or proximal popliteal artery disease due to claudication and rest pain on a 2:1 basis to be treated with the DCB (IN.PACT Admiral, Medtronic) or percutaneous transluminal angioplasty (PTA). Prakash Krishnan, MD, from Icahn School of Medicine at Mount Sinai, presented 3-year results at VIVA 16. The DCB had previously been shown to be superior to PTA in primary patency and clinically driven target lesion revascularization at 1 year and 2 years.
“DCBs have significantly changed the landscape for the treatment of femoropopliteal artery disease,” Krishnan said at a press conference. “Specifically, the IN.PACT Admiral [DCB] has demonstrated what some call best-in-class patency results at 1 and 2 years.”
At 3 years, the rate of primary patency was 69.5% in the DCB group and 45.1% in the PTA group (difference, 24.4%; log-rank P < .001), Krishnan said.
Freedom from clinically driven TLR at 3 years was 84.5% in the DCB group and 70.4% in the PTA group (difference, 14.1%; log-rank P < .001), according to Krishnan.
He said the DCB was also superior at 3 years in the following effectiveness outcomes: clinically driven TLR (P = .002), all TLR (P < .001), time to first clinically driven TLR (P < .001) and primary sustained clinical improvement, defined as freedom from target limb amputation, target vessel revascularization and increase in Rutherford class (P = .012). There was no difference between the groups in ankle-brachial index or toe-brachial index (P = .429).
The primary safety outcome of freedom from device- and procedure-related death at 30 days and target limb major amputation and clinically driven TVR at 3 years was 81.2% in the DCB group and 64.1% in the PTA group (P < .001), Krishnan said.
All-cause death at 3 years was higher in the DCB group (10.7% vs. 1.9%; P = .006), but no deaths in either group were attributed to the device or procedure, he said. Neither group had any target limb major amputations.
The 3-year rate of clinically driven TLR favored the DCB group (18.8% vs. 35.9%; P = .002), and there was a trend toward the rate of major adverse events favoring the DCB group (27.9% vs. 37.9%; P = .089), Krishnan said.
“It’s clear that the INPACT.SFA in this trial showed superior 3-year patency and low reintervention rates,” Krishnan said at the press conference. “It demonstrated its durability as the first independently adjudicated randomized pivotal [investigational device exemption] trial to show a durable treatment effect with a DCB at 3 years. The results also demonstrated long-term safety durability, with no adverse events related to the drug or procedure.”
The 3-year results of the 6-minute walk test were similar in both groups (P = .741) as was the percentage with walking impairment (P = .499), although “DCB patients achieved the same level of function with 48% fewer reinterventions,” he said.
“The data support IN.PACT Admiral as possibly a first-line treatment for symptomatic peripheral artery disease based on the patency rates at 3 years and, more importantly, the reduction in clinically driven TLR,” Krishnan said at the press conference. – by Erik Swain
Krishnan P, et al. Late-Breaking Clinical Trials. Presented at: VIVA 16; Sept. 18-22, 2016; Las Vegas.
The study was funded by Medtronic. Krishnan reports financial ties with Abbott Laboratories, C.R. Bard, Medtronic and Spectranetics.