IN.PACT SFA: DCB for PAD confers less TLR vs. angioplasty at 4 years
LAS VEGAS — At 4 years, the rate of target lesion revascularization was lower among patients with femoropopliteal lesions who received a drug-coated balloon compared with those who received percutaneous transluminal angioplasty, according to new data from the IN.PACT SFA trial.
The superiority in safety is consistent with results from the first 3 years, Peter A. Schneider, MD, chief of vascular therapy at Kaiser Foundation Hospital, Honolulu, said during a press conference at VIVA 17.
“This trial sets somewhat of a new standard in that primary patency and clinically driven TLR were followed through 3 years,” Schneider said. “Then, clinically driven TLR and all the other safety endpoints were followed through 5 years. This will be the longest follow-up in any trial [of a DCB].”
The researchers enrolled 331 patients with symptomatic Rutherford class 2 to 4 femoropopliteal lesions and randomly assigned them on a 2:1 basis to the DCB (IN.PACT Admiral, Medtronic) or PTA.
The outcome of interest was clinically driven TLR at 4 years.
The Kaplan-Meier estimate of freedom from clinically driven TLR at 4 years was 76.8% in the DCB group and 70.4% in the PTA group (log-rank P = .0399), Schneider said.
In addition, time to first clinically driven TLR within 4 years was longer in the DCB group than the PTA group (739.2 days vs. 302.9 days; P < .001), he said.
The groups did not differ in rate of major adverse events (DCB group, 38%; PTA group, 40.8%; P = .705).
No device- or procedure-related deaths and no major target limb amputations were reported in either group.
Vessel thrombosis was low in both groups (DCB group, 2.2%; PTA group, 4.9%; P = .29) and no new cases occurred between 3 and 4 years, Schneider said.
“This is the first independently adjudicated, randomized, blinded pivotal [investigational device exemption trial of a DCB] to go out 4 years, and it shows a favorability with respect to clinically driven TLR in the DCB group. There’s a significantly longer time to reintervention with the DCB,” Schneider said. “The key thing here is that in the treatments we have for peripheral vascular disease, there really is a peak of repeat narrowing. Usually it comes around 6 or 12 months. ... We’re trying to take an acute situation and make it so patients won’t get a repeat narrowing, but if they do, it’s further down the road, and not as soon as 6 or 12 months, which is the case with so many treatments.” – by Erik Swain
Schneider PA, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
Disclosures: The study was funded by Medtronic. Schneider reports he is a consultant for Cagent, Cook Medical and Intact Vascular; holds common stock in Cagent and Intact Vascular; and has received research grants from Boston Scientific, C.R. Bard and W.L. Gore and Associates.