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IN.PACT SFA: DCB for PAD confers less TLR vs. angioplasty at 4 years
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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
Reference:
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.
Perspective
Back to TopD. Christopher Metzger, MD, FACC, FSCAI
It is encouraging that we can do a balloon procedure and three out of the four patients are not going to need another intervention in 4 years. It can be done safely, and there is nothing left behind. Because the prognosis of people with peripheral vascular disease is often bad, if we have kept them free of more procedures for 4 years, we have done them a great service and hopefully improved their quality of life.
Perspective
Back to Top
Krishna J. Rocha-Singh, MD, FACC, FAHA, FSCAI, FSVM
These results may be perceived as disappointing to some because the difference in clinically driven TLR between the groups is less at 4 years than it was at previous time points. But we have to consider this in the context that CMS is now reviewing this technology for reimbursement. If they focus on the fact that these are claudicants who are not dying any time soon and because of that it may be difficult to determine a value proposition, they may lose sight of the fact that in the PTA arm, there are substantially more clinically driven TLRs for the first several years. In the first year, there was a clear improvement in symptoms with the DCB, which may not be reflected because that wasn’t evaluated out to 4 years.
All of us are now anticipating the 2-year data from the ILLUMENATE trial of the Spectranetics DCB (Stellarex), which will be presented next year at the Leipzig Interventional Course. We already have insights on the Bard device (Lutonix 035). We may have hit a glass ceiling with regards to DCBs in TASC II A and B lesions. Now we need to work together to figure out what to do with the more complex patients. The REALITY study, enrolling now, may provide some answers in the future.
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