This article is more than 5 years old. Information may no longer be current.
Longer-term IN.PACT SFA data show continued promise for DCB as PAD treatment approach
SAN FRANCISCO — Drug-coated balloons were found to be superior to percutaneous transluminal angioplasty in the treatment of patients with peripheral artery disease, 2-year results from the IN.PACT SFA trial show.
“There is really no defined standard of care for the treatment of femoropopliteal disease,” John R. Laird, MD, of the University of California, Davis, told Healio.com. “Many of the treatments that have been tried over the years, including balloon angioplasty, atherectomy and stenting, have not provided us the type of results we would like to see. There’s been great interest in anti-restenotic therapies such as [DCBs] to try and improve the results in the [superficial femoral artery].”
John R. Laird
At 2 years, the investigators assessed primary patency, freedom from clinically driven target lesion revascularization and major adverse events, as well as quality of life (based on EQ-5D quality-of-life questionnaire) and functional outcomes (based on walking impairment questionnaire and 6-minute walk test).
The IN.PACT SFA trial results at 1-year already showed primary patency superiority and reduction in clinically driven TLR with DCB compared with PTA.
In this next period, patients also demonstrated higher primary patency with DCB compared with PTA (78.9% vs. 50.1%; P < .001), and the rates of clinically driven TLR were respectively lower (9.1% vs. 28.3%; P < .001). The overall mortality rate was 8.1% in the DCB group vs. 0.9% in the PTA group (P = .008).
No deaths related to the devices or procedures occurred in either group over 2 years, and there were no major amputations. The incidence of vessel thrombosis was 1.5% with DCB vs. 3.8% with PTA (P = .243), and no new events were reported between 1 and 2 years.
The two groups experienced similar functional improvement at follow-up; however, patients in the DCB group underwent 58% fewer reinterventions.
“For those patients with [PAD], which is extremely common — with a prevalence that is growing with the aging of our population — we now have a potentially better technique,” Laird said. “This will, ultimately, result in a paradigm shift in how we treat [PAD], particularly in the femoropopliteal segment, which is the most common location for patients to get occlusive lesions.” – by Allegra Tiver
References:
Laird JR, et al. IN.PACT SFA: A prospective randomized trial of a drug-coated balloon for femoropopliteal lesions — two-year outcomes. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Laird JR, et al. J Am Coll Cardiol. 2015;doi:10.1016/j.jacc.2015.09.063.
Disclosure: Laird reports consulting for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific and Medtronic, and research grants from Medtronic and W.L Gore. Please see the full study for a list of all other authors’ relevant financial disclosures.