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Paclitaxel-coated balloon for long femoropopliteal artery lesions shows durable safety, efficacy
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LAS VEGAS — In patients with long femoropopliteal artery disease, treatment with a paclitaxel-coated balloon yielded a 70.4% rate of primary patency and 84.7% rate of freedom from clinically driven target lesion revascularization at 2 years, according to new data from the SFA-LONG study.
The prospective, multicenter, single-arm SFA-LONG study evaluated outcomes with the IN.PACT Admiral paclitaxel-coated balloon (PCB; Medtronic) for the treatment of long (TASC C and D) femoropopliteal lesions.
At VIVA 16, Antonio Micari, MD, PhD, interventional cardiologist with the CLI Program at Maria Cecilia Hospital in Cotignola, Ravenna, Italy, presented 2-year follow-up data on 93 patients (86% of the 105 enrolled).
“To our knowledge, this is the first study focused on the use of [a paclitaxel-coated balloon] in very long SFA lesions with outcomes data through 24 months,” Micari said during a late-breaking clinical trial presentation.
All patients had Rutherford class 2 to 4 disease with femoropopliteal lesions > 15 cm long and a reference vessel diameter of 4 to 7 mm. Mean lesion length treated was 251 mm, 91% were de novo lesions and 63% were moderate to severely calcified lesions. The rate of total occlusions was 49.5%. CV comorbidities were prevalent, with hypertension in 88%, hyperlipidemia in 78% and diabetes in 57%. The mean age was 68 years and 82% were men, according to data presented here.
The primary endpoint was primary patency within 12 months after the index procedure, defined as free from clinically driven TLR and > 50% restenosis in the treated lesion.
According to Kaplan-Meier estimate, freedom from the composite endpoint of TLR or > 50% restenosis was 71% at 720 days. Micari reported that the secondary patency rate was 79.6%.
The researchers also compared outcomes in occlusive vs. stenotic lesions and long (< 25 cm) vs. very long (> 25 cm) lesions. At 2 years, the rate of patency was 74% in patients with stenotic lesions vs. 68% in patients with occlusive lesions (P = .42) and 75% in patients with long lesions vs. 66% in patients with very long lesions (P = .25).
In other results, one or more major adverse events occurred in 10.2% of patients. The rate of death from any cause was 5.1%; no deaths were determined to be related to the device. The rate of thrombosis was 2%. About 11% of patients required bailout stenting.
There was “significant improvement” in Rutherford classification during follow-up, according to Micari. At 2 years, 51% of patients had Rutherford class 0 disease and 12% had Rutherford class 1 disease.
Walking Impairment Questionnaire scores also improved over time, from 20.9 at baseline to 15.1 at 2 years.
“Strong 2-year results support the safety and usefulness of this technology in achieving a good primary patency rate and in limiting the need for clinically driven revascularization,” Micari said. “These instrumental results are corroborated by good maintenance of clinical benefit.” – by Katie Kalvaitis
Reference:
Micari A, et al. Late-Breaking Clinical Trials. Presented at: VIVA 16; Sept. 18-22, 2016; Las Vegas.
Disclosure: Micari reports receiving honoraria from AstraZeneca, Boston Scientific, Lutonix, Medtronic and Terumo and research/clinical trial/drug study funds from Medtronic.
Perspective
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Mark W. Burket, MD
These results are remarkably good. It’s surprising to me that there was no correlation between lesion length and outcome. Intuitively, one would think shorter lesions are at less risk for restenosis.
We are now at the point where we need a randomized trial between drug-eluting stents and DCBs. The issue of course is who will fund it. It is revolutionary that there will be a head-to-head trial between two DES, though it’s logical that the maker of a new entrant into the field would be willing to sponsor a trial. It’s hard to say who would be willing to do that for a DES vs. a DCB.
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