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DCB yields better results than PTA for femoropopliteal occlusive disease
In patients with femoropopliteal occlusive disease, drug-coated balloons appear to be superior to percutaneous transluminal angioplasty, according to results of the German cohort of the LEVANT 2 study.
In the subanalysis study, researchers evaluated 126 of the 476 patients enrolled in LEVANT 2, a prospective, global, multicenter, single blind, randomized pivotal trial that compared the DCB (Lutonix, C.R. Bard) with standard percutaneous transluminal angioplasty (PTA) for the treatment of occlusive disease in native femoropopliteal arteries.
Patients included in the present study were enrolled at the eight participating German sites of LEVANT 2 between August 2011 and July 2012. All patients in LEVANT 2 had symptomatic claudication or ischemic rest pain (Rutherford categories 2-4) and significant atherosclerotic lesions (> 70% diameter stenosis and ≤ 15 cm length) in the superficial femoral and/or popliteal arteries, with patent outflow to the foot, according to the researchers. The mean age of the patients in the substudy was 67 years, and 79 patients were men. Patients were randomly assigned at a 2:1 ratio to treatment with DCB (n = 83) or PTA using an uncoated balloon (n = 43).
The primary outcome was 1-year primary patency, defined as freedom from target lesion binary restenosis and freedom from target lesion revascularization. The primary safety outcome was freedom from all-cause death at 30 days and 1-year freedom from a composite of new limb amputation, index limb reintervention and index limb-associated mortality, the researchers wrote.
Better patency
At 12 months, the primary patency rate was 79.4% with DCB vs. 57.8% with PTA (P = .015). In the DCB group, a lower rate of TLR also was observed, with 96.1% of the DCB group vs. 82% of the PTA group achieving freedom from TLR through 12 months (P = .012).
The composite safety endpoint also demonstrated the superiority of DCB vs. PTAs (93.5% vs. 71.9%; P = .001), according to the researchers.
No amputations occurred, and the groups had similar rates of death and thrombosis. The rate of TVR was 6.8% in the DCB group vs. 28.2% in the PTA group (P = .002).
Both groups demonstrated comparable improvements in functional and quality-of-life parameters. At 12 months, Rutherford scores were improved in 91.2% of the DCB group vs. 78.8% of the PTA group (P = .008).
The superiority of DCB over PTA was seen in both men and women, the researchers wrote.
Stenosis results
Although baseline stenosis of treated lesions was higher in the German cohort than the non-German cohort, this group had a lower final postprocedural diameter stenosis (19% vs. 22%; P = .04), according to the study data.
“In the German cohort of LEVANT 2, the rates of primary patency, freedom from TLR and composite safety for the DCB group were superior to those for PTA,” the researchers wrote. “Differences in angioplasty outcomes as measured by lower diameter stenosis after DCB and shorter DCB delivery time may explain the superior outcomes compared to the LEVANT 2 [intention-to-treat] population.” – by Jennifer Byrne
Disclosure: The trial was sponsored by Lutonix, a subsidiary of C.R. Bard. Some researchers report consulting for C.R. Bard. Please see the full study for a list of all the researchers’ relevant financial disclosures.