LEVANT 2: DCB Beats Standard Balloon Angioplasty at 1 Year in Femoropopliteal Disease
Using a paclitaxel-coated balloon to treat femoropopliteal artery disease results in better primary patency than does standard balloon angioplasty at 1 year and is associated with good safety outcomes, according to a study published online June 24, 2015, ahead of print in the New England Journal of Medicine.
In October 2014, Lutonix 035 (Bard; Murray Hill, NJ) became the first drug-coated balloon (DCB) to be approved by the FDA for the indication of femoropopliteal artery disease.
For LEVANT 2, researchers led by Kenneth Rosenfield, MD, of Massachusetts General Hospital (Boston, MA), randomized 476 symptomatic patients (mean age 68 years; 63% men) from 54 international sites to the Lutonix DCB (n = 316) or standard balloon angioplasty (n = 160) between July 2011 and July 2012. Most (61%) were classified as Rutherford stage 3. Per angiographic analysis, all patients were unlikely to need a stent.
Mean lesion length was 62.8 mm, total treated length was 107.9 mm, and 21% of all lesions were occlusions. Procedural success was 88.9% with the DCB and 86.8% with standard balloon angioplasty. While baseline and procedural characteristics between the groups were well matched, provisional stenting occurred less often with DCBs than with standard angioplasty (2.5% vs 6.9%; P = .02).
Six-month results, presented at TCT 2013, showed higher primary patency in the DCB arm than the standard balloon arm in the intention-to-treat analysis (92.3% vs 82.7%; P = .003). The primary safety endpoint—freedom from perioperative death and from limb amputation, reintervention, or limb-related death at 1 year—was similar between the groups, meeting noninferiority criteria in the intention-to-treat analysis (P = .005).
DCB Still Takes the Cake
Not much has changed with the 12-month data, Dr. Rosenfield told TCTMD in a telephone interview. “The data are just cleaned and refined,” he said, adding that the FDA and Centers for Medicare & Medicaid Services “both have essentially reaffirmed the importance of this technology and the additional benefit that it can provide for patients.”
The primary patency rate at 12 months (primary efficacy endpoint) was higher with the DCB than with standard balloon angioplasty, with a consistent pattern observed in the prespecified Kaplan-Meier survival analysis. For the primary safety endpoint at 12 months, the DCB again matched standard angioplasty. Also, the rate of event-free survival did not differ between the treatment arms (table 1).
Fewer instances of TLR were noted in the DCB group than in the standard angioplasty group, but the difference did not reach statistical significance. Other measures, including the ankle-brachial index, Rutherford stage, and Walking Impairment Questionnaire scores, each improved from baseline to 12 months in both groups. However, only the Walking Impairment Questionnaire showed favored DCB treatment over standard balloon angioplasty at 12 months.
Lastly, there were no between-group differences in individual secondary safety endpoints, such as death, amputation, and thrombosis requiring reintervention, at 12 months. All deaths were deemed unrelated to the device, procedure, or index limb.
Juggling the Options
“The availability of these devices will change the algorithm and the paradigm for treating patients with femoropopliteal disease,” Dr. Rosenfield said. “In fact, in my practice and in many of my colleagues' practices, it already has.”
Ultimately, he explained, it comes down to the idea that if an operator is already planning on using a balloon to treat a patient, “why would you not reach for a balloon that will provide more durability and a better long-term patency for your patient?”
Additionally, Dr. Rosenfield observed, “use of this technology may enable us to provide a good, durable result without necessarily having to implant a permanent prosthesis. That increases the options.” Some lesions—behind the knee or at flexion points—are not well suited to treatment with stents, he added.
A benefit of DCBs, Dr. Rosenfield said, is that the learning curve associated with implantation is minimal. “They’re utilized the same as any standard balloon with the exception of the fact that the delivery time has to be fairly short,” he noted. “Once you introduce the balloon into the bloodstream, it has to get to the site and be inflated within some 30 seconds to a minute.”
Because the LEVANT 2 protocol included predilatation using a slightly undersized balloon, “that’s the labeling for the product,” he reported.
Many benefits are associated with this practice, Dr. Rosenfield continued. “It helps with sizing, and it helps determine whether the patient might not need a stent and if you can get away with the balloon alone. There also may be some previously unrecognized benefit to that predilatation where you might be more likely to get away without causing a significant disruption in the plaque in such [a way] that you would require stenting.”
Going forward, Dr. Rosenfield suggested there may be additional roles for paclitaxel-coated balloons “in other locations and other circumstances, such as in-stent restenosis.”
While choices are usually a good thing, he concluded, “one of the challenges that we all face in the area of peripheral artery treatment—and femoropopliteal disease in particular—is that we have a lot of options available.”
Considering the availability of standard balloon angioplasty, DCBs, stents, and various atherectomy devices, it is uncertain which technology is best for each particular circumstance, Dr. Rosenfield said. “That question remains to be answered and will require lots of additional investigation.”
Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. New Engl J Med. 2015;Epub ahead of print.
- LEVANT 2 was supported by Bard.
- Dr. Rosenfield reports receiving grant support from Atrium, Cordis, Lutonix Corporation/Bard, and the National Institutes of Health; grant support and personal fees from Abbott Vascular; and personal fees from VIVA Physicians.