Paclitaxel-coated balloons may be a good choice for the revascularization of femoropopliteal lesions longer than 15 cm, according to the SFA-Long study.
Primary patency was maintained in 83.2% of patients treated with the IN.PACT Admiral balloon over 1 year of follow-up, and major adverse events — the composite of all-cause death, major target limb amputation, thrombosis, and clinically-driven target vessel revascularization — occurred in 6.2%. There were no procedure- or device-related deaths, with cases of mortality instead attributed to cerebral infarction, myocardial infarction, pulmonary embolism, and lung cancer.
At 12 months, there was a marked improvement in walking (P=0.01) and quality of life. The ankle brachial index also jumped from 0.63 to 0.95 (P<0.001), Antonio Micari, MD, PhD, of Maria Eleonora Hospital in Italy, and colleagues reported online in JACC: Cardiovascular Interventions.
“Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization,” the authors concluded. “These findings signal that a stentless therapy approach with the IN.PACT Admiral paclitaxel-coated balloon and optimal percutaneous transluminal angioplasty [PTA] provides favorable outcomes and is likely to leave more interventional options open for the future.”
“Primary patency was favorably maintained in most patients despite a low bailout stenting rate during the index procedure,” they added. “Accordingly, successful repeat revascularization was required in only a minority of patients.”
For this type of long peripheral blockage, paclitaxel-eluting balloons may be a step up from nitinol stents, which “demonstrate a linear relationship between stent length and restenosis,” according to Ehrin J. Armstrong, MD, and Stephen W. Waldo, MD, of VA Eastern Colorado Health System in Denver.
In an accompanying editorial, the duo commented that “the available observational data suggest that treatment with a drug-coated balloon may provide similar or superior 1-year patency when compared to currently available stent technologies.”
“While the lack of head-to-head data makes it difficult to directly compare technologies, the reported patency rates in this cohort are comparable or superior to published studies of nitinol stents for similar lesion lengths (49% to 55%) as well as currently available drug-eluting stents [DES] for longer lesions (78%). The results are also similar to or surpass the reported patency of covered self-expanding stents (67% to 71%) and interwoven nitinol stents (81%),” they wrote.
Micari’s group added: “In contrast to an elective stent strategy such as DES, paclitaxel-coated balloons may present an optimal long-term therapeutic option for patients with claudication. Extensive stenting might affect the biomechanics of the superficial femoral artery, bending, temporarily occluding, and stretching the native artery. Given the unavoidable disease progress, paclitaxel-coated balloons represent a viable option that is less likely to affect future interventions compared with any first-line stent strategy.”
The prospective study included 105 consecutive patients who had Rutherford class 2 to 4 disease due to femoropopliteal lesions measuring more than 15 cm long. There were six participating sites in Italy, with three centers contributing 86% of cases.
Lesions measured a mean of 25.1 cm. Of those analyzed, 63.4% had moderate-to-severe calcification and 49.5% had total occlusions.
With operators limiting stenting as much as possible, the bailout stent rate was 10.9%. “This low bailout stent rate strongly highlights the importance of careful PTA technique and long-duration balloon inflations,” the authors noted.
Yet Armstrong and Waldo cited that aspect as limiting the study’s generalizability, as it’s unknown if other centers can replicate the low rate of bailout stenting.
Micari and colleagues acknowledged the limitations of the non-randomized and noncomparative design of their study. Other caveats included the focus on a single treatment strategy and the focus on patients with claudication, they added, as well as the fact that three sites contributing the majority of cases “might have influenced the results.”
To that, the editorialists added that longer-term patency data is still lacking in the evidence base for drug-coated balloons in long femoropopliteal lesions.
The study was supported by the ES Research Foundation and Medtronic.
Micari disclosed consulting for Medtronic.
Armstrong reported consulting and serving on advisory boards for Abbott Vascular, Boston Scientific, Cardiovascular Systems, Medtronic, Merck, and Spectranetics.
Waldo declared no relevant conflicts of interest.
JACC: Cardiovascular Interventions
Micari A, et al “1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease: evidence from the SFA-long study” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.02.014.
JACC: Cardiovascular Interventions
Armstrong EJ and Waldo SW “Drug-coated balloons for long superficial femoral artery disease: leave nothing behind in the real-world” JACC: Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.03.006.