Treatment of femoropopliteal lesions in patients with peripheral artery disease (PAD) using drug-coated balloon (DCB) vs conventional balloon angioplasty was associated with better primary patency and freedom from revascularization of the target vessel 2 years after intervention, without increasing the risk for mortality, according to study results published in Radiology.
Although DCB angioplasty is often the preferred therapeutic approach for PAD femoropopliteal revascularization procedures, associated mortality remains a concern. Investigators hypothesized that angioplasty with the Luminor-35 paclitaxel-coated balloon would be safe and be superior to the conventional procedure after 2 years.
In this study, 171 patients with symptomatic PAD (mean age, 69±8 years; 64.9% men) with singular short or medium (≤150 mm) superficial stenoses/occlusions were enrolled in the Effectiveness of Paclitaxel-Coated Luminor Balloon Catheter Versus Uncoated Balloon Catheter in the Ateria Femoralis Superficialis (EffPac; ClinicalTrials.gov identifier: NCT02540018) multi-center, prospective, randomized controlled trial between September 2015 and December 2016. Participants were randomly assigned 1:1 to undergo DCB (n=85; mean age, 68±8 years; 60% men) or conventional (n=86; mean age, 68±9 years; 70% men) balloon angioplasty and were followed for 2 years.
The primary study outcome was 6-month late lumen loss. Secondary outcomes included 2-year primary patency and target lesion revascularization rates; clinical, hemodynamic and quality of life measures; and target limb amputation and all-cause mortality rates.
At 6 months, the late lumen loss was superior in patients who had received DCB vs conventional balloon angioplasty. After 2 years, binary restenosis rate was higher in the conventional vs DCB group (46.7% vs 20.3%, respectively; odds ratio, 0.30; 95% CI, 0.12-0.74; P =.009), the primary patency was greater in the DCB group (90.2%; 95% CI, 80.4%-95.2%) compared with the conventional group (62.7%; 95% CI, 50.0%-73.0%; P <.001), and freedom from target lesion revascularization was also higher in the DCB group (97.2%; 95% CI, 89.1%-99.3%) vs the conventional group (78%; 95% CI, 66.5%-86.0%; P =.001).
Sustained improvement in Rutherford-Becker category from baseline to the 2-year follow-up was comparable between the 2 groups (row mean scores difference, 1.7; P = 19). The improvement in mean scores on the Walking Impairment Questionnaire was comparable between the 2 groups (mean difference, -0.8%; 95% CI, -11.8% to 10.2%; P =.88Improvements on the ankle-brachial index were significant in both groups (P <.001 for both) over the 2-year follow-up, and comparable between the 2 groups (mean difference, 0.03; 95% CI, -0.08 to 0.14; P =.57). Improvement in quality of life, assessed using EuroQol Group’s 5-dimension index, from baseline to 2 years was also comparable in patients who had received DCB vs conventional balloon angioplasty (mean difference, -0.06; 95% CI, -0.17 to 0.03; P =.20).
There were no major amputations of any target limbs in this cohort. There were 1 and 2 fatalities in the DCB and conventional angioplasty groups, respectively (risk ratio, 0.48; 95% CI, 0.04-5.10; P =.54).
Study limitations include insufficient power to detect differences in mortality and a lack of blinding of researchers.
“The 2-year results presented here add relevant information regarding clinical outcome and safety to previously published data of our study,” noted the authors.
Funding and Conflicts of Interest Disclosures:
Study supported by iVascular S.L.U., Barcelona, Spain; and Endoscout, Freiburg, Germany.
Please see original article for conflict of interest declarations.
Teichgräber U, Lehmann T, Aschenbach R, et al. Drug-coated balloon angioplasty of femoropopliteal lesions maintained superior efficacy over conventional balloon: 2-year results of the randomized EffPac trial. Radiology. March 2020:1-10. doi:10.1148/radiol.2020191619