Two-year results of EffPac—a randomised controlled trial to assess the safety and efficacy of a novel drug-coated balloon (DCB) with a nanotechnology coating—have been announced. The investigators, Ulf Teichgräber (University Hospital Jena, Germany) and colleagues, report that use of the DCB in question, iVascular’s Luminor, resulted in a significantly lower incidence of binary restenosis compared to plain old balloon angioplasty (POBA).
The new data, presented for the first time at the Annual Scientific Meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE 2019; 7–11 September, Barcelona, Spain), also showed a significant clinical and haemodynamic improvement from baseline, similar to the level of improvement achieved with POBA, but with considerably fewer repeat revascularisations. The investigators found no difference to POBA regarding safety.
The EffPac (Effectiveness of paclitaxel-coated Luminor balloon catheter versus uncoated balloon catheter in the arteria femoralis superficialis) trial was designed to assess the safety and efficacy of the Luminor paclitaxel drug-eluting balloon in inhibiting restenosis and in ensuring long-term patency. The investigators compared the DCB catheter to non-coated POBA in stenotic or occlusive lesions of the femoropopoliteal artery.
Between September 2015 and December 2016, the investigators enrolled 171 subjects across 11 German study centres. Eighty-five of these patients were randomised to DCB angioplasty, with the remaining 86 being assigned to the POBA group. They note that before the 24-month mark, analysis was discontinued for 25 patients in the DCB group and 30 patients in the POBA cohort.
The primary endpoint of the study was defined as late lumen loss at six months. The secondary endpoints at six, 12, and 24 months included primary patency, target lesion (TLR) and vessel (TVR) revascularisation, quality of life—assessed by the EQ-5D—change of Rutherford-Becker classification (RBC), ankle-brachial index (ABI), and major and minor amputation rates, among others.
The authors comment that 12 months in to the study, the investigational DCB catheter proved “highly effective and safe in inhibiting restenosis,” and demonstrated a walking improvement in change of RBC compared to POBA.
Twelve-month results of the safety and efficacy of the Luminor device had been released prior to the CIRSE 2019 presentation. The authors detail that at six months, the late lumen loss was on average 0.92mm lower in the DCB group than in the POBA group (95% confidence interval [CI]: -1.36mm; -0.49mm, p<0.001). Significantly more patients showed a walking improvement after DCB treatment at six months (p=0.021).
Looking now at the 24-month results, Teichgräber and colleagues reveal that primary patency (the rate of freedom from restenosis) was 90.2% (80.4–95.2) in the DCB arm, compared to 94.7% (86.4–98) at 12 months. The corresponding figures for the POBA cohort were 62.7% (50–73) and 71.3% (59.4–80.3).
Freedom from TLR in the DCB group was 97.2% (89.1–99.3) at 24 months, compared to 98.7% (91.1–99.8) at 12 months. In the POBA group, the figures were 78% (66.5–86) and 81.6% (71–88.7), respectively.
The investigators detail that in both groups patients were of similar age. While the DCB cohort was 68±7.5 years old, on average, the POBA group was 68.1±8.8 (p=0.979). There were slightly fewer male patients in the DCB group (60%) than in the POBA group (69.8%; p=0.239), and also slightly fewer diabetic patients in the DCB group (36.5%), compared to 40.4% in the POBA group (p=0.681). There were fewer current smokers in the POBA group than among DCB patients (40.5% vs. 43%; p=0.856). There were just over double the number of patients with critical limb ischaemia in the DCB group (3.6%) than there were in the POBA group (1.2%; p=0.929).