Novel DCB may improve outcomes in patients with femoropopliteal artery lesions
Patients with femoropopliteal artery lesions who were treated by angioplasty with a drug-coated balloon showed improved symptoms and freedom from target lesion revascularization compared with those with uncoated balloons, according to results presented at the Charing Cross Symposium.
“The [DCB] has a later-generation coating with low-dose paclitaxel on the balloon surface, and with this specific coating, the study demonstrated efficacy results which are matching best-in-class results, which are typically achieved at significantly higher doses,” Dierk Scheinert, MD, chairman of the division of interventional angiology at the University Hospital Leipzig in Germany, told Cardiology Today’s Intervention. “We believe that being able to have the same efficacy, but with a much lower dose of paclitaxel … is very important for patients because it potentially can improve the safety margin on the treatment.”
Researchers analyzed 105 patients with femoropopliteal artery lesions from 10 sites in Europe who were assigned percutaneous transluminal angioplasty with the paclitaxel-coated balloon (Ranger, Boston Scientific; n = 71; mean age, 68 years; 75% men) or an uncoated balloon (n = 34; mean age, 67 years; 68% men).
The primary endpoint was in-segment late lumen loss in the treated portion at 6 months after the procedure. Clinical success, restenosis and patency rates, quality of life and hemodynamic success were among the secondary endpoints. Researchers defined primary patency as the percentage of lesions without a hemodynamically significant ultrasound or stenosis, and without the need for TLR or bypass.
At 6 months, patients assigned the DCB experienced less late lumen loss compared with the control group (DCB, –0.16 mm; control, 0.76 mm; P = .0017), Scheinert said during a presentation.
According to the Kaplan-Meier estimate, primary patency was higher in patients with the DCB (86%) vs. the control group (56%) at 12 months. Survival time also was greater in the DCB group (log-rank P < .001). No target limb amputations were necessary, and three deaths occurred between the two groups, but none of them were caused by the procedure or device. Adverse events were similar in both groups (P > .05).
“The rates of primary patency and freedom from [TLR] are among the highest observed in this type of first-in-man trials at 1 year,” Scheinert said in a press release. “As a clinician, it is important to have a treatment option like the Ranger [DCB] that exhibits consistent performance and outcomes. For patients, these attributes impact their quality of life, such as alleviating pain and discomfort, as well as reducing the probability of repeat procedures.”
Instances of TLR were lower for patients with the DCB vs. controls (P = .03). At 1 year, according to the Kaplan-Meier estimate, freedom from TLR was higher in the DCB group (91%) vs. the control group (70%; log-rank P = .01).
At 12 months, 84% of patients in the DCB group were Rutherford category 0 or 1. Although this improvement was similar in the control group, the DCB group had approximately one-third as many revascularizations, Scheinert said during the presentation.
“This was a first-in-man study, which provided initial evidence that the coating worked,” Scheinert said to Cardiology Today’s Intervention. “Now … larger randomized trials are on the way to use more standard clinical endpoints at the 1-year timepoint and of later timepoints beyond 1 year, which need to be conducted to reconfirm the study results in a larger cohort.” – by Darlene Dobkowski
Scheinert D, et al. Drug-coated balloon consensus update. Presented at: Charing Cross Symposium; April 25-28, 2017; London.
Disclosure: Scheinert reports serving on an advisory board and consulting for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular and Upstream Peripheral Technologies.