Six-Month RANGER-SFA Results Presented for Boston Scientific's Ranger DCB

September 21, 2016—Prof. Dierk Scheinert, MD, presented the 6-month results from the RANGER-SFA trial at CIRSE 2016, the annual meeting of the Cardiovascular and Interventional Radiology Society of Europe, held in Barcelona, Spain. Prof. Scheinert serves as Principal Investigator of RANGER SFA.

The first-in-human RANGER-SFA trial is evaluating Boston Scientific’s Ranger paclitaxel-coated percutaneous transluminal angioplasty balloon catheter for the treatment of lesions in the superficial femoral artery (SFA) and popliteal artery. The trial seeks to prove that the performance of the Ranger drug-coated balloon (DCB) is superior to noncoated balloons at 6 months postprocedure in these lesions when comparing late lumen loss (LLL). The prospective, multicenter, randomized (2:1) controlled trial will conduct follow-up through 3 years.

The investigators concluded that the 6-month results demonstrated significantly less LLL for patients treated with the Ranger DCB versus the control. Additionally at 6 months, the target lesion revascularization (TLR) rates trended toward separation between the Ranger DCB and control groups. Finally, patients treated with the Ranger DCB demonstrated significant improvements in symptoms and hemodynamics at 6 months.

The investigators enrolled 105 patients with femoropopliteal artery lesions at 10 sites in Germany, France, and Austria. Patients were randomized to treatment with the Ranger DCB (n = 71) or to the control therapy (n = 34). In the Ranger DCB group of 71 patients, there were 63 patients available at 6-month follow-up (two patients withdrew and six patients missed their visits). In the control group, 6-month follow-up was completed for 25 of 34 patients; there was no 6-month follow-up for nine patients because of one death, two withdrawals from the study, and six missed follow-up visits.

There were similar patient and lesion characteristics in the Ranger DCB group and the control group. Technical and procedural success rates were also similar between the two groups.

Prof. Scheinert reported that the study met its primary efficacy endpoint of in-segment LLL of the treated segment as observed by angiography at 6 months postprocedure, which was significantly less for the Ranger DCB group than for the control group. 

For the control group (n = 19) and the Ranger DCB group (n = 47), respectively, the minimum lumen diameters were: preoperative, 0.88 mm versus 0.79 mm (P = .92); postoperative, 3.3 mm versus 3.5 mm (P = .58); and at 6 months, 2.5 mm versus 3.5 mm (P = .0083), with postoperative to 6-month LLL of +0.76 mm versus -0.16 mm (P = .0017).

Secondary safety endpoints included cumulative TLR rates through 6 months of 12% for the control group versus 5.6% for the Ranger DCB group (P = .47). Prof. Scheinert noted that the Ranger DCB achieved one of the highest reported rates (94.4%) of freedom from clinically driven TLR at 6 months; investigators are awaiting full 12-month follow-up data.

The rates of adverse events and serious adverse events were similar in the two groups, with no target limb amputations and one death in the control group at 6 months. There were no reported unanticipated serious adverse device effects. Additionally, in the Ranger DCB group, 81% of patients presented with no or mild symptoms (Rutherford class 0–1) at 6-month follow-up and distributions for both control and Ranger DCB groups showed improvement, with a shift to lower Rutherford categories and no significant difference between groups.

In both groups, there was significant improvement in ankle brachial index (ABI) and hemodynamic success at 6 months (P < .05). The mean rate of hemodynamic success (positive ABI change ≥ 0.1) was 76% for the Ranger DCB and 56% for the control (P = .1214). There were no significant differences between groups in terms of walking function or quality of life, reported Prof. Scheinert at CIRSE 2016.

Also at the CIRSE 2016 conference, Peter von Bilderling, MD, presented interim results from the multicenter Ranger All-Comers Registry evaluating the Ranger DCB in the treatment of femoropopliteal atherosclerotic lesions. Michael Lichtenberg, MD, is the principal investigator for the registry.

The registry has enrolled 180 patients in Germany and Switzerland. Key inclusion criteria are patients with peripheral arterial occlusive disease of the SFA – PIII and Rutherford class 2–5. 

The primary efficacy endpoint is primary patency at 12 and 24 months, defined as freedom from ≥ 50% restenosis as indicated by duplex ultrasound peak systolic velocity ratio ≥2.4 in the target lesion with no reintervention. The primary safety endpoint is major adverse events, defined as a composite of device or procedure related mortality and major target limb amputation at 6 months. 

Dr. von Bilderling presented interim findings on 149 patients and 210 lesions treated with the Ranger DCB. Patients’ mean age is 70 years, 63% are male, with a baseline mean ankle brachial index of 0.6 (0.01–1.43).

Procedural outcomes included 73% technical success for DCB only (no flow limiting dissection) and 100% success for DCB plus adjunctive therapy (stenting). Residual angiographic stenosis was 12%.

With 105 treated patients available at 6-month follow up, Dr. von Bilderling advised that 91% of treated limbs improved by one or more Rutherford categories and 80% improved by two or more Rutherford categories. There was statistically significant ABI improvement in the treated limbs from 0.583 at baseline to 0.879 at 6 months (P < .01).

At 6-months after treatment with the Ranger DCB, the primary patency was 91.1% (Kaplan-Meier estimate) and freedom from target lesion revascularization was 91.9%, reported Dr. von Bilderling at CIRSE 2016.