In the Journals

RANGER SFA provides more evidence on paclitaxel-coated balloons for femoropopliteal treatment

At 1 year, use of a paclitaxel-coated balloon in the femoropopliteal segment resulted in greater rates of patency and fewer interventions compared with use of conventional balloon angioplasty.

However, researchers observed similar symptomatic, hemodynamic and health-related quality-of-life improvements with the drug-coated balloon (Ranger, Boston Scientific) and conventional balloon angioplasty.

“The [RANGER SFA] study adds to the available information on peripheral treatment with drug-coated balloons, providing clinical evidence unique to the Ranger drug-coated balloon,” Sabine Steiner, MD, MSc, with the University of Leipzig in Germany, and colleagues wrote in JACC: Cardiovascular Interventions.

The prospective, randomized study enrolled 105 patients at 10 centers in Europe who presented with symptomatic lower limb ischemia (Rutherford category 2-4), a lesion between 20 mm to 150 mm in length and stenotic lesions in the nonstented superficial femoral artery or proximal popliteal segment. Patients were randomly assigned to treatment with the 2 g/mm2 paclitaxel-coated balloon (n = 71) or conventional balloon angioplasty (n = 34). The mean age of the patients was 68 years, and most were men. Twenty-one percent of the DCB group required bailout stenting vs. 12% of the conventional balloon group.

At 1 year, the Kaplan-Meier estimate of primary patency was 86.4% with the DCB vs. 56.5% with conventional balloon angioplasty (log rank P < .001), and the absolute primary patency rate was 86% vs. 52%, respectively (P = .002). The researchers noted that the primary patency rate in RANGER SFA falls “at the high end” of the range compared with other recent randomized studies of DCBs for femoropopliteal disease, including IN.PACT SFA (IN.PACT Admiral, Medtronic), LEVANT 2 (Lutonix 035, Bard Peripheral Vascular) and ILLUMENATE (Stellarex, Spectranetics). However, they wrote, “direct comparisons are limited due to differences in the devices studied as well as characteristics of included patients and treated lesions.”

Freedom from target lesion revascularization at 1 year was 91.2% with the DCB vs. 69.9% with conventional balloon angioplasty (P = .01). According to the researchers, the observed incidence of TLR at 1 year in the DCB group was one-third of that in the control group (8.5% vs. 26.5%; P = .03).

No target limb amputations or deaths related to the device occurred during follow-up.

At 1 year, lower limb ischemia improved so that 62.5% of patients were classified as Rutherford category 0 and 21.4% as Rutherford category 1.

These findings build on previous data from this trial showing significantly lower angiographic late lumen loss at 6 months after treatment with the DCB (–0.16 ± 0.99 vs. 0.76 ± 1.4; P = .002).

“DCBs are alternative treatment options, which have exhibited clear superiority over conventional balloon angioplasty in numerous studies of the femoropopliteal anatomy. DCB designs vary with respect to the drug dose, the drug and excipient formulations used in their coatings, and in the manner by which coatings are applied to the balloons. These differences could have implications for both efficacy and safety and results from study of one device are not generalizable to another,” Steiner and colleagues wrote. “Dedicated clinical trials for the different technologies are required.”

Konstantinos Katsanos, MD, PhD, from Patras University Hospital School of Medicine, Greece, discussed the findings in an accompanying editorial.

“Unsurprisingly, the characteristics of the recruited patients and the current midterm outcomes reported by the RANGER SFA European randomized study are very much in line with previously reported outcomes from the IN.PACT SFA, the LEVANT 2 and the ILLUMENATE randomized studies that evaluated competing commercial paclitaxel-coated balloon catheters and were also sponsored by the industry. In spite of similar treatment effects at 1 year, previous reports have questioned the class effect of paclitaxel-coated balloons in the femoropopliteal segment taking into consideration the differences in the nominal dose, applied excipient and ensuing pharmacokinetic profile and arterial tissue bioavailability of paclitaxel between different paclitaxel-coated balloon catheters. Head-to-head studies between different paclitaxel-coated balloons are therefore warranted,” Katsanos wrote.

Although the study provides new information on this DCB, Katsanos said “major questions remain” about the use of DCBs in more complex lesions, in those with critical limb ischemia, and surrounding cost-utility and cost-effectiveness. – by Katie Kalvaitis

Disclosures: Steiner reports consulting for Abbott and C.R. Bard. Please see the study for all other authors’ relevant financial disclosures. Katsanos reports he receives honoraria from Boston Scientific and consults for Medtronic.

At 1 year, use of a paclitaxel-coated balloon in the femoropopliteal segment resulted in greater rates of patency and fewer interventions compared with use of conventional balloon angioplasty.

However, researchers observed similar symptomatic, hemodynamic and health-related quality-of-life improvements with the drug-coated balloon (Ranger, Boston Scientific) and conventional balloon angioplasty.

“The [RANGER SFA] study adds to the available information on peripheral treatment with drug-coated balloons, providing clinical evidence unique to the Ranger drug-coated balloon,” Sabine Steiner, MD, MSc, with the University of Leipzig in Germany, and colleagues wrote in JACC: Cardiovascular Interventions.

The prospective, randomized study enrolled 105 patients at 10 centers in Europe who presented with symptomatic lower limb ischemia (Rutherford category 2-4), a lesion between 20 mm to 150 mm in length and stenotic lesions in the nonstented superficial femoral artery or proximal popliteal segment. Patients were randomly assigned to treatment with the 2 g/mm2 paclitaxel-coated balloon (n = 71) or conventional balloon angioplasty (n = 34). The mean age of the patients was 68 years, and most were men. Twenty-one percent of the DCB group required bailout stenting vs. 12% of the conventional balloon group.

At 1 year, the Kaplan-Meier estimate of primary patency was 86.4% with the DCB vs. 56.5% with conventional balloon angioplasty (log rank P < .001), and the absolute primary patency rate was 86% vs. 52%, respectively (P = .002). The researchers noted that the primary patency rate in RANGER SFA falls “at the high end” of the range compared with other recent randomized studies of DCBs for femoropopliteal disease, including IN.PACT SFA (IN.PACT Admiral, Medtronic), LEVANT 2 (Lutonix 035, Bard Peripheral Vascular) and ILLUMENATE (Stellarex, Spectranetics). However, they wrote, “direct comparisons are limited due to differences in the devices studied as well as characteristics of included patients and treated lesions.”

Freedom from target lesion revascularization at 1 year was 91.2% with the DCB vs. 69.9% with conventional balloon angioplasty (P = .01). According to the researchers, the observed incidence of TLR at 1 year in the DCB group was one-third of that in the control group (8.5% vs. 26.5%; P = .03).

No target limb amputations or deaths related to the device occurred during follow-up.

At 1 year, lower limb ischemia improved so that 62.5% of patients were classified as Rutherford category 0 and 21.4% as Rutherford category 1.

These findings build on previous data from this trial showing significantly lower angiographic late lumen loss at 6 months after treatment with the DCB (–0.16 ± 0.99 vs. 0.76 ± 1.4; P = .002).

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“DCBs are alternative treatment options, which have exhibited clear superiority over conventional balloon angioplasty in numerous studies of the femoropopliteal anatomy. DCB designs vary with respect to the drug dose, the drug and excipient formulations used in their coatings, and in the manner by which coatings are applied to the balloons. These differences could have implications for both efficacy and safety and results from study of one device are not generalizable to another,” Steiner and colleagues wrote. “Dedicated clinical trials for the different technologies are required.”

Konstantinos Katsanos, MD, PhD, from Patras University Hospital School of Medicine, Greece, discussed the findings in an accompanying editorial.

“Unsurprisingly, the characteristics of the recruited patients and the current midterm outcomes reported by the RANGER SFA European randomized study are very much in line with previously reported outcomes from the IN.PACT SFA, the LEVANT 2 and the ILLUMENATE randomized studies that evaluated competing commercial paclitaxel-coated balloon catheters and were also sponsored by the industry. In spite of similar treatment effects at 1 year, previous reports have questioned the class effect of paclitaxel-coated balloons in the femoropopliteal segment taking into consideration the differences in the nominal dose, applied excipient and ensuing pharmacokinetic profile and arterial tissue bioavailability of paclitaxel between different paclitaxel-coated balloon catheters. Head-to-head studies between different paclitaxel-coated balloons are therefore warranted,” Katsanos wrote.

Although the study provides new information on this DCB, Katsanos said “major questions remain” about the use of DCBs in more complex lesions, in those with critical limb ischemia, and surrounding cost-utility and cost-effectiveness. – by Katie Kalvaitis

Disclosures: Steiner reports consulting for Abbott and C.R. Bard. Please see the study for all other authors’ relevant financial disclosures. Katsanos reports he receives honoraria from Boston Scientific and consults for Medtronic.