PCB outperforms PTA at 2 years, including in challenging patients with PAD
In patients with peripheral artery disease and femoropopliteal lesions, a low-dose paclitaxel-coated balloon enhanced patency and reduced risk for reintervention compared with percutaneous transluminal angioplasty, researchers reported.
In subgroup analyses that were not prespecified, the differences were present in patients with chronic total occlusion or moderate-to-severe calcification, and the patency benefit was similar in men and women.
As Healio previously reported, in the 1-year results of the RANGER II SFA trial, the PCB (Ranger, Boston Scientific) was superior to PTA in patency and target lesion revascularization. Ravish Sachar, MD, physician-in-chief at North Carolina Heart & Vascular, University of North Carolina – Rex Health Care, presented 2-year results at VIVA 21.
“Through 2 years, patients treated with the Ranger DCB sustained improved primary patency with fewer reinterventions compared with those treated with uncoated balloon angioplasty, with no difference in mortality rates,” Sachar said during a presentation.
The analysis included patients with Rutherford class 2, 3 or 4 lesions in the superficial femoral or proximal popliteal arteries and reference vessel diameter 4 to 8 mm. Patients either had 70% to 99% stenosis in lesions up to 180 mm or chronic total occlusion in lesions 100 mm or less.
Patients were randomly assigned on a 3:1 basis to the PCB or PTA. The mean age was 71 years in the PCB group and 69 years in the PTA group. Women comprised 38% of the PCB group and 32% of the PTA group.
At 2 years, the groups did not differ in all-cause death (PCB, 5.7%; PTA, 3.2%; P = .4218) or target limb amputation (PCB, 0.4%; PTA, 1.1%; P = .4583), Sachar said, noting there were no major target limb amputations in either group.
In 2-year Kaplan-Meier analyses, primary patency was 84% in the PCB group compared with 71.4% in the PTA group (log-rank P = .0129), while freedom from TLR was 87.4% in the PTA group compared with 79.5% in the PTA group (log-rank P = .0316), he said.
Primary sustained clinical improvement, defined as improvement of at least 1 Rutherford class without TLR, at 2 years occurred in 80.4% of the PCB group and 71.1% of the PTA group (P = .0823), Sachar said, noting that 80.8% of the PCB group and 78.3% of the PTA group achieved Rutherford class 0 or 1.
In patients with CTO, at 2 years, 76.6% of the PCB group and 58.6% of the PTA group achieved primary patency (log-rank P = .1038), while 85.6% of the PCB group and 62.8% achieved freedom from TLR (log-rank P = .0172), he said.
In patients with calcification grade 3 or 4, the PCB was superior to PTA in primary patency (89.1% vs. 72.4%; log-rank P = .0052) and freedom from TLR (90.9% vs. 79.6%; log-rank P = .0246) at 2 years, according to the researchers.
In the PCB group, freedom from TLR at 2 years was comparable in men (89.9%) and women (83.4%; log-rank P = .1415), Sachar said.
“These subgroup analyses suggest a consistent benefit of DCB vs. PTA among patients with a historically poorer lesion subtype,” he said.
Collapse
Sachar R, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).