The IN.PACT 014 paclitaxel drug-coated balloon (DCB) showed no difference in effectiveness and no safety concerns compared with percutaneous transluminal angioplasty (PTA) in chronic limb ischemia (CLI) patients with chronic total occlusions (CTOs) in the infrapopliteal arteries, according to study results presented Sunday at the TCT Connect virtual conference.
Antonio Micari, MD, of the University of Messina, Italy, presented the results of the IN.PACT BTK study, . which was a prospective, multicenter, randomized (1-to-1) feasibility study.
Fifty CLI patients with infrapopliteal CTOs were enrolled at nine sites in five European countries and followed through 36 months. The primary effectiveness endpoint was late lumen loss at 9 months after the index procedure. The primary safety endpoint was a composite of 30-day freedom from device- and procedure-related mortality and freedom from major target limb amputation through 9 months and freedom from clinically driven target lesion revascularization through 9 months.
At baseline, patients in both groups were mostly well-matched. The mean age was 73.1±7.4 years in the DCB arm and 69.6±9.4 years in the PTA arm. The patients were mostly men (DCB 82.6% vs. PTA 74.1%). The PTA arm did have a significantly higher percentage of patients with diabetes (DCB 73.9% vs. PTA 96.3%). All patients in both arms were Rutherford classification category 4 or 5. TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II category was similar between the groups (C and D lesions: DCB 92% vs. PTA 86%).
Lesion characteristics were also similar between the groups (lesion length, DCB 215.41±83.81 mm vs. PTA 218.19±80.43 mm; total occluded lesion length, DCB 159±84.6 mm vs. PTA 136.43±72.82 mm).
Classic late lumen loss was smaller in the DCB arm, but this did not reach statistical significance (DCB 0.89±0.77 mm vs. PTA 1.31±0.72 mm; p=0.07). However, sub-segmental late lumen loss was significantly lower in the DCB arm (0.59±0.94 mm vs. 1.26±0.81 mm; p=0.017).
Micari said the segmental measurements along the entire lesion allow for better assessment of late lumen loss than measuring at one single point in the lesion.
There were no differences in the composite safety outcome at 9 months (DCB 91.3% vs. PTA 87.5%; p=1.0). This was also true of all-cause death (DCB 4.3% vs. PTA 8%; p=1.0) and thrombosis at the target lesion site (DCB 4.3% vs. PTA 4.2%; p=1.0). Finally, there were no major amputations within 9 months of the procedure in either arm.
This study, Micari concluded, provides an opportunity to affect further below-the-knee studies and treatment algorithms.
The study was funded by Medtronic.