IN.PACT BTK - IN.PACT BTK

Contribution To Literature:

The IN.PACT BTK trial was inconclusive regarding potential benefit for drug-coated balloon angioplasty for infrapopliteal disease.

Description:

The goal of the trial was to evaluate drug-coated balloon angioplasty compared with standard balloon angioplasty among patients with infrapopliteal disease.

Study Design

  • Randomized
  • Parallel

Patients with critical limb ischemia from infrapopliteal chronic total occlusions were eligible for the study. After the lesion was crossed and underwent successful dilatation, subjects were randomized to drug-coated balloon angioplasty (n = 23) versus no further treatment (n = 27).

  • Total number of enrollees: 50
  • Duration of follow-up: 9 months
  • Mean patient age: 73 years
  • Percentage female: 17%
  • Percentage with diabetes: 74%

Inclusion criteria:

  • Critical limb ischemia from infrapopliteal chronic total occlusion
  • Lesion ≥40 mm
  • Rutherford category 4-5
  • Infection grade 0-1
  • Ischemia grade 2-3

Other salient features/characteristic:

  • Mean lesion length: 215 mm

Principal Findings:

The primary effectiveness outcome, late lumen loss at 9 months (classic assessment; worse lesion within the entire treated segment), was 0.89 ± 0.77 mm in the drug-coated balloon angioplasty group compared with 1.31 ± 0.72 mm in the standard balloon angioplasty group (p = 0.07). Late lumen loss at 9 months (subsegmental assessment; assessment within each of 10 segments with the entire treated segment) was 0.59 ± 0.94 mm in the drug-coated balloon angioplasty group compared with 1.26 ± 0.81 mm in the standard balloon angioplasty group (p = 0.017).

The primary safety outcome, freedom from device- and procedure-related all-cause death within 30 days, freedom from major target limb amputation through 9 months, and freedom from clinically driven target lesion revascularization through 9 months, occurred in 91.3% of the drug-coated balloon angioplasty group compared with 87.5% of the standard balloon angioplasty group (p = 1.0).

Secondary outcomes:

  • All-cause death at 9 months: 4.3% of the drug-coated balloon group compared with 8.0% of the standard balloon angioplasty group (p = 1.0)

Interpretation:

Among patients with critical limb ischemia due to infrapopliteal chronic total occlusion, drug-coated balloon angioplasty was associated with a numerically lower late lumen loss compared with standard balloon angioplasty. When late lumen loss was assessed by a subsegmental approach, drug-coated balloon angioplasty was associated with a lower late lumen loss compared with standard balloon angioplasty.

The primary composite safety outcome appeared to be similar between treatment groups. All-cause mortality was also similar between treatment groups. This trial was underpowered, preventing definitive conclusions to be made regarding the role of drug-coated balloon angioplasty for infrapopliteal disease.

References:

Presented by Dr. Antonio Micari at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 18, 2020.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Amputation, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Coronary Occlusion, Dilatation, Geriatrics, Ischemia, Myocardial Revascularization, Popliteal Artery, TCT20, Transcatheter Cardiovascular Therapeutics, Vascular Diseases


< Back to Listings