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.
The goal of the trial was to evaluate drug-coated balloon angioplasty compared with standard balloon angioplasty among patients with infrapopliteal disease.
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%
- 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
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).
- 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)
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.
Presented by Dr. Antonio Micari at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 18, 2020.
Keywords: Amputation, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Coronary Occlusion, Dilatation, Geriatrics, Ischemia, Myocardial Revascularization, Popliteal Artery, TCT20, Transcatheter Cardiovascular Therapeutics, Vascular Diseases
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