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; worst 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
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