AcoArt I Trial - AcoArt I
Contribution To Literature:
The AcoArt I trial showed that paclitaxel-coated balloon angioplasty was superior to noncoated balloon angioplasty at improving late lumen loss.
The goal of the trial was to evaluate paclitaxel-coated balloon angioplasty versus standard peripheral balloon angioplasty among patients with femoropopliteal artery disease.
Patients with femoropopliteal artery disease were randomized to paclitaxel-coated balloon angioplasty (n = 100) versus standard peripheral balloon angioplasty (n = 100). Balloon inflation was recommended for 30-60 seconds. Stenting was allowed for an unsatisfactory result or flow-limiting dissection.
- Total number of enrollees: 200
- Duration of follow-up: 12 months
- Mean patient age: 66 years
- Percentage female: 26%
- Percentage diabetics: 55%
- Patients with claudication or rest pain due to femoropopliteal artery disease
- Intervention beyond the superficial femoral artery at the index procedure
- Significant renal insufficiency
- Acute thrombosis
- Lack of runoff vessels
- Pregnancy or lactation
- Life expectancy <2 years
- Allergy to aspirin, heparin, clopidogrel, paclitaxel, or contrast agent
Other salient features/characteristics:
- Mean lesion length: approximately 150 mm
- Provision stenting performed in 20%
The primary outcome, angiographic late lumen loss at 6 months, was 0.05 mm in the drug-coated balloon group compared with 1.15 mm in the uncoated balloon group (p < 0.001).
Secondary outcomes: Primary patency at 12 months was 76% with the drug-coated balloon versus 34% with the uncoated balloon (p < 0.001). Serious adverse events were similar between the treatment groups.
Among patients with claudication or rest ischemia due to femoropopliteal artery disease, paclitaxel-coated balloon angioplasty was superior to noncoated balloon angioplasty. Paclitaxel-coated balloon angioplasty improved late lumen loss at 6 months (primary outcome) and primary vessel patency at 12 months (secondary outcome). Serious adverse events were similar between treatment groups. Drug-coated balloon angioplasty represents a viable treatment option for revascularization of femoropopliteal arteries.
Jia X, Zhang J, Zhuang B, et al. Acotec Drug-Coated Balloon Catheter: Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial. JACC Cardiovasc Interv 2016;9:1941-9.
Editorial Comment: Liistro F, Bolognese L. Drug-Coated Balloon in Complex Clinical and Anatomical Scenario: Evidence or Hope? JACC Cardiovasc Interv 2016;9:1950-52.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and Vascular Medicine
Keywords: Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Catheters, Intermittent Claudication, Ischemia, Myocardial Revascularization, Paclitaxel, Primary Prevention, Stents, Vascular Diseases, Vascular Patency
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