AcoArt I Trial - AcoArt I

Oct 11, 2016
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Acotec Scientific
Date Published:
09/19/2016
Date Updated:
10/11/2016
Original Posted Date:
10/11/2016
References

Contribution To Literature:

The AcoArt I trial showed that paclitaxel-coated balloon angioplasty was superior to noncoated balloon angioplasty at improving late lumen loss.

Description:

The goal of the trial was to evaluate paclitaxel-coated balloon angioplasty versus standard peripheral balloon angioplasty among patients with femoropopliteal artery disease.

Study Design

  • Randomized
  • Parallel

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%

Inclusion criteria:

  • Patients with claudication or rest pain due to femoropopliteal artery disease

Exclusion criteria:

  • 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%

Principal Findings:

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.

Interpretation:

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.

References:

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.

Keywords: Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Catheters, Intermittent Claudication, Ischemia, Myocardial Revascularization, Paclitaxel, Primary Prevention, Stents, Vascular Diseases, Vascular Patency


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