Intravascular Stenting and Angiographic Results: A randomized trial comparing paclitaxel-eluting balloon angioplasty plus stenting versus standard balloon angioplasty plus stenting versus directional atherectomy for symptomatic femoral artery disease - ISAR-STATH

Contribution To Literature:

The ISAR-STATH trial showed that paclitaxel-eluting balloon angioplasty plus stenting was superior to other endovascular strategies at preventing restenosis.

Description:

The goal of the trial was to evaluate three endovascular strategies for treating symptomatic superficial femoral artery disease. 

Study Design

  • Randomized
  • Parallel

Patients with symptomatic superficial femoral artery disease were randomized to paclitaxel-eluting balloon angioplasty plus stenting (n = 48) versus plain balloon angioplasty plus stenting (n = 52) versus directional atherectomy with distal protection and bailout stenting (n = 55).

Inclusion criteria:

  • Patients with claudication and >70% stenosis or occlusion of the superficial femoral artery
  • Total number of enrollees: 155
  • Duration of follow-up: 24 months
  • Mean patient age: 71 years
  • Percentage female: 31%
  • Percentage with diabetes: 33%

Exclusion criteria:

  • Acute ischemia of the superficial femoral artery
  • Untreated ipsilateral iliac stenosis >70%
  • Previous stenting of the superficial femoral artery
  • Popliteal stenosis >70%
  • Severe renal insufficiency
  • Limited life expectancy

Principal Findings:

The primary outcome, percent diameter stenosis at 6 months, occurred in 34% of the paclitaxel-eluting balloon angioplasty plus stenting group and 56% of the plain balloon angioplasty plus stenting group versus 55% of the directional atherectomy with distal protection and bailout stenting group (p = 0.009 for paclitaxel-eluting balloon plus stent versus plain balloon angioplasty plus stent group and p = 0.007 for paclitaxel-eluting balloon plus stent versus directional atherectomy group).

The secondary outcome, target lesion revascularization, was 17% for  paclitaxel-eluting balloon plus stent, 37% for plain balloon angioplasty plus stent group, and 53% for directional atherectomy plus bailout stent group (p = 0.017 for paclitaxel-eluting balloon versus other groups).

Interpretation:

Among patients with symptomatic superficial femoral artery disease, paclitaxel-eluting balloon angioplasty plus stenting appeared to be superior to plain balloon angioplasty plus stenting or to directional atherectomy with distal embolic protection plus bailout stenting. Paclitaxel-eluting balloon angioplasty plus stenting was associated with the lowest percent diameter stenosis at 6 months (primary outcome) and the lowest incidence of target lesion revascularization at 24 months (secondary outcome).

References:

Ott I, Cassese S, Groha P, et al. Randomized Comparison of Paclitaxel-Eluting Balloon Angioplasty Plus Stenting Versus Standard Balloon Angioplasty Plus Stenting Versus Directional Atherectomy for Symptomatic Femoral Artery Disease (ISAR-STATH). Circulation 2017;Apr 19:[Epub ahead of print].

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, Atherectomy, Constriction, Pathologic, Coronary Occlusion, Diabetes Mellitus, Endovascular Procedures, Femoral Artery, Intermittent Claudication, Myocardial Revascularization, Paclitaxel, Stents, Secondary Prevention, Vascular Diseases


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