Excimer Laser Atherectomy vs. Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis - EXCITE ISR

Description:

The optimal treatment of femoropopliteal in-stent restenosis is unknown. The goal of the trial was to evaluate treatment with excimer laser atherectomy plus adjunctive angioplasty compared with angioplasty alone among participants with femoropopliteal in-stent restenosis.

Hypothesis:

Excimer laser atherectomy plus angioplasty will improve vessel patency.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Femoropopliteal in-stent restenosis lesion ≥4 cm
  • Rutherford classification 1-4
  • Reference vessel diameter 5-7 mm
  • ≥1 patent tibial artery

    Number of enrollees: 250
    Duration of follow-up: 12 months
    Mean patient age: 69 years
    Percentage female: 37%

Exclusions:

  • Target lesion extends >3 cm beyond stent margin
  • Untreated inflow lesion
  • Grade 4 or 5 stent fracture

Primary Endpoints:

  • Primary efficacy endpoint: freedom from clinically driven TLR at 6 months
  • Primary safety endpoint: major adverse events at 30 days (death, major amputation, or TLR)

Drug/Procedures Used:

Participants with femoropopliteal in-stent restenosis were randomized to excimer laser atherectomy plus adjunctive angioplasty (n = 169) versus angioplasty alone (n = 81).

The Turbo Tandem device was used for large lumens and the Turbo Elite for pilot channel creation.

Principal Findings:

Overall, 250 patients were randomized. The mean age was 69 years, 37% were women, 85% had smoking history, and 47% had diabetes.

The mean lesion length was 19.6 cm, 30.5% had a total occlusion, and 40.2% had distal protection. Procedural success was achieved in 93.5% of the laser group versus 82.7% of the angioplasty alone group (p = 0.03). Bailout stenting was required in 4.1% of the laser group versus 11.1% of the angioplasty alone group (p = 0.02). Embolization occurred in 8.3% of the laser group versus 4.9% of the angioplasty alone group (p = 0.47).

The primary efficacy endpoint, freedom from target lesion revascularization (TLR) at 6 months, occurred in 73.5% of the laser group versus 51.8% of the angioplasty alone group (p < 0.005). Freedom from TLR favored the laser group versus the angioplasty group at 12 months (p < 0.003). Laser versus angioplasty appeared to be more effective for longer lesions.

The primary safety endpoint, freedom from major adverse events at 30 days, occurred in 94.2% of the laser group versus 79.2% of the angioplasty alone group (p < 0.001). Freedom from major adverse events favored the laser group versus the angioplasty group at 12 months (p < 0.001).

Interpretation:

Among patients with femoropopliteal in-stent restenosis, the use of excimer laser plus angioplasty was superior compared with angioplasty alone. Acute procedural success was higher in the atherectomy group. Superiority was achieved for efficacy (freedom from TLR) and safety (freedom from major adverse events) at 12 months.

References:

Presented by Dr. Eric J. Dippel at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2014), Washington, DC, September 16, 2014.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Aortic Surgery, Smoking

Keywords: Atherectomy, Angioplasty, Diabetes Mellitus, Smoking, Lasers, Excimer, Stents, Transcatheter Cardiovascular Therapeutics


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