Cryoplasty Or Conventional Balloon Post-dilation of Nitinol Stents For Revascularization of Peripheral Arterial Segments - COBRA

Description:

The goal of the trial was to compare post-dilation of a nitinol self-expanding stent with cryoplasty (PolarCath, Boston Scientific) versus conventional balloon angioplasty for revascularization of the superficial femoral artery.

Hypothesis:

Post-dilation with a cryoplasty balloon will reduce restenosis.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Diabetic patients at least 21 years of age with lifestyle-limiting claudication
  • Use of a nitinol self-expanding stent ≥60 mm in a superficial femoral artery ≥5 mm

    Number of screened applicants: 121
    Number of enrollees: 90
    Duration of follow-up: 1 year
    Mean patient age: 63 years
    Percentage female: 18%

Exclusions:

  • Serum creatinine ≥2.0 mg/dl
  • Absence of at least one vessel brisk infrapopliteal run-off to the foot
  • Left ventricular ejection fraction ≤25%
  • Allergy to iodinated contrast, aspirin, or clopidogrel
  • Contraindication to anticoagulation
  • Pregnancy
  • Leukopenia (<3000/L), anemia (<10 g/dl), or thrombocytopenia (<100,000/L)

Primary Endpoints:

  • Binary restenosis at 12 months, defined as ≥2.5 times increase in peak systolic velocity by duplex ultrasound

Drug/Procedures Used:

At baseline, the use of aspirin was 69%, clopidogrel 40%, statin 89%, and angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker 80%.

Concomitant Medications:

Diabetic patients with lifestyle-limiting claudication were randomized to post-dilation of a nitinol self-expanding stent with cryoplasty (n = 45) versus conventional balloon angioplasty (n = 45).

Principal Findings:

Overall, 90 patients were randomized. The mean age was 63 years, 18% were women, 67% had coronary artery disease, 16% of the diabetics were insulin requiring, and the mean glycated hemoglobin was 7.4. The mean Rutherford stage was 3.2, mean ankle-brachial index was 0.6, 56% of lesions were chronic total occlusions, mean lesion length was 147 mm, mean total stent length was 184 mm, and mean stent diameter was 6 mm.

The primary endpoint, restenosis at 12 months, occurred in 29.3% of the cryoplasty group versus 55.8% of the conventional balloon angioplasty group (p = 0.01).

Interpretation:

Among diabetic patients with lifestyle-limiting claudication, post-dilation of a nitinol self-expanding stent with cryoplasty reduced restenosis compared with conventional balloon angioplasty. Cryoplasty represents a novel treatment approach to improve revascularization of the lower extremities.

References:

Presented by Dr. Subhash Banerjee at the Transcatheter Cardiovascular Therapeutics Meeting (TCT 2011), San Francisco, CA, November 11, 2011.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Insulin, Life Style, Ankle Brachial Index, Femoral Artery, Ticlopidine, Lower Extremity, Angioplasty, Balloon, Coronary, Stents, Hemoglobin A, Glycosylated, Diabetes Mellitus


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