PTA Versus Carbofilm-Coated Stents in Infrapopliteal Arteries: Pilot Study

Journal Article · Wed Feb 15 04:00:00 EST 2006 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-005-0276-9· OSTI ID:21091277

Rand, T; Basile, A; Cejna, M ^[1]; Fleischmann, D ^[2]; Funovics, M ^[1]; Gschwendtner, M ^[3]; Haumer, M ^[4]; Katzler, I von; Kettenbach, J; Lomoschitz, F ^[1]; Luft, C ^[5]; Minar, E ^[4]; Schneider, B ^[6]; Schoder, M; Lammer, J ^[1]

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1. University of Vienna, Department of Angiography and Interventional Radiology (Austria)
2. Stanford University Medical Center, Department of Radiology (United States)
3. Elisabethinen Hospital Linz, Department of Radiology (Austria)
4. 2nd Clinic of Internal Medicine, University of Vienna, Department of Angiology (Austria)
5. Barmherzige Brueder Hospital Linz, Department of Radiology (Austria)
6. University of Vienna, Department for Medical Statistics (Austria)

Purpose: To determine the primary success and short-term patency of stent application as a primary treatment modality for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia in a randomized prospective study. Methods: Endovascular therapy was performed on 95 lesions in 51 patients (mean age 72.0 years, range 47-80 years) who presented clinically with Fontaine stages III and IV. One patient underwent treatment in both limbs. After angiographic lesion identification, patients were randomized for treatment by PTA (53 lesions in 27 patients) or stent application (42 lesions in 24 patients). Follow-up by clinical investigation and conventional angiography or spiral CT angiography was performed in 37 patients (57 lesions) 6 to 12 months after the procedure, or when clinically indicated. Evaluation was performed by two observers, double-blinded, with thresholds for lesion restenosis of 50% and 70%. Statistical evaluation was performed on a lesion basis by Kaplan-Meier estimated probability rates, and log-rank and Wilcoxon tests. The primary endpoint was the angiographic patency rate of treated lesions. Results: The inter-reader agreement was high ({kappa} = 0.82). For the stent group the cumulative primary patency at 6 months was 83.7% at the 70% restenosis threshold, and 79.7% at the 50% restenosis threshold. For PTA, the primary patency at 6 months was 61.1% at the 70% restenosis threshold and 45.6% at the 50% restenosis threshold. Both results were statistically significant (p < 0.05). Conclusion: Infrapopliteal stent application is an effective treatment modality for high-grade lesions in chronic critical limb ischemia. Compared with PTA, higher patency rates can be expected after 6 months.

• OSTI ID: 21091277
• Journal Information: Cardiovascular and Interventional Radiology, Journal Name: Cardiovascular and Interventional Radiology Journal Issue: 1 Vol. 29; ISSN 0174-1551; ISSN CAIRDG
• Country of Publication: United States
• Language: English

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