Abstract

Purpose A prospective study of feasibilty and efficacy of drug eluting balloons (DEB) and drug eluting stents (DES) in the treatment of peripheral vascular disease (PVD) Materials and Methods From September 2009 to July 2012, 191 consecutive patients underwent treatment of PVD using DEB and/or DES. The indications for using DEB/DES were divided into 4 groups: 1) residual stenosis/occlusion after previous therapy (n=116); 2) insufficient result after conventional balloon angioplasty (PTA) and stentimplantation should be avoided (n=19); 3) high risk of residual stenosis in patient suffering from critical limb ischemia (n=53) and 4) miscellaneous (n=3). According to Fontaine classification, 85 patients (45%) had grade 3 or 4 (limb threatening ischemia), and 106 grade 2 (claudicants). All patients were followed-up by physical examination and Doppler sonography and if indicated conventional angiography (DSA). Estimates for the cumulative patency, survival and restenosis rates were calculated by using life table analysis. Results After a mean follow-up of 6 months, residual stenosis (TLR=target lesion region) was seen in 37 patients (20%). Complications were seen in 18 patients (9%), and 4 patients (2%) required surgery. There was no 30-day mortality observed. During follow-up, 13 patients (7%) went to bypass-surgery. The limb salvage rate in patients suffering from limb threatening ischemia was 97% (83/85). Conclusion Using DEB/DES in patients suffering from severe PVD showing complex lesions, gives high immediate and mid-term success rates. Compared to historical data in the literature, the clinical outcome is higher than using conventional methods

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