The use of drug-eluting balloons (DEB) and drug-eluting stents (DES) in patients with severe peripheral vascular disease (PVD) showing complex lesions is associated with high immediate and mid-term success rates, according to a study by researchers from Klinikum Friedrichshafen, Friedrichshafen, Germany. They reported their research at SIR 2013, held in April 2013 in New Orleans.
From September 2009 to July 2012, a total of 191 consecutive patients underwent treatment of PVD using DEB and/or DES. According to the research protocol, the indications for DEB/DES were residual stenosis/occlusion after previous therapy (n=116); insufficient result after conventional balloon angioplasty (PTA) (stent implantation should be avoided) (n=19); high risk of residual stenosis in patient suffering from critical limb ischemia (n=53); and miscellaneous (n=3). According to Fontaine classification, 85 patients (45%) had grade 3 or 4 (limb threatening ischemia), and 106 grade 2 (claudicants). The researchers followed up all patients 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.
According to the investigators, after a mean follow-up of six months, residual stenosis (TLR=target lesion region) was seen in 37 patients (20%). Complications were seen in 18 patients (9%), and four 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).