Drug-eluting balloons show promise in SFA in-stent restenosis
A primary patency rate of more than 70% was reported in a cohort of patients who received drug-eluting balloons for superficial femoral artery in-stent restenosis.
Researchers in Italy suggested that the use of drug-eluting balloons (DEB) for superficial femoral artery (SFA) in-stent restenosis has yielded acceptable primary patency outcomes at 1 year, but that little research has been conducted for outcomes beyond that time point. They added that restenosis may increase by 50% between the first and second years of follow-up in this patient population.
The current prospective registry was conducted to determine 2-year safety and efficacy outcomes of DEB in SFA in-stent restenosis in a cohort of 39 patients accrued at a single center in Italy. Consecutive patients were enrolled between December 2009 and December 2010.
Clinicians performed conventional SFA transluminal angioplasty to the entire patient population. All patients then underwent final post-dilation using the In.Pact paclitaxel-eluting balloon (Medtronic) and were evaluated for up to 24 months.
There were two fatalities during follow-up, for a 2-year mortality rate of 5.12%. One death was attributed to HF and the other to sudden death.
A 70.3% primary patency rate was reported at 2 years. Eleven patients experienced restenosis during follow-up.
Class I in-stent restenosis lesions were associated with a 12.5% rate of recurrent restenosis compared with 33.3% for class II lesions and 36.3% for class III (P=.005).
“The data suggest that adjunctive use of DEB for the treatment of SFA [in-stent restenosis] is a safe and effective therapeutic strategy up to 2 years of follow-up,” the researchers concluded.
Disclosure: The researchers report no relevant financial disclosures.