We evaluated the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone. (NCT00998439).

In this prospective, single-blind, multicenter, trial we randomly assigned 110 patients with Instent-Restnosis of drug eluting stents to undergo treatment either with paclitaxel coated balloon (SeQuent Please, BBraun, Melsungen) or balloon angioplasty alone. Primary endpoint was in-stent late lumen loss at 6 months. Secondary clinical endpoint was composited of cardiac death, myocardial infarction attributed to the target vessel or TLR.

There was no difference in patient baseline characteristics. Lesion length was 11.2±6.5mm in the DCB- and 12.2±8.2mm in the POBA-group (p=n.s). Post PCI, for the stented segment and the total segment minimal lumen diameter and diameter stenosis were not different. Clinical follow-up after 12 months was 100%. Treatment with DCB was superior to balloon angioplasty alone with an in-stent late loss of 0.43±0.61mm vs. 1.03±0.77mm (p<0.001). Minimal lumen diameter was significantly larger and percent diameter stenosis significantly lower with use of the DCB for both the stented and total segment. Restenosis rate was reduced from 58.1% to 17.2% (P<0.001) and the clinical endpoint at 6 months was reduced from 50% to 16.7% (P<0.001), respectively. After 12 months the effect of DCB persisted (clinical endpoint 52.6% vs. 16.7%; p<0.001 and TLR 36.8% vs. 15.3%, p=0.005, respectively). There was one probable stent thrombosis in the POBA group. Clinical follow-up after 2 years will be completed in May 2013 and presented.

Paclitaxel coated balloon angioplasty was superior to balloon angioplasty alone for the treatment of instent-restenosis of drug-eluting stents. The favorable effects of the DCB-therapy persisted over 12 months.