In-stent restenosis: the gold standard has changed

Abstract

In-stent restenosis remains an important issue even in the drug-eluting stent (DES) era today. In recent years, drug-eluting balloons (DEB) have emerged as a potential alternative to the treatment of in-stent restenosis. Paclitaxel was identified as the primary drug for DEB because of its rapid uptake and prolonged retention. Non-stent-based local drug delivery using DEB maintains the antiproliferation properties of DES, but without the limitations of DES such as subacute stent thrombosis, stent fractures, prolonged antiplatelet therapy and more importantly, avoiding a "stent-in-a-stent" approach. The first major impact of drug-eluting balloon (DEB) in the management of bare metal instent restenosis was the "PACCOCATH ISR I" randomised trial, comparing the efficacy of drug-eluting balloon versus uncoated balloon. The six months angiographic results showed a binary restenosis of 5% and 4% MACE in the drug-eluting balloon group, compared with 43% binary restenosis and 31% MACE, in the uncoated balloon group (p=0.002 and 0.02). The second major DEB trial is the "PEPCAD II Trial", comparing the efficacy of the SeQuent Please DEB with the Taxus drug-eluting stent in the treatment of bare-metal stent instent restenosis. At 6-month follow-up, in-segment late lumen loss was 0.38 ± 0.61 mm in the DES group versus 0.17 ± 0.42 mm (p=0.03) in the DEB group, resulting in a binary restenosis rate of 12/59 (20%) versus 4/57 (7%; p=0.06). At 12 months, MACE rates were 22% in the Taxus group and 9% in the DEB group (P=0.08). The TLR at 12 months was 15% in the Taxus group and 6% in the DEB group (p=0.15). Based on these two pivotal trials, the European Society of Cardiology Guidelines for Percutaneous Coronary Intervention (2010) recommended that DEB should be considered for the treatment of in-stent restenosis after prior bare-metal stent. This was accorded a class 2 IIa indication, with a level B evidence.