Treatment of in-stent restenosis using a paclitaxel-eluting stent: acute results and long-term follow-up of a matched-pair comparison with intracoronary beta;-radiation therapy

AIMS: Intracoronary radiation therapy (ICR) has significantly improved the long-term outcome after treatment of diffuse in-stent restenosis (ISR). The efficacy of drug eluting stents in this setting remains less well defined. This matched-pair analysis compared the procedural and long-term clinical and angiographic outcome after treatment of diffuse ISR using a paclitaxel-eluting stent (PES) with intracoronary beta-radiation therapy. METHODS AND RESULTS: Twenty-two patients receiving 25 PES (ACHIEVE, Cook, 3.1 microg paclitaxel per square millimeter, non-polymer based coating) for ISR underwent 6-month angiographic and 12-month clinical follow-up. From a database including 141 patients (174 lesions) undergoing intracoronary beta-radiation for ISR, 25 lesions (25 patients) were pair-matched with the former group for lesion length and vessel size. PES implantation and ICR were successful in all patients with a significantly lower postprocedural in-stent diameter stenosis in the PES group (8+/-12% vs. 18+/-8%, p < 0.01). Angiographic binary in-lesion restenosis at 6 month was 20% (5/25 lesions) in the PES group and 16% (4/25) in the ICR group (p = 1.0). PES implantation resulted in significantly higher in-stent MLD at FU (2.10+/-0.71 vs. 1.75+/-0.36, p = 0.03) and a higher in-stent net gain (PES: 1.19+/-0.69, ICR: 0.84+/-0.49, p = 0.04). Two patients in the PES group and 6 patients in the ICR group experienced a target lesion revascularisation at 12-month follow-up (p = 0.25). CONCLUSION: Implantation of a non-polymer based paclitaxel-elution stent and conventional ICR therapy for complex ISR lead to comparable acute and long-term clinical and angiographic follow-up results.