Advantage of sirolimus-eluting stents compared to intracoronary radiation therapy 30 months after treatment of in-stent restenosis.

Abstract

Sirolimus-eluting stents (SES) have been shown during short follow-up periods to be effective for treatment of in-stent restenosis (ISR). This study evaluated the 30-months clinical efficacy after SES for treatment of ISR in comparison with intracoronary radiation therapy (IRT). Seventy-two consecutive ISR lesions in native coronary arteries (<30 mm lesion length, reference diameter <3.5 mm) of 72 patients were treated with SES. SES were used in 16 lesions after failed IRT and in 56 lesions for first time ISR. Seventy-two patients with 72 lesions from a prospective registry of 141 patients treated with IRT (beta-radiation) were matched for diabetes, reference vessel diameter, lesion length, and pattern of ISR to present the control group. At 6-months in-stent late loss was 0.29+/-0.48 vs 0.53+/-0.63 mm for the SES group compared to the IRT group (p=0.025). Target lesion revascularisation (TLR) at 12 month follow-up was performed in 7 lesions (10%) after SES and in 17 lesions (24%) after IRT (P=0.025). TLR rate at 30-months was 13% in the SES group vs 32% in the IRT group (P=0.008). MACE (death, myocardial infarction, target lesion revascularisation) at 30-months was observed in 13 patients (18%) in the SES group and in 25 patients (35%) in the IRT group (P=0.024). Considering only patients treated with SES for first-time ISR, TLR rate was 3.5% at 30-months. In the 16 patients treated with SES after failed IRT TLR rate was 44% at 30-months. Thirty month clinical follow-up of patients treated with SES for first time ISR is favourable compared to follow-up after IRT. However, use of SES after IRT failure is associated with a high rate of recurrent and potentially late treatment failure.