Background: Treatment of in-stent restenosis (ISR) is a challenging clinical problem. Recent studies have verified the safety and efficacy of first-generation DES for the treatment of ISR. The safety and effectiveness of new-generation drug-eluting stents (nDES) for ISR has not been previously investigated. The aim of the present study was to prospectively evaluate the clinical outcomes after treatment with nDES implantation in patients with bare metal stent (BMS) ISR.
Methods: Consecutive patients with ISR after BMS implantation were included. Primary end-point was a major adverse cardiac event (MACE), defined as death, myocardial infarction (MI), or target vessel revascularization (TVR). The incidence of stent thrombosis was also evaluated.
Results: A total of 46 consecutive patients were enrolled for the treatment of ISR, 23 patients from ZES and 23 from EES group. There were two (8.7%) cases of TVR in ZES cohort due to proliferative ISR at 6 and 7 months after DES implantation, and none in EES. One (4.3%) patient underwent percutaneous coronary intervention and the other (4.3%) was treated surgically. Neither acute nor subacute thrombosis was observed during the 13.3+/-6.3 months follow-up period. In all other patients, stress test was negative for ischemia at 6 months.
Conclusions: In this prospective study, we showed that direct nDES implantation is highly effective for ISR and seems to be a promising management for the treatment of ISR.