Drug-eluting stents for the treatment of in-stent restenosis--'real world' double centre experience in consecutive patients.

Abstract

Objectives: We evaluated clinical outcome of consecutive patients with in stent restenosis (ISR) treated with drug-eluting stents (DES) at two intervention centres from April 2002 to April 2004, reflecting 'real world' practice.

Background: ISR is the major limitation to successful long-term outcome after implantation of bare metal stents during percutaneous coronary intervention (PCI). The optimal strategy for the treatment of ISR has yet to be determined.

Methods: 121 consecutive patients with significant ISR were treated with DES. Sirolimus DES were used in 60 patients and paclitaxel DES in the remainder. All patients were followed up to evaluate the incidence of major adverse cardiac events (MACE), angina class and clinically driven angiography. Data were collected between 7 and 27 months after the procedure (mean follow up of 16.5 months).

Results: Overall MACE rate at 16.5 months was 13.2% (16 patients) including 4 deaths (3%). Fifteen (12.3%) patients underwent clinically driven angiography. Eight patients (6.6%) developed ISR within the treated segment, of whom, four underwent further PCI and 4 CABG. Mean Canadian angina class decreased from 2.46+/-0.7 pre-procedure to 0.69+/-0.6 at follow up. All patients achieved an improvement in angina, with 59% being rendered angina free and 87% free of MACE. There were no differences in clinical outcome in those who received a paclitaxel and sirolimus DES.

Conclusions: The use of DES implantation for the treatment of ISR is safe, effective and associated with low recurrence rates in a 'real world' large cohort of patients with a complex mix of anatomical and clinical factors.