[Coronary angioplasty in the real world: the RESTEM registry. Outcome of patients treated with sirolimus-eluting stents].

BACKGROUND: RESTEM, a prospective multicenter registry collecting all percutaneous coronary interventions made over 20 months and monitored up to 2 years, had been performed to assess, in the real world, the impact of sirolimus-eluting stents (SES) versus bare metal stents (BMS) on patients' outcomes.

METHODS: The registry includes 5524 consecutive patients treated with BMS (72%), SES (15%), BMS+SES (4%) or other techniques (9%). The combination of death, acute myocardial infarction, unstable angina and revascularization had been chosen as primary endpoint.

RESULTS: The 2-year adjusted results confirm a significant advantage of SES in target vessel revascularization (8.3 vs 13.7%, odds ratio [OR] 0.66), a benefit for overall revascularizations (18.3 vs 25.6%, OR 0.76) without reducing mortality, other clinical events and primary endpoint, therefore denying the benefit on primary endpoint observed at 12 months (18.5 vs 25.0%, OR 0.68 at 1 year and 25.8 vs 32.4%, OR 0.84 at 2 years).

CONCLUSIONS: RESTEM results confirm the SES capacity to reduce target vessel revascularization without decreasing other clinical events, suggest that this advantage is limited to the first 6 months after percutaneous coronary intervention, and show no evidence of excess of deaths, acute myocardial infarction and late thrombosis following SES implantation described in recent meta-analyses.