Coronary stenting with the sirolimus-eluting stent in clinical practice: final results from the prospective multicenter German Cypher Stent Registry.

AIMS

Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice.

METHODS AND RESULTS

We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 +/- 0.41 SES were implanted with a mean length of 21.1 +/- 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery.

CONCLUSIONS

These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters.