Long-term follow-up after coronary stenting with the sirolimus-eluting stent in clinical practice: results from the prospective multi-center German Cypher Stent Registry.

AIMS

To obtain long-term follow-up data of the sirolimus-eluting coronary stent (SES) and to determine factors associated with clinical events and target vessel revascularization (TVR).

METHODS AND RESULTS

Between 2002 and 2005, 5,946 patients were treated with at least one SES. A follow-up after a median of 4.1 years was obtained in 5,247 patients (88.2 %). During the follow-up, death occurred in 9.2 % of patients, nonfatal myocardial infarction in 5.9 %, nonfatal stroke in 2.2 % and MACCE (death/myocardial infarction/stroke) in 16.3 %. Any TVR was performed in 20.3 %. Independent predictors of MACCE were: older age (p < 0.0001), renal insufficiency (p < 0.0001), prior myocardial infarction (p < 0.0001), diabetes mellitus (p < 0.0001), cardiogenic shock (p = 0.0002), three-vessel disease (p = 0.0012), reduced left ventricular function (p = 0.0048), target vessel = bypass graft (p = 0.0122), indication for treatment = ACS (p = 0.0181) and PCI before implantation (p = 0.0308). Independent predictors of TVR were target vessel = coronary bypass (<0.0001), two- or three-vessel disease (p < 0.0001), ostial lesions (p < 0.0001), total length of SES implanted (p = 0.0012) and older age being a protective factor (p = 0.0187).

CONCLUSIONS

Long-term follow-up of the SES in clinical practice showed clinical event rates that were comparable to randomized trials with a MACCE rate of 16.3 % and TVR rate of 20.3 %.