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

Abstract

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). Between 2002 and 2005, 5,946 patients were treated with at least one SES. A follow-up after a median of 4.1years 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). 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%.