194 Three year clinical outcomes associated with the use of the zotarolimus-eluting stent in an unrestricted contemporary practice

Abstract

BACKGROUND: Drug eluting stents (DES) have improved clinical outcomes by reducing the need for target vessel revascularization. However, the randomized trials from which this data originated included only patients with single, non-complex lesions and excluded patients with acute coronary syndromes. There has been a suggestion in the literature that DES may be associated with late ( 1 year) stent thrombosis. The objective of this study was to evaluate clinical outcomes associated with the use of the Endeavor stent in a single center unrestricted clinical practice over a three-year period. METHODS: Percutaneous coronary intervention was performed at the discretion of the Interventional Cardiologist. Telephone follow-up and review of hospital and clinic records were conducted 2 years post procedure. At three years, hospital and clinic records were re-reviewed and patients living outside the immediate Ottawa area were re-contacted by telephone. The primary outcome was clinically driven target vessel revascularization (TVR), target lesion revascularization (TLR) and stent thrombosis (ST) at one, two and three years. Secondary endpoints included acute myocardial infarction (MI), cardiac death and non-cardiac death. RESULTS: Four hundred ninety four consecutive patients treated with Endeavor stents from June 2005 to Feb 2007 were followed. 717 stents were used to treat 625 lesions. Clinicallydriven TLR rates were 6.2%, 1.1% and 0.3% at 1, 2 and 3 years respectively. TVR rates were 8.1%, 2.4% and 0.5% for the same time periods. The cumulative rates of TLR and TVR for the three-year period were 7.7% and 11.0%, respectively. There were 4 cases of ARC definite stent thrombosis involving 3 patients and 1 case of ARC probable stent thrombosis, all occurring within 12 months, with a rate of 0.7%. The cumulative rate of MI was 6.1% with rates at 1, 2 and 3 years were 4.0%, 1.4% and 0.6%, respectively. All cause mortality was 2.8%, 2.4% and 0.6%, whereas cardiac mortality was 1.6%, 1.8 % and 0.6% at 1, 2 and 3 year followup, respectively. CONCLUSIONS: The rates of the clinical outcomes of TVR and TLR in this study were relatively low and were similar to those reported in earlier randomized studies, despite use of the Endeavor stent in an unrestricted population. Our results do not suggest an increased rate of late stent thrombosis.