Two-year clinical follow up of coronary drug-eluting stent in patients at high risk for coronary restenosis

OBJECTIVE: To evaluate the long-term follow up of patients at high risk for coronary restenosis. BACKGROUND: Drug-eluting stents (DES) have been proven to reduce restenosis and reintervention compared with bare-metal stents (BMS). Although the safety of DES is not different from that of BMS in the short-to-medium term, concern has arisen about the potential for late stent thrombosis related to delayed endothelialization of the stent struts. METHODS: Among 495 patients who underwent percutaneous coronary intervention between June 2004 and March 2005, we retrospectively identified a subset of 150 patients (30%) at high risk for coronary restenosis on the basis of angiographic characteristics who were treated with DES. We assessed the incidence of major adverse cardiac events (MACE) during a 2-year follow-up period. The risk of MACE was estimated by computing the hazard ratio and the 95% confidence interval using the Cox regression method. RESULTS: At baseline, 31% of the patients had diabetes mellitus, 43% had previous myocardial infarction (MI), and 12% had ST-elevation acute MI as the cause of admission. The most frequent selection criteria observed were the presence of a long lesion (73% of patients) and the execution of multivessel angioplasty (43% of patients). Overall, 284 lesions were treated (1.9 lesions/patient) and 318 stents were implanted (2 stents/patient). Two-year cumulative incidence of the combined endpoint of death or MI, target vessel revascularization (TVR), MACE and target lesion revascularization were 7.3%, 10%, 16% and 7.3%, respectively. Significant predictors of MACE at 2 years were total occlusion, number of lesions treated and age. Significant predictors of TVR at 2 years were bypass graft treatment, total occlusion, number of stents implanted and number of lesions treated. Stent thrombosis occurred in 3 patients (2%). CONCLUSION: In these real-world patients at high risk for coronary restenosis, the use of DES was associated with a low incidence of cardiac events.