Long-term follow-up of drug-eluting stents in patients with or without acute coronary syndrome

Objectives: Drug eluting stents (DES) reduce neointimal hyperplasia after stenting, leading to decreased late luminal loss and decreased angiographic restenosis, as compared with bare-metal stents (BMS) and therefore reducing the need for subsequent revascularisation procedures. Excitement of DES and their promise of reduced restenosis rates have been tempered by recent concerns about safety of these devices. We documented the two years follow-up in a cohort of patients with acute coronary syndromes or stable coronary disease in a single academic medical center. Methods: Between April 2002 and December 2004 543 patients requiring percutaneous coronary intervention (PCI) and receiving a DES were included into the study. Clinical and procedural data were collected. Primary outcome was the occurrence of major adverse cardiac events (MACE), defined as death of all cause, non-fatal myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR). Secondary endpoints included stent thrombosis, stroke and major bleeding. Results: 7.6% of patients had a MACE, 2.0% due to a non-fatal MI, 1.7% TLR, and 1.5% TVR. Death occurred in 2.4% of patients but only in patients with severe comorbidities and was not related to DES implantation. Stent thrombosis occurred in 1.3% of patients, 6 out of 7 cases occurred in patients initially treated for ST-elevation MI. No cases of stroke or major bleeding could be identified. In univariate analysis the use of abciximab for 12 h after intervention and no shock on admission improved outcome. Left ventricular ejection fraction <50% on admission, ventricular fibrillation on admission, the use of >1 stent and elevated CK, CK-MB and troponin levels worsened outcome. In multivariate analysis only elevated troponin was related with worsened outcome. Conclusion: In this cohort study, the results confirm the safety and efficacy of DES implantation in daily routine practice in a two years follow-up.