BACKGROUND: Although superior to bare metal stents (BMS) in reducing restenosis, drug-eluting stents (DES) long-term safety, especially after being deployed to treat complex lesions, has not been completely established. We sought to evaluate very late clinical outcomes of DES in the off-label scenario. METHODS: Between May 2002 and January 2008 all consecutive patients treated solely with DES were prospectively enrolled in the single center DESIRE registry. Patients with acute myocardial infarction and saphenous vein grafts were excluded. Patients were divided into two groups, according to their "label" status: on-label group, patients with a single de novo lesion located in a native coronary artery of 2.5 to 3.5 mm in diameter and < 28 mm (Taxus®) or < 30 mm (Cypher®) in length. The off-label group included the remaining patients. Our primary objective was to compare the long-term (> 1 year) incidence of cardiac death, non-fatal myocardial infarction (MI) and stent thrombosis (ST) between the 2 groups. RESULTS: Most of the enrolled patients were off-label [1,702 (78.5%) patients of 2,167]. Complete follow-up data were obtained in 98.3% of the cases. off-label patients presented a higher incidence of cardiac death (3.0% vs. 2.6%; P = 0.037), MI (4.1% vs. 2.0%; P = 0.005) and ST (1.9% vs. 0.6%; P = 0.021). Need for repeat lesion revascularization was similar between groups. CONCLUSION: In the DESIRE registry, DES in patients with a very complex profile was associated with low rates of major adverse cardiac events (< 11%) and ST (< 2.0%) up to 6-year follow-up; however, the outcomes in this subset are still inferior compared to those with strict indications for DES.
Drug-eluting stents; Treatment outcome; Thrombosis
