Background: The Sirolimus-eluting Stent (SES) is currently being used in patients (pts) undergoing percutaneous coronary intervention (PCI). We report our initial results from a post marketing surveillance with the use of SES in everyday ���real world��� clinical practice.
Methods: Data of the first 1252 consecutive pts (1405 lesions) treated with the SES since its approval was collected and analyzed. All pts were discharged with antiplatelet therapy for 3 to 12 months. Pts were followed at 30 days and 6 months from the date of SES implantation by telephone contact or office visit.
Results: Baseline characteristics included mean age 64짹11 years, males 64.2%, and diabetics 34.4%. The SES was implanted in complex lesions (type B/C lesion) 92.1%, in-stent restenosis (ISR) 8.1%, total occlusion 3.5 %, acute myocardial infarction (MI) 9.1%, left main 1.5%, ostial lesion 5.1% and saphenous vein grafts 3.8%. The overall number of SES utilized per procedure was 1.28짹0.6. The mean SES length was 21.96짹6.5 mm and 438 lesions (31.2 %) were implanted with long SES (>25 mm). The mean SES diameter was 3.17짹1.2 mm and 306 lesions (21.8 %) received a small SES (2.5 mm). IVUS guided PCI was performed in 80.3% of cases. The procedural success rate was 97.3% and the clinical success was 98.6%. In-hospital, 30-day and 180-day clinical outcomes are shown in the table.
Conclusion: The initial experience with the routine use of SES for PCI showed high feasibility and safety with low overall clinical event rates up to 6 months. Efforts should be directed to minimize the thrombosis rate and to ensure the durability of these results.