Objectives: This study sought to evaluate the effectiveness and safety of the sirolimus-eluting stent in the treatment of in-stent restenosis(ISR) in consecutive unselected patients undergoing coronary intervention in a real-world scenario. Background: Restenosis after bare metal stenting is characterized by a high rate of re-restenosis once treated with repeated percutaneous coronary intervention. Methods: The study was designed as a prospective two-center registry. We enrolled 244 patients with ISR in a native coronary artery or saphenous vein graft who had clinical indication for repeat intervention. Results: Sirolimus stent implantation was successful in all lesions. At 9-month follow-up, death occurred in 4(1.6%) patients, myocardial infarction in 4(1.6%), and ischemia-driven target lesion revascularization(TLR) in 12(4.9%), for a cumulative event-free survival of 227(93%). Although 9-month follow-up angiography was planned in all patients, only 150(62%) patients completed it, and restenosis was present in 13(8.7%) patients. Diabetes and non-ST-segment elevation acute coronary syndrome at presentation were the only independent predictors of freedom from ischemia-driven TLR and major adverse cardiac events. Conclusions: Sirolimus stent implantation for the treatment of ISR is effective and safe. In diabetic patients and in those with acute coronary syndrome, the higher rate of recurrence requires further evaluation.
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