1 SIROLIMUS-ELUTING STENTS FOR IN-STENT RESTENOSIS TREATMENT IN 278 UNSELECTED PATIENTS: INSIGHTS ON LONG-TERM OUTCOMES FROM A LARGE TWO-CENTER REGISTRY I. SHEIBAN1, A. CHIRIBIRI1, S. GALLI2, G. BIONDI-ZOCCAI1, P. MONTORSI2, S. BENINATI1, F. FABIOCCHI2, C. MORETTI1, G. TREVI1, A. BARTORELLI2 (1) Interventional Cardiology, University of Turin, Turin, Italy (2) Interventional Cardiology, Centro Cardiologico Monzino, Milan, Italy

2 BACKGROUND In-stent restenosis (ISR) occurs not infrequently after intracoronary stenting Many techniques have been proposed for the treatment of ISR, but drug-eluting stents (DES) seem to provide the best early and mid-term results We aimed to appraise whether such effectiveness of DES for ISR is maintained even on the long-term

3 OBJECTIVES To appraise the long-term results of sirolimus-eluting stent (SES) implantation for the management of bare-metal stent (BMS) restenosis

4 METHODS All patients admitted from July 2002 to December 2004, with known coronary artery disease, previously treated with BMS, who demonstrated ISR and were treated during the index hospitalization with SES implantation (Cypher, Cordis, Miami, FL, USA), the prevalent DES in our Institutions, were enrolled into a dedicated database SES were either implanted at high pressure or initially expanded at moderate-to-high pressure, and then post- dilated with semi-compliant or non-compliant balloons at high pressure

5 METHODS At the time of discharge, all patients were receiving 100 mg of aspirin once daily, as well as 75 mg of clopidogrel daily for at least 3 months The primary end point was freedom from major cardiovascular events (MACE) at long-term (≥24 months) follow-up, defined as a composite end point of death, non-fatal myocardial infarction, target vessel revascularization (TVR), or stent thrombosis

6 METHODS Secondary end points were early complications (intra- procedural or in-hospital death, acute or subacute stent thrombosis, stroke, need for urgent coronary artery bypass, and peripheral vascular complications), technical success of stent implantation, and individual components of MACE Stent thrombosis was distinguished as acute (≤24 hours), subacute (≤30 days), late (>30 days), or very late (>1 year). A comprehensive thrombosis definition, encompassing definite as well as probable thrombosis, was used

7 RESULTS A total of 271 consecutive patients were enrolled (331 sirolimus- eluting stents). Procedural success was obtained in all patients with no case of in-hospital death, acute/subacute stent thrombosis, stroke, or urgent coronary bypass. Survival free from MACE decreased progressively from 98.8% at 1 month, to 95.7%, 83.7%, 75.4%, and 65.8% at 6 months, 12 months, 24 months and 30 months, respectively. Similarly, a similar attrition in freedom from repeat target vessel was found (from 97.6% at 6 months to 76.7% at 30 months). Finally, a total of 5 stent thrombosis were adjudicated, all occurring several months after clopidogrel discontinuation and in patients on life-long aspirin

8 BASELINE PATIENT CHARACTERISTICS

9 BASELINE ANGIOGRAPHIC FEATURES

10 OUTCOMES

11 CONCLUSIONS This study supports the mid-term safety and effectiveness of sirolimus-eluting stents for the treatment of ISR Whether the late catch-up phenomenon hereby observed in repeat target revascularization and stent thrombosis is an incidental finding deserve further rigorous scrutiny

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