The SICTO Study CYPHER Sirolimus-eluting stent in Chronic

The SICTO Study CYPHER Sirolimus-eluting stent in Chronic Total Occlusion TM Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M. J. Suttorp MD, William Wijns MD

SICTO STUDY DESIGN A multicenter, prospective, non-randomized study to assess the feasibility and restenosis/reocclusion rates of coronary stenting with the Cypher. TM Sirolimus-eluting stent in patients with chronic total occlusion - 25 patients were treated with the Cypher. TM Sirolimuseluting stent after successful balloon angioplasty and IVUS examination. - Clinical follow-up at 30 days, 6, 12, 18 and 24 months - repeat angiography and IVUS at 6 months follow-up.

SICTO - Baseline Demographics & Risk Factors Males (N) Age (years) Prior MI Prior revascularization Smoker (present / past) Family History Diabetes Hypertension Hyperlipidemia 18 63 52% 24% 60% (12% / 48%) 60% 16% 60% 80%

SICTO - Baseline Angiographic & IVUS Data Lesion length (mm) 30. 2 + 12. 0* Stent length (mm) - IVUS Stent length (mm) - QCA RVD (mm) 35. 7 + 10. 3* 28. 4 + 11. 0** 2. 6 + 0. 5** * IVUS estimate (N = 18), **QCA (N=25) CX 28% LAD 40% RCA 32%

SICTO - IVUS data 6 -month follow-up IVUS post IVUS f/u Mean stent area 8. 6 ± 1. 8 8. 7 ± 1. 7 Mean lumen area 8. 6 ± 1. 8 8. 3 ± 1. 9 Min. Lumen area 6. 7 ± 1. 7 6. 4 ± 2. 2 n. a. 13. 1 ± 18. 3 % stent plaque volume

SICTO - Angiographic Data 6 -Month Follow-Up Angio post Angio f/u RVD mm 2. 6 ± 0. 5 2. 8 ± 0. 6 MLD mm 1. 9 + 0. 6 2. 0 ± 0. 7 In-Stent % Stenosis 15. 7 + 8. 6 19. 3 + 11. 0 n. a. - 0. 1 ± 0. 3 In-Stent Late Loss (post minus follow-up) mm

SICTO - Events to 6 months MACE (overall) 0 Death 0 MI 0 Emergency CABG Target lesion PTCA 0 0 TVR* Acute/Subacute Thrombosis 2 (8%) 0 * 1 patient proximal + distal stenosis outside stent 1 patient distal dissection at index procedure, treated at follow-up

Case from SICTO Study § Main complaint: severe shortness of breath and chest pain on mild exertion, increasing over last 6 months § Risk factors: Hyperlipidemia (10 y), DM (25 y), HTN § 66 year-old female § Coronary angiography revealed diffusely diseased extremely small coronary arteries with a proximal occlusion in the LAD (arrow)

Case from SICTO Study Baseline Post procedure 6 mos. follow-up § Patient underwent successful recanalization of the LAD with implantation of 2 long Cypher stents (2. 5/23). § Patient’s condition improved significantly after procedure and returned to functional Class I. § Despite very long lesion (2 stents) in a very diffuse small artery, 6 months follow-up shows stents are widely patent. Chaim Lotan MD Hadassah-Hebrew University Medical Center, Jerusalem Israel

SICTO – Conclusion § In this feasibility study the CYPHERTM Sirolimuseluting stent was very effective in the treatment of CTO, with very low rates of TLR (0%), MACE (0%) and TVR (8%) compared to historical data with bare stents (30 -50%). § The CYPHERTM Sirolimus-eluting stent significantly inhibits intimal hyperplasia in CTO. § These preliminary data will come in addition of larger database with CTO subpopulation (e. g. e. Cypher)