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

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

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 Sirolimus- eluting 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)18 Age (years)63 Prior MI52% Prior revascularization24% Smoker (present / past) 60% (12% / 48%) Family History60% Diabetes16% Hypertension60% Hyperlipidemia80%

SICTO - Baseline Angiographic & IVUS Data Lesion length (mm) * Stent length (mm) - IVUS * Stent length (mm) - QCA ** RVD (mm) ** * IVUS estimate (N = 18),**QCA (N=25) RCA 32% CX 28% LAD 40%

SICTO - IVUS data 6-month follow-up IVUS postIVUS f/u Mean stent area8.6 ± ± 1.7 Mean lumen area8.6 ± ± 1.9 Min. Lumen area6.7 ± ± 2.2 % stent plaque volumen.a.13.1 ± 18.3

SICTO - Angiographic Data 6-Month Follow-Up Angio postAngio f/u RVD mm2.6 ± ± 0.6 MLD mm ± 0.7 In-Stent % Stenosis In-Stent Late Loss (post minus follow-up) mm n.a ± 0.3

SICTO - Events to 6 months 6 months MACE (overall)0 Death0 MI0 Emergency CABG0 Target lesion PTCA0 TVR*2 (8%) Acute/Subacute Thrombosis0 * 1 patient proximal + distal stenosis outside stent 1 patient distal dissection at index procedure, treated at follow-up

 Main complaint: severe shortness of breath and chest pain on mild exertion, increasing over last 6 months  Risk factors: Hyperlipidemia (10 y), DM (25y), 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 CYPHER TM Sirolimus- eluting 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 CYPHER TM 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)