Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD,

William Wijns MD

The SICTO Study

CYPHERTM 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 CypherTM Sirolimus-eluting stent in patients with chronic total occlusion

- 25 patients were treated with the CypherTM 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 MI 52%

Prior revascularization 24%

Smoker

(present / past)

60%

(12% / 48%)

Family History 60%

Diabetes 16%

Hypertension 60%

Hyperlipidemia 80%

SICTO - Baseline Angiographic & IVUS Data

Lesion length (mm) 30.2 + 12.0*

Stent length (mm) - IVUS 35.7 + 10.3*

Stent length (mm) - QCA 28.4 + 11.0**

RVD (mm) 2.6 + 0.5**

* IVUS estimate (N = 18),**QCA (N=25)

RCA

32%

CX

28%LAD

40%

SICTO - IVUS data6-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

% stent plaque volume n.a. 13.1 ± 18.3

SICTO - Angiographic Data6-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

In-Stent Late Loss(post minus follow-up) mm

n.a. - 0.1 ± 0.3

SICTO - Events to 6 months

6 months

MACE (overall) 0

Death 0

MI 0

Emergency CABG 0

Target lesion PTCA 0

TVR* 2 (8%)

Acute/Subacute Thrombosis 0

* 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

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 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 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)