the sicto study cypher tm s i rolimus-eluting stent in c hronic t otal o cclusion
DESCRIPTION
The SICTO Study CYPHER TM S i rolimus-eluting stent in C hronic T otal O cclusion. Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD, William Wijns MD. SICTO. STUDY DESIGN - PowerPoint PPT PresentationTRANSCRIPT
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)