Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD, William Wijns MD The SICTO Study...
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Transcript of Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD, William Wijns MD The SICTO Study...
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)