The SICTO Study CYPHERTM Sirolimuseluting stent in Chronic Total Occlusion

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

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SICTO - Baseline Demographics Risk Factors
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SICTO - Baseline Angiographic IVUS Data
IVUS estimate (N 18),QCA (N25)
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SICTO - IVUS data6-month follow-up
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SICTO - Angiographic Data6-Month Follow-Up
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SICTO - Events to 6 months
1 patient proximal distal stenosis outside
stent 1 patient distal dissection at index
procedure, treated at follow-up
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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 (25y),
  HTN
• 66 year-old female
• Coronary angiography revealed diffusely diseased
  extremely small coronary arteries with a proximal
  occlusion in the LAD (arrow)

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Case from SICTO Study
Post procedure
6 mos. follow-up
Baseline

• Patient underwent successful recanalization of
  the LAD with implantation of 2 long Cypher stents
  (2.5/23).
• Patients 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
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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)