What future trials do we need in CTOs? Ulf Landmesser, Germany The Experts “Live” Workshop 2017 Saturday, September 16th, 2017

1. CBFKARDIOLOGIE
U. Landmesser
Chairman, Department of Cardiology (CBF); BIH Professor of Cardiology;
Chair – Cardiovascular Center
Charité – Universitätsmedizin Berlin
16.9.2017 Berlin – EUROCTO CLUB
What Future Trials Do We
Need in CTOs ?

2. CBFKARDIOLOGIE
1) CTO and Coronary Revascularisation
in Stable CAD and Prognosis ?
1) CTO Revascularisation and
Symptomatic Improvement
2) Further Improvement in CTO Outcomes
– IC Imaging ?
What Future Trials Do We
Need in CTOs ?

3. CBFKARDIOLOGIE
Eur Heart J. 2014 Aug 29. pii: ehu278. [Epub ahead of print]
European Guideline for Treatment of CAD:
ESC/EACTS Guidelines on Myocardial revascularisation

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The indications for revascularization in patients with SCAD are
persistence of symptoms despite medical treatment and/or
improvement of prognosis
Indications for revascularization in patients with stable
angina or silent ischemia
Eur Heart J. 2014 Aug 29. pii: ehu278. [Epub ahead of print]

5. CBFKARDIOLOGIE
Impact of ischaemia on therapeutic benefit derived from
myocardial revascularisation vs. medical therapy
Modeling revealed > 10 % total myocardium associated with a survival benefit
13 555 patients; 7 year FU for All cause mortality
Hachamovitch et al.; European Heart Journal (2011) 32, 1012–1024

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Update ISCHEMIA Trial in Stable CAD

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Update ISCHEMIA Trial in Stable CAD

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CTO Revascularisation and Cardiovascular
Outcome in Randomized Trials
Di Mario C, Sorini Dini C, Werner GS. JACC Cardiovasc Interv. 2017 Aug 14;10(15):1535-1537

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CTO associated with increased Recurrence of
Ventricular Arrhythmias in Ischemic Cardiomyopathy
JACC Cardiovasc Interv. 2017 May 8;10(9):879-888.

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JACC Cardiovasc Interv. 2017 May 8;10(9):879-888.
CTO associated with increased Recurrence of
Ventricular Arrhythmias in Ischemic Cardiomyopathy

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Coronary revascularisation in Ischemic cardio-
myopathy and Mortality – The STICHES Study
N Engl J Med. 2016 Apr 21;374(16):1511-20

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N Engl J Med. 2016 Apr 21;374(16):1511-20
Revascularisation in ischemic
cardiomyopathy:STICHES Trial
Coronary disease and
LV-EF ≤35%

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This STICH Extension Study (STICHES):
•15-year effort, achieving a 98% rate of follow-up
of 1212 patients with heart failure and severe left
ventricular dysfunction
•Randomly assigned to receive either medical
therapy alone or medical therapy plus coronary-
artery bypass grafting (CABG).
N Engl J Med. 2016 Apr 21;374(16):1511-20
vascularisation in ischemic cardiomyopath
STICH Extension Study
(STICHES)

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vascularisation in ischemic cardiomyopath
STICHES Trial:
All Cause and CV Mortality
N Engl J Med. 2016 Apr 21;374(16):1511-20
8 % ARR

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Hazard ratio (solid line) and 95% confidence interval (CI; gray area) for the effect of
coronary artery bypass grafting vs medical therapy across the range of ages.
Age and Ten-Year Outcomes After CABG – STICHES Study
in Patients With Heart Failure and Left Ventricular Systolic
DysfunctionClinical Perspective
Mark C. Petrie et al.
Circulation. 2016;134:1314-1324

17. CBFKARDIOLOGIE
- 1) Large area of ischemia
- 2) Impaired LV Function
- 3) Younger patients ?
- 4) Long-term Follow-Up
will be needed
In which patients one may expect a potential
prognostic benefit from CTO recanalisation

18. CBFKARDIOLOGIE
1) CTO and Coronary Revascularisation
in Stable CAD and Prognosis ?
1) CTO Revascularisation and
Symptomatic Improvement
2) Further Improvement in CTO Outcomes
– IC Imaging ?
What Future Trials Do We
Need in CTOs ?

19. CBFKARDIOLOGIE
OPEN CTO Registry; JACC Cardiovasc Interv. 2017 Aug 14;10(15):1523-1534
CTO Indications: OPEN-CTO Registry
All operators enrolling in OPEN-CTO trial received training in hybrid
approach and had performed over 100 cases using this method.

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JACC Cardiovasc Interv. 2017 Aug 14;10(15):1523-1534.
Predictors of Net Clinical Benefit ?
Symptomatic improvement vs. Risk of Procedere

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Indications for revascularization in patients with stable
angina or silent ischemia

22. CBFKARDIOLOGIE
1) CTO and Coronary Revascularisation
in Stable CAD and Prognosis ?
1) CTO Revascularisation and
Symptomatic Improvement
2) Further Improvement in CTO Outcomes
– IC Imaging ?
What Future Trials Do We
Need in CTOs ?

23. CBFKARDIOLOGIE
IVUS-Guided PCI (using DES) and
impact on clinical outcomes
- Included 7 randomized trials
with 3192 patients.
- This meta-analysis suggests
that for complex coronary
lesions (mean length coronary
lesions: 32 mm) IVUS-guided
PCI was superior to
angiography-guided PCI in
reducing the risk of MACE
(primarily: reduction in the risk
of ischemia-driven target lesion
revascularization).
Elgendy et al.: Circ Cardiovasc Interv. 2016; 9: e003700

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ILUMIEN IV Study:
Prognostic impact of OCT-guided Coronary Intervention
Pre-PCI OCT Angiography
OCT Stent Sizing Guidance, per
study protocol
OCT guided Optimization per
study protocol
Angiography guided PCI, per
“local standard practice”
Angiographic optimization, per
“local standard practice”
Post-PCI OCT
Angiography
Randomization to OCT or
angiography- guided PCI
Identification of study lesion
Procedure Complete
Post-PCI OCT, blinded to
investigator
1-year follow-up
Inclusion
High-risk clinical characteristics
•Medically treated DM, or
•Troponin positive ACS w/in 7 days,
OR
Complex-target lesion
•Long or multiple lesions
(stent length ≥ 28mm), or
•Bifurcation with 2 planned stents, or
•Angiographic severe Ca2+
, or
•CTO (crossed and pre-dilated) , or
•Diffuse or multi-focal in-stent restenosis

25. CBFKARDIOLOGIE
1) CTO and Coronary Revascularisation
in Stable CAD and Prognosis ?
1) CTO Revascularisation and
Symptomatic Improvement
2) Further Improvement in CTO Outcomes
– IC Imaging ?
What Future Trials Do We
Need in CTOs ?

26. CBFKARDIOLOGIE
CBFKARDIOLOGIE
Thank you