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Sessin 2 - Assessing the randomized trials
1. Univ. Prof. Dr. med. Ulf Landmesser
Chairman, Department of Cardiology
Chair, Center for Cardiovascular Medicine
Charité Universitätsmedizin Berlin
Germany
Assessing the
randomized trials
2. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
Clinical impact of CTO recanalisation ?
01
ISCHEMIA trial
02
Assessing the randomized trials
4. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
Indication of CTO-PCI ?
Brilakis ES, Mashayekhi K, Burke MN. Circulation. 2019; 139(14):1684-1687
5. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
Recent randomized clinical CTO trials
DECISION-CTO EURO-CTO
Design Open label RCT Open label RCT
Setting Korea
19 centers
Europe
26 centers
Subjects SAP or ACS [74% vs 26%] SAP
Recruitment (N)
Target (N)
Time (Yrs)
815
1284
6
407*
600/1200
3
Comparison OMT vs CTO-PCI OMT vs CTO-PCI
Primary Endpoint MACCE 3yr
[Death, MI, stroke, repeat
revascularisation]
SAQ health status 12M
Death, MI 3yr
Werner GS et al.;
Eur Heart J. 2018; 39(26):2484-2493
Lee SW et al.;
Circulation 2019;139(14):1674-1683.
6. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
EuroCTO trial – Clinical Outcomes
Werner GS et al.; Eur Heart J. 2018 Jul 7;39(26):2484-2493
7. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
Clinical impact of CTO recanalisation ?
01
ISCHEMIA trial
02
Assessing the randomized trials
12. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
Study outcomes
• “The primary outcome was a composite of death
from cardiovascular causes, myocardial
infarction, or hospitalization for unstable angina,
heart failure, or resuscitated cardiac arrest”
• “A key secondary outcome was death from
cardiovascular causes or myocardial infarction”
Maron DJ et al. N Engl J Med 2020;382:1395-407
14. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
…but if peri-procedural MI is re-defined
as above x5 URL, this early adverse
outcome becomes much bigger, tilting
the balance in favor of OMT alone!!
16. HERZMEDIZIN DER ZUKUNFT
Ulf Landmesser
Medical Therapies Used Post-Randomization
Ischemia Main Trial
Figure 3.8.1
Proportion of Participants With Beta Blocker Use by Treatment Across Visit
Intent-to-Treat Population
Beta-blockers
Ischemia Main Trial
Figure 3.20.1
Proportion of Participants With Calcium Channel Blocker Use by Treatment Across Visit
Intent-to-Treat Population
Ca-channel blockers
Ischemia Main Trial
Figure 3.22.1
Proportion of Participants With dual antiplatelet (DAPT) Use1
by Treatment Across Visit
Intent-to-Treat Population
1 DAPT use is defined as the use of aspirin and another antiplatelet medication.
DAPT