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Intracoronary infusion of BM-‐MNC early or late a5er AMI -‐
4 months results of the SWISS-‐AMI trial
Daniel Sürder, MD Fondazione Cardiocentro Ticino Lugano – Switzerland [email protected]
ClinicalTrials.gov Identifier: NCT00355186
2012 Scien?fic Sessions of the AHA -‐ Late breaking trials
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Background Intracoronary BM-MNC infusion in the infarct related artery after AMI has been shown to be safe; however, its efficacy is still debated.
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Optimal timing for cell delivery post-AMI is unknown. Previous studies indicated potential time dependent efficacy in subgroup analyses.
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Schächinger V, et al N Engl J Med 2006
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Study design & Methods BM-MNC - BM-Aspiration from the
iliac crest (60ml) - Centralized cell
processing using density gradient centrifugation, without adding Heparin (UTC Lugano)
CMR - Standardized protocol
including cine and delayed enhancement
- Core-lab analysis (University Hospital Zurich)
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EF <45%
within 24h
Sürder et al. Am Heart J 2010
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Endpoints & sample size Primary endpoint: Change in global LVEF at 4 mo. vs. baseline
Assumption: Δ LVEF = 3.5%; SD of 6-7%; drop out = 10%
For a independent sample t-test 58 paired CMR per group
are needed - including drop out n = 64 per group
Secondary endpoints: Change in LV volumes, infarct size (DE CMR) and regional
myocardial thickening
MACE (death, MI, coronary revascularization, stroke)
Predictors for efficacy (time to reperfusion, transmurality,
microvascular obstruction)
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Pa?ent flow chart
Total 345 CMR analyses (24.430 slices)
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* control vs. early ‡ control vs. late
Baseline characteris?cs of the pa?ents
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* control vs. early ‡ control vs. late
Characteris?cs of index AMI
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* n = 29 ** n = 30
Characteris?cs of BM-‐MNC
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swissami Results
Mean LVEF at baseline and 4 months
p = 0.74 p = 0.12 p = 0.45
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Primary Endpoint
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Mean change in LVEF 4 months vs. baseline
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Primary Endpoint
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Mean change in LVEF 4 months vs. baseline
Adjus?ng for baseline LVEF with ANCOVA tes?ng:
Es$mate (95%CI) p-‐value
1.25 (-‐1.83 to 4.32) 0.42 early vs. control
0.55 (-‐2.61 to 3.71) 0.73 late vs. control
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P = 0.03 vs. control
P = 0.89 vs. control
P = 0.07 vs. control
P = 0.79 vs. control
Secondary Endpoints
Control Early Late Control Early Late
100
50
0
-‐50
-‐100
LVEDV (ml) LVESV (ml)
Change in LV-‐volumes 4 months vs. baseline
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P = 0.82 vs. control
P = 0.59 vs. control
20
0
-‐20
-‐40
-‐60
Control Early Late Control Early Late
10
5
0
-‐5
Secondary Endpoints
Change in scar size and regional LV funcSon
Scar size (g) Myocardial thickening in the infarct territory (mm)
P = 0.54 vs. control
P = 0.67 vs. control
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swissami Predictors for treatment efficacy
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Change in LVEF
< 4.5h < 4.5h > 4.5h > 4.5h
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swissami Clinical events during follow up
* control vs. early ‡ control vs. late
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Summary
Intracoronary infusion of BM-‐MNC, either 5-‐7 d or 3-‐4 wks a\er primary PCI for STEMI, did not improve LV-‐func?on as assessed by CMR at 4 months compared with control.
Subgroup analysis indicates potenSal benefit of i.c. BM-‐MNC in paSents with early reperfusion (within 4.5 h from the onset of pain).
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Summary
Intracoronary infusion of BM-‐MNC, either 5-‐7 d or 3-‐4 wks a\er primary PCI for STEMI, did not improve LV-‐func?on as assessed by CMR at 4 months compared with control.
Subgroup analysis indicates potenSal benefit of i.c. BM-‐MNC in paSents with early reperfusion (within 4.5 h from the onset of pain).
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Adapted from Jeevanantham et al. Circulation 2012
SWISS AMI: Δ LVEF early vs. control = 2.1%
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Acknowledgements
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swissamiPI: Roberto CorS Co-‐PI: Daniel Sürder
CMR core lab: Robert Manka Juerg Schwiber ValenSn Gisler Florian Mayer ChrisSna Scheiben
USZ: Ines Bühler Simone Kaufmann
Inselspital: Aris MoschoviSs Stephan Windecker Andreas Wahl Christa Schönenberger
KS Luzern: Paul Erne Michel Zuber Christof Auf der Maur Peiman Jamshidi Doris Erne Brigiba Mehmann
SebasSan Stoll Christoph Wyss Manuel Zipponi
CCT / UTC core lab: Tiziano Mocceh Lucia Turchebo Sabrina Soncin Viviana Lo Cicero Marina Radrizzani Giuseppe Astori Elena Pecchi