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REVIVED-BCIS2 Trial
By Philippe Taieb, MD
Background: Hibernating Myocardium
STICH(ES) TRIAL
• EF≤35% + CAD randomized to CABG vs CABG+ OMT. LM
excluded.
• RCT 1:1
• Multicenter (99 sites over 22 countries )
• Funded by NIH.
• 1212 patients recruited between July 2002 to May
2007.
• Primary outcome: death from any cause
• Secondary outcome: death from CV causes, Composite
of all-cause death (ACD) + Hospitalization (CV, HF, all
cause), ACD + revasc, ACD + MI, ACD + stroke
• 10 year FU.
At 5 year FU, 1⁰ outcome
with HR of 0.86 but p=
0.12. All secondary
outcomes, already
statistically significant
with similar HRs.
REVIVED-BCIS2
• RCT 1:1
• Multicenter (40 centers in UK)
• Funded by UK Department of Health (NIHR).
• 700 patients recruited between August 2013
and March 2020.
BCIS-JS
• BCIS-JS ≥ 6 represents
LM, PROX LAD, PROX
LCX in Left dominant
system or Multivessel
disease.
• No mention of ischemia,
lesion severity, FFR/iFR.
• Not much evidence of
BCIS-JS validity aside
from strong specificity
for >12% ischemia on
CMR.
Viability
• CMR(70%): ≤25% transmural
LGE. For 26-50%, adjudication
at the discretion of the
recruiting centers.
• DSE (26%): improvement in
contraction by ≥ 1 grade
during low-dose Dobutamine.
• SPECT: tracer uptake >50%
than maximal uptake
segment at rest.
• PET : perfusion-metabolism
mismatch.
4%
63% in STICH
36% in STICH
59% in STICH
60 y.o. in STICH
Same as STICH
Results of REVIVED Trial
Results
Results
Mean EF difference 0.9% (95%CI -
1.7 to 3.4)
No significant difference in
Symptoms, NYHA class or CCS class
Relatively low number of events rates.
Underpowered?
OMT: REVIVED VS STICH
ICD
STICH ->
Full Revascularization?
Viability: does it matter?
Food for thoughts
• Relatively low recruitment rate- no disclosure
of number screened. More severe disease not
enrolled in study?
• Healthier patients than average patient with
severe ICM =>50% with ≤2 vessel disease, 2/3
without angina and NYHA I/II => Tx dilution
effect.
• 10% crossover from OMT to PCI.
• Benefit will emerge after longer FU period?
REVIVED-BCIS2 Trial.pptx

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REVIVED-BCIS2 Trial.pptx

  • 3. STICH(ES) TRIAL • EF≤35% + CAD randomized to CABG vs CABG+ OMT. LM excluded. • RCT 1:1 • Multicenter (99 sites over 22 countries ) • Funded by NIH. • 1212 patients recruited between July 2002 to May 2007. • Primary outcome: death from any cause • Secondary outcome: death from CV causes, Composite of all-cause death (ACD) + Hospitalization (CV, HF, all cause), ACD + revasc, ACD + MI, ACD + stroke • 10 year FU.
  • 4. At 5 year FU, 1⁰ outcome with HR of 0.86 but p= 0.12. All secondary outcomes, already statistically significant with similar HRs.
  • 5. REVIVED-BCIS2 • RCT 1:1 • Multicenter (40 centers in UK) • Funded by UK Department of Health (NIHR). • 700 patients recruited between August 2013 and March 2020.
  • 6.
  • 7.
  • 8. BCIS-JS • BCIS-JS ≥ 6 represents LM, PROX LAD, PROX LCX in Left dominant system or Multivessel disease. • No mention of ischemia, lesion severity, FFR/iFR. • Not much evidence of BCIS-JS validity aside from strong specificity for >12% ischemia on CMR.
  • 9. Viability • CMR(70%): ≤25% transmural LGE. For 26-50%, adjudication at the discretion of the recruiting centers. • DSE (26%): improvement in contraction by ≥ 1 grade during low-dose Dobutamine. • SPECT: tracer uptake >50% than maximal uptake segment at rest. • PET : perfusion-metabolism mismatch. 4%
  • 10. 63% in STICH 36% in STICH 59% in STICH 60 y.o. in STICH Same as STICH
  • 13. Results Mean EF difference 0.9% (95%CI - 1.7 to 3.4) No significant difference in Symptoms, NYHA class or CCS class
  • 14. Relatively low number of events rates. Underpowered?
  • 19. Food for thoughts • Relatively low recruitment rate- no disclosure of number screened. More severe disease not enrolled in study? • Healthier patients than average patient with severe ICM =>50% with ≤2 vessel disease, 2/3 without angina and NYHA I/II => Tx dilution effect. • 10% crossover from OMT to PCI. • Benefit will emerge after longer FU period?

Editor's Notes

  1. Poland, India, Russia, Canada and USA.
  2. Looks like curves might start to diverge but really not enough data to say for sure.
  3. Sample size for event rate of 43% but in fact around 38%.
  4. Not huge difference in medications aside from 20% of ARNI with similar number of patients on RAAS blockade, MRA, BB statins. Not clear how many patients on SLGT2.
  5. Signal for potential effect of full revascularization in longer term?