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. 2020 Jun 4;2020(6):CD013002. doi: 10.1002/14651858.CD013002.pub2

Bonnefoy‐Cudraz 2014.

Study characteristics
Methods Study design: RCT
Study grouping: not described
Total duration of the study: not described
Number of study sites and locations: not described
Study setting: not described
Date of the study: not described
Participants People with CS secondary to AMI
Baseline characteristics not described
Total number of participants randomised to intervention: 15
Number of participants lost to follow‐up: 2
Number of participants analysed: 13
Interventions Impella LP5.0 + IABP vs IABP alone
Intervention characteristics
MCS
  • Type of MCS: LVAD Impella LP5.0 + IABP

  • Duration from diagnosis to intervention: N/A

  • Duration of treatment: N/A

  • Concomitant medications: N/A


IABP
  • Duration from diagnosis to intervention: N/A

  • Duration of treatment: N/A

  • Concomitant medications: N/A

Outcomes Haemodynamic effect
  • CPI after 12 hours of support was increased but not significantly in people with the Impella LP5.0 + IABP compared with people with IABP (LP5.0 + IABP: CPI 0.08 (SD 0.08) watt/m²; IABP: CPI –0.02 (SD 0.25) watt/m²; P = 0.415).


Survival: 30 day
  • 30‐day mortality was 28.6% (2 deaths 1 week after inclusion) in Impella LP5.0 + IABP group compared to 0 in IABP group.


Survival measured to: transplant: unsupported cardiac function
  • Not reported


Quality of life
  • Not reported


Major adverse cardiovascular events
  • Not reported


Dialysis‐dependent
  • Not reported


Length of hospital stay
  • Not reported


Length of ICU stay
  • Not reported


Major adverse events
  • Not reported

Identification Sponsorship source: not stated
Country: France
Setting: not reported
Authors name: E Bonnefoy‐Cudraz
Institution: Hospital Louis Pradel of Bron, Intensive Cardiac Care, Lyon, France
Email: N/A
Address: N/A
Year: 2014
Notes Published as a conference abstract.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of selection not described.
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not described.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not described.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described.
Incomplete outcome data (attrition bias)
All outcomes High risk 2 participants randomised not included or accounted for in analysis.
Selective reporting (reporting bias) Low risk Outcomes were objective and described for all cases that were accounted for in analysis.
Other bias Unclear risk No information regarding how they dealt with minimising bias. The full paper has not been published.