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. 2015 May 18;2015(5):CD009503. doi: 10.1002/14651858.CD009503.pub3

Fokkema 2009.

Methods Date of publication: 2009
 Design: not reported
 Allocation: randomised
 Country: Netherlands
Participants Diagnosis: acute STEMI for PPCI
Number: 448 (adenosine 226; control 222)
Age, years: adenosine (mean 62.4 ± 12.2); control (mean 62.5 ± 13.0)
Sex: 75% men
Inclusion: chest pain suggestive of myocardial ischaemia for at least 30 minutes; time from onset of symptoms of 12 hours before hospital admission; and ECG showing ST‐segment elevation of 0.1 mV in 2 or more leads
Exclusion: cardiogenic shock; presence of a life‐threatening disease with a life expectancy of 6 months; receiving pharmacotherapy for chronic obstructive pulmonary disease; no informed consent
Withdrawals or losses to follow‐up: not reported
Interventions Adenosine
  • Dose: 2 high‐dose boluses (2 × 120 μg in 20 mL 0.9% NaCl)

  • Route of administration: intracoronary

  • Timing: during PPCI, after thrombus aspiration and after stenting


Control
  • Dose: 2 × 20 mL 0.9% NaCl

  • Route of administration: intracoronary

  • Timing: during PPCI, after thrombus aspiration and after stenting

Outcomes
  • All‐cause death at short term

  • Non‐fatal MI (reinfarction)

  • TIMI (RR 0.92, 95% Cl 0.44 to 1.90)

  • MBG

  • Side effects: bradycardia, hypotension, AV block

  • Treatment cost: not reported

  • Quality of life: not reported


Follow‐up: 30 days (collected from hospital records, written questionnaires and telephone interviews)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised, no further description
Allocation concealment (selection bias) High risk "a single‐center, prospective randomized open trial with blinded evaluation of end points"
Blinding (performance bias and detection bias) 
 All outcomes Low risk "Coronary angiograms were reviewed by 2 observers blinded for treatment allocation and clinical data"
"QuBE was measured blinded to clinical data and treatment allocation by 2 observers"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No withdrawals or drop‐outs were reported, but for some outcomes not all participant data were addressed, with no reason given. Missing outcome data were balanced across groups
Selective reporting (reporting bias) Low risk All outcomes stated in Methods are reported in Results
Other bias Low risk Not obvious