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

Grygier 2011.

Methods Date of publication: 2011
 Design: not reported
 Allocation: randomised
 Country: Poland
Participants Diagnosis: acute STEMI for PPCI
Number: 70 (adenosine 35; control 35)
Age, years: adenosine (mean 65.3 ± 11), control (mean 64.5 ± 13)
Sex: 63% men
Inclusion: referred for PPCI within 6 hours of symptoms; culprit lesion was suitable for PCI and had presented with TIMI flow 0 to 2
Exclusion: chronic obstructive pulmonary disease or asthma; those who had received previous thrombolysis; patients presenting with TIMI flow 3
Withdrawals or losses to follow‐up: not reported
Interventions Adenosine
  • Dose: 2 mg to the left or 1 mg to the right coronary artery in 10 mL 0.9% NaCl × 2 times

  • Route of administration: intracoronary

  • Timing: during PPCI, immediately after crossing the lesion by guide wire and after the first balloon inflation


Control
  • Dose: 10 mL 0.9% NaCl × 2 times

  • Route of administration: intracoronary

  • Timing: during PPCI, immediately after crossing the lesion by guide wire and after the first balloon inflation

Outcomes
  • Death

  • Non‐fatal MI

  • TIMI (RR 0.38, 95% Cl 0.11 to 1.30)

  • MBG

  • Side effects: bradycardia, hypotension, AV block (not useable)


Follow‐up: 1 month
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "the patient was included in the present study and randomized after informed consent had been given"; no further description
Allocation concealment (selection bias) Unclear risk Not stated
Blinding (performance bias and detection bias) 
 All outcomes Low risk "Angiograms were reanalyzed as a single group by 2 observers, who had not participated in the invasive procedure and were unaware of the treatment received"
"MBG was assessed by 2 observers who were unaware of the others' findings and of the clinical data"
"physicians in charge of the patients on the coronary care floor were informed of the angiographic results of the primary PCI but were unaware of the study treatment administered during the procedure"
"The electrocardiograms were analysed in a blinded fashion by an experienced cardiologist"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No incomplete outcome data
Selective reporting (reporting bias) Low risk All outcomes stated in Methods are reported in Results
Other bias Low risk Not obvious