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Table 1 Characteristics of included studies

From: Statin prophylaxis and inflammatory mediators following cardiopulmonary bypass: a systematic review

Trial Methods Participants Interventions Outcomes
Berkan et al.[28] Randomized but method not clear; unclear allocation concealment but adequate blinding; unclear risk of bias. CABG with CPB. Statin group n = 23, age, mean = 65.4, SD 11.2; control group n = 23, age, mean 67.7, SD 9.6.
Statin group duration of CPB, mean 122.4, SD 36.9; control group duration of CPB, mean 113, SD 27.2.
Fluvastatin 80 mg daily for 3 weeks before CPB. Control group received placebo in same manner. sP-selectin level; clinical outcomes (inotrope use, length of ICU and hospital stay, incidence of MI).
Caorsi et al.[29] Randomized but method not clear; unclear allocation concealment and not blinded; high risk of bias. CABG with CPB. Statin group n = 21, age, mean = 68.2, SD 7.2; control group n = 22, age, mean 67.9, SD 7.3.
Statin group duration of CPB, mean 93.8, SD 9.1; control group duration of CPB, mean 94.1, SD 7.7.
40 mg pravastatin daily from 48 hours prior to CPB to post-operative day 7; additional dose 1 hour after CPB. Control group received standard of care with no placebo. Both groups received aspirin 6 hours after CPB. Inflammatory cytokines
Chello et al. (2006)[30] Randomized but method not clear; unclear allocation concealment but adequate blinding; unclear risk of bias. a CABG with CPB. Statin group n = 15, age, mean = 65.7, SD 7.7; control group n = 15, age, mean 63.7, SD 7.1.
Statin group duration of CPB, mean 97, SD 5.5; control group duration of CPB, mean 94.3, SD 8.6.
Atorvastatin 20 mg daily for 3 weeks before CPB. Control group received placebo in same manner. Inflammatory cytokines; neutrophil adhesion and function; endothelial nitric oxide release; SIRS
Chello et al. (2007)[27] Randomized but method not clear; unclear allocation concealment but adequate blinding; unclear risk of bias. CABG with CPB. Statin group n = 15, age, mean = 67.7, SD 6.2; control group n = 15, age, mean 66.3, SD 7.5.
Statin group duration of CPB, mean 97.9 SD 19.4; control group duration of CPB, mean 102.5, SD 28.2.
Simvastatin 40 mg daily starting 3 weeks prior to CPB. Control group received placebo in same manner. Inflammatory cytokines; neutrophils apoptosis and function.
Florens et al.[33] Randomized but method not clear; unclear allocation concealment; not blinded; some patients received aprotinin, although indications not given; high risk of bias. b Heart surgery with CPB. Statin group n = 10, age, mean = 68, SD 18; control group n = 10, age, mean 62, SD 12. Statin group duration of CPB, mean 89, SD 24; control group duration of CPB, mean 93, SD 35. Atorvastatin 40 mg 18 hrs pre-operatively and 40 mg immediately pre-operatively. Control group received standard of care with no placebo. Inflammatory cytokines;atrial biopsy for nuclear factor kappa B; clinical outcomes (ventilation time, fever, leukocytosis, renal dysfunction, MI, inotrope use)
Mannacio et al.[31] Randomized; allocation concealed and adequate blinding; low risk of bias. CABG with CPB. Statin group n = 100, age, mean 61.3, SD 9.2; control group n = 100, age, mean 59.3, SD 8.4.
Statin group duration of CPB, mean 80.6, SD 22.4; control group duration of CPB, mean 83.8, SD 25.2
Rosuvastatin 20 mg daily starting 7 days before CPB; Control group received placebo in same manner. hsCRP; myocardial damage; atrial fibrillation; low output syndrome; renal failure
Patti et al.[32] Randomized; allocation concealed and adequate blinding; low risk of bias. Heart surgery with CPB (CABG, valve repair, aortic aneurysm repair). Statin group n = 101, age, mean 65.5, SD 8.8; control group n = 99, age, mean 67.3, SD 8.1. Statin group duration of CPB, mean 113, SD 37; control group duration of CPB, mean 105, SD 30. Atorvastatin 40 mg daily for 7 days before CPB; continued day after surgery until discharge. Control group received placebo in same manner. Post-operative atrial fibrillation; length of post-operative hospital stay; major cardiac/cerebrovascular adverse events; hsCRP levels.
Tamayo et al.[24] Randomized but method not clear; unclear allocation concealment; state that except for perfusionist, no member of medical team knew what group patient was randomized to; however there was no placebo given. Blinding of investigators is unclear. c CABG with CPB. Statin group n = 22, age, mean 67.7, SD 7.3; control group n = 22, age, mean 68, SD 6.9. Statin group duration of CPB, mean 106.8, SD 26.9; control group duration of CPB, mean 96.2, SD 24.6. Simvastatin 20 mg/day for 3 weeks before surgery versus no pre-operative simvastatin treatment. hsCRP; IL-6; C4; clinical outcomes (renal dysfunction, ventilation).
  1. CABG = coronary artery bypass graft; CPB = cardiopulmonary bypass; C4 = complement component 4; hsCRP = high sensitivity C-reactive protein; ICU = intensive care unit; IL-6 = interleukin-6; MI = myocardial infarction; SD = standard deviation; SIRS = systemic inflammatory response score; sP-selectin = soluble P-selectin
  2. a No response to letter requesting details.
  3. b Statistical tests requiring the assumption of normal distribution were used to detect between-group differences in cytokine levels (despite small sample size and no confirmation that data was indeed normally distributed, graphical representation suggests that data is likely skewed).
  4. c Data in the original paper is presented in graphical form. The author was contacted and provided exact point estimates and variability of the data which was not included in the published form.