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). |