title: Multicentric outcome analysis of sirolimus-based immunosuppression in 252 liver transplant recipients.
abstract: The use of sirolimus (SRL) in orthotopic liver transplantation (OLT) has been controversial after experimental data suggested an increased risk of hepatic artery thrombosis (HAT). To assess the safety and efficacy of SRL as de novo immunosuppression in OLT recipients. Outcomes of 252 OLT patients who received SRL were compared with outcomes of 291 OLT recipients who received calcineurin inhibitor in a retrospective study. Primary outcomes of this study were: patient- and graft survivals, vascular, biliary, wound complications and rejection rates. Secondary outcomes were: postoperative infection rate, bone marrow and renal function and changes of lipid levels. Patient- and graft survivals, rejection and infection rates were similar. In the SRL group, HAT occurred in 1.2%, biliary complications in 19.4%, and incisional hernias in 9.1%. In the control group the incidence of HAT was 5.8% (P = 0.004), biliary complications 18.5% (P = NS) and incisional hernias 7.2% (P = NS). Patients on SRL experienced significantly higher levels of serum triglycerides but fewer acute cellular rejections. Bone marrow and renal functions were similar in both the groups. Our findings would suggest that SRL is safe and effective for very selected OLT recipients. Randomized controlled trials are necessary to confirm our results.
authors.affiliation: Department of Surgery, Dalhousie University Medical Center, Halifax, NS, Canada. michele.molinari@cdha.nshealth.ca
authors.forename: Michele
authors.initials: M
authors.lastname: Molinari
authors.forename: Kenneth
authors.initials: K
authors.lastname: Berman
authors.forename: Glenda
authors.initials: G
authors.lastname: Meeberg
authors.forename: James A
authors.initials: JA
authors.lastname: Shapiro
authors.forename: David
authors.initials: D
authors.lastname: Bigam
authors.forename: James F
authors.initials: JF
authors.lastname: Trotter
authors.forename: Norman
authors.initials: N
authors.lastname: Kneteman
mesh_terms: D000328:Adult; D001649:Bile Duct Diseases / Q000209:etiology; D001853:Bone Marrow / Q000502:physiology; D065095:Calcineurin Inhibitors; D015331:Cohort Studies; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival; D006499:Hepatic Artery; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000502:physiology; D008055:Lipids / Q000097:blood; D016031:Liver Transplantation / Q000009:adverse effects / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000209:etiology; D011183:Postoperative Complications / Q000209:etiology; D012189:Retrospective Studies; D020123:Sirolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013530:Surgical Wound Infection / Q000209:etiology; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D008055:Lipids; D020123:Sirolimus