ABSTRACT
BACKGROUND: Prior retrospective studies have suggested that tacrolimus monotherapy is an option associated with excellent outcomes and reduced toxicities. METHOD: We conducted a prospective, randomized, 2-center study of tacrolimus combination therapy vs monotherapy. From April 16, 2004, to September 15, 2005, 58 adult heart transplant patients were studied. All received oral tacrolimus, mycophenolate mofetil, and corticosteroids. Patients were then randomized to a group where mycophenolate was maintained (COMBO) or to a group where it was discontinued (MONO) 14 days post-transplant. Corticosteroids were rapidly withdrawn in both groups between 8 and 12 weeks. RESULT: The primary end point (mean 6-month International Society of Heart and Lung Transplantation biopsy score) was 0.44 +/- 0.04 in the MONO group and 0.60 +/- 0.05 in the COMBO group (p = 0.013, unpaired Student's t-test). The freedom from rejection grade of 2R or higher at 6 and 12 months was 93.3% with MONO and 92.9% with COMBO (p = NS). CONCLUSION: Tacrolimus monotherapy appears to be safe and efficacious in heart transplant recipients and is not associated with excess rejection in the first year post-transplant. Further studies of this approach are warranted.
Subject(s)
Heart Transplantation , Immunosuppressive Agents/therapeutic use , Mycophenolic Acid/analogs & derivatives , Tacrolimus/therapeutic use , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Cytomegalovirus Infections/chemically induced , Drug Administration Schedule , Drug Therapy, Combination , Female , Graft Survival , Humans , Immunosuppressive Agents/adverse effects , Male , Middle Aged , Mycophenolic Acid/adverse effects , Mycophenolic Acid/therapeutic use , Postoperative Complications , Tacrolimus/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Octogenarians are increasingly being referred for coronary artery revascularization. However, the prevalence of comorbid events and the propensity for neurologic dysfunction place octogenarians at higher risk for cardiopulmonary bypass-induced morbidity and mortality. Therefore, octogenarian patients represent a particularly attractive target for application of off-pump coronary artery bypass grafting. METHODS: From January 1999 to August 2001, 113 octogenarians had off-pump coronary artery bypass grafting. Their data were prospectively entered into the cardiac surgery database and analyzed retrospectively. Follow-up information was obtained through telephone survey. RESULTS: The mean age of the patients was 83 +/- 2.5 years, and the mean number of grafts per patient was 3.3 +/- 1. The most prevalent postoperative complication was atrial fibrillation (43%). Postoperative neurologic complications were seen in 5 patients (4%). There was one postoperative death (30-day mortality rate, 0.9%). The mean follow-up was 13.2 +/- 7 months and was complete for 90% of the patients. At the time of telephone survey, 85 (87%) of 98 patients were free from angina, and 91 (88%) were free from cardiac-related readmission. There were three late deaths. The majority of octogenarians (66%) reported that in retrospect, they would have the operation again. CONCLUSIONS: Off-pump multivessel revascularization in octogenarians is associated with excellent early and intermediate outcomes and provides a satisfactory quality of life.
