Abstract 151: Outcomes Associated With Prophylactic Amiodarone Protocol in Patients Undergoing Cardiac Surgery: A Single Center Experience

Background: The incidence of post-operative atrial fibrillation (POAF) in patients undergoing cardiac surgery is approximately 25-40% and has significant consequences. One large randomized control trial demonstrated that the use of amiodarone prophylaxis decreases the incidence of POAF. To improve the quality of care for cardiac surgery patients and improve outcomes, an amiodarone prophylaxis protocol was implemented at our institution in July 2007. The protocol consisted of administering intravenous amiodarone (150 mg) after surgery, in patients without contraindications, followed by a week of 400 mg of oral amiodarone twice a day and 200 mg daily for one more week. In order to encourage utilization, an order care set was created in the electronic medical record system. We studied the effect of this intervention on practice and clinical outcomes. Methods: We included all patients ≥ 18 years of age without pre-existing atrial fibrillation, undergoing cardiac surgery in 5-year periods before and after the implementation of the amiodarone prophylaxis protocol in July 2007. Data were obtained from the Society of Thoracic Surgery (STS) National Database. The primary outcome was the rate of utilization of amiodarone and secondary outcomes were incidence of STS-defined POAF, stroke, myocardial infarction (MI) and 30-day mortality. Outcomes in the January 2002 to July 2007 time-period were compared with those in the September 2007 to June 2012 time-period. Results: From January 2002 to June 2012, 5473 patients underwent cardiac surgery. The mean age was 66 years, 69% were male and 93% were Caucasian. In the September 2007 to June 2012 time-period, 54% of patients (1303 of 2405) received amiodarone as compared to 11% of patients (330 of 3068) in the January 2002 to July 2007 time-period (p<0.01). The STS-defined incidence of POAF decreased in the September 2007 to June 2012 time-period as compared to the January 2002 to July 2007 time-period [36% (861 of 2405) vs. 38% (1178 of 3068), p= 0.04]. The incidence of stroke [4% (93 of 2405) vs. 6% (103 of 1696), p<0.01] and peri-operative MI [4% (90 of 2405) vs. 12% (378 of 3068), p<0.01] decreased as well but there was no change in 30 day mortality [2% (55 of 2405) vs. 2% (78 of 3068), p = 0.55]. Conclusions: Implementation of an amiodarone prophylaxis protocol order care set was associated with greater utilization of amiodarone. It was also associated with a modest decrease in the incidence of STS-defined POAF, stroke and MI but was not associated with a change in 30-day mortality in patients undergoing cardiac surgery. Further studies are needed to study the cost-effectiveness and risk-benefit analysis of routine amiodarone as prophylaxis.

The Use of NeuroAiD (MLC601) in Postischemic Stroke Patients

Aim. We aimed to assess the efficacy of MLC601 on functional recovery in patients given MLC601 after an ischemic stroke.Methods. This is a retrospective cohort study comparing poststroke patients given open-label MLC601 (; 9 female) for three months and matching patients who did not receive MLC601 from our Stroke Data Bank. Outcome assessed was modified Rankin Scale (mRS) at three months and analyzed according to: (1) achieving a score of 0-2, (2) achieving a score of 0-1, and (3) mean change in scores from baseline.Results. At three months, 21 patients on MLC601 became independent as compared to 17 patients not on MLC601 (OR 1.79; 95% CI 0.62–5.2; ). There were twice as many patients () on MLC601 who attained mRS scores similar to their prestroke state than in the non-MLC601 group () (OR 3.14; 95% CI 1.1–9.27; ). Mean improvement in mRS from baseline was better in the MLC601 group than in the non-MLC601 group (−1.7 versus −0.9; mean difference −0.73; 95% CI −1.09 to −0.38; ).Conclusion. MLC601 improves functional recovery at 3 months postischemic stroke. An ongoing large randomized control trial of MLC601 will help validate these results.

Nilotinib: A Review of its Use in Chronic Myelogenous Leukemia

Chronic myeloid leukemia (CML) is characterized by the reciprocal chromosomal translocation, t(9;22), forming the BCR-ABL oncogene known as the Philadelphia chromosome. The development of imatinib, a small-molecule kinase inhibitor targeted against BCR-ABL, has revolutionized the management of CML and significantly improved the prognosis and outcome and until very recently was the standard of care in patients presenting with newly diagnosed CML. Nilotinib (Tasigna®) is an orally administered kinase inhibitor made by the Novartis Pharmaceuticals Corporation that was rationally designed to bind to the ABL kinase domain of BCR-ABL resulting in enhanced BCR-ABL inhibition. It is well tolerated and has a favourable safety profile. Nilotinib has been shown to be effective in patients who have failed prior therapy with imatinib. Recently a large randomized control trial comparing imatinib and nilotinib has demonstrated that niloitinb is superior to imatinib in the frontline treatment of CML. This review summarizes the preclinical and clinical data supporting the use of nilotinib in the frontline and secondline treatment of CML.

Approach to maintaining comparability of biochemical data during long-term clinical trials

Our objective was to design a structured approach to maintaining comparability of biochemical data during a long clinical trial. Maintaining the comparability of clinical and biochemical data obtained in long-term studies is essential, even though analytical methods in the laboratory may be changed, conventions on specimen handling and storage revised, calibration procedures updated, quality-control systems replaced, and secular changes may occur. The United Kingdom Prospective Diabetes Study (UKPDS), a large randomized control trial investigating therapy for type 2 diabetes, was the setting for the study. Data were collected from 5102 subjects randomized since 1977. Our techniques included quality control, external quality assurance, direct comparison of laboratory methods when updating assays and statistical techniques for the detection of unsuspected changes in assay bias, laboratory comparisons of new with old assay methodologies, the realigning of data to current methods, the use of a suitable reference population for long-term monitoring, and rules to aid decision-making about clinical vs statistical significance. Procedures by which comparability of data is assured should be specified for all long-term trials and, where possible, comparison with reference methods should be detailed to allow results from different laboratories to be compared.