Abstract 3501: Azimilide Reduces Arrhythmic-Related ER visits and Hospitalizations in Patients with an ICD: Results from the SHIELD trial
Background: Many patients (pts) with ICDs require emergency room visits and hospitalizations (ER/Hosp) related to arrhythmias requiring ICD therapies. However, the long term effects of adjunctive antiarrhythmic therapy in ICD pts on ER/Hosp are not well established. The SHIELD study was a randomized controlled trial of 75 and 125 mg daily doses of azimilide (AZ) or placebo in pts with an ICD and a history of ventricular arrhythmias.
Methods and Results: A total of 633 pts were randomized in the SHIELD trial. Cardiac and arrhythmic ER/Hosp data were collected prospectively over 1 year. Baseline characteristics among groups were not different (mean [SD] age: 63 , female: 10%, EF≤40: 72%, NYHA Class II/III: 54%, history of MI: 64%; use of beta blockers: 77%; pre-existing ICD: 84%). All pts had symptomatic sustained VT (72%) or VF (28%) prior to study entry. Of 633 pts, 44% (n=276) experienced at least 1 cardiac-ER/Hosp. Out of these 276 pts, 185 (67%) experienced at least 1 arrhythmic-ER/Hosp. Cox regression model showed that AZ 75 and 125 mg significantly reduced arrhythmic ER/Hosp (figure⇓) compared to placebo, without significant difference between the two doses. For every 1000 pts treated with AZ 75 mg, 165 would avoid arrhythmic ER/Hosp (NNT=6). In a stepwise logistic regression model controlling for treatment, CHF (NYHA Class II/III) was the only independent clinical predictor of cardiac ER/Hosp.
Conclusion: Cardiac-related ER visits and hospitalizations are common in pts with an ICD. Azimilide reduces arrhythmic-related ER visits and hospitalizations in these pts.