WITHDRAWAL OF BETA BLOCKERS AND ACE INHIBITORS AFTER LEFT VENTRICLE RECOVERY IN DILATED CARDIOMYOPATHY A RANDOMIZED CONTROL TRIAL
CCC ePoster Library. Giannetti N. 10/26/19; 280534; 299
Dr. Nadia Giannetti
Dr. Nadia Giannetti
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Abstract
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BACKGROUND: Recovery of left ventricle (LV) systolic function with normalization of ejection fraction (LVEF) occurs in 10 - 27% of patients with 80% maintaining recovery. However, the need for medical therapy after recovery is often questioned. Previous randomized studies of treatment withdrawal were small, not selected for non-ischemic dilated cardiomyopathy (DCM) and had a reference of improved or recovered EF to > 40% or > 10% change from LVEF at time of diagnosis.

METHODS AND RESULTS: Hypothesis: In patients with DCM with recovery of the LV systolic function to an EF (>50%), medical therapy withdrawal is possible without rebound LV systolic dysfunction. Method: This was a pilot randomized control open-label trial with 2:1 randomization for withdrawal of b-blockers and ACE inhibitors in patients with recovered LV systolic function. Patients' medication discontinuation occurred in 2 phases with a six-month interval and patients were followed for one year. In phase 1, the b-blockers were withdrawn. In phase II, the ACE inhibitors were withdrawn. The primary endpoint was LVEF reduction ( < 40%). Results: There were 22 patients (10 females) enrolled. The mean age was 60 ± 12y. The mean LVEF at enrollment was 58 ± 5% with no significant difference in the mean LVEF in both groups. Sixteen patients were assigned to the withdrawal group and 6 assigned to the control group. The primary endpoint occurred in 44% of the withdrawal group compared none of control. Event free survival at 6 month and 1 year were 87.5% and 73% respectively, p-value 0.087. The mean LVEF at 1 year for the treatment withdrawal group was 46.8 ± 12% and control 55 ± 6%. The mean LVEF reduction was 10.6 ± 11%. The difference in the mean between the groups at 1 year was 8% with 95% CI (-3.3,20) at p-value 0.15. The difference in the mean LVEF at enrollment and at 1 year follow up for the medication withdrawal group was 10.6 ± 11% and 95% CI (4.6,16.49) with p-value 0.0017.

CONCLUSION: In DCM patients with recovery of LV systolic function, we observed worsening of LVEF after withdrawal of b-blockers and ACE inhibitors.
BACKGROUND: Recovery of left ventricle (LV) systolic function with normalization of ejection fraction (LVEF) occurs in 10 - 27% of patients with 80% maintaining recovery. However, the need for medical therapy after recovery is often questioned. Previous randomized studies of treatment withdrawal were small, not selected for non-ischemic dilated cardiomyopathy (DCM) and had a reference of improved or recovered EF to > 40% or > 10% change from LVEF at time of diagnosis.

METHODS AND RESULTS: Hypothesis: In patients with DCM with recovery of the LV systolic function to an EF (>50%), medical therapy withdrawal is possible without rebound LV systolic dysfunction. Method: This was a pilot randomized control open-label trial with 2:1 randomization for withdrawal of b-blockers and ACE inhibitors in patients with recovered LV systolic function. Patients' medication discontinuation occurred in 2 phases with a six-month interval and patients were followed for one year. In phase 1, the b-blockers were withdrawn. In phase II, the ACE inhibitors were withdrawn. The primary endpoint was LVEF reduction ( < 40%). Results: There were 22 patients (10 females) enrolled. The mean age was 60 ± 12y. The mean LVEF at enrollment was 58 ± 5% with no significant difference in the mean LVEF in both groups. Sixteen patients were assigned to the withdrawal group and 6 assigned to the control group. The primary endpoint occurred in 44% of the withdrawal group compared none of control. Event free survival at 6 month and 1 year were 87.5% and 73% respectively, p-value 0.087. The mean LVEF at 1 year for the treatment withdrawal group was 46.8 ± 12% and control 55 ± 6%. The mean LVEF reduction was 10.6 ± 11%. The difference in the mean between the groups at 1 year was 8% with 95% CI (-3.3,20) at p-value 0.15. The difference in the mean LVEF at enrollment and at 1 year follow up for the medication withdrawal group was 10.6 ± 11% and 95% CI (4.6,16.49) with p-value 0.0017.

CONCLUSION: In DCM patients with recovery of LV systolic function, we observed worsening of LVEF after withdrawal of b-blockers and ACE inhibitors.
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