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Withdrawal of Neurohumoral Blockade After CRT
Study Questions:
What is the feasibility and safety of neurohumoral blocker withdrawal in patients with normalized ejection fractions after cardiac resynchronization therapy (CRT)?
Methods:
The investigators randomized 80 subjects to withdrawal of renin-angiotensin-aldosterone system inhibitors and/or beta-blockers versus continuation of treatment in this prospective, open-label, randomized, controlled pilot trial with a 2 x 2 factorial design. The primary endpoint was a recurrence of negative remodeling, defined as an increase in left ventricular (LV) end-systolic volume index of >15% at 24 months. The secondary endpoint was a composite safety endpoint of all-cause mortality, heart failure–related hospitalizations, and incidence of sustained ventricular arrhythmias at 24 months. Kaplan-Meier survival plots were used to display the time to the primary and secondary endpoints. The log-rank test was used to formally compare the Kaplan-Meier curves.
Results:
Eighty subjects were consecutively enrolled and randomized among four groups (continuation of neurohumoral blocker therapy, n = 20; withdrawal of renin-angiotensin-aldosterone system inhibitors, n = 20; withdrawal of beta-blockers, n = 20; and withdrawal of renin-angiotensin-aldosterone system inhibitors and beta-blockers, n = 20). Of the 80 subjects, six (7.5%) met the primary and four (5%) the secondary endpoint. However, re-initiation of neurohumoral blockers occurred in 17 subjects because of hypertension or supraventricular arrhythmias.
Conclusions:
The authors concluded that the incidence of the primary and secondary endpoints over a follow-up period of 2 years was low in both the control group and in the groups in which neurohumoral blockers were discontinued.
Perspective:
This pilot study of patients with normalized ejection fractions after CRT reports that it was feasible to withdraw neurohumoral blockers in two thirds of subjects without observing changes in clinical condition, LV volume, and natriuretic peptides over a follow-up period of 2 years. In the small proportion of subjects in whom increases in LV volume were observed, prompt reinitiation of neurohumoral blockers led to recovery within 6 months. Additional prospective larger trials are indicated to confirm the equivalence of neurohumoral blocker discontinuation after LV function recovery and to assess optimal treatment strategies in patients with HF who undergo CRT with recovery of ejection fraction.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure, Hypertension
Keywords: Adrenergic beta-Antagonists, Arrhythmias, Cardiac, Cardiac Resynchronization Therapy, Heart Failure, Hypertension, Natriuretic Peptides, Renin-Angiotensin System, Secondary Prevention, Stroke Volume
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