GDMT Withdrawal After AF Ablation Linked to 13% Heart Failure Deterioration in Pilot RCT

Withdrawal of guideline-directed medical therapy (GDMT) for heart failure (HF) is a common practice after successful atrial fibrillation (AF) catheter ablation and subsequent recovery of cardiac function. However, the safety profile of this approach remains largely uncertain, posing a significant clinical dilemma. Current GDMT protocols are designed for long-term management of HF, and discontinuing these therapies, even in patients with improved left ventricular ejection fraction (LVEF), could potentially lead to adverse outcomes. This study addresses the critical gap in understanding the feasibility and safety of such phased GDMT withdrawal.

This open-label pilot randomized clinical trial enrolled 50 adult patients at Beijing Anzhen Hospital, China, from April 2023 to September 2024, with a 6-month follow-up. Eligible patients had highly suspected AF-mediated cardiomyopathy at 3 months post-ablation, characterized by sustained sinus rhythm, LVEF improvement from ≤45% to ≥55%, normalized LV end-diastolic diameter (LVEDD), NT-proBNP levels <250 ng/L, and no HF symptoms. Patients were randomized 1:1 to either phased GDMT withdrawal or GDMT continuation. The primary endpoint was HF deterioration, defined by specific criteria including LVEF decline >10% to <55%, LVEDD increase >10%, NT-proBNP doubling to >400 ng/L, or worsening HF symptoms.

Among 50 patients randomized, 47 completed the 6-month follow-up (23 in the GDMT withdrawal group, 24 in the continuation group). The median age was 56.0 years (IQR 48.0-60.5 years), with 37 males (78.7%). The primary endpoint of HF deterioration occurred in 3 patients in the GDMT withdrawal group. This translates to a deterioration rate of 13.0% within the 6-month follow-up period for those discontinuing therapy. The abstract does not provide the rate of HF deterioration in the GDMT continuation group, preventing a direct comparison of efficacy. Secondary outcomes, including cardiovascular events, changes in echocardiographic and cardiac magnetic resonance (CMR) parameters, NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scores, atrial arrhythmia recurrence, and adverse drug events, were also assessed, but specific numerical results for these endpoints were not detailed in the abstract. This pilot study primarily focused on establishing the feasibility and initial safety signals. The observed deterioration rate highlights a potential risk.