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Early Rhythm Control in AF and High Comorbidity Burden
Quick Takes
- Systematic early rhythm control (ERC) therapy reduces cardiovascular complications compared with usual care (UC) in patients with a high comorbidity burden, defined by a CHA2DS2-VASc score ≥4.
- Among patients with fewer comorbidities, reflected by CHA2DS2-VASc scores of 2 or 3, ERC therapy does not reduce outcomes compared with UC.
- These hypothesis-generating data suggest that older patients with recently diagnosed AF and multiple comorbidities may be preferentially treated with ERC; however, dedicated trials are needed to validate the findings given this was a subanalysis.
Study Questions:
What is the effectiveness and safety of early rhythm control (ERC) therapy in patients with atrial fibrillation (AF) and multiple comorbidities?
Methods:
The investigators conducted a prespecified subanalysis of the randomized EAST-AFNET4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial) trial and assessed whether presence of cardiovascular comorbidities as summarized by a high CHA2DS2-VASc score modifies the treatment effect of ERC therapy in the EAST-AFNET4 data set. The analysis stratified cohorts into patients with higher (CHA2DS2-VASc score ≥4) and lower comorbidity burden. Sensitivity analyses ignored sex (CHA2DS2-VASc score).
Results:
EAST-AFNET4 randomized 1,093 patients with CHA2DS2-VASc score ≥4 (aged 74.8 ± 6.8 years, 61% female) and 1,696 with CHA2DS2-VASc score <4 (67.4 ± 8.0 years, 37% female). ERC reduced the composite primary efficacy outcome of cardiovascular death, stroke, or hospitalization for worsening of heart failure or for acute coronary syndrome in patients with CHA2DS2-VASc score ≥4 (ERC, 127/549 patients with events; usual care [UC], 183/544 patients with events; hazard ratio [HR], 0.64 [0.51–0.81]; p < 0.001) but not in patients with CHA2DS2-VASc score <4 (ERC, 122/846 patients with events; UC, 133/850 patients with events; HR, 0.93 [0.73–1.19]; p = 0.56, p for interaction = 0.037).
The primary safety outcome (death, stroke, or serious adverse events of rhythm control therapy) was not different between study groups in patients with CHA2DS2-VASc score ≥4 (ERC, 112/549 patients with events; UC, 132/544 patients with events; HR, 0.84 [0.65–1.08]; p = 0.175), but occurred more often in patients with CHA2DS2-VASc scores <4 randomized to ERC (ERC, 119/846 patients with events; UC, 91/850 patients with events; HR, 1.39 [1.05–1.82]; p = 0.019, p for interaction = 0.008). Life-threatening events or death was not different between groups (CHA2DS2-VASc score ≥4, ERC, 84/549 patients with event, UC, 96/544 patients with event; CHA2DS2-VASc scores <4, ERC, 75/846 patients with event, UC, 73/850 patients with event). When female sex was ignored for the creation of higher- and lower-risk groups (CHA2DS2-VA score), the p interaction was not significant for the primary efficacy outcome (p = 0.25), but remained significant (p = 0.044) for the primary safety outcome.
Conclusions:
The authors reported that patients with recently diagnosed AF and CHA2DS2-VASc score ≥4 should be considered for ERC to reduce cardiovascular outcomes, whereas those with fewer comorbidities may have less favorable outcomes with ERC.
Perspective:
These prespecified subanalyses of EAST-AFNET4 suggest that systematic ERC therapy reduces cardiovascular complications compared with usual care (UC) in patients with a high comorbidity burden, defined by a CHA2DS2-VASc score ≥4. On the other hand, among patients with fewer comorbidities, reflected by CHA2DS2-VASc scores of 2 or 3, ERC therapy does not reduce outcomes compared with UC. Furthermore, rhythm control therapy is associated with an increase in serious adverse events attributable to bradycardia or drug toxicity among patients with fewer comorbidities and the risk/benefit of ERC may not be favorable. These hypothesis-generating data suggest that older patients with recently diagnosed AF and multiple comorbidities may be preferentially treated with ERC; however, dedicated trials are needed to validate these findings given this was a subanalysis.
Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Prevention, Anticoagulation Management and ACS, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Acute Coronary Syndrome, Anti-Arrhythmia Agents, Anticoagulants, Arrhythmias, Cardiac, Bradycardia, Comorbidity, Geriatrics, Heart Failure, Risk, Secondary Prevention, Stroke, Treatment Outcome
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