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Landmark Study Questions routine Care for Atrial Fibrillation

Uppsala, Sweden – September 1, 2025 – A landmark study presented today at ESC Congress 2025 casts doubt on whether a highly individualized treatment approach improves outcomes for patients with atrial fibrillation (AF). The ABC-AF trial, conducted across 39 Swedish sites, found no meaningful benefit in stroke or death rates when treatment decisions were guided by biomarker-based risk scores compared to standard, guideline-based care.

Atrial fibrillation increases the risk of stroke, and oral anticoagulants (OACs) are a cornerstone of prevention. Though, OACs carry a risk of bleeding, necessitating a careful risk-benefit assessment. Current European Society of Cardiology (ESC) guidelines recommend a risk-based approach to treatment, and researchers have developed biomarker-based scores – such as the ABC-AF-stroke and ABC-AF-bleeding scores – to aid in those assessments.

The ABC-AF trial aimed to determine if tailoring treatment recommendations based on these scores led to better clinical outcomes. 3,933 patients with AF were randomized to either receive treatment guided by ABC-AF risk scores or usual care. Investigators receiving the risk score facts were provided with tailored treatment recommendations.Notably, the trial was prematurely terminated due to safety concerns – a trend towards higher mortality in patients with higher CHA2DS2-VASc scores (a pre-existing risk score).

Key Findings:

After a median follow-up of 2.6 years, there was no significant difference in the rate of stroke or death between the two groups (hazard ratio 1.19,95% confidence interval 0.96-1.4).
The proportion of patients receiving any OAC increased in both groups, rising to 97.8% in the risk-score guided arm and 92.6% in the standard care arm.
There were shifts in the types of OACs used, with increased use of apixaban and dabigatran, and reduced use of rivaroxaban and warfarin in the risk-score group.
Use of antiplatelet therapy was halved in both groups, while statin use increased.

“While novel biomarker-based risk scores have been validated in different populations, the clinical utility of risk scores to guide treatment decisions and improve clinical outcomes has rarely been prospectively evaluated,” explained Professor Jonas Oldgren, the study’s principal investigator from Uppsala University. “Our study suggests that, in routine clinical practice, these scores do not necessarily translate to improved outcomes.”

Implications:

The findings challenge the assumption that individualized treatment based on biomarker-based risk scores automatically leads to better outcomes for AF patients. Further research is needed to understand why the ABC-AF trial did not demonstrate a benefit, and to explore whether specific patient subgroups might be more likely to benefit from such a tailored approach.

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risk-Adapted Treatment for Atrial Fibrillation Yields No Better Outcomes Than Standard Approaches

Dr. priya Deshmukh, MD, FACC

atrial fibrillation (AFib), a common heart rhythm disorder, affects millions worldwide. For years, the medical community has explored whether tailoring AFib treatment – a strategy known as risk-adapted therapy – could improve patient outcomes compared too the more traditional, “one-size-fits-all” approach.Recent research, though, suggests this isn’t necessarily the case. This article delves into the findings,exploring why risk stratification in atrial fibrillation hasn’t translated into superior results,and what this means for AFib management going forward.

Understanding Risk Stratification in AFib

The core idea behind risk adaptation is to identify patients at higher risk of stroke or other complications and intensify their treatment accordingly. Several AFib risk scores are used, including:

CHA2DS2-VASc score: This is the most widely used tool, assessing risk factors like Congestive heart failure, Hypertension, Age ≥75, Diabetes mellitus, Stroke/TIA/Thromboembolism history, Vascular disease, Age 65-74, and Sex category (female).

HAS-BLED score: Focuses on bleeding risk factors – Hypertension,abnormal renal/liver function,Stroke,Bleeding history or predisposition,Labile INR,Elderly (age >65),Drugs/alcohol abuse,and Genetics.

EHRA-AFAST score: Specifically evaluates symptoms and their impact on quality of life.

The ARISTOTLE II trial: This study, examining different doses of apixaban (an anticoagulant) based on creatinine clearance, found no meaningful difference in outcomes between the risk-adapted and standard-dose groups.

The RE-LY trial follow-up: Long-term follow-up data from the RE-LY trial, comparing dabigatran to warfarin, showed that tailoring the dose of dabigatran based on renal function didn’t improve outcomes.

Catheter Ablation Studies: While AFib ablation is a cornerstone of rhythm control, studies attempting to selectively ablate based on AFib burden or substrate complexity haven’t consistently demonstrated superior efficacy compared to a more standardized ablation approach.

These findings suggest that while risk assessment for AFib is crucial for identifying risk, it doesn’t necessarily translate into improved outcomes when used to guide treatment intensity.The complexity of AFib pathophysiology appears to outweigh the benefits of fine-tuning treatment based solely on these scores.

Why Isn’t Risk adaptation Working as was to be expected?

Several factors may contribute to the lack of benefit from risk-adapted approaches:

1. Imperfect Risk Scores: Existing risk scores, while helpful, aren’t perfect predictors of individual patient outcomes. They capture vital factors but miss nuances in individual physiology and lifestyle.
2. Treatment Adherence: Even with a tailored plan, patient adherence to medication and lifestyle recommendations remains a significant challenge. Non-adherence can negate the benefits of any treatment strategy.
3. Drug-Drug Interactions & Comorbidities: Patients with AFib often have multiple co-existing conditions and take numerous medications, increasing the risk of interactions and complicating treatment decisions.
4. The “Threshold Effect” of Anticoagulation: For stroke prevention, achieving adequate anticoagulation is often more important than precisely tailoring the dose. Once a certain level of anticoagulation is reached, further dose adjustments may not yield significant additional benefit.
5. AFib Subtypes: The growing understanding of different AFib types (paroxysmal, persistent, long-standing persistent) suggests that treatment strategies may need to be tailored to the subtype of AFib, rather than solely relying on overall risk scores.

Implications for Clinical Practice: What Does This Mean for Doctors and Patients?

The recent research doesn’t invalidate the importance of AFib risk assessment. It does suggest a shift in focus.

Prioritize Adequate Anticoagulation: For patients requiring anticoagulation, ensuring they receive an appropriate dose and adhere to their medication regimen is paramount. Regular monitoring and patient education are crucial.

Focus on Complete Management: AFib treatment should encompass more than just medication. Lifestyle modifications (diet, exercise, weight management, limiting alcohol) and management of co-existing conditions (hypertension, diabetes, sleep apnea) are equally critically important.

Individualized, But Not Necessarily Risk-Adapted: Treatment plans should be individualized based on patient preferences, co-morbidities, and potential drug interactions, but not solely dictated by risk scores.

Continued Research: Further research is needed to identify biomarkers and imaging techniques that can more accurately predict individual patient outcomes and guide treatment decisions. Exploring the role of genetic testing in AFib may also prove valuable.

Embrace Shared Decision-Making: Engage patients in the decision-making process, discussing the risks and benefits of different treatment options and considering their individual values and preferences.

Simplicity: Easier to implement and manage in clinical practice.

Cost-Effectiveness: avoids the need for extensive and potentially expensive testing to refine risk scores.

Reduced Variability: Minimizes variations in care, ensuring all patients receive a baseline level of quality treatment.

Improved Patient Education: Focuses on empowering patients to manage their condition through lifestyle modifications and medication adherence.

Take your medication as prescribed. Don’t skip doses or adjust your dosage without consulting your doctor.

Maintain a healthy lifestyle. Eat a heart-healthy diet, exercise regularly, and maintain a healthy weight.

Limit alcohol consumption.

Manage your other health conditions. Control your blood pressure, cholesterol, and diabetes.

Attend regular check-ups. Discuss any concerns or side effects with your doctor.

* Know your risk score. Understand your individual risk of stroke and bleeding.

Keywords: Atrial Fibrillation, AFib, Risk Stratification, Anticoagulation, Stroke Prevention, AFib Treatment, CHA2DS2-VASc, HAS-BLED, AFib Ablation, direct Oral Anticoagulants (DOACs), Warfarin,