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OPTIMAS Trial Challenges Guidelines: Early Anticoagulation Safe After Ischemic Stroke In Atrial Fibrillation

UK: In a recent study known as OPTIMAS, researchers have found that initiating direct oral anticoagulants (DOACs) within four days of an ischaemic stroke associated with atrial fibrillation is as safe as delaying treatment. The findings were published online in The Lancet.

This multicentre, phase 4, randomised controlled trial involving blinded endpoints revealed that starting DOAC therapy within four days following an ischemic stroke related to atrial fibrillation (AF) showed comparable safety to delayed initiation, with no significant difference in the composite outcomes of ischemic stroke, intracranial hemorrhage, unclassifiable stroke, or systemic embolism at 90 days.

Traditionally, guidelines have recommended postponing the initiation of anticoagulation therapy following an ischaemic stroke. This cautious approach aims to mitigate the risks of potential complications, such as further strokes or intracranial hemorrhages.

"Our findings challenge the widely accepted practice and guidelines that recommend delaying DOAC initiation following an ischemic stroke in patients with atrial fibrillation," the researchers wrote.

Prof David J Werring, University College London Queen Square Institute of Neurology, London, UK, and colleagues examined the efficacy and safety of starting DOACs early versus delaying their initiation in patients experiencing acute ischemic stroke related to AF.

For this purpose, the researchers conducted a multicentre, open-label, blinded-endpoint, parallel-group, phase 4 randomized controlled trial at 100 UK hospitals. Adults with atrial fibrillation and a clinical diagnosis of acute ischemic stroke, whose physicians were uncertain about the timing of DOAC initiation, were included. Participants were randomly assigned (1:1) to receive anticoagulation either early (≤4 days post-stroke) or delayed (7–14 days).

While participants and clinicians were aware of treatment assignments, outcomes were adjudicated by a masked independent committee reviewing clinical records and imaging reports. The primary outcome measured was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, unclassifiable stroke, or systemic embolism within 90 days in a modified intention-to-treat population. The study employed a gatekeeper approach for sequential testing of a non-inferiority margin of 2 percentage points, followed by superiority testing.

The following were the key findings of the study:

  • Between July 5, 2019, and January 31, 2024, 3,648 patients were randomly assigned to either early or delayed initiation of DOACs.
  • After excluding 27 participants who did not meet eligibility criteria or withdrew consent, 3,621 patients were included in the modified intention-to-treat analysis (1,814 in the early group and 1,807 in the delayed group; 1,981 men and 1,640 women).
  • The primary outcome occurred in 3.3% of participants in both the early and delayed groups (adjusted risk difference [RD] 0.000).
  • The upper limit of the 95% CI for the adjusted RD was below the non-inferiority margin of 2 percentage points, but superiority was not demonstrated.
  • Regarding symptomatic intracranial hemorrhage, 0.6% in the early group experienced this outcome, compared to 0.7% in the delayed group (adjusted RD 0.001).
  • The OPTIMAS trial has demonstrated that early initiation of direct oral anticoagulants after ischemic stroke associated with AF is non-inferior to delayed initiation regarding the composite outcomes of ischemic stroke, intracranial hemorrhage, unclassifiable stroke, or systemic embolism within 90 days. There was no increase in the risk of intracranial hemorrhage, nor was there a reduction in the risk of recurrent ischemic stroke.

    "These findings challenge current guidelines that recommend delaying DOAC initiation due to concerns about early intracranial hemorrhage, especially in patients with moderate to severe strokes," the researchers concluded.

    Reference: https://www.Thelancet.Com/journals/lancet/article/PIIS0140-6736(24)02197-4/fulltext


    Benefits Of Catheter Ablation For Atrial Fibrillation In Individuals With HCM

    Photo Credit: Aleksandr Zyablitskiy

    The following is a summary of "Impact of Ablation on AF burden and symptoms in HCM," published in the October 2024 issue of Cardiology by Ahluwalia et al.  

    Atrial Fibrillation (AF) is a common issue for people with hypertrophic cardiomyopathy (HCM), often leading to bothersome symptoms.   

    Researchers conducted a retrospective study assessing the effectiveness of AF catheter ablation in reducing AF burden and improving symptoms in patients with HCM.  

    They created a multicenter registry to enroll patients with HCM who had cardiac implantable electronic devices and underwent catheter ablation for AF from 2017 to 2021, tracking AF recurrence and burden 12 months before and after the procedure. Odds ratios were provided with 95% CIs, and the significance level for all tests was set at α<0.05.  

    The results showed that 81 patients with HCM underwent catheter ablation for AF, with follow-ups lasting at least 1 year (median 35 [IQR: 23-50] months). Prior to the procedure, AF was paroxysmal in 38 patients (46.9%), and the AF burden was 27.0% (Q1-Q3 range, 3.0% to 99.0%). Within a year, 35 patients (43.2%) experienced a recurrence of AF/atrial tachycardia. After ablation, the burden dropped to 0.5% (Q1-Q3 range, 0.0% to 11.1%) (P=0.001), showing a 95% CI reduction of 13.8% to 100%. Patients with recurrence saw a burden reduction of –33.7% (Q1-Q3 range, -88.9% to –13.8%) (P<0.001), with 20 (57.1%) patients reporting symptomatic improvement of ≥1 European Heart Rhythm Association class. The decrease in AF burden was linked to a decrease in symptoms (r = -0.67; P<0.001).  

    Investigators concluded that catheter ablation significantly reduced AF burden and improved symptoms in patients with HCM, showcasing its effectiveness in improving their overall quality of life.  

    Source: acc.Org/Latest-in-Cardiology/Journal-Scans/2024/10/23/17/43/impact-of-catheter-ablation  


    When To Go To Hospital For AFib

    Anyone experiencing their first atrial fibrillation (AFib) episode should go to a hospital. Those with an AFib diagnosis should go if they feel unwell during an episode or have symptoms of a heart attack or stroke.

    Instead of strong, rhythmic heart chamber contractions, a person experiencing AFib may feel their heart racing or fluttering. They may also feel heart palpitations, shortness of breath, or light-headedness.

    AFib episodes can sometimes have no symptoms. However, doctors can still detect asymptomatic AFib using an electrocardiogram.

    In AFib with rapid ventricular response, the atria (upper chambers of the heart) contract rapidly, making the ventricles (bottom chambers of the heart) beat too fast. This makes the ventricles unable to receive and pump blood adequately to meet the body's need for oxygenated blood, which can lead to heart failure.

    Other AFib symptoms that require an immediate evaluation include symptoms of a heart attack or stroke. Find more information in the "Emergency AFib symptoms" section below.

    Managing AFib outside the emergency room

    In a person with pre-diagnosed AFib , an AFib episode on its own may not be an emergency. However, if the symptoms do not self-resolve or stabilize, a person should notify a doctor.

    Some people have persistent AFib that lasts longer than 7 days. Cardiologists can sometimes manage these episodes in an outpatient setting with close cardiology follow-ups. However, if a person feels unwell during AFib or their heart rate is excessively fast, it may be best to visit an ER.

    AFib can increase a person's chance of having a stroke or a heart attack, which are medical emergencies that require prompt care.

    The acronym "FAST" can help people can remember the warning signs of a stroke:

  • Face drooping or numbness, usually more noticeable on one side
  • Arm weakness, such as when a person holds their arms up, but one drifts downward
  • Speech changes, including slurring, difficulty making clear sounds, or inability to talk at all
  • Time for medical care as soon as possible
  • Even if the symptoms above fade or stop, it is important for a person who experiences them to undergo a prompt medical evaluation.

    Is it a heart attack?

    Heart attacks occur when there is a lack of blood supply to the heart. Symptoms include:

  • chest pain, pressure, or tightness
  • pain that may spread to arms, neck, jaw, or back
  • nausea and vomiting
  • sweaty or clammy skin
  • heartburn or indigestion
  • shortness of breath
  • coughing or wheezing
  • lightheadedness or dizziness
  • anxiety that can feel similar to a panic attack
  • If someone has these symptoms:

  • Dial 911 or the number of the nearest emergency department.
  • Stay with them until the emergency services arrive.
  • If a person stops breathing before emergency services arrive, perform manual chest compressions:

  • Lock fingers together and place the base of hands in the center of the chest.
  • Position shoulders over hands and lock elbows.
  • Press hard and fast, at a rate of 100 to 120 compressions per minute, to a depth of 2 inches.
  • Continue these movements until the person starts to breathe or move.
  • If needed, swap over with someone else without pausing compressions.
  • Use an automated external defibrillator (AED) available in many public places:

  • An AED provides a shock that may restart the heart.
  • Follow the instructions on the defibrillator or listen to the guided instructions.
  • At the hospital, a person with AFib may receive:

  • medications to control their heart rate
  • anticoagulants (blood thinners) to reduce the chance of complications such as a stroke
  • cardioversion, which involves using electric shock to regulate the person's heart rhythm
  • Heart rate

    A heart rate between 60 and 100 bpm indicates that AFib is likely stable. However, doctors categorize a heart rate above 120 bpm as AFib with rapid ventricular response.

    In these cases, doctors may use treatments that include cardioversion and an intravenous (IV) infusion of anticoagulant medication. An IV infusion is an injection into a vein that a person receives over time.

    Hemodynamic instability

    Hemodynamic instability refers to changes in a person's heart rate and blood pressure that prevent blood from properly circulating through the body. This is another instance in which doctors might use cardioversion to treat AFib.

    Wolff-Parkinson-White syndrome

    Sometimes AFib occurs with Wolff-Parkinson-White (WPW) syndrome, a congenital (present from birth) heart irregularity. WPW involves electrical circuit differences between the atria and ventricles of the heart and can cause a fast heart rate.

    Cardioversion may be part of managing AFib with WPW, along with a cardiologist consultation.

    Congestion

    In cases with heart failure, diuretics can help reduce fluid retention, and doctors may also use rhythm control strategies using medications or cardioversion.

    Studies indicate that when doctors restore the heart rate in those with AFib and heart failure to a steady rhythm, the heart's ability to pump blood improves.

    This helps the left ventricle, the main pumping chamber of the heart, function better, potentially alleviating some symptoms of heart failure.

    While people can manage AFib and the condition often does not affect lifespan, it does increase the chance of some complications, including:

  • Stroke: During an AFib episode, a person's blood can pool in the chambers of their heart, increasing the chance of a blood clot forming and traveling to the brain.
  • Heart failure: AFib episodes that feature a high heart rate may impede the heart's ability to circulate blood. Heart failure refers to a state in which the heart can not pump enough blood to meet the body's needs.
  • Heart rhythm problems: AFib can interfere with the heart's electrical activity and lead to other heart rhythm issues.
  • It is generally possible to live a long, active, and healthy life with AFib.

    However, the condition can increase a person's chance of complications such as stroke and heart disease. For this reason, it is important to manage AFib risk factors and reduce exposure to triggers as much as possible.

    How do you calm down an AFib episode?

    How long is it OK to be in AFib?

    If stable AFib symptoms last more than 24 hours, a person should contact a doctor.

    People should visit an ER right away if they feel unwell during an AFib episode or have symptoms of a heart attack or stroke.

    What heart rate is too high with AFib?

    Stable AFib involves a resting heart rate of 60 to 100 bpm. If a person's heart rate is higher than this, they should call 911 or have someone take them to a hospital.

    Atrial fibrillation (AFib) episodes often resolve on their own. However, if symptoms are persistent or a person feels unwell, it may be time to seek medical help.

    Anyone with AFib who experiences signs of a heart attack or stroke should call 911 or have someone take them to a hospital.






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