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Postoperative Atrial FibrillationAFAFNCT04307225

Atrial Fibrillation After CABG and PCI

An observational study of Postoperative Atrial Fibrillation and Post PCI Atrial Fibrillation, run by Region Örebro County at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Atrial fibrillation (AF) is the most common arrhythmia seen in clinical practice and is associated with an increased risk of stroke, heart failure and death. Oral anticoagulation (OAC) is the only treatment so far being able to reduce mortality in AF patients, despite new antiarrhythmic drugs and ablation techniques. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Zenicor
Type of treatment
Medical device
How many people
250 participants
Where
1 siteSweden
Study dates
Aug 2015to Jan 2022
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients undergoing CABG or PCI due to: * NSTEMI * stable angina * unstable angina * with no prior history of atrial fibrillation

Who may be able to join

  • NSTEMI
  • Stable or unstable angina requiring revascularization therapy.
  • No prior hitory of Atrial Fibrillation

Who cannot join

  • Previous History of Atrial Fibrillation.
  • Any condition that contraindicates oral anticoagulation treatment

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Department of Cardiothoracic and Vascular surgery, Örebro University Hospital

    Örebro

Other trials in Sweden

About this study

Atrial fibrillation (AF) is the most common arrhythmia seen in clinical practice and is associated with an increased risk of stroke, heart failure and death. Oral anticoagulation (OAC) is the only treatment so far being able to reduce mortality in AF patients, despite new antiarrhythmic drugs and ablation techniques. Postoperative AF affects one-third of patients undergoing aortocoronary bypass surgery (CABG). Postoperative AF is associated with an increased 30-day mortality compared to patients who are in sinus rhythm during the hospital stay. . The risk of future AF is increased in patients with postoperative AF, and one-fourth of patients with an episode of postoperative AF develop later AF. At six years follow-up, 9.1% of patients with postoperative AF have had a lethal or non-lethal episode of ischemic stroke, compared to 3.0% of patients in SR (p=.002). Atrial fibrillation is a common complication of myocardial infarction, with an incidence of new-onset AF between 5-20%. New-onset AF occurs postoperatively in 5-6% of patients undergoing acute percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), and is marker of adverse outcomes. However, studies of heart rhythm beyond the post procedural period following PCI are lacking. About one third of all AF is asymptomatic, silent and often paroxysmal. The risk of stroke seems to be the same for silent AF as for those with symptomatic AF. In trials comparing PCI and CABG, there is a consistent difference in stroke rate. Several studies have shown an increased risk of late cardiovascular death and ischemic stroke in postoperative AF patients, and the difference in stroke rate between PCI and CABG may be explained by unprotected episodes of AF after discharge. The investigators therefore hypothesize that patients undergoing CABG have an increased risk of silent AF postoperatively compared to patients undergoing PCI and that this difference may explain some of the differences in stroke rate between PCI and CABG patients.

Read the detailed description

Atrial fibrillation (AF) is the most common arrhythmia seen in clinical practice and is associated with an increased risk of stroke, heart failure and Death. Oral anticoagulation (OAC) is the only treatment so far being able to reduce mortality in AF patients, despite new antiarrhythmic drugs and ablation techniques.

Postoperative AF affects one-third of patients undergoing aortocoronary bypass surgery (CABG). It is typically characterized by an episode of AF lasting 24-48 hours, starting at the second postoperative day, and affected patients are usually discharged in sinus rhythm. Postoperative AF is associated with an increased 30-day mortality compared to patients who are in sinus rhythm during the hospital stay. Later studies have shown that CABG patients with an episode of postoperative AF have an increased long-term mortality compared to patients in sinus rhythm (SR). In particular, patients with postoperative AF have a doubled cardiovascular long-term mortality, mainly explained by an increased risk of fatal ischemic stroke and cardiac death. The risk of future AF is increased in patients with postoperative AF, and one-fourth of patients with an episode of postoperative AF develop later AF. At six years follow-up, 9.1% of patients with postoperative AF have had a lethal or non-lethal episode of ischemic stroke, compared to 3.0% of patients in SR (p=.002).

All patients undergoing CABG are offered single or dual antiplatelet therapy depending on the presence of drug-eluting stents and type of coronary artery disease. Antiplatelet therapy does not offer any protection of thromboembolic disease in patients with AF. The indication for anticoagulation in patients with an episode of postoperative AF is basically not different from other types of AF. Given the short duration of a typical episode of postoperative AF, warfarin is seldom prescribed at discharge (3.6% in one study).

Atrial fibrillation is a common complication of myocardial infarction, with an incidence of new-onset AF between 5-20%. New-onset AF occurs postoperatively in 5-6% of patients undergoing acute percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), and is marker of adverse outcomes. However, studies of heart rhythm beyond the post procedural period following PCI are lacking.

About one third of all AF is asymptomatic, silent and often paroxysmal. The risk of stroke seems to be the same for silent AF as for those with symptomatic AF. Screening for silent AF using handheld ambulatory ECG recorders has proven to be an effective way of capturing episodes of AF and superior to 24 hour Holter recordings.

In trials comparing PCI and CABG, there is a consistent difference in stroke rate. In the Syntax trial, the stroke incidence at one-year follow-up was 2.2% in the CABG group compared to 0.6% in the PCI group. In the Freedom trial, the stroke incidence at five years was 5.2% in the CABG group and 2.4% in the PCI group. Of note, differences in the incidence of postoperative AF or treatment with OAC were not recorded in these trials.

In conclusion, several studies have shown an increased risk of late cardiovascular death and ischemic stroke in postoperative AF patients, and the difference in stroke rate between PCI and CABG may be explained by unprotected episodes of AF after discharge.

The investigators therefore hypothesize that patients undergoing CABG have an increased risk of silent AF postoperatively compared to patients undergoing PCI and that this difference may explain some of the differences in stroke rate between PCI and CABG patients. This study can improve AF detection in patient cohorts and by initiating OAC also in patients with silent AF potentially decrease the risk of stroke.

Being tested
Zenicor
Keywords
Atrial Fibrillation, Stroke, Oral Anticoagulation
Medical subject headings
Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZenicorDevice

    Handheld Thumb ECG monitoring device

Study groups in NCT04307225
Study groupRoleWhat they receive
CABGPatients whom has undergone CABG surgery for NSTEMI, stable or unstable angina, with no previous history of Atrial Fibrillation
Receives: Device: Zenicor
PCIPatients whom has undergone PCI for NSTEMI, stable or unstable angina, with no previous history of Atrial Fibrillation
Receives: Device: Zenicor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Incidence of Postoperative/postinterventional Atrial Fibrillation

    Measured: through study completion, an average of 2 years

  2. Oral Anticoagulation treatment to those who develope Atrial fibrillation

    Oral Anticoagulation treatment to those who develope Atrial fibrillation, according to individual risk assessment by CHA2D2VASC score (Congestive heart failure, hypertension, age, diabetes, stroke, vascular disease, sex - score, min 0 Points (good), max 9 Points):

    • Congestive heart failure 1p
    • Uncontrolled hypertension 1p
    • Age ≥ 75 years 2p
    • Age 65-74 years 1p
    • Diabetes 1p
    • Stroke / TIA / Thromboembolism 2p
    • Vascular disease 1p
    • Female gender 1p 2p or more warrants oral anticoagulation, if no contraindication given individual predictive bleeding assessment.

    Measured: During 2 years of follow-up

Secondary outcomes (1)
  1. Predictors of postoperative atrial fibrillation

    Predictive markers for development of postoperative/postinterventional Atrial Fibrillation

    Measured: 1 month, 3 months, 12 months and 24 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study startAug 2015
  3. Primary completionDec 2021
  4. Study completionJan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307225
Sponsor's protocol ID
2015-08-3
Acronym
AFAF
Status last verified
Apr 2022
First submitted
13 Nov 2017
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wickbom A, Fengsrud E, Alfredsson J, Engdahl J, Kalm T, Ahlsson A. Incidence of atrial fibrillation after coronary artery bypass graft surgery and percutaneous coronary intervention: a prospective 2-year follow-up observational study. BMJ Open. 2025 Nov 28;15(11):e106364. doi: 10.1136/bmjopen-2025-106364.

    PubMed 41314845

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Atrial Fibrillation and Post PCI Atrial Fibrillation, run by Region Örebro County at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Incidence of Postoperative/postinterventional Atrial Fibrillation (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04307225, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.

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