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.
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
- Conditions the study is for
- Postoperative Atrial Fibrillation, Post PCI Atrial Fibrillation, Stroke
- 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
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.
- Conditions
- Postoperative Atrial Fibrillation, Post PCI Atrial Fibrillation, Stroke, Oral Anticoagulation
- 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 group | Role | What they receive |
|---|---|---|
| CABG | Patients whom has undergone CABG surgery for NSTEMI, stable or unstable angina, with no previous history of Atrial Fibrillation Receives: Device: Zenicor | |
| PCI | Patients 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.
Change in Incidence of Postoperative/postinterventional Atrial Fibrillation
Measured: through study completion, an average of 2 years
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)
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.
- First posted13 Mar 2020
- Study startAug 2015
- Primary completionDec 2021
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, University Hospital, Linkoeping
- Responsible party
- Principal investigator, Anders Ahlsson, Region Stockholm
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation After CABG and PCI
- ClinicalTrials.gov ID
- NCT04307225
- Acronym / sponsor ID
- AFAF / 2015-08-3
- Conditions
- Postoperative Atrial Fibrillation, Post PCI Atrial Fibrillation, Stroke, Oral Anticoagulation
- Keywords
- Atrial Fibrillation, Stroke, Oral Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Danderyd Hospital, University Hospital, Linkoeping
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG | – | Device: ZenicorPatients whom has undergone CABG surgery for NSTEMI, stable or unstable angina, with no previous history of Atrial Fibrillation |
| PCI | – | Device: ZenicorPatients whom has undergone PCI for NSTEMI, stable or unstable angina, with no previous history of Atrial Fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing CABG or PCI due to: * NSTEMI * stable angina * unstable angina * with no prior history of atrial fibrillation
Key inclusion criteria (3 listed)
- NSTEMI
- Stable or unstable angina requiring revascularization therapy.
- No prior hitory of Atrial Fibrillation
Key exclusion criteria (2 listed)
- Previous History of Atrial Fibrillation.
- Any condition that contraindicates oral anticoagulation treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZenicorHandheld Thumb ECG monitoring device | Device | CABG, PCI |
Primary outcome
Change in Incidence of Postoperative/postinterventional Atrial Fibrillation
Time frame: through study completion, an average of 2 years
Oral Anticoagulation treatment to those who develope Atrial fibrillation
Time frame: During 2 years of follow-up
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.
1 secondary outcome
Predictors of postoperative atrial fibrillation
Time frame: 1 month, 3 months, 12 months and 24 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 41314845Wickbom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.