Atrial Fibrillation After CABG and PCI

NCT04307225 | Completed

• 1 other identifier: 2015-08-3
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Atrial Fibrillation; Post PCI Atrial Fibrillation; Stroke; Oral Anticoagulation

Keywords

Atrial Fibrillation; Stroke; Oral Anticoagulation

Outcome Measures

Primary Outcomes (2)

• Change in Incidence of Postoperative/postinterventional Atrial Fibrillation

  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.

  During 2 years of follow-up

Secondary Outcomes (1)

• Predictors of postoperative atrial fibrillation

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

Study Arms (2)

CABG

Patients whom has undergone CABG surgery for NSTEMI, stable or unstable angina, with no previous history of Atrial Fibrillation

Device: Zenicor

PCI

Patients whom has undergone PCI for NSTEMI, stable or unstable angina, with no previous history of Atrial Fibrillation

Device: Zenicor

Interventions

Zenicor DEVICE

Handheld Thumb ECG monitoring device

CABG; PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Örebro County: lead
• Danderyd Hospital: collaborator
• University Hospital, Linkoeping: collaborator

Study Sites (1)

Department of Cardiothoracic and Vascular surgery, Örebro University Hospital

Örebro, Sweden

Location

Related Publications (1)

• 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.

  PMID: 41314845 DERIVED

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: March 13, 2020
• Study Start: August 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)