Background This randomized controlled trial was conducted to evaluate the impact of posterior pericardiotomy on the prevention of postoperative atrial fibrillation (POAF) in patients who underwent off-pump coronary artery bypass grafting (CABG).
Methods Adult patients who were scheduled to undergo isolated off-pump CABG were assessed for eligibility, and eligible patients were randomly assigned in a 1:1 manner to pericardiotomy or no intervention. Patients and postoperative caregivers were blinded to treatment assignment. The primary endpoint was the occurrence rate of POAF, and the secondary endpoints were the cumulative time spent in POAF and early outcomes, including operative mortality.
Results A total of 403 patients were screened for eligibility, and 270 patients were randomly assigned to the posterior pericardiotomy group (n=136) or control group (n=134). The mean age was 67.8±10.3 years, and 20.4% (55 of 270 patients) were female. There was no intergroup difference in baseline characteristics or surgical data. Off-pump CABG was performed as planned in all patients except one. All patients received the assigned treatment regarding pericardiotomy, and no intergroup crossover occurred. POAF occurred in 27.8% (75 of 270 patients) of patients at a median of 2 days (interquartile range 1–3 days) after surgery. There was no significant difference in the occurrence rate of POAF between the two groups (30.1% and 25.4% in the pericardiotomy and control groups, P =.38). There were no significant differences in the secondary endpoints between the two groups.
Conclusions Posterior pericardiotomy does not reduce the occurrence rate of POAF in patients undergoing off-pump CABG. (NCT06159985)
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT06159985
Funding StatementNo funding.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The Seoul National University Hospital Institutional Review Board approved the study.
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Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityUpon request, deidentified participant data could be shared at the discretion of the corresponding author (HYH) by e-mail contact.
AbbreviationsAFatrial fibrillationCABGcoronary artery bypass graftingECGelectrocardiogramIQRinterquartile rangeLADleft anterior descending arteryLCXleft circumflex arteryLITAleft internal thoracic arteryMIDCABminimally invasive direct coronary artery bypassPALACSThe Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac SurgeryPOAFpostoperative atrial fibrillationPPposterior pericardiotomyRCAright coronary arteryRCTrandomized controlled trialRITAright internal thoracic arterySVsaphenous vein
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