Statins have rapid and significant actions that have potentially important (but not yet proven) implications for postoperative atrial fibrillation and cardiac protection in patients undergoing cardiac surgery.
The focus of this study is, therefore, on patients having surgical aortic valve replacement (with aortotomy) and the development of postoperative atrial fibrillation (POAF).
Our aims are: to investigate the risk of POAF, infection or other complications after SAVR in continuous versus preoperative discontinuous treatment with statins.
The study is a single centre randomized controlled trial with continuance treatment with statin vs. discontinuance (7 to 14 days prior surgery until the 30th post-operative day included), on patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statins the last 3 months and of at least 7 days.
This randomized studies will address 2 separate hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that
1. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\<30 days) risk of POAF. 2. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\<30 days) and intermediate (\<1 year) risk of mortality, MI, stroke and rehospitalisation.
Patients undergoing elective solitary SAVR with bioprosthesis
Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery
In treatment with HMG-CoA reductase inhibitors in the past 3 months and of at least 7 days
Age >60 years
Prior history of atrial fibrillation
Prior history of cardiac surgery
Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
Creatinine >200 µmol/L
Parallel
Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative
DrugDiscontinuance of prior statin therapy
No-intervention.
DrugContinuance of prior statin therapy
Number of Participants with POAF - In-hospital
In-hospital POAF assessed by Holter monitoring.
Number of Participants with POAF - Early
Early assessed by anamnesis and electronic health record (EHR).
Duration of POAF in-hospital
Duration of POAF monitered with continuous ECG monitoring (eight-- lead ward monitor) up to 24 weeks.
Number of Participants with NOAF
NOAF assessed by anamnesis and EHR.
Rate of all-cause mortality - In-hospital
Number of deaths in each group.
Rate of all-cause mortality - Early
Number of deaths in each group.
Rate of all-cause mortality - intermediate
Number of deaths in each group.
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Lars Peter Riber
Lead sponsor
Odense University Hospital
Sponsor institution
Odense Patient Data Explorative Network
Collaborator
GCP-unit at Odense University Hospital
Collaborator
