Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins - Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of Participants with POAF - In-hospital
Study Overview
Brief Summary
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
- 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.
- 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.
Detailed Description
Trial Participants:
Enrolment for the study is planned to start February 2022 and continue until 100 patients have been enrolled.
DEFINITION OF POAF:
Postoperative AF (I48) is defined as irregular RR-intervals without a traceable p-wave before each QRS complex during at least 30 seconds or entire 12-lead ECG in symptomatic or asymptomatic patients with no prior history of atrial fibrillation or flutter are considered4. Continuous ECG monitoring (8-lead ward monitor) will recognise AF during the entire hospitalization. Anamnesis, electronic health record (EHR), or confirmatory rhythm strip or 12-lead ECG of AF until 30th postoperative day are also considered.
We will also report the burden of atrial fibrillation, and treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Willingness and provision of informed consent to be randomized
Exclusion Criteria
- •Prior history of atrial fibrillation
- •Prior history of cardiac surgery
- •Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
- •Creatinine >200 µmol/L
Arms & Interventions
Continuance
Continuance prior statin therapy.
Intervention: No-intervention. (Drug)
Discontinuance
Discontinuance prior statin therapy. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
Intervention: Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative (Drug)
Outcomes
Primary Outcomes
Number of Participants with POAF - In-hospital
Time Frame: In-hospital up to 10 days.
In-hospital POAF assessed by Holter monitoring.
Number of Participants with POAF - Early
Time Frame: Early (≤30 days) incidence of POAF
Early assessed by anamnesis and electronic health record (EHR).
Duration of POAF in-hospital
Time Frame: In-hospital
Duration of POAF monitered with continuous ECG monitoring (eight-- lead ward monitor) up to 24 weeks.
Secondary Outcomes
- Number of Participants with NOAF(Intermediate (1 year) incidence of NOAF)
- Rate of all-cause mortality - In-hospital(In-hospital up to 10 days.)
- Rate of all-cause mortality - Early(Early (≤30 days))
- Rate of all-cause mortality - intermediate(Intermediate (1 year))
- Myocardial injury - Tn(After surgery until discharge up to 10 days)
- Myocardial injury - CKMB(After surgery until discharge up to 10 days)
- Stroke - Early(Early (≤30 days).)
- Stroke - Intermediate(Intermediate (1 year))
- Trans ischemic attack - Early(Early (≤30 days))
- Trans ischemic attack - Intermediate(Intermediate (1 year))
- Myocardial infarction - Early(Early (≤30 days))
- Myocardial infarction - Intermediate(Intermediate (1 year))
- Permanent pacemaker - Early(Early (≤30 days))
- Permanent pacemaker - Intermediate(Intermediate (1 year))
- ICD implantation - Early(Early (≤30 days))
- ICD implantation - Intermediate(Intermediate (1 year))
- Acute kidney injury - Early(Early (≤30 days))
- Strain(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- LVEF(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- TAPSE(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- Length of stay on ICU(Day of surgery to the day of discharge from ICU. Up to 52 weeks.)
- Length of stay in hospital(Day of surgery to the day of discharge from the hospital. Up to 52 weeks.)
Investigators
Lars Peter Riber
MD, Associate Professor, Ph.D., DMSc
Odense University Hospital