Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Type of surgery assigned by surgeon in consultation with patient
Standard care can consist of dietary intervention, physiotherapy or drug treatment in accordance to the care given in the region of Sweden where the patient resides.
MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis.
Data will be obtained for the Swedish national patient registry and other national quality registries.
Time frame: Through study completion, expected average of 6 years
Total event rate
Based on events listed in the primary outcome measure. Data will be obtained for the Swedish national patient registry and other national quality registries.
Time frame: Through study completion, expected average of 6 years
All-cause mortality
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Cardiovascular death
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Remission of type 2 diabetes (T2D) and hypertension
Number of patients in remission
Time frame: Through study completion, expected average of 6 years
Myocardial infarction
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Stroke
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Myocardial revascularization (not related to MI)
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
hospital admission because of heart failure as a primary ICD diagnosis.
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
hospital admission because of atrial fibrillation as a primary ICD diagnosis.
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
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