About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
MI (as defined by the universal definition of MI) at least 1 year before inclusion.
BMI ≥35 kg/m2
Written informed consent obtained
Disqualifiers
Any condition that may influence the patient's ability to comply with study protocol.
Earlier MBS or operation for gastric or duodenal ulcer or reflux disease
Other condition that makes patient not suitable for MBS according to responsible surgeon and anesthesiologist
Unable to understand Swedish.
Trial design
Parallel
Treatments tested in this trial
Bariatric surgery
Procedure/SurgeryType of surgery assigned by surgeon in consultation with patient
Standard care
Procedure/SurgeryStandard 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
All-cause mortality
Data will be obtained for the Swedish national national quality registries.
Cardiovascular death
Data will be obtained for the Swedish national national quality registries.
Remission of type 2 diabetes (T2D) and hypertension
Number of patients in remission
Other outcomes
Safety, i.e., no excess of severe complications (Clavien-Dindo ≥3b (a complication requiring intervention under general anesthesia or resulting in organ failure or death)) and long-term morbidity.
Data will be obtained for the Swedish national patient registry and other national quality registries.
Body weight change
Change in kg from baseline during long-term follow-up.
Change in quality of life
Assessed by EQ-5D-5L questionnaire
All-cause hospitalizations
Based on ICD 10 diagnosis in national patient registry and other national quality registries
Locations
Sponsors and contacts
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Danderyd Hospital
Lead sponsor
Karolinska Institutet
Collaborator
The 21 healthcare regions in Sweden
Collaborator
This trial is not recruiting at the moment. You can still explore other options: