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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-00453 | Other Grant/Funding Number | Swdeish research council |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| The 21 healthcare regions in Sweden | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric surgery | Active Comparator | Gastric bypass or gastric sleeve |
|
| Standard care | Active Comparator | Standard obesity treatment offered in Swedish regions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Type of surgery assigned by surgeon in consultation with patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, expected average of 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, expected average of 6 years |
| All-cause mortality |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, expected average of 6 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik Näslund, MD, PhD | Contact | 46812355017 | Erik.Naslund@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Erik Näslund, MD, PhD | Karolinska Institutet/Danderyd hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33103469 | Background | Naslund E, Stenberg E, Hofmann R, Ottosson J, Sundbom M, Marsk R, Svensson P, Szummer K, Jernberg T. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Previous Myocardial Infarction and Severe Obesity: A Nationwide Cohort Study. Circulation. 2021 Apr 13;143(15):1458-1467. doi: 10.1161/CIRCULATIONAHA.120.048585. Epub 2020 Oct 26. |
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Data will not be shared openly at a repository since it contains personal data. Data will be made available upon request after ensuring compliance with relevant legislation and Karolinska Institutet guidelines.
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Standard care | Procedure | 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. |
|
Data will be obtained for the Swedish national national quality registries. |
| Through study completion, expected average of 6 years |
| Cardiovascular death | Data will be obtained for the Swedish national national quality registries. | Through study completion, expected average of 6 years |
| Remission of type 2 diabetes (T2D) and hypertension | Number of patients in remission | Through study completion, expected average of 6 years |
| Myocardial infarction | Data will be obtained for the Swedish national national quality registries. | Through study completion, expected average of 6 years |
| Stroke | Data will be obtained for the Swedish national national quality registries. | 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. | 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. | 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. | Through study completion, expected average of 6 years |
| Body weight change | Change in kg from baseline during long-term follow-up. | 5-year follow-up |
| Change in quality of life | Assessed by EQ-5D-5L questionnaire | 5-year follow-up |
| All-cause hospitalizations | Based on ICD 10 diagnosis in national patient registry and other national quality registries | Through study completion, expected average of 6 years |
| Change in quality of life | Assessed by RAND 36 | 5-year follow-up |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |