Effect of Classic Secondary Prevention in Type 2 MI: a Target Trial Emulation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14,000
- 试验地点
- 1
- 主要终点
- Composite
研究概览
简要总结
A classic heart attack is caused by a blockage to the coronary arteries that supplies the heart muscle with oxygenated blood. The medical term for this condition is type 1 myocardial infarction. There is strong scientific evidence that the usage of pharmacological drugs such as statins, beta blockers, Renin-Angiotensin-Aldosterone System blockers and platelet inhibitors after a type 1 myocardial infarction improves survival and reduces the risk for new myocardial infarctions. However, a myocardial infarction may also occur without blockage to the coronary arteries when other acute conditions causes either a decreased supply or an increased demand of oxygenated blood to the heart. The medical term for the latter is type 2 myocardial infarction. There are currently no scientific evidence that any pharmacological drug improves survival in patients with a type 2 myocardial infarction, of whom only one in three patients are alive after five years.
The aim of this study is to investigate if those drugs that improves the prognosis after a type 1 myocardial infarction (Beta blockers, Renin-Angiotensin-Aldosterone System blockers, Statins and platelet inhibitors) also affects the prognosis after a type 2 myocardial infarction.
The best way to answer this question would be to conduct clinical trials for each drug where type 2 myocardial infarction patients are randomized to either receiving the drug of interest or receiving placebo (sugar pills) and then compare the survival and outcomes in both groups over time.
However, clinical trials are costly, time consuming and also difficult to conduct with type 2 myocardial infarction patients since these patients are treated at various hospital departments.
Therefore, this study will instead include patients in a Swedish national register for myocardial infarction, in which myocardial infarction patients are reported from all Swedish hospitals, and compare type 2 myocardial infarction patients that did receive or did not receive each treatment. To minimize the risk of making inaccurate conclusions about the causal relationship between treatment and outcome, the study will define the optimal clinical trial for each treatment and then specifically emulate these trials in all possible aspects using the register data. This method is called "target trial emulation".
详细描述
While acute and long term treatments in type 1 myocardial infarction (MI) are well documented, there are no evidence based treatments altering the prognosis in type 2 MI patients, of whom only one in three are alive after five years. Classic secondary preventive treatment in type 1 MI include the use of statins, beta blockers, renin-angiotensin-aldosterone system (RAAS) inhibitors, single antiplatelet therapy (SAPT) and dual antiplatelet therapy (DAPT). While some observational studies suggest classic secondary preventive MI treatment to be associated with better survival in type 2 MI, others do not.
The aim of this study is to investigate if there is an association between treatment with each of statins, beta blockers, RAAS inhibitors, SAPT or DAPT; and all-cause mortality or long-term cardiovascular events in patients with type 2 MI.
The study will be conducted as (several) registry-based observational studies emulating pre-specified target trials. A protocol of a pragmatic randomized controlled trial (a target trial) will be specified for each of statins, beta blockers, RAAS inhibitors, SAPT and DAPT; including eligibility criteria, treatment assignment, time zero and follow up, outcomes, causal contrast and statistical analyses.
Each of these components will then be emulated using registry data. The target trial, as well as the registry-based study emulating the target trial, will differ slightly for each treatment.
The study will include all, approximately 14 000, patients reported as type 2 MI (first reporting for each patient) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) from 2010 and onward. Data from SWEDEHEART will be merged with data from the National Patient Register, the Swedish Cause of Death Register and the Longitudinal Integrated Database for Health Insurance and Labour Market Studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reported as Type 2 MI in SWEDEHEART
- •Age >18 years
- •Alive at time zero (hospital discharge)
排除标准
- •Already on beta blocker
- •Heart failure with reduced ejection fraction
- •Hypertrophic obstructive cardiomyopathy
- •Systolic blood pressure <90 mmHg
- •Heart rate <50 bpm
- •Metastatic cancer (proxy for terminal disease)
- •History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
- •Missing data for any exclusion criteria
- •RAAS blocker target trial emulation:
- •Inclusion Criteria:
- •Reported as Type 2 MI in SWEDEHEART
- •Age >18 years
- •Alive at time zero (hospital discharge)
- •Exclusion Criteria:
- •Already on RAAS blocker
- •Heart failure with reduced ejection fraction
- •Combination of prior myocardial infarction and diabetes mellitus
- •Diabetic nephropathy,
- •Systolic blood pressure <90 mmHg
- •Hyperkalemia
- •Acute renal failure
- •Pregnancy
- •Metastatic cancer (proxy for terminal disease)
- •History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
- •Missing data for any exclusion criteria
- •Statin target trial emulation:
- •Inclusion Criteria:
- •Reported as Type 2 MI in SWEDEHEART
- •Age >18 years
- •Alive at time zero (hospital discharge)
- •Exclusion Criteria:
- •Already on Statin
- •Revascularization during hospitalization
- •Obstructive coronary artery disease detected during hospitalization
- •History of myocardial infarction or coronary revascularization
- •History of stroke
- •History of peripheral artery disease
- •Familial hypercholesterolemia
- •Pregnancy
- •Acute or chronic liver failure
- •Metastatic cancer (proxy for terminal disease)
- •History of dementia or substance abuse last 6 months (proxy for unable to adhere to treatment)
- •Missing data for any exclusion criteria
- •Single Antiplatelet Therapy target trial emulation:
- •Inclusion Criteria:
- •Reported as Type 2 MI in SWEDEHEART
- •Age >18 years
- •Alive at time zero (hospital discharge)
- •Exclusion Criteria:
- •Already on antiplatelet therapy
- 另有 30 项未显示
研究组 & 干预措施
Type 2 myocardial infarction
All patients reported as type 2 myocardial infarction (first reporting) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)
干预措施: Beta Blocker Therapy or No Therapy (Control) (Drug)
Type 2 myocardial infarction
All patients reported as type 2 myocardial infarction (first reporting) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)
干预措施: RAAS blocker Therapy or No therapy (Control) (Drug)
Type 2 myocardial infarction
All patients reported as type 2 myocardial infarction (first reporting) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)
干预措施: Statin Therapy or No Therapy (Control) (Drug)
Type 2 myocardial infarction
All patients reported as type 2 myocardial infarction (first reporting) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)
干预措施: Single Antiplatelet Therapy or No Therapy (Control) (Drug)
Type 2 myocardial infarction
All patients reported as type 2 myocardial infarction (first reporting) in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)
干预措施: Dual Antiplatelet Therapy or No Therapy (Control) (Drug)
结局指标
主要结局
Composite
时间窗: From enrollment (hospital discharge after type 2 MI) until Composite endpoint, Loss to follow-up or End of follow up (date of data collection: 05-May-2022)
Composite endpoint: All-cause mortality, readmission for MI, stroke or heart failure
次要结局
- All-cause mortality(From enrollment (hospital discharge after type 2 MI) until Death, Loss to follow-up or End of follow up (date of data collection: 05-May-2022))
- Cardiovascular mortality(From enrollment (hospital discharge after type 2 MI) until Cardiovascular death, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.)
- Readmission for MI(From enrollment (hospital discharge after type 2 MI) until Readmission for MI, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.)
- Readmission for stroke(From enrollment (hospital discharge after type 2 MI) until Readmission for Stroke, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.)
- Readmission for heart failure(From enrollment (hospital discharge after type 2 MI) until Readmission for Heart failure, Loss to follow-up or End of follow up (date of data collection: 05-May-2022). Competing risk methodology applied.)