Introduction
Objectives
Methods
Study elements | Description |
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Participants | Patients with an indication for inhibition of the renin-angiotensin aldosterone system, stratified into those with (i) hypertension and (ii) heart failure. |
Intervention | Angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACEis) |
Control or comparison | Placebo, or other classes of antihypertensive agent |
Outcome | Standardisation will be performed to estimate the effect of a 10 mmHg reduction in blood pressure with each class of drug on the relative risk of each outcome. Primary: myocardial infarction and all-cause mortality Secondary: cardiovascular mortality, stroke, heart failure and revascularization |
Eligibility criteria
Information sources
Search strategy
Study records
Selection process
Data management
Data extraction
Data items
Data item | Description and rationale |
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Study characteristics | |
Study ID | Unique identifier for each study retrieved. |
Trial acronym/first author | Either the trial acronym (if applicable, e.g. HOPE, VALUE) or first author of the primary study report if not (e.g. Smith AB et al.). |
Year | Year of primary study publication. |
Study design | Placebo-controlled, active comparator-controlled or PROBE design. |
Duration of follow-up | Time period (in months) over which participants underwent follow-up |
Age | Mean age of all patients included in analysis. |
Sex | Number (%) of male study participants. |
Hypertension | Number (%) of study participants with hypertension. |
Heart failure | Number (%) of study participants with heart failure. |
Diabetes | Number (%) of study participants with diabetes. |
Ischaemic heart disease | Number (%) of study participants with ischaemic heart disease. |
Loss to follow-up | Number (%) of study participants lost to follow-up |
Revascularisation | Number (%) of study participants that underwent invasive coronary revascularisation |
Concomitant drug therapy | Number (%) of study participants receiving other cardiovascular agents (β-blockers, calcium channel blockers, etc.) |
Exposures and outcomes for each group | |
Group class | Class of agent in the intervention and comparator arms (i.e. ACEi or ARB and placebo or active comparator). |
Group agent | Identity of agent given to participants randomised to the intervention and comparator arms |
n in group | Number in intervention and comparator arms (included in final analysis) |
Baseline SBP | Baseline systolic blood pressure (mmHg) in each group. If multiple are provided (e.g. sitting, ambulatory, supine, etc.) sitting/clinic measurement will be used. |
Follow-up SBP | Systolic blood pressure measured during follow-up in each group (mmHg). Any SBP measured at ‘steady-state’ during follow-up, or SBP averaged across visits may be included. If serial measurements are reported, the last measurement will be extracted. SBP after the first-dose of the medication will not be included. |
Within-group difference in SBP | The within-group change in SBP from baseline to follow-up either directly reported or calculated as per Fig. 2. Directly reported differences will supersede calculated values. |
Between-group difference in SBP | The between-group difference in SBP change, either directly reported or calculated as per Fig. 2. Directly-reported differences will supersede calculated values. |
Baseline DBP | Baseline diastolic blood pressure (mm Hg) in each group. If multiple are provided (e.g. sitting, ambulatory, supine, etc.) sitting/clinic measurement will be used. |
Follow-up DBP | Diastolic blood pressure measured during follow-up in each group (mm Hg). Any DBP measured at ‘steady-state’ during follow-up, or SBP averaged across visits may be included. If serial measurements are reported, the last measurement will be extracted. DBP after the first-dose of the medication will not be included. |
Within-group difference in DBP | The within-group change in DBP from baseline to follow-up either directly reported or calculated as per Fig. 2. Directly-reported differences will supersede calculated values. |
Between-group difference in DBP | The between-group difference in DBP change either directly reported or calculated as per Fig. 2. Directly reported differences will supersede calculated values. |
All-cause mortality | The total number of deaths, of any cause, that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified. |
Cardiovascular mortality | The number of cardiovascular deaths that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified. |
Definition of cardiovascular mortality | Study definition of cardiovascular mortality, as per Table 2, below. |
Myocardial infarction | The number of myocardial infarctions that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified. |
Definition of myocardial infarction | Study definition of cardiovascular mortality, as per Table 2, below. |
Stroke | The number of strokes that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified. |
Definition of stroke | Study definition of stroke, as per Table 2, below. |
Outcomes
Outcome | Status | Rank | Explanation |
---|---|---|---|
All-cause mortality | Primary | 1 | Total number of deaths in each study group due to any attributed cause. |
Myocardial infarction | Primary | 1 | Non-fatal or fatal myocardial infarction, or sudden cardiac death |
2 | Non-fatal or fatal myocardial infarction | ||
3 | Fatal myocardial infarction, or sudden cardiac death | ||
4 | Non-fatal myocardial infarction only | ||
5 | Fatal myocardial infarction only | ||
6 | Any other definition of a myocardial infarction-related endpoint | ||
Cardiovascular mortality | Secondary | 1 | Fatal myocardial infarction, stroke, other cardiovascular disease or sudden death |
2 | Fatal myocardial infarction, stroke or other cardiovascular disease | ||
3 | Fatal myocardial infarction, stroke or sudden death | ||
4 | Fatal myocardial infarction or stroke | ||
5 | Any other definition of cardiovascular mortality | ||
Stroke | Secondary | 1 | Non-fatal or fatal stroke, not including transient ischaemic attack |
2 | Fatal stroke | ||
3 | Non-fatal stroke | ||
4 | Non-fatal stroke or transient ischaemic attack | ||
5 | Non-fatal or fatal stroke or transient ischaemic attack | ||
6 | Any other definition of a stroke-related endpoint | ||
Revascularisation | Secondary | 1 | Any need for unplanned revascularisation |
Heart failure | Secondary | 1 | Management of heart failure, requiring medical attention, hospital attendance or admission |