Baptiste (2024)

Cardiovascular disease

Cardiology • Ehr Data • UK

Study Metrics
Total Sample 137155
Treatment Group 40553
Control Group 96602
Covariates 39
PICO Comparisons 11
Quality Indicators
Transparency High
DAG Usage No
QBA Performed No

Study Information

First Author: Baptiste
Publication Year: 2024
DOI: https://doi.org/10.1093/aje/kwae137
Preprint: https://doi.org/10.1101/2022.12.02.22282220

Institution & Funding

Institutions: London School of Hygiene & Tropical Medicine, Queen Mary University of London, Friedrich Alexander University, McMaster University, Analysis Group Inc.
Funding: Declared: Private, research institute, NGO
Funding Institutions: This work was supported by the funding from a GlaxoSmithKline PhD studentship held by PB as part of an ongoing collaboration between GSK and the London School of Hygiene and Tropical Medicine. This research was funded in whole, or in part, by the Wellcome Trust [Senior Research Fellowship 224485/Z/21/Z to EW]. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.

Study Context

Disease: Cardiovascular disease
Disease Category: Cardiology
Data Type: Electronic Health Records
Number of Data Sources: 3
Geography: UK
Eligible Sample: 137155.0
Number of Emulations: 1
Number of Treatments: 2

Analytical Methods

Missing Data Method: Multiple imputation
Matching Method: PS matching
Analysis Method: Cox PH

Quality Methods

Directed Acyclic Graph (DAG) Not Used
Quantitative Bias Analysis (QBA) Not Performed

Target Trial Information

Target Trial Name: ONTARGET
Registration Number: NCT00153101
Target Trial DOI: https://doi.org/10.1056/NEJMoa0801317

TTE vs RCT Comparisons

Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.

≥30% increase in serum creatinine
ONTARGET
RR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

≥30% increase in serum creatinine

RCT Result

1.14

95% CI: [0.80, 1.62]


vs
TTE Result

1.38

95% CI: [1.34, 1.43]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
Angioedema
ONTARGET
RR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Angioedema

RCT Result

0.40

95% CI: [0.19, 0.86]


vs
TTE Result

1.14

95% CI: [0.72, 1.80]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions
Cough
ONTARGET
RR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Cough

RCT Result

0.26

95% CI: [0.21, 0.33]


vs
TTE Result

1.29

95% CI: [1.16, 1.43]

Concordance Assessment
Confidence Interval Overlap: No
CIs do not overlap
Direction Agreement: Different Direction
Different conclusions
Death from any cause
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Death from any cause

RCT Result

0.98

95% CI: [0.90, 1.07]


vs
TTE Result

0.97

95% CI: [0.93, 1.01]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
Death from cardiovascular causes
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Death from cardiovascular causes

RCT Result

1.00

95% CI: [0.89, 1.12]


vs
TTE Result

0.96

95% CI: [0.90, 1.03]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions
Death from non-cardiovascular causes
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Death from non-cardiovascular causes

RCT Result

0.96

95% CI: [0.83, 1.10]


vs
TTE Result

0.97

95% CI: [0.92, 1.02]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
Hospitalisation for heart failure
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Hospitalisation for heart failure

RCT Result

1.12

95% CI: [0.97, 1.29]


vs
TTE Result

0.97

95% CI: [0.90, 1.05]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions
Main secondary outcome: Death from cardiovascular causes, myocardial infarction or stroke
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Main secondary outcome: Death from cardiovascular causes, myocardial infarction or stroke

RCT Result

0.99

95% CI: [0.91, 1.07]


vs
TTE Result

0.98

95% CI: [0.94, 1.02]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
Myocardial infarction
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Myocardial infarction

RCT Result

1.07

95% CI: [0.94, 1.22]


vs
TTE Result

0.97

95% CI: [0.92, 1.01]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions
Primary composite: Death from cardiovascular causes, myocardial infarction, stroke, or hospitalisation for heart failure
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Primary composite: Death from cardiovascular causes, myocardial infarction, stroke, or hospitalisation for heart failure

RCT Result

1.01

95% CI: [0.94, 1.09]


vs
TTE Result

0.98

95% CI: [0.94, 1.02]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions
Stroke
ONTARGET
HR Efficacy
Population

High-risk patients aged ≥55 years with history of either coronary artery, peripheral artery, or cerebrovascular disease, or high-risk diabetes with end organ damage

Intervention

Angiotensin receptor blocker (ARB)

Comparison

Angiotensin-converting enzyme inhibitor (ACEi)

Outcome

Stroke

RCT Result

0.91

95% CI: [0.79, 1.05]


vs
TTE Result

1.04

95% CI: [0.97, 1.12]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions

Transparency Indicators

Protocol Registration Available
Data Sharing Not Available
Code Sharing Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.

Conflicts & Funding

Conflicts of Interest: Declared: Financial
COI Institutions: GSK, Compass Pathways, Ontario Ministry of Health, Sanofi, Pfizer, Leo Pharma, Astellas, Janssen, Amgen, Boehringer-Ingelheim, Baxter, Fresenius Medical Care, AstraZeneca, Vifor Fresenius Medical Care, Relypsa, Bayer HealthCare, Novo Nordisk, UpToDate Inc., Idorisia, Labchem, Parexel, Roche
Funding Source: Declared: Private, research institute, NGO
Funding Institutions: This work was supported by the funding from a GlaxoSmithKline PhD studentship held by PB as part of an ongoing collaboration between GSK and the London School of Hygiene and Tropical Medicine. This research was funded in whole, or in part, by the Wellcome Trust [Senior Research Fellowship 224485/Z/21/Z to EW]. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.