Study Metrics
Total Sample
4940
Treatment Group
2634
Control Group
2306
Covariates
21
PICO Comparisons
4
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Matthews |
| Publication Year: | 2021 |
| DOI: | https://doi.org/10.1161/jaha.120.020357 |
| Preprint: | https://doi.org/10.1101/2021.02.01.21250739 |
Institution & Funding
| Institution Type: | Academic |
| Institutions: | Karolinska Institutet, Karolinska University Hospital, Harvard T.H. Chan School of Public Health, Uppsala University, Lund University, Skåne University Hospital, Danderyd University Hospital, Harvard-MIT |
| Funding: | Declared: Public |
| Funding Institutions: | This work was supported by a grant from the Swedish Research Council (registration number 2018-03028). |
Study Context
| Disease: | Myocardial infarction |
| Disease Category: | Cardiology |
| Data Type: | Registry |
| Geography: | Sweden |
| Eligible Sample: | 4940.0 |
| Number of Treatments: | 2 |
Analytical Methods
| Missing Data Method: | Complete case |
| Matching Method: | IPTW |
| Analysis Method: | logistic regression |
| Estimand: | PP |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | VALIDATE-SWEDEHEART |
| Registration Number: | NCT02311231 |
| Target Trial DOI: | https://doi.org/10.1056/nejmoa1706443 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Composite of death from any cause, MI, or major bleeding events by 180 days
VALIDATE
RR
Efficacy
Population
patients undergoing percutaneous coronary intervention in Sweden
Intervention
bivalirudin
Comparison
heparin
Outcome
Composite of death from any cause, MI, or major bleeding events by 180 days
RCT Result
0.96
95% CI: [0.83, 1.10]
vs
TTE Result
0.93
95% CI: [0.77, 1.12]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Same Direction
Both point to similar conclusion
Both point to similar conclusion
Death by 180 days
VALIDATE
RR
Efficacy
Population
patients undergoing percutaneous coronary intervention in Sweden
Intervention
bivalirudin
Comparison
heparin
Outcome
Death by 180 days
RCT Result
1.05
95% CI: [0.78, 1.41]
vs
TTE Result
1.21
95% CI: [0.88, 1.68]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Same Direction
Both point to similar conclusion
Both point to similar conclusion
Major bleeding by 180 days
VALIDATE
RR
Efficacy
Population
patients undergoing percutaneous coronary intervention in Sweden
Intervention
bivalirudin
Comparison
heparin
Outcome
Major bleeding by 180 days
RCT Result
1.00
95% CI: [0.84, 1.19]
vs
TTE Result
0.69
95% CI: [0.50, 0.95]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
MI by 180 days
VALIDATE
RR
Efficacy
Population
patients undergoing percutaneous coronary intervention in Sweden
Intervention
bivalirudin
Comparison
heparin
Outcome
MI by 180 days
RCT Result
0.84
95% CI: [0.60, 1.19]
vs
TTE Result
1.08
95% CI: [0.76, 1.54]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
Transparency Indicators
Protocol Registration
Available
Data Sharing
Not Available
Code Sharing
Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.
Conflicts & Funding
| Conflicts of Interest: | Declared: Financial |
| COI Institutions: | AstraZeneca, Cytel, ProPublica |
| Funding Source: | Declared: Public |
| Funding Institutions: | This work was supported by a grant from the Swedish Research Council (registration number 2018-03028). |