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Assessing the external validity of the VALIDATE-SWEDEHEART trial

Rylance, Rebecca T LU orcid ; Wagner, Philippe ; Omerovic, Elmir ; Held, Claes ; James, Stefan ; Koul, Sasha LU and Erlinge, David LU orcid (2021) In HIV Clinical Trials 18(4). p.427-435
Abstract

AIMS: The VALIDATE-SWEDEHEART trial was a registry-based randomized trial comparing bivalirudin and heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention. It showed no differences in mortality at 30 or 180 days. This study examines how well the trial population results may generalize to the population of all screened patients with fulfilled inclusion criteria in regard to mortality at 30 and 180 days.

METHODS: The standardized difference in the mean propensity score for trial inclusion between trial population and the screened not-enrolled with fulfilled inclusion criteria was calculated as a metric of similarity. Propensity scores were then used in an inverse-probability weighted Cox... (More)

AIMS: The VALIDATE-SWEDEHEART trial was a registry-based randomized trial comparing bivalirudin and heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention. It showed no differences in mortality at 30 or 180 days. This study examines how well the trial population results may generalize to the population of all screened patients with fulfilled inclusion criteria in regard to mortality at 30 and 180 days.

METHODS: The standardized difference in the mean propensity score for trial inclusion between trial population and the screened not-enrolled with fulfilled inclusion criteria was calculated as a metric of similarity. Propensity scores were then used in an inverse-probability weighted Cox regression analysis using the trial population only to estimate the difference in mortality as it would have been had the trial included all screened patients with fulfilled inclusion criteria. Patients who were very likely to be included were weighted down and those who had a very low probability of being in the trial were weighted up.

RESULTS: The propensity score difference was 0.61. There were no significant differences in mortality between bivalirudin and heparin in the inverse-probability weighted analysis (hazard ratio 1.11, 95% confidence interval (0.73, 1.68)) at 30 days or 180 days (hazard ratio 0.98, 95% confidence interval (0.70, 1.36)).

CONCLUSION: The propensity score difference demonstrated that the screened not-enrolled with fulfilled inclusion criteria and trial population were not similar. The inverse-probability weighted analysis showed no significant differences in mortality. From this, we conclude that the VALIDATE results may be generalized to the screened not-enrolled with fulfilled inclusion criteria.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Anticoagulants/therapeutic use, Hemorrhage, Heparin/therapeutic use, Hirudins, Humans, Myocardial Infarction/drug therapy, Peptide Fragments/therapeutic use, Percutaneous Coronary Intervention, Randomized Controlled Trials as Topic/standards, Recombinant Proteins/therapeutic use, Treatment Outcome
in
HIV Clinical Trials
volume
18
issue
4
pages
427 - 435
publisher
SAGE Publications
external identifiers
  • pmid:34011198
  • scopus:85106448959
ISSN
1740-7753
DOI
10.1177/17407745211012438
language
English
LU publication?
yes
id
6d45a389-c298-4b8e-80b0-7e9066a6f875
date added to LUP
2025-04-07 11:34:10
date last changed
2025-04-08 04:05:38
@article{6d45a389-c298-4b8e-80b0-7e9066a6f875,
  abstract     = {{<p>AIMS: The VALIDATE-SWEDEHEART trial was a registry-based randomized trial comparing bivalirudin and heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention. It showed no differences in mortality at 30 or 180 days. This study examines how well the trial population results may generalize to the population of all screened patients with fulfilled inclusion criteria in regard to mortality at 30 and 180 days.</p><p>METHODS: The standardized difference in the mean propensity score for trial inclusion between trial population and the screened not-enrolled with fulfilled inclusion criteria was calculated as a metric of similarity. Propensity scores were then used in an inverse-probability weighted Cox regression analysis using the trial population only to estimate the difference in mortality as it would have been had the trial included all screened patients with fulfilled inclusion criteria. Patients who were very likely to be included were weighted down and those who had a very low probability of being in the trial were weighted up.</p><p>RESULTS: The propensity score difference was 0.61. There were no significant differences in mortality between bivalirudin and heparin in the inverse-probability weighted analysis (hazard ratio 1.11, 95% confidence interval (0.73, 1.68)) at 30 days or 180 days (hazard ratio 0.98, 95% confidence interval (0.70, 1.36)).</p><p>CONCLUSION: The propensity score difference demonstrated that the screened not-enrolled with fulfilled inclusion criteria and trial population were not similar. The inverse-probability weighted analysis showed no significant differences in mortality. From this, we conclude that the VALIDATE results may be generalized to the screened not-enrolled with fulfilled inclusion criteria.</p>}},
  author       = {{Rylance, Rebecca T and Wagner, Philippe and Omerovic, Elmir and Held, Claes and James, Stefan and Koul, Sasha and Erlinge, David}},
  issn         = {{1740-7753}},
  keywords     = {{Anticoagulants/therapeutic use; Hemorrhage; Heparin/therapeutic use; Hirudins; Humans; Myocardial Infarction/drug therapy; Peptide Fragments/therapeutic use; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic/standards; Recombinant Proteins/therapeutic use; Treatment Outcome}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{427--435}},
  publisher    = {{SAGE Publications}},
  series       = {{HIV Clinical Trials}},
  title        = {{Assessing the external validity of the VALIDATE-SWEDEHEART trial}},
  url          = {{http://dx.doi.org/10.1177/17407745211012438}},
  doi          = {{10.1177/17407745211012438}},
  volume       = {{18}},
  year         = {{2021}},
}