Assessing the external validity of the VALIDATE-SWEDEHEART trial
Research article published in Clin Trials (2021)
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 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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
Propensity score weighted analysis assessed external validity of VALIDATE-SWEDEHEART trial; results may be generalized to screened not-enrolled population with no significant differences in mortality.
Warum dies für die Hirudotherapie relevant ist
Diese Studie bewertete die externe Validität der VALIDATE-SWEDEHEART-Studie – die Bivalirudin versus Heparin bei Patienten mit akutem Myokardinfarkt und perkutaner Koronarintervention verglich – mittels Propensity-Score-Gewichtung, um Studienteilnehmer mit gescreenten, aber nicht eingeschlossenen Patienten, die die Einschlusskriterien erfüllten, zu vergleichen. Der Propensity-Score-Unterschied von 0,61 zeigte, dass die beiden Populationen nicht ähnlich waren, doch die invers-probabilistisch gewichtete Analyse zeigte keine signifikanten Mortalitätsunterschiede zwischen Bivalirudin und Heparin nach 30 oder 180 Tagen. Das Abstract enthält keine Erwähnung von Blutegeln, Hirudotherapie oder aus Blutegeln gewonnenen Verbindungen, sodass keine vertretbare Verbindung zum ASH-Bereich abgeleitet werden kann. Es handelt sich um eine methodologische Generalisierbarkeitsanalyse einer kardiologischen Studie.
Zitation
Assessing the external validity of the VALIDATE-SWEDEHEART trial.
Rylance RT et al. · Clin Trials, 2021
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