Document Detail

External validity of ST elevation myocardial infarction trials: the Zwolle studies.
MedLine Citation:
PMID:  17253599     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Guidelines are mainly based upon results of randomised controlled clinical trials. However, due to low external validity of these trials, their results can not reasonably be applied to all patients in routine practice. In our hospital, all patients with ST-elevation myocardial infarction (STEMI) are eligible for inclusion in one of our ongoing trials or registries. To asses differences between patients enrolled versus not-enrolled in a trial or registry, we evaluated all patients with a discharge diagnose of STEMI during the study period. METHODS: Retrospectively, individual patient data from all patients with a discharge diagnosis of STEMI between Jan 2001 and Dec 2001 were evaluated. Follow-up data were obtained until Dec 2004. RESULTS: A total of 583 patients were discharged with a diagnosis of STEMI. About 455 (78%) patients were enrolled in one of the ongoing clinical trials or registry and 128 were not. Not-enrolled patients were significantly older; more often had a history of previous MI and had higher risk profiles. Multivariate analysis revealed that higher age was the only independent predictor for non enrollment. Not-enrolled patients were more often treated conservatively and had a higher mortality rate (36% vs. 6%, P << 0.001). After multivariate analysis, non-enrollment (OR: 95% CI) 4.02 (1.98-8.16), age 1.07 (1.04-1.12), and diabetes 2.39 (1.17-4.89) were the only independent predictors of long term mortality. CONCLUSIONS: This study shows important differences in baseline characteristics, treatment, and prognosis between patients with STEMI who were enrolled or not in a trial. To better reflect daily clinical practice, guidelines should also consider results of observational studies of unselected patients.
Saman Rasoul; Jan Paul Ottervanger; Jan-Henk E Dambrink; Menko-Jan de Boer; Jan C A Hoorntje; A T Marcel Gosselink; Felix Zijlstra; Harry Suryapranata; Arnoud W J van 't Hof
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  69     ISSN:  1522-1946     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-03     Completed Date:  2007-08-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  632-6     Citation Subset:  IM    
Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands.
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MeSH Terms
Age Factors
Aged, 80 and over
Clinical Trials as Topic
Follow-Up Studies
Heart Conduction System / physiopathology
Kaplan-Meiers Estimate
Logistic Models
Middle Aged
Multivariate Analysis
Myocardial Infarction / epidemiology*,  physiopathology,  therapy
Netherlands / epidemiology
Patient Discharge
Predictive Value of Tests
Reproducibility of Results
Retrospective Studies
Time Factors

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