Show simple item record

dc.contributor.authorSteg, Phillippe Gabriel
dc.contributor.authorLopez-Sendon, Jose
dc.contributor.authorLopez de Sa, Esteban
dc.contributor.authorGoodman, Shaun G.
dc.contributor.authorGore, Joel M.
dc.contributor.authorAnderson, Frederick A. Jr.
dc.contributor.authorHimbert, Dominique
dc.contributor.authorAllegrone, Jeanna
dc.contributor.authorVan de Werf, Frans
dc.date2022-08-11T08:08:08.000
dc.date.accessioned2022-08-23T15:44:04Z
dc.date.available2022-08-23T15:44:04Z
dc.date.issued2007-01-11
dc.date.submitted2011-09-23
dc.identifier.citationArch Intern Med. 2007 Jan 8;167(1):68-73. <a href="http://dx.doi.org/10.1001/archinte.167.1.68">Link to article on publisher's site</a>
dc.identifier.issn0003-9926 (Linking)
dc.identifier.doi10.1001/archinte.167.1.68
dc.identifier.pmid17210880
dc.identifier.urihttp://hdl.handle.net/20.500.14038/27233
dc.description.abstractBACKGROUND: Patients enrolled in randomized clinical trials (RCTs) may not reflect those seen in real-life practice. Our goal was to compare patients eligible for enrollment but not enrolled in contemporary RCTs of reperfusion therapy with patients who would have been ineligible and also with patients with acute myocardial infarction (AMI) participating in RCTs. METHODS: Consecutive patients with AMI (n = 8469) enrolled in the GRACE registry (Global Registry of Acute Coronary Events) were divided into 3 groups: RCT participants (11%; n = 953), eligible nonenrolled patients (55%; n = 4669), and ineligible patients (34%; n = 2847). Our main outcome measures were hospital mortality rates. RESULTS: Based on baseline characteristics or GRACE risk-score distribution, RCT participants had the lowest a priori risk of death; eligible patients had a higher risk; and ineligible patients had the highest risk. Actual hospital mortality showed a similar gradient (3.6%, 7.1%, and 11.4%, respectively) (P<.001). Multivariable analysis adjusting for baseline risk, use and type of reperfusion therapy, and delay from symptom onset to admission consistently showed a higher mortality rate for eligible nonenrolled patients than for RCT participants (odds ratio, 1.61; 95% confidence interval, 1.06-2.43; and odds ratio, 1.97; 95% confidence interval, 1.24-3.13, respectively). CONCLUSIONS: Patients with AMI participating in RCTs have a lower baseline risk and experience lower mortality than nonenrolled patients, even when they are trial eligible. This difference is not entirely explained by differences in baseline risk, use and type of reperfusion therapy, and/or delays in presentation. Caution is necessary when extending the findings obtained in RCTs to the general population with AMI.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=17210880&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1001/archinte.167.1.68
dc.subjectAged
dc.subjectFemale
dc.subjectHospital Mortality
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectMulticenter Studies as Topic
dc.subjectMyocardial Infarction
dc.subjectOdds Ratio
dc.subjectRandomized Controlled Trials as Topic
dc.subjectTreatment Outcome
dc.subjectHealth Services Research
dc.titleExternal validity of clinical trials in acute myocardial infarction
dc.typeArticle
dc.source.journaltitleArchives of internal medicine
dc.source.volume167
dc.source.issue1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/cor_grace/53
dc.identifier.contextkey2254973
html.description.abstract<p>BACKGROUND: Patients enrolled in randomized clinical trials (RCTs) may not reflect those seen in real-life practice. Our goal was to compare patients eligible for enrollment but not enrolled in contemporary RCTs of reperfusion therapy with patients who would have been ineligible and also with patients with acute myocardial infarction (AMI) participating in RCTs.</p> <p>METHODS: Consecutive patients with AMI (n = 8469) enrolled in the GRACE registry (Global Registry of Acute Coronary Events) were divided into 3 groups: RCT participants (11%; n = 953), eligible nonenrolled patients (55%; n = 4669), and ineligible patients (34%; n = 2847). Our main outcome measures were hospital mortality rates.</p> <p>RESULTS: Based on baseline characteristics or GRACE risk-score distribution, RCT participants had the lowest a priori risk of death; eligible patients had a higher risk; and ineligible patients had the highest risk. Actual hospital mortality showed a similar gradient (3.6%, 7.1%, and 11.4%, respectively) (P<.001). Multivariable analysis adjusting for baseline risk, use and type of reperfusion therapy, and delay from symptom onset to admission consistently showed a higher mortality rate for eligible nonenrolled patients than for RCT participants (odds ratio, 1.61; 95% confidence interval, 1.06-2.43; and odds ratio, 1.97; 95% confidence interval, 1.24-3.13, respectively).</p> <p>CONCLUSIONS: Patients with AMI participating in RCTs have a lower baseline risk and experience lower mortality than nonenrolled patients, even when they are trial eligible. This difference is not entirely explained by differences in baseline risk, use and type of reperfusion therapy, and/or delays in presentation. Caution is necessary when extending the findings obtained in RCTs to the general population with AMI.</p>
dc.identifier.submissionpathcor_grace/53
dc.contributor.departmentDepartment of Medicine, Division of Cardiovascular Medicine
dc.contributor.departmentCenter for Outcomes Research
dc.source.pages68-73


This item appears in the following Collection(s)

Show simple item record