Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study

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dc.contributor.authorMahaffey, KW
dc.contributor.authorHarrington, RA
dc.contributor.authorAkkerhuis, M
dc.contributor.authorKleiman, NS
dc.contributor.authorBerdan, LG
dc.contributor.authorCrenshaw, BS
dc.contributor.authorTardiff, BE
dc.contributor.authorGranger, CB
dc.contributor.authorDeJong, I
dc.contributor.authorBhapkar, M
dc.contributor.authorWidimsky, P
dc.contributor.authorCorbalon, R
dc.contributor.authorLee, KL
dc.contributor.authorDeckers, JW
dc.contributor.authorSimoons, ML
dc.contributor.authorTopol, EJ
dc.contributor.authorCaliff, RM
dc.date.accessioned2025-01-21T01:31:00Z
dc.date.available2025-01-21T01:31:00Z
dc.date.issued2001
dc.description.abstractBackground Limited information has been published regarding how specific processes for event adjudication can affect event rates in trials. We reviewed nonfatal myocardial infarctions (MIs) reported by site investigators in the international Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide) Therapy (PURSUIT) trial and those adjudicated by a central clinical events committee (CEC) to determine the reasons for differences in event rates.
dc.description.abstractMethods The PURSUIT trial randomised 10,948 patients with acute coronary syndromes to receive eptifibatide or placebo. The primary end-point was death or post-enrolment MI at 30 days as assessed by the CEC; this end-point was also constructed using site-reported events. The CEC identified suspected MIs by systematic review of clinical, cardiac enzyme, and electrocardiographic data.
dc.description.abstractResults The CEC identified 5005 (46%) suspected events, of which 1415 (28%) were adjudicated as MI. The site investigator and CEC assessments of whether a MI had occurred disagreed in 983 (20%) of the 5005 patients with suspected MI, mostly reflecting site misclassification of post-enrolment MIs (as enrolment MIs) or underreported periprocedural MIs. Patients for whom the CEC and site investigator agreed that no end-point MI had occurred had the lowest mortality at 30 days and between 30 days and 6 months, and those with agreement that a MI had occurred had the highest mortality.
dc.description.abstractConclusion CEC adjudication provides a standard, systematic, independent, and unbiased assessment of end-points, particularly for trials that span geographic regions and clinical practice settings. Understanding the review process and reasons for disagreement between CEC and site investigator assessments of MI is important to design future trials and interpret event rates between trials.
dc.fuente.origenWOS
dc.identifier.issn1468-6694
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/96953
dc.identifier.wosidWOS:000173941300007
dc.issue.numero4
dc.language.isoen
dc.pagina.final194
dc.pagina.inicio187
dc.revistaCurrent controlled trials in cardiovascular medicine
dc.rightsacceso restringido
dc.subjectacute coronary syndromes
dc.subjectadjudication
dc.subjectclinical events committee
dc.subjectend-points
dc.subjectmyocardial infarction
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleDisagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study
dc.typeartículo
dc.volumen2
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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