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

Table 1 Myocardial infarctions identified by site investigators but not confirmed by the clinical events committee

	Eastern Europe	Latin America	North America	Western Europe	Overall
Clinical scenario	(n = 24)	(n = 8)	(n = 57)	(n = 78)	(n = 167)
Enrolment myocardial infarction^*	8 (33)	4 (50)	24 (42)	28 (36)	64 (38)
Ischemic event without infarction^†	7 (29)	0 (0)	8 (14)	19 (24)	34 (20)
Peri-death infarction^‡	6 (25)	2 (25)	13 (23)	8 (10)	29 (17)
Percutaneous coronary intervention related	0 (0)	1 (12.5)	6 (11)	10 (13)	17 (10)
Coronary artery bypass surgery related	2 (8)	1 (12.5)	5 (9)	7 (9)	15 (9)
Miscellaneous	1 (4)	0 (0)	1 (2)	6 (8)	8 (5)

Data presented as n (%). ^* Not an end-point event per protocol. ^† Clinical evidence of ischemia without electrocardiography (ECG) or cardiac enzyme evidence of infarction. ^‡ Infarction suspected at the time of death without supporting clinical, ECG, or cardiac enzyme data.

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