Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee

2006 ◽  
Vol 27 (3) ◽  
pp. 260-268 ◽  
Author(s):  
John L. Petersen ◽  
Ghazala Haque ◽  
Anne S. Hellkamp ◽  
Greg C. Flaker ◽  
N.A. Mark Estes ◽  
...  
Keyword(s):  
Mode Selection ◽  
Clinical Events ◽  
Clinical Events Committee

Abstract 13030: Causes of Cardiovascular and Non-cardiovascular Mortality in the Ischemia Trial

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Mandeep S Sidhu ◽  
Karen P Alexander ◽  
Zhen Huang ◽  
Sean M O’Brien ◽  
Bernard R Chaitman ◽  
...  
Keyword(s):  
Management Strategies ◽  
Multivariable Analysis ◽  
International Study ◽  
Factors Associated ◽  
Clinical Events ◽  
All Cause Mortality ◽  
History Of ◽  
Multivariable Analyses ◽  
Clinical Events Committee

Background: In the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial, all-cause mortality was similar in patients with stable ischemic heart disease (SIHD) randomized to invasive (INV) and conservative (CON) management strategies. This analysis details specific causes of cardiovascular (CV) and non-CV mortality by treatment group. Methods: In ISCHEMIA, 289 deaths occurred after a median follow-up of 3.2 years; 145 (5.6%) in INV and 144 (5.6%) in CON (HR 1.05, CI 0.83-1.32). Deaths were adjudicated by an independent Clinical Events Committee as CV, non-CV with or without a CV contributor or undetermined. The protocol defined CV death as deaths from CV causes, non-CV causes with CV contributor, and cause undetermined; non-CV death was defined as death from non-CV causes without a CV contributor. Multivariable analyses were used to identify factors associated with cause-specific death. Results: CV death was similar between groups [INV 92 (3.6%), CON 111 (4.3%); HR 0.87 (CI 0.66, 1.15)], but INV had more non-CV death [INV 53 (2.0%), CON 33 (1.3%); HR 1.63 (CI 1.06, 2.52)]; fewer undetermined deaths [INV 12 (0.5%) and CON 26 (1.0%); HR 0.48 (0.24, 0.95)] and more malignancy deaths [INV 41 (1.6%), CON 20 (0.8%); HR 2.11 (1.24, 3.61)]. In multivariable analysis, risk factors associated with CV death were age [HR 1.42 (CI 1.19-1.70) per 10-year increase], diabetes [HR 1.39 (CI 1.03-1.87)], history of heart failure [HR 1.96 (CI 1.33-2.91)], and eGFR [HR 1.18 (CI 1.11-1.26) per 5-ml/min decrease below 80ml/min]. Factors associated with non-CV death were age [HR 2.31 (CI 1.75-3.03) per 10-year increase] and randomization to INV [HR 1.76 (CI 1.13-2.75)]. Conclusions: In ISCHEMIA, all-cause mortality was similar for the INV and CON strategies. Excess non-CV deaths in INV with a higher number of deaths from malignancy but a higher number of undetermined deaths in CON requires further evaluation.

Misreporting of myocardial infarction end points: Results of adjudication by a central clinical events committee in the PARAGON-B trial

2002 ◽  
Vol 143 (2) ◽  
pp. 242-248 ◽  
Author(s):  
Kenneth W. Mahaffey ◽  
Matthew T. Roe ◽  
Christopher K. Dyke ◽  
L.Kristin Newby ◽  
Neal S. Kleiman ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
End Points ◽  
Clinical Events ◽  
Clinical Events Committee

Abstract 18938: Prognostically Important Myocardial Infarctions are Markedly Underreported in Patients Undergoing Percutaneous Coronary Intervention: Insights from CHAMPION PHOENIX

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Kenneth W Mahaffey ◽  
Deepak L Bhatt ◽  
Gregg W Stone ◽  
C. Michael Gibson ◽  
P. Gabriel Steg ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Composite Endpoint ◽  
Coronary Intervention ◽  
Myocardial Infarctions ◽  
Clinical Events ◽  
Percutaneous Coronary ◽  
Baseline Characteristics ◽  
Treatment Comparisons ◽  
The Impact ◽  
Clinical Events Committee

Objectives: In the CHAMPION PHOENIX trial, cangrelor was shown to reduce the primary composite endpoint of death, myocardial infarction (MI), ischemia driven revascularization, or stent thrombosis at 48 hours. We explored the effect of cangrelor on MI including different types of MI and the impact of event adjudication. Methods: A central clinical events committee (CEC) systematically identified and adjudicated MI events using pre-defined MI criteria. 30-day death was modeled using baseline characteristics including PCI related MIs. Results: Overall, 10,942 patients were included in the primary analyses; 462 patients had at least one MI at 48 hours reported by the CEC (207 [3.8 %] cangrelor; 255 [4.7 %] clopidogrel; OR 0.80; 95% CI [0.67, 0.97]; P = 0.022), and 143 patients had at least one MI at 48 hours reported by the site investigators (60 [1.1%] cangrelor; 83 [1.5%] clopidogrel; OR 0.72; 95% CI [0.52, 1.01]; P = 0.053). The Table shows the MI types reported by the CEC, the site investigator reported MIs and treatment comparisons. Of the 462 MIs reported by the CEC, 92 (19.9%) were also reported by site investigators, and 370 (80.1%) were not (170 in cangrelor group, 200 in clopidogrel group). Of the 143 MI events reported by the Site Investigators, CEC reported an MI in 92 (64.3%). CEC reported MI events were independently predictive of 30 day mortality OR 3.48; 95% CI (2.00 - 6.03). Conclusions: In patients with ACS undergoing PCI, CEC procedures identified three times as many MIs as the site investigators reported. Site investigators under-report MIs related to percutaneous coronary intervention. MIs reported by the CEC were independently associated with worse 30-day death. The overall efficacy of cangrelor was similar on MIs reported by the site investigators or the CEC.

P71 Impact of the clinical events committee process on data safety monitoring

1996 ◽  
Vol 17 (2) ◽  
pp. S135 ◽  
Author(s):  
Barbara E. Tardiff ◽  
Kenneth W. Mahaffey ◽  
James E. Tcheng ◽  
Christopher B. Granger ◽  
Robert M. Califf ◽  
...  
Keyword(s):  
Safety Monitoring ◽  
Data Safety ◽  
Clinical Events ◽  
Data Safety Monitoring ◽  
Clinical Events Committee

Release, Aggregation and Lysis of Human Platelets by Antilymphocyte Globulin and Antiplatelet Serum

1976 ◽  
Vol 36 (02) ◽  
pp. 411-423 ◽  
Author(s):  
Nicholas Lekas ◽  
J. C Rosenberg
Keyword(s):  
Platelet Aggregation ◽  
Gamma Globulin ◽  
Human Platelets ◽  
Plasma Medium ◽  
Release Reaction ◽  
Clinical Events ◽  
Thrombotic Complications ◽  
Platelet Release ◽  
Free Media

SummaryHuman platelets labeled with 51Cr were used to determine the contribution made by platelet lysis to the platelet release reaction and platelet aggregation induced by rabbit antihuman platelet serum (APS) and equine antihuman thymocyte globulin (ATG). Platelets were tested in both plasma (PRP) and non-plasma containing media. Antibodies directed against platelets, either as APS or ATG, induced significant amounts of platelet release and aggregation, as well as some degree of lysis, in the absence of complement. The presence of complement increased platelet lysis and aggregation, but not the release reaction. Non-immune horse gamma globulin produced different responses depending upon whether platelets were investigated in PRP or non-plasma containing media. Aggregation was seen in the latter but not the former. These differences can be explained by the presence of plasma components which prevent non-specific immune complexes from causing platelet aggregation. Since platelets in vivo are always in a plasma medium, one must be wary of utilizing data from platelet studies in synthetic plasma-free media as the basis of explaining clinical events. These observations demonstrate at least two, and possibly three, different mechanisms whereby ATG could activate platelets causing thrombotic complications and thrombocytopenia, i.e., via 1) specific and, 2) non-specific non-lytic pathways and 3) a lytic pathway.

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