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Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing
Christoph B Olivier1,2, Deepak L Bhatt3, Sergio Leonardi4
1Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, CA (C.B.O., K.W.M.).
Insights
Cangrelor significantly reduced myocardial infarction (MI) in patients undergoing percutaneous coronary intervention, as identified by central adjudication. Both centrally adjudicated and site-reported MIs independently predicted increased 30-day mortality risk.
Area of Science:
- Cardiology
- Clinical Trials
- Interventional Cardiology
Background:
- The CHAMPION PHOENIX trial demonstrated cangrelor's efficacy in reducing composite endpoints in percutaneous coronary intervention (PCI).
- This analysis focuses on the impact of myocardial infarction (MI) event adjudication by a clinical events committee (CEC) versus site investigators (SIs).
- Understanding discrepancies in MI reporting and their prognostic significance is crucial for accurate trial interpretation.
Purpose of the Study:
- To evaluate the impact of central adjudication (CEC) versus site investigator (SI) reporting of myocardial infarction (MI) in the CHAMPION PHOENIX trial.
- To assess the prognostic importance of MIs identified by CEC or SI on 30-day mortality.
- To compare the incidence of MI between cangrelor and clopidogrel treatment groups based on different adjudication methods.
Main Methods:
- Analysis of data from 10,942 patients undergoing PCI in the CHAMPION PHOENIX trial.
- Systematic MI identification and adjudication by a CEC using predefined criteria, algorithms, and biomarker review.
- Comparison of MI events reported by CEC versus SI, and their association with 30-day mortality using logistic regression models.
Main Results:
- Central adjudication identified significantly more MIs (4.2%) compared to SI reporting (1.3%).
- Cangrelor significantly reduced MIs identified by CEC (3.8% vs. 4.7% for clopidogrel; OR 0.80) and showed a similar trend for SI-reported MIs (1.1% vs. 1.5%; OR 0.72).
- All MI categories (CEC-identified, SI-reported, or both) were independently associated with increased 30-day mortality (ORs ranging from 4.69 to 15.4).
Conclusions:
- Central adjudication by CEC identified substantially more MIs than SI reporting, highlighting discrepancies in event ascertainment.
- Cangrelor demonstrated a significant reduction in MIs adjudicated by CEC, with a similar relative risk reduction for SI-reported MIs.
- Both centrally adjudicated and site-reported MIs are independently associated with increased 30-day mortality, underscoring the prognostic importance of MI events in PCI patients.
Background:
In the CHAMPION PHOENIX trial, cangrelor reduced the primary composite end point of death, myocardial infarction (MI), ischemia-driven revascularization, or stent thrombosis at 48 hours. This study aimed to explore the impact of event adjudication and the prognostic importance of MI reported by a clinical events committee (CEC) or site investigators (SIs).
Methods And Results:
Data from the CHAMPION PHOENIX trial of patients undergoing elective or nonelective percutaneous coronary intervention were analyzed. A CEC systematically identified and adjudicated MI using predefined criteria, a computer algorithm to identify suspected events, and semilogarithmic plots to review biomarker changes. Thirty-day death was modeled using baseline characteristics. Of 10 942 patients, 462 (4.2%) patients had at least 1 MI by 48 hours identified by the CEC (207 [3.8%] cangrelor; 255 [4.7%] clopidogrel; odds ratio [OR] 0.80; 95% CI, 0.67-0.97; P=0.022), and 143 patients had at least 1 MI by 48 hours reported by the SI (60 [1.1%] cangrelor; 83 [1.5%] clopidogrel; OR, 0.72; 95% CI, 0.52-1.01; P=0.053). Of the 462 MIs identified by the CEC, 92 (20%) were reported by SI, and 370 (80%) were not. Of the 143 MI reported by the SI, 51 (36%) were not confirmed by CEC. All categories were associated with an increased adjusted risk for 30-day death (CEC: OR, 5.35; 95% CI, 2.56-11.2; P<0.001; SI: 9.08 [4.01-20.5]; P<0.001; CEC and SI: 10.9 [3.23-36.6]; P<0.001; CEC but not SI: 4.69 [1.94-11.3]; P<0.001; SI but not CEC: 15.4 [5.26-44.9]; P<0.001).
Conclusions:
In patients undergoing percutaneous coronary intervention, CEC procedures identified 3 times as many MIs as the SI reported. Compared with clopidogrel, cangrelor significantly reduced MIs identified by the CEC with a qualitatively similar relative risk reduction in MIs reported by the SI. MIs identified by CEC or reported by SI were independently associated with worse 30-day death. Central adjudication identified additional, prognostically important events.
Clinical Trial Registration:
URL: https://www.clinicaltrials.gov . Unique identifier: NCT01156571.
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