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Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.

ABSTRACT: Background:The ATTEMPT study is a multicenter, randomized controlled trial which is investigator-based and open label in nature. For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group). To improve the quality of the study's analysis and to minimize analysis bias based on the study's findings. Methods:The design of the statistical analysis plan (SAP) was created by chief investigators and statisticians and received permission from the aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) management committee. Treatment allocation and research data were reviewed by the Data Safety and Monitoring Committee and researchers were kept blind. We produced data shells based on a pre-existing published protocol and produced detailed descriptions of statistical analyses. This study includes primary, secondary and safety endpoints. Relevant statistical comparisons were planned and discussed in a transparent manner. They are publicly available, verifiable and were determined prior to the data collection process being completed. Results:We developed a SAP for the ATTEMPT study and an outline and list of mock tables were also created. We produced descriptions of analyses of baseline characteristics, patient care approaches, efficacy measures, and outcomes. This study defined five previously specified subgroups and compared the statistics of groups within these subgroups. Conclusions:This SAP has been developed for the ATTEMPT study and has high-quality standards of internal validity to minimize analysis bias. Trial registration:ClinicalTrials.gov number, NCT02067195.

SUBMITTER: Liu J

PROVIDER: S-EPMC7210191 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.

Liu Jin J Guo Zhaodong Z Lei Li L Sun Guoli G He Yibo Y Song Feier F Chen Jiyan J Tan Ning N Chen Shiqun S Liu Yong Y

Annals of translational medicine 20200401 7

<h4>Background</h4>The ATTEMPT study is a multicenter, randomized controlled trial which is investigator-based and open label in nature. For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group). To improve the quality of the study's analysis and to minimize analysis bias base ...[more]

PMID: 32395501

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Project description:Background Despite restoration of epicardial flow following primary percutaneous coronary intervention (PPCI), microvascular reperfusion as reflected by ST-elevation resolution (ST-ER) resolution remains variable and its pathophysiology remains unclear. Methods and Results Using principal component analyses, we explored associations between 91 serum biomarkers drawn before PPCI clustered into 14 pathobiologic processes (including NT-proBNP [N-terminal pro-B-type natriuretic peptide] as an independent cluster), and (1) ST-ER resolution ≥50% versus <50%; and (2) 90-day composite of death, shock, and heart failure. Network analyses were performed to understand interbiomarker relationships between the ST-ER groups. Among the 1160 patients studied, 861 (74%) had ST-ER ≥50% at a median 40 (interquartile range, 23-70) minutes following PPCI, yet both groups had comparable post-PPCI TIMI (Thrombolysis in Myocardial Infarction) grade 3 flow (86.6% versus 82.9%; P=0.25). ST-ER ≥50% was associated with significantly lower pre-PPCI concentrations of platelet activation cluster (particularly P-selectin, von Willebrand factor, and platelet-derived growth factor A) and NT-proBNP, including after risk adjustment. Across both ST-ER groups, strong interbiomarker relationships were noted between pathways indicative of myocardial stretch, platelet activation, and inflammation, whereas with ST-ER <50% correlations between iron homeostasis and inflammation were observed. Of all 14 biomarker clusters, only NT-proBNP was significantly associated with the 90-day clinical composite. Conclusions Suboptimal ST-ER is common despite achieving post-PPCI TIMI grade 3 flow. The cluster of platelet activation proteins and NT-proBNP were strongly correlated with suboptimal ST-ER and NT-proBNP was independently associated with 90-day outcomes. This analysis provides insights into the pathophysiology of microvascular reperfusion in ST-segment-elevation myocardial infarction and suggests novel pre-PPCI risk targets potentially amenable to enhancing tissue-level reperfusion following PPCI.

Dataset Information

Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.

Publications

Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.

Similar Datasets

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