The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.
Standardized End Point Definitions for Coronary Intervention Trials
Abstract
The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.
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Citations
Cites
Third Universal Definition of Myocardial Infarction
Thygesen, K., Alpert, J. S., Jaffe, A. S., Simoons, M. L., Chaitman, B. R., & White, H. D. (2012) · Circulation · doi:10.1161/cir.0b013e31826e1058 · Cited by 2,985
Standardizing Patient Outcomes Measurement
Porter, M. E., Larsson, S., & Lee, T. H. (2016) · New England Journal of Medicine · doi:10.1056/nejmp1511701 · Cited by 626 · cited 1×
“Quantifying health status is therefore a critical requirement for more completely defining the benefits of treatment.(21,22) Patient-reported outcomes systematically measure health status directly from the patient, without amendment or interpretation of the response by a clinician or anyone else.”
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Cited by
Généreux, P., Piazza, N., Alu, M. C., Nazif, T., Hahn, R. T., Pibarot, P., Bax, J. J., Leipsic, J. A., Blanke, P., Blackstone, E. H., et al. (2021) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.02.038 · Cited by 1,313
Self-citationVARC-3 WRITING COMMITTEE, Généreux, P., Piazza, N., Alu, M. C., Nazif, T., Hahn, R. T., Pibarot, P., Bax, J. J., Leipsic, J. A., Blanke, P., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehaa799 · Cited by 915
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Metadata
- Authors
- Garcia-Garcia, H. M., McFadden, E. P., Farb, A., Mehran, R., Stone, G. W., Spertus, J., Onuma, Y., Morel, M.-A., van Es, G.-A., Zuckerman, B., Fearon, W. F., Taggart, D., Kappetein, A.-P., Krucoff, M. W., Vranckx, P., Windecker, S., Cutlip, D., Serruys, P. W., & Academic Research Consortium
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2018-06-11
- Volume
- 39
- Issue
- 23
- Pages
- 2192-2207
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- OpenAlex
- W2808359328
- Cited by
- 326
- References
- 2
- FWCI
- 22.86
- Type
- journal article
- Language
- en
- Open access
- closed
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- The paper
- Garcia-Garcia, H. M., McFadden, E. P., Farb, A., Mehran, R., Stone, G. W., Spertus, J., Onuma, Y., Morel, M.-A., van Es, G.-A., Zuckerman, B., Fearon, W. F., Taggart, D., Kappetein, A.-P., Krucoff, M. W., Vranckx, P., Windecker, S., Cutlip, D., Serruys, P. W., & Academic Research Consortium. (2018). Standardized End Point Definitions for Coronary Intervention Trials. European Heart Journal. https://doi.org/10.1093/eurheartj/ehy223
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
