Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary Article Swipe
Robert A. Byrne
,
Patrick W. Serruys
,
Andreas Baumbach
,
Javier Escaned
,
Jean Fajadet
,
Stefan James
,
Michael Joner
,
Semih Oktay
,
Peter Jüni
,
Adnan Kastrati
,
George Sianos
,
Giulio Stefanini
,
William Wijns
,
Stephan Windecker
·
YOU?
·
· 2015
· Open Access
·
· DOI: https://doi.org/10.1093/eurheartj/ehv203
YOU?
·
· 2015
· Open Access
·
· DOI: https://doi.org/10.1093/eurheartj/ehv203
The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
Related Topics
Concepts
Medicine
Guideline
Clinical trial
European union
Randomized controlled trial
Task force
Percutaneous coronary intervention
Directive
Systematic review
Executive summary
Medical physics
Cardiology
Internal medicine
MEDLINE
Myocardial infarction
Finance
Pathology
Computer science
Programming language
Political science
Business
Public administration
Law
Economic policy
Economics
Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1093/eurheartj/ehv203
- https://academic.oup.com/eurheartj/article-pdf/36/38/2608/17154566/ehv203.pdf
- OA Status
- bronze
- Cited By
- 218
- References
- 26
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2148529685
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2148529685Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1093/eurheartj/ehv203Digital Object Identifier
- Title
-
Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summaryWork title
- Type
-
reviewOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2015Year of publication
- Publication date
-
2015-06-12Full publication date if available
- Authors
-
Robert A. Byrne, Patrick W. Serruys, Andreas Baumbach, Javier Escaned, Jean Fajadet, Stefan James, Michael Joner, Semih Oktay, Peter Jüni, Adnan Kastrati, George Sianos, Giulio Stefanini, William Wijns, Stephan WindeckerList of authors in order
- Landing page
-
https://doi.org/10.1093/eurheartj/ehv203Publisher landing page
- PDF URL
-
https://academic.oup.com/eurheartj/article-pdf/36/38/2608/17154566/ehv203.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
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https://academic.oup.com/eurheartj/article-pdf/36/38/2608/17154566/ehv203.pdfDirect OA link when available
- Concepts
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Medicine, Guideline, Clinical trial, European union, Randomized controlled trial, Task force, Percutaneous coronary intervention, Directive, Systematic review, Executive summary, Medical physics, Cardiology, Internal medicine, MEDLINE, Myocardial infarction, Finance, Pathology, Computer science, Programming language, Political science, Business, Public administration, Law, Economic policy, EconomicsTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
218Total citation count in OpenAlex
- Citations by year (recent)
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2025: 10, 2024: 11, 2023: 13, 2022: 16, 2021: 14Per-year citation counts (last 5 years)
- References (count)
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26Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.The | 0, 164, 189, 231 |
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