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Five-Year Results o...
Five-Year Results of the Bioflow-III Registry : Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent
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- Waltenberger, Johannes (author)
- Department of Cardiovascular Medicine, Medical Faculty, University of Münster, Münster, Germany
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- Brachmann, Johannes (author)
- II. Medizinische Klinik, Klinikum Coburg, Coburg, Germany
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- van der Heyden, Jan (author)
- Department of Cardiology, St. Antionius Ziekenhuis, Nieuwegein, the Netherlands
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- Richardt, Gert (author)
- Department of Cardiology and Angiology, Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany
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- Fröbert, Ole, 1964- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Cardiology
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- Seige, Markus (author)
- I. Medizinische Klinik, Krankenhaus Martha Maria gGmbH, Halle-Dölau, Germany
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- Friedrich, Guy (author)
- Innere Medizin III, Kardiologie, University Hospital Innsbruck, Innsbruck, Austria
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- Erglis, Andrejs (author)
- Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia
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- Winkens, Mark (author)
- Department of Cardiology, Elisabeth-Tweesteden Ziekenhuis (ETZ), AD Tilburg, the Netherlands
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- Hegeler-Molkewehrum, Christian (author)
- Kardiologisch-Angiologische Praxis Hegeler, Bremen, Germany
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- Neef, Martin (author)
- Department of Cardiology, University Leipzig, Leipzig, Germany
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- Hoffmann, Stefan (author)
- Department Internal Medicine and Cardiology, Vivantes Klinikum im Friedrichshain, Berlin, Germany
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Department of Cardiovascular Medicine, Medical Faculty, University of Münster, Münster, Germany II Medizinische Klinik, Klinikum Coburg, Coburg, Germany (creator_code:org_t)
- Elsevier, 2020
- 2020
- English.
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In: Cardiovascular Revascularization Medicine. - : Elsevier. - 1553-8389 .- 1878-0938. ; 21:1, s. 63-69
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Purpose: We aimed to assess long-term safety and performance of the Orsiro sirolimus-eluting coronary stent with biodegradable polymer in a large unselected population and in pre-specified subgroups.Methods: BIOFLOW-III is a prospective, multicenter, international, observational registry with follow-up visits scheduled at 6 and 12 months, and at 3 and 5 years (NCT01553526).Results: 1356 patients with 1738 lesions were enrolled. Of those, 392 (28.9%) declined to participate in the study extension from 18 months to 5 years, 37 (2.7%) withdrew consent, and 89 (6.6%) were lost to follow-up. At 5-years, Kaplan-Meier estimates of target lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, coronary artery bypass grafting and clinically driven target lesion revascularization was 10.0% [95% confidence interval (CI): 8.4; 12.0] in the overall population, and 14.0% [95% CI: 10.5; 18.6], 10.3% [95% CI: 7.8; 13.5], 1.8% [95% CI: 0.3; 12.0], and 11.3% [95% CI: 8.5; 15.1] in the pre-defined risk groups of patients with diabetes mellitus, small vessels <= 2.75 mm, chronic total occlusion, and acute myocardial infarction. Definite stent thrombosis was observed in 0.3% [95% CI: 0.1; 0.9] of patients.Conclusion: These long-term outcomes provide further evidence on the safety and performance of a sirolimus-eluting biodegradable polymer stent within daily clinical practice. The very lowdefinite stent thrombosis rate affirms biodegradable polymer safety and performance.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Coronary artery stenosis
- Drug-eluting stent
- Biodegradable polymer
- Hybrid stent
- Diabetes
Publication and Content Type
- ref (subject category)
- art (subject category)
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Waltenberger, Jo ...
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Brachmann, Johan ...
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van der Heyden, ...
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Richardt, Gert
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Fröbert, Ole, 19 ...
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Seige, Markus
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Friedrich, Guy
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Erglis, Andrejs
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Winkens, Mark
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Hegeler-Molkeweh ...
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Neef, Martin
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Hoffmann, Stefan
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Cardiovascular R ...
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Örebro University