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Rationale and desig...
Rationale and design of INFINITY-SWEDEHEART : A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent
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- Erlinge, David (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Molecular Cardiology,Lund University Research Groups,Skåne University Hospital
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- Andersson, Jonas (author)
- Umeå University,Umeå universitet,Kardiologi
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- Fröbert, Ole, 1964- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Örebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden; Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark,Aarhus University Hospital
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- Törnerud, Mattias (author)
- Karolinska Institute
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- Böhm, Felix (author)
- Uppsala University
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- Held, Claes (author)
- Uppsala University
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- Elek, Candace (author)
- Elixir Medical Corporation, CA, Milpitas, United States
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- Sirhan, Motasim (author)
- Elixir Medical Corporation, CA, Milpitas, United States
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- Oldgren, Jonas (author)
- Uppsala University
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- James, Stefan (author)
- Uppsala University
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(creator_code:org_t)
- Elsevier, 2024
- 2024
- English.
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In: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 277, s. 1-10
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Abstract
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- BACKGROUND: Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI).METHODS: The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients.SUMMARY: The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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- ref (subject category)
- art (subject category)
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- By the author/editor
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Erlinge, David
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Andersson, Jonas
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Fröbert, Ole, 19 ...
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Törnerud, Mattia ...
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Böhm, Felix
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Held, Claes
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Elek, Candace
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Sirhan, Motasim
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Oldgren, Jonas
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James, Stefan
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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American Heart J ...
- By the university
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Örebro University
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Umeå University
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Lund University