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Bioresorbable Scaff...
Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.
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Wykrzykowska, Joanna J (author)
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Kraak, Robin P (author)
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Hofma, Sjoerd H (author)
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van der Schaaf, Rene J (author)
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Arkenbout, E Karin (author)
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IJsselmuiden, Alexander J (author)
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Elias, Joëlle (author)
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van Dongen, Ivo M (author)
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Tijssen, Ruben Y G (author)
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Koch, Karel T (author)
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Baan, Jan (author)
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Vis, M Marije (author)
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de Winter, Robbert J (author)
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Piek, Jan J (author)
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Tijssen, Jan G P (author)
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Henriques, Jose P S (author)
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- James, Stefan (author)
- Uppsala universitet,Institutionen för medicinska vetenskaper,Uppsala kliniska forskningscentrum (UCR)
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(creator_code:org_t)
- 2017
- 2017
- English.
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In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 376:24, s. 2319-2328
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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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- BACKGROUND: Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice.METHODS: We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events.RESULTS: The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan-Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001).CONCLUSIONS: In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077 .).
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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Wykrzykowska, Jo ...
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Kraak, Robin P
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Hofma, Sjoerd H
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van der Schaaf, ...
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Arkenbout, E Kar ...
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IJsselmuiden, Al ...
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show more...
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Elias, Joëlle
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van Dongen, Ivo ...
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Tijssen, Ruben Y ...
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Koch, Karel T
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Baan, Jan
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Vis, M Marije
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de Winter, Robbe ...
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Piek, Jan J
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Tijssen, Jan G P
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Henriques, Jose ...
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James, Stefan
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show less...
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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 ...
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New England Jour ...
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Uppsala University