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Sökning: WFRF:(van der Schaaf Rene J) > Bioresorbable Scaff...

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FältnamnIndikatorerMetadata
00004407naa a2200481 4500
001oai:DiVA.org:uu-342873
003SwePub
008180223s2017 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3428732 URI
0247 a https://doi.org/10.1056/NEJMoa16149542 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Wykrzykowska, Joanna J4 aut
2451 0a Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.
264 1c 2017
338 a print2 rdacarrier
500 a Collaborator Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.
520 a 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 .).
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kardiologi0 (SwePub)302062 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cardiac and Cardiovascular Systems0 (SwePub)302062 hsv//eng
7001 a Kraak, Robin P4 aut
7001 a Hofma, Sjoerd H4 aut
7001 a van der Schaaf, Rene J4 aut
7001 a Arkenbout, E Karin4 aut
7001 a IJsselmuiden, Alexander J4 aut
7001 a Elias, Joëlle4 aut
7001 a van Dongen, Ivo M4 aut
7001 a Tijssen, Ruben Y G4 aut
7001 a Koch, Karel T4 aut
7001 a Baan, Jan4 aut
7001 a Vis, M Marije4 aut
7001 a de Winter, Robbert J4 aut
7001 a Piek, Jan J4 aut
7001 a Tijssen, Jan G P4 aut
7001 a Henriques, Jose P S4 aut
7001 a James, Stefanu Uppsala universitet,Institutionen för medicinska vetenskaper,Uppsala kliniska forskningscentrum (UCR)0 (Swepub:uu)stjam367
7102 a Uppsala universitetb Institutionen för medicinska vetenskaper4 org
7730 t New England Journal of Medicineg 376:24, s. 2319-2328q 376:24<2319-2328x 0028-4793x 1533-4406
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-342873
8564 8u https://doi.org/10.1056/NEJMoa1614954

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