Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/175954
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Windecker, Stephan | - |
dc.contributor.author | Latib, Azeem | - |
dc.contributor.author | Kedhi, Elvin | - |
dc.contributor.author | Kirtane, Ajay J. | - |
dc.contributor.author | Kandzari, David E. | - |
dc.contributor.author | Mehran, Roxana | - |
dc.contributor.author | Price, Matthew J. | - |
dc.contributor.author | Abizaid, Alexandre | - |
dc.contributor.author | Simon, Daniel I. | - |
dc.contributor.author | Worthley, Stephen G. | - |
dc.contributor.author | Zaman, Azfar | - |
dc.contributor.author | Hudec, Martin | - |
dc.contributor.author | Poliacikova, Petra | - |
dc.contributor.author | Abdul Ghapar, Kahar Bin | - |
dc.contributor.author | Selvaraj, Kamaraj | - |
dc.contributor.author | Petrov, Ivo | - |
dc.contributor.author | Mylotte, Darren | - |
dc.contributor.author | Pinar, Eduardo | - |
dc.contributor.author | Moreno, Raúl | - |
dc.contributor.author | Fabbiocchi, Franco | - |
dc.contributor.author | Pasupati, Sanjeevan | - |
dc.contributor.author | Kim, Hyo-Soo | - |
dc.contributor.author | Aminian, Adel | - |
dc.contributor.author | Tie, Charles | - |
dc.contributor.author | Wlodarczak, Adrian | - |
dc.contributor.author | Hur, Seung-Ho | - |
dc.contributor.author | Marx, Steven O. | - |
dc.contributor.author | Jankovic, Ivana | - |
dc.contributor.author | Brar, Sandeep | - |
dc.contributor.author | Bousquette, Lisa | - |
dc.contributor.author | Liu, Minglei | - |
dc.contributor.author | Stone, Gregg W. | - |
dc.contributor.author | ONYX ONE Investigators (Cequier, A.) | - |
dc.date.accessioned | 2021-03-31T11:43:46Z | - |
dc.date.available | 2021-03-31T11:43:46Z | - |
dc.date.issued | 2020-03-26 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/175954 | - |
dc.description.abstract | Background: polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. Methods: in an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. Results: a total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). Conclusions: among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.). | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa191002 | - |
dc.relation.ispartof | New England Journal of Medicine, 2020, vol. 382, num. 13, p. 1208-1218 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa191002 | - |
dc.rights | (c) Massachusetts Medical Society, 2020 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Artèries coronàries | - |
dc.subject.classification | Efectes secundaris | - |
dc.subject.classification | Immunosupressió | - |
dc.subject.classification | Ús terapèutic | - |
dc.subject.classification | Polímers | - |
dc.subject.other | Coronary arteries | - |
dc.subject.other | Side effects | - |
dc.subject.other | Immunosuppression | - |
dc.subject.other | Therapeutic use | - |
dc.subject.other | Polymers | - |
dc.title | Polymer-based or polymer-free stents in patients at high bleeding risk | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 706449 | - |
dc.date.updated | 2021-03-31T11:43:46Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 32050061 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
706449.pdf | 661.6 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.