Polymer-based or polymer-free stents in patients at high bleeding risk

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,...

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Detalles Bibliográficos
Autores: Windecker, Stephan, Latib, Azeem, Kedhi, Elvin, Kirtane, Ajay J., Kandzari, David E., Mehran, Roxana, Price, Matthew J., Abizaid, Alexandre, Simon, Daniel I., Worthley, Stephen G., Zaman, Azfar, Hudec, Martin, Poliacikova, Petra, Abdul Ghapar, Kahar Bin, Selvaraj, Kamaraj, Petrov, Ivo, Mylotte, Darren, Pinar, Eduardo, Moreno, Raúl, Fabbiocchi, Franco, Pasupati, Sanjeevan, Kim, Hyo-Soo, Aminian, Adel, Tie, Charles, Wlodarczak, Adrian, Hur, Seung-Ho, Marx, Steven O., Jankovic, Ivana, Brar, Sandeep, Bousquette, Lisa, Liu, Minglei, Stone, Gregg W., ONYX ONE Investigators (Cequier, A.)
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/175954
Acceso en línea:https://hdl.handle.net/2445/175954
Access Level:acceso abierto
Palabra clave:Artèries coronàries
Efectes secundaris
Immunosupressió
Ús terapèutic
Polímers
Coronary arteries
Side effects
Immunosuppression
Therapeutic use
Polymers
Descripción
Sumario: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.).

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