TY - JOUR
T1 - Polymer-based or polymer-free stents in patients at high bleeding risk
AU - ONYX ONE Investigators
AU - Windecker, S.
AU - Latib, A.
AU - Kedhi, E.
AU - Kirtane, A. J.
AU - Kandzari, D. E.
AU - Mehran, R.
AU - Price, M. J.
AU - Abizaid, A.
AU - Simon, D. I.
AU - Worthley, S. G.
AU - Zaman, A.
AU - Hudec, M.
AU - Poliacikova, P.
AU - Abdul Ghapar, A. K.
AU - Selvaraj, K.
AU - Petrov, I.
AU - Mylotte, D.
AU - Pinar, E.
AU - Moreno, R.
AU - Fabbiocchi, F.
AU - Pasupati, S.
AU - Kim, H. S.
AU - Aminian, A.
AU - Tie, C.
AU - Wlodarczak, A.
AU - Hur, S. H.
AU - Marx, S. O.
AU - Jankovic, I.
AU - Brar, S.
AU - Bousquette, L.
AU - Liu, M.
AU - Stone, G. W.
N1 - Funding Information:
The trial was funded by Medtronic, and the protocol was developed jointly by the executive committee and the sponsor (Table S1 in the Supplementary Appendix). Investigators at each site gathered the data, which were stored and analyzed by the sponsor. All the statistical analyses were performed by the sponsor and validated independently by the Baim Institute for Clinical Re- search. The sponsor was responsible for site selection, data monitoring, and overall clinical-trial management. An external, independent data and safety monitoring board and clinical-events committee assessed safety and performed event adjudication. Source document monitoring was performed in 100% of patient records. An independent angiographic core laboratory evaluated all baseline and event angiograms. The Cardiovascular Research Foundation oversaw the data and safety monitoring board, the clinical-events committee, and the angiographic core laboratory.
Publisher Copyright:
Copyright © 2020 Massachusetts Medical Society.
PY - 2020/3/26
Y1 - 2020/3/26
N2 - 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 drugcoated 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.
AB - 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 drugcoated 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.
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U2 - 10.1056/NEJMoa1910021
DO - 10.1056/NEJMoa1910021
M3 - Article
C2 - 32050061
AN - SCOPUS:85082394370
VL - 382
SP - 1208
EP - 1218
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 13
ER -