Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.

Immunosuppressive Agents; Platelet Aggregation Inhibitors; Polymers; H4GXR80IZE (zotarolimus); U36PGF65JH (umirolimus); W36ZG6FT64 (Sirolimus); Coronary Artery Disease/therapy; Coronary Thrombosis/etiology/mortality; Drug Therapy, Combination; Drug-Eluting Stents/adverse effects; Heart Diseases/mortality; Hemorrhage/chemically induced; Humans; Immunosuppressive Agents/administration & dosage; Kaplan-Meier Estimate; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors/adverse effects/therapeutic use; Prosthesis Design; Single-Blind Method; Sirolimus/administration & dosage/analogs & derivatives

Abstract :

[en] 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.).

Disciplines :

Cardiovascular & respiratory systems

Author, co-author :

Windecker, Stephan; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Latib, Azeem; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Kedhi, Elvin; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Kirtane, Ajay J; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Kandzari, David E; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Mehran, Roxana; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Price, Matthew J; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Abizaid, Alexandre; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Simon, Daniel I; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Worthley, Stephen G; From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

More authors (23 more)

Other collaborator :

Friedrich, Guy

Basic, Daniel

Brenner, Christoph

Dichtl, Wolfgang

Doerler, Jakob

Kirchmair, Rudolf

Klug, Gert

Mair, Johannes

Metzler, Bernhard

Moes, Nico

More authors (879 more)

Language :

English

Title :

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.

Publication date :

26 March 2020

Journal title :

New England Journal of Medicine

ISSN :

0028-4793

eISSN :

1533-4406

Publisher :

Massachusetts Medical Society, Us ma

Volume :

382

Issue :

Pages :

1208-1218

Peer reviewed :

Peer Reviewed verified by ORBi

Funding number :

Funded the ONYX ONE Trial/Medtronic/International

Commentary :

Available on ORBi :

since 24 June 2022

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