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N Engl J Med. 2020 Feb 12. doi: 10.1056/NEJMoa1910021. [Epub ahead of print]

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

Author information

1
From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (S.W.); Montefiore Medical Center (A.L.), Columbia University Irving Medical Center-New York-Presbyterian Hospital (A.J.K., S.O.M.), the Cardiovascular Research Foundation (A.J.K., S.O.M., I.J., G.W.S.), Mount Sinai Medical Center (R. Mehran), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S.) - all in New York; Isala Zwolle, Zwolle, the Netherlands (E.K.); Medical University of Silesia, Katowice (E.K.), and Poland Miedziowe Centrum Zdrowia, Lubin (A.W.) - both in Poland; Piedmont Heart Institute, Atlanta (D.E.K.); the Division of Cardiovascular Diseases, Scripps Clinic, La Jolla (M.J.P.), and Medtronic, Santa Rosa (S.B., L.B., M.L.) - both in California; Instituto Dante Pazzanese de Cardiologia, São Paulo (A. Abizaid); University Hospitals Cleveland Medical Center, Cleveland (D.I.S.); GenesisCare Cardiology, Alexandria, NSW (S.G.W.), and St. Andrew's Hospital, Adelaide, SA (C.T.) - both in Australia; Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom (A.Z.); Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia (M.H., P.P.); Hospital Serdang, Kajang, Malaysia (A.K.A.G., K.S.); Acibadem City Clinic, Sofia, Bulgaria (I.P.); Galway University Hospitals-University Hospital Galway, Galway, Ireland (D.M.); Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar (E.P.), and Hospital Universitario La Paz and Hospital La Paz Institute for Health Research, Madrid (R. Moreno) - all in Spain; Centro Cardiologico Monzino IRCCS, Milan (F.F.); Waikato Hospital, Hamilton, New Zealand (S.P.); Seoul National University Hospital, Seoul (H.-S.K.), and Keimyung University Dongsan Medical Center, Daegu (S.-H.H.) - both in South Korea; and Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium (A. Aminian).

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.).

PMID:
32050061
DOI:
10.1056/NEJMoa1910021

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