Stephan Windecker1, Azeem Latib1, Elvin Kedhi1, Ajay J Kirtane1, David E Kandzari1, Roxana Mehran1, Matthew J Price1, Alexandre Abizaid1, Daniel I Simon1, Stephen G Worthley1, Azfar Zaman1, Martin Hudec1, Petra Poliacikova1, A Kahar Bin Abdul Ghapar1, Kamaraj Selvaraj1, Ivo Petrov1, Darren Mylotte1, Eduardo Pinar1, Raul Moreno1, Franco Fabbiocchi1, Sanjeevan Pasupati1, Hyo-Soo Kim1, Adel Aminian1, Charles Tie1, Adrian Wlodarczak1, Seung-Ho Hur1, Steven O Marx1, Ivana Jankovic1, Sandeep Brar1, Lisa Bousquette1, Minglei Liu1, Gregg W Stone1. 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.).
RCT Entities:
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.).
Authors: Alexandru Burlacu; Simonetta Genovesi; Carlo Basile; Alberto Ortiz; Sandip Mitra; Dimitrios Kirmizis; Mehmet Kanbay; Andrew Davenport; Frank van der Sande; Adrian Covic Journal: J Nephrol Date: 2020-05-29 Impact factor: 3.902
Authors: Davide Capodanno; Deepak L Bhatt; C Michael Gibson; Stefan James; Takeshi Kimura; Roxana Mehran; Sunil V Rao; Philippe Gabriel Steg; Philip Urban; Marco Valgimigli; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2021-08-23 Impact factor: 32.419