{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T00:08:46Z","timestamp":1792195726436,"version":"4.4.0"},"reference-count":21,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2020,11]]},"abstract":"\n Background:<\/jats:title>\n Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US\/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.<\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n Among patients enrolled in Onyx ONE US\/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (\n P<\/jats:italic>\n <0.001).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions:<\/jats:title>\n Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention.<\/jats:p>\n <\/jats:sec>\n \n Registration:<\/jats:title>\n \n URL:\n https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n ; Unique identifier NCT03647475.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/circinterventions.120.009565","type":"journal-article","created":{"date-parts":[[2020,11,10]],"date-time":"2020-11-10T05:00:28Z","timestamp":1604984428000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":62,"title":["One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients"],"prefix":"10.1161","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct03647475","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0868-6655","authenticated-orcid":true,"given":"David E.","family":"Kandzari","sequence":"first","affiliation":[{"name":"Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA (D.E.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0061-1058","authenticated-orcid":true,"given":"Ajay J.","family":"Kirtane","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Columbia University Irving Medical Center\/New York-Presbyterian Hospital (A.J.K., T.N.)."},{"name":"Cardiovascular Research Foundation, New York, NY (A.J.K., G.W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Windecker","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Diseases, University Hospital, University of Bern, Switzerland (S.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9035-343X","authenticated-orcid":true,"given":"Azeem","family":"Latib","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Montefiore Medical Center, New York, NY (A.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elvin","family":"Kedhi","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Isala Zwolle, the Netherlands (E.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5546-262X","authenticated-orcid":true,"given":"Roxana","family":"Mehran","sequence":"additional","affiliation":[{"name":"Department of Cardiology, School of Medicine at Mount Sinai, New York, NY (R.M., G.W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Price","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA (M.J.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandre","family":"Abizaid","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, S\u00e3o Paulo, Brazil (A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel I.","family":"Simon","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, University Hospitals Cleveland Medical Center, OH (D.I.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen G.","family":"Worthley","sequence":"additional","affiliation":[{"name":"Department of Cardiology, GenesisCare, Alexandria, Australia (S.G.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azfar","family":"Zaman","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom (A.Z.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James W.","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Baylor Scott and White Heart and Vascular Hospital, Dallas, TX (J.W.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald","family":"Caputo","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, St. Joseph's Hospital, Syracuse, NY (R.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihir","family":"Kanitkar","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Huntsville Hospital, AL (M.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent","family":"McLaurin","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Anmed Health Medical Center, Anderson, SC (B.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srinivasa","family":"Potluri","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, The Heart Hospital Baylor Plano, TX (S.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9697-2095","authenticated-orcid":true,"given":"Timothy","family":"Smith","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, The Christ Hospital, Cincinnati, OH (T.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Spriggs","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Morton Plant Hospital, Clearwater, FL (D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thaddeus","family":"Tolleson","sequence":"additional","affiliation":[{"name":"Department of Cardiology, UT Health East Texas, Tyler (T.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamim","family":"Nazif","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Columbia University Irving Medical Center\/New York-Presbyterian Hospital (A.J.K., T.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Parke","sequence":"additional","affiliation":[{"name":"Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., L.C.L., T.-H.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3997-3785","authenticated-orcid":true,"given":"Lilian C.","family":"Lee","sequence":"additional","affiliation":[{"name":"Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., 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