دورية أكاديمية
One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.
| العنوان: | One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. |
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| المؤلفون: | Kandzari DE; Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA (D.E.K.)., Kirtane AJ; Department of Interventional Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital (A.J.K., T.N.).; Cardiovascular Research Foundation, New York, NY (A.J.K., G.W.S.)., Windecker S; Department of Cardiovascular Diseases, University Hospital, University of Bern, Switzerland (S.W.)., Latib A; Department of Interventional Cardiology, Montefiore Medical Center, New York, NY (A.L.)., Kedhi E; Department of Cardiology, Isala Zwolle, the Netherlands (E.K.)., Mehran R; Department of Cardiology, School of Medicine at Mount Sinai, New York, NY (R.M., G.W.S.)., Price MJ; Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA (M.J.P.)., Abizaid A; Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.)., Simon DI; Department of Interventional Cardiology, University Hospitals Cleveland Medical Center, OH (D.I.S.)., Worthley SG; Department of Cardiology, GenesisCare, Alexandria, Australia (S.G.W.)., Zaman A; Department of Cardiology, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom (A.Z.)., Choi JW; Department of Interventional Cardiology, Baylor Scott and White Heart and Vascular Hospital, Dallas, TX (J.W.C.)., Caputo R; Department of Interventional Cardiology, St. Joseph's Hospital, Syracuse, NY (R.C.)., Kanitkar M; Department of Interventional Cardiology, Huntsville Hospital, AL (M.K.)., McLaurin B; Department of Interventional Cardiology, Anmed Health Medical Center, Anderson, SC (B.M.)., Potluri S; Department of Interventional Cardiology, The Heart Hospital Baylor Plano, TX (S.P.)., Smith T; Department of Interventional Cardiology, The Christ Hospital, Cincinnati, OH (T.S.)., Spriggs D; Department of Interventional Cardiology, Morton Plant Hospital, Clearwater, FL (D.S.)., Tolleson T; Department of Cardiology, UT Health East Texas, Tyler (T.T.)., Nazif T; Department of Interventional Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital (A.J.K., T.N.)., Parke M; Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., L.C.L., T.-H.L.)., Lee LC; Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., L.C.L., T.-H.L.)., Lung TH; Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., L.C.L., T.-H.L.)., Stone GW; Cardiovascular Research Foundation, New York, NY (A.J.K., G.W.S.).; Department of Cardiology, School of Medicine at Mount Sinai, New York, NY (R.M., G.W.S.). |
| مؤلفون مشاركون: | Onyx ONE US/Japan Investigators |
| المصدر: | Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2020 Nov; Vol. 13 (11), pp. e009565. Date of Electronic Publication: 2020 Nov 10. |
| نوع المنشور: | Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 101499602 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1941-7632 (Electronic) Linking ISSN: 19417640 NLM ISO Abbreviation: Circ Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Hagerstown, MD : Lippincott Williams & Wilkins |
| مواضيع طبية MeSH: | Drug-Eluting Stents* , Dual Anti-Platelet Therapy*/adverse effects, Cardiovascular Agents/*administration & dosage , Coronary Artery Disease/*therapy , Percutaneous Coronary Intervention/*instrumentation , Platelet Aggregation Inhibitors/*administration & dosage , Sirolimus/*analogs & derivatives, Aged ; Aged, 80 and over ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/mortality ; Drug Administration Schedule ; Female ; Hemorrhage/chemically induced ; Humans ; Japan ; Male ; Middle Aged ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/mortality ; Platelet Aggregation Inhibitors/adverse effects ; Prospective Studies ; Prosthesis Design ; Randomized Controlled Trials as Topic ; Risk Assessment ; Risk Factors ; Sirolimus/administration & dosage ; Time Factors ; Treatment Outcome ; United States |
| مستخلص: | Background: 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. Methods: 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. Results: 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% ( P <0.001). Conclusions: 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. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475. |
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| فهرسة مساهمة: | Keywords: Japan; drug-eluting stents; goals; hemorrhage; stents |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03647475 |
| المشرفين على المادة: | 0 (Cardiovascular Agents) 0 (Platelet Aggregation Inhibitors) H4GXR80IZE (zotarolimus) W36ZG6FT64 (Sirolimus) |
| تواريخ الأحداث: | Date Created: 20201110 Date Completed: 20210621 Latest Revision: 20210621 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC7665241 |
| DOI: | 10.1161/CIRCINTERVENTIONS.120.009565 |
| PMID: | 33167705 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1941-7632 |
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| DOI: | 10.1161/CIRCINTERVENTIONS.120.009565 |