Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement
Background Current guidelines and expert consensus recommend lifelong single antiplatelet therapy for patients undergoing transcatheter aortic valve replacement who have no indication for anticoagulation or dual antiplatelet therapy. However, there is no direct evidence from randomized controlled tr...
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Wiley
2025-04-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.124.039350 |
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| author | Ran Liu Yang Li Lihua Zhang Zhinan Lu Zhaolin Fu Thomas Modine Hasan Jilahawi Stuart Pocock Yongjian Wu Guangyuan Song |
| author_facet | Ran Liu Yang Li Lihua Zhang Zhinan Lu Zhaolin Fu Thomas Modine Hasan Jilahawi Stuart Pocock Yongjian Wu Guangyuan Song |
| author_sort | Ran Liu |
| collection | DOAJ |
| description | Background Current guidelines and expert consensus recommend lifelong single antiplatelet therapy for patients undergoing transcatheter aortic valve replacement who have no indication for anticoagulation or dual antiplatelet therapy. However, there is no direct evidence from randomized controlled trials supporting this practice. Furthermore, the optimal duration of antiplatelet therapy in this population has not been adequately investigated. Methods and Results CREATE (A Multicenter Randomized Controlled Study to Evaluate Cessation of Antithrombotic Therapy at 1 Year in TAVR Patients–The CREATE Study) is a prospective, multicenter, open‐label, randomized controlled trial for patients who have undergone successful transcatheter aortic valve replacement and have no indication for long‐term oral anticoagulation or antiplatelet therapy. Eligible patients are free from major bleeding and ischemic events for 1 year postprocedure before being randomized 1:1 to single antiplatelet therapy (control group) or no antiplatelet therapy (experimental group). The primary efficacy end point is the incidence of bleeding events, defined by the VARC‐3 (Valve Academic Research Consortium‐3) criteria, at 1‐year postrandomization. The primary safety end point is a composite of cardiac death, myocardial infarction, and ischemic stroke at 1 year. The trial is powered for both superiority in efficiency and noninferiority in safety. Accordingly, a total of 3380 patients will be enrolled. Conclusions The CREATE trial aims to assess if stopping antiplatelet therapy at 1‐year after transcatheter aortic valve replacement reduces bleeding risk without increasing ischemic events in patients not requiring chronic antithrombotic therapy. Registration URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2400087454. |
| format | Article |
| id | doaj-art-663c08e327f7412ea6b4f625f4baa954 |
| institution | Kabale University |
| issn | 2047-9980 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-663c08e327f7412ea6b4f625f4baa9542025-08-20T03:24:52ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802025-04-0114710.1161/JAHA.124.039350Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve ReplacementRan Liu0Yang Li1Lihua Zhang2Zhinan Lu3Zhaolin Fu4Thomas Modine5Hasan Jilahawi6Stuart Pocock7Yongjian Wu8Guangyuan Song9Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing ChinaInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing ChinaCardiovascular Disease Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing ChinaInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing ChinaInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing ChinaDepartment of Cardiology and Cardio‐Vascular Surgery Hôpital Cardiologique de Haut‐Leveque, Bordeaux University Hospital Bordeaux FranceCedars‐Sinai Medical Center Smidt Heart Institute Los Angeles CA USALondon School of Hygiene and Tropical Medicine London United KingdomCardiovascular Disease Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing ChinaInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing ChinaBackground Current guidelines and expert consensus recommend lifelong single antiplatelet therapy for patients undergoing transcatheter aortic valve replacement who have no indication for anticoagulation or dual antiplatelet therapy. However, there is no direct evidence from randomized controlled trials supporting this practice. Furthermore, the optimal duration of antiplatelet therapy in this population has not been adequately investigated. Methods and Results CREATE (A Multicenter Randomized Controlled Study to Evaluate Cessation of Antithrombotic Therapy at 1 Year in TAVR Patients–The CREATE Study) is a prospective, multicenter, open‐label, randomized controlled trial for patients who have undergone successful transcatheter aortic valve replacement and have no indication for long‐term oral anticoagulation or antiplatelet therapy. Eligible patients are free from major bleeding and ischemic events for 1 year postprocedure before being randomized 1:1 to single antiplatelet therapy (control group) or no antiplatelet therapy (experimental group). The primary efficacy end point is the incidence of bleeding events, defined by the VARC‐3 (Valve Academic Research Consortium‐3) criteria, at 1‐year postrandomization. The primary safety end point is a composite of cardiac death, myocardial infarction, and ischemic stroke at 1 year. The trial is powered for both superiority in efficiency and noninferiority in safety. Accordingly, a total of 3380 patients will be enrolled. Conclusions The CREATE trial aims to assess if stopping antiplatelet therapy at 1‐year after transcatheter aortic valve replacement reduces bleeding risk without increasing ischemic events in patients not requiring chronic antithrombotic therapy. Registration URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2400087454.https://www.ahajournals.org/doi/10.1161/JAHA.124.039350antiplatelet therapyaortic stenosistranscatheter aortic valve replacementtreatment withdrawal |
| spellingShingle | Ran Liu Yang Li Lihua Zhang Zhinan Lu Zhaolin Fu Thomas Modine Hasan Jilahawi Stuart Pocock Yongjian Wu Guangyuan Song Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease antiplatelet therapy aortic stenosis transcatheter aortic valve replacement treatment withdrawal |
| title | Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement |
| title_full | Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement |
| title_fullStr | Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement |
| title_full_unstemmed | Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement |
| title_short | Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement |
| title_sort | rationale and design of the create trial a multicenter randomized comparison of continuation or cessation of single antithrombotic therapy at 1 year after transcatheter aortic valve replacement |
| topic | antiplatelet therapy aortic stenosis transcatheter aortic valve replacement treatment withdrawal |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.124.039350 |
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