Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden
Introduction ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes...
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e076476.full |
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| author | Fen Dong Zhen Zhang Xuecheng Zhao Jingyi Ren Di Sun Zhen Meng Zhaoxue Sheng Wuqiang Che Shuoyan An Zhengqin Zhai Yaliu Yang Zixiang Ye Enmin Xie Peizhao Li Changan Yu Yanxiang Gao Zhu Xiao Yanfen Wu Jingang Zheng |
| author_facet | Fen Dong Zhen Zhang Xuecheng Zhao Jingyi Ren Di Sun Zhen Meng Zhaoxue Sheng Wuqiang Che Shuoyan An Zhengqin Zhai Yaliu Yang Zixiang Ye Enmin Xie Peizhao Li Changan Yu Yanxiang Gao Zhu Xiao Yanfen Wu Jingang Zheng |
| author_sort | Fen Dong |
| collection | DOAJ |
| description | Introduction ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently proposed treatment approach that theoretically reduces thrombus volume and the risk of microvascular dysfunction. However, the safety and efficacy of intrathrombus thrombolysis lack sufficient clinical evidence.Methods and analysis The intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion trial is a multicentre, prospective, open-label, randomised controlled trial with the blinded assessment of outcomes. A total of 2500 STEMI patients with high thrombus burden who undergo primary percutaneous coronary intervention will be randomised 1:1 to intrathrombus thrombolysis with a pierced balloon or upfront routine manual aspiration thrombectomy. The primary outcome will be the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, heart failure readmission, stent thrombosis and target-vessel revascularisation up to 180 days.Ethics and dissemination The trial was approved by Ethics Committees of China-Japan Friendship Hospital (2022-KY-013) and all other participating study centres. The results of this trial will be published in peer-reviewed journals.Trial registration number NCT05554588. |
| first_indexed | 2024-03-09T09:30:02Z |
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| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T09:30:02Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj.art-6ecfa9026d63496f93e941b98ca9ff4b2023-12-02T04:15:08ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2023-076476Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burdenFen Dong0Zhen Zhang1Xuecheng Zhao2Jingyi Ren3Di Sun4Zhen Meng5Zhaoxue Sheng6Wuqiang Che7Shuoyan An8Zhengqin Zhai9Yaliu Yang10Zixiang Ye11Enmin Xie12Peizhao Li13Changan Yu14Yanxiang Gao15Zhu Xiao16Yanfen Wu17Jingang Zheng18Department of Clinical Research and Data management, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaPeking University China-Japan Friendship School of Clinical Medicine, Beijing, ChinaChinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaPeking University China-Japan Friendship School of Clinical Medicine, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Cardiology, China-Japan Friendship Hospital, Beijing, ChinaIntroduction ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently proposed treatment approach that theoretically reduces thrombus volume and the risk of microvascular dysfunction. However, the safety and efficacy of intrathrombus thrombolysis lack sufficient clinical evidence.Methods and analysis The intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion trial is a multicentre, prospective, open-label, randomised controlled trial with the blinded assessment of outcomes. A total of 2500 STEMI patients with high thrombus burden who undergo primary percutaneous coronary intervention will be randomised 1:1 to intrathrombus thrombolysis with a pierced balloon or upfront routine manual aspiration thrombectomy. The primary outcome will be the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, heart failure readmission, stent thrombosis and target-vessel revascularisation up to 180 days.Ethics and dissemination The trial was approved by Ethics Committees of China-Japan Friendship Hospital (2022-KY-013) and all other participating study centres. The results of this trial will be published in peer-reviewed journals.Trial registration number NCT05554588.https://bmjopen.bmj.com/content/13/11/e076476.full |
| spellingShingle | Fen Dong Zhen Zhang Xuecheng Zhao Jingyi Ren Di Sun Zhen Meng Zhaoxue Sheng Wuqiang Che Shuoyan An Zhengqin Zhai Yaliu Yang Zixiang Ye Enmin Xie Peizhao Li Changan Yu Yanxiang Gao Zhu Xiao Yanfen Wu Jingang Zheng Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden BMJ Open |
| title | Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden |
| title_full | Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden |
| title_fullStr | Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden |
| title_full_unstemmed | Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden |
| title_short | Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden |
| title_sort | design and rationale of the attractive trial a randomised trial of intrathrombus thrombolysis versus aspiration thrombectomy during primary percutaneous coronary intervention in st segment elevation myocardial infarction patients with high thrombus burden |
| url | https://bmjopen.bmj.com/content/13/11/e076476.full |
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