Rajesh K Kharbanda, James Kennedy, Zahra Jamal, Matthew Dodd, Richard Evans, Kiran K Bal, Alexander D Perkins, Daniel J Blackman, David Hildick-Smith, Adrian P Banning, Andreas Baumbach, Peter Ludman, Stephen Palmer, Rodney H Stables, Robert Henderson, Clare Appleby, James Cotton, Nick Curzen, Muhiddin Ozkor, Jonathan Byrne, Rajesh Aggarwal, Rajiv Das, Sagar Doshi, Stuart Watkins, Douglas F Muir, Richard Anderson, Saqib Chowdhary, Richard Varcoe, Stephen Dorman, Sam Firoozi, Raj Chelliah, Colum Owens, Simon Redwood, Bernard Prendergast, Javaid Iqbal, Karim Ratib, Ciprian Dospinescu, Venkatesan Suresh, Nicholas Cruden, Thirumaran Rajathurai, Iqbal S Malik, Andrew Wiper, Charis Costopoulos, Ayush Khurana, Amerjeet Banning, Tim Clayton
{"title":"经导管主动脉瓣植入术中常规脑栓塞保护。","authors":"Rajesh K Kharbanda, James Kennedy, Zahra Jamal, Matthew Dodd, Richard Evans, Kiran K Bal, Alexander D Perkins, Daniel J Blackman, David Hildick-Smith, Adrian P Banning, Andreas Baumbach, Peter Ludman, Stephen Palmer, Rodney H Stables, Robert Henderson, Clare Appleby, James Cotton, Nick Curzen, Muhiddin Ozkor, Jonathan Byrne, Rajesh Aggarwal, Rajiv Das, Sagar Doshi, Stuart Watkins, Douglas F Muir, Richard Anderson, Saqib Chowdhary, Richard Varcoe, Stephen Dorman, Sam Firoozi, Raj Chelliah, Colum Owens, Simon Redwood, Bernard Prendergast, Javaid Iqbal, Karim Ratib, Ciprian Dospinescu, Venkatesan Suresh, Nicholas Cruden, Thirumaran Rajathurai, Iqbal S Malik, Andrew Wiper, Charis Costopoulos, Ayush Khurana, Amerjeet Banning, Tim Clayton","doi":"10.1056/NEJMoa2415120","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic-valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection (CEP) devices may reduce embolization to the cerebral circulation and hence the incidence of stroke.</p><p><strong>Methods: </strong>We conducted a randomized, controlled trial across 33 centers in the United Kingdom. We randomly assigned 7635 participants with aortic stenosis in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome was stroke within 72 hours after TAVI or before discharge from the hospital (if discharge occurred sooner).</p><p><strong>Results: </strong>A total of 3815 participants were assigned to the CEP group and 3820 to the control group. A primary-outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 participants (2.2%) in the control group (difference, -0.02 percentage points; 95% confidence interval, -0.68 to 0.63; P = 0.94). Disabling stroke occurred in 47 participants (1.2%) in the CEP group and in 53 (1.4%) in the control group. Death occurred in 29 participants (0.8%) in the CEP group and in 26 (0.7%) in the control group. Overall access-site complications appeared to be similar in the two groups (8.1% in the CEP group and 7.7% in the control group). A total of 24 serious adverse events occurred in 22 of 3798 participants (0.6%) in the CEP group, and 13 serious adverse events occurred in 13 of 3803 participants (0.3%) in the control group.</p><p><strong>Conclusions: </strong>Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours. (Funded by the British Heart Foundation and Boston Scientific; BHF PROTECT-TAVI ISRCTN Registry number, ISRCTN16665769.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2000,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation.\",\"authors\":\"Rajesh K Kharbanda, James Kennedy, Zahra Jamal, Matthew Dodd, Richard Evans, Kiran K Bal, Alexander D Perkins, Daniel J Blackman, David Hildick-Smith, Adrian P Banning, Andreas Baumbach, Peter Ludman, Stephen Palmer, Rodney H Stables, Robert Henderson, Clare Appleby, James Cotton, Nick Curzen, Muhiddin Ozkor, Jonathan Byrne, Rajesh Aggarwal, Rajiv Das, Sagar Doshi, Stuart Watkins, Douglas F Muir, Richard Anderson, Saqib Chowdhary, Richard Varcoe, Stephen Dorman, Sam Firoozi, Raj Chelliah, Colum Owens, Simon Redwood, Bernard Prendergast, Javaid Iqbal, Karim Ratib, Ciprian Dospinescu, Venkatesan Suresh, Nicholas Cruden, Thirumaran Rajathurai, Iqbal S Malik, Andrew Wiper, Charis Costopoulos, Ayush Khurana, Amerjeet Banning, Tim Clayton\",\"doi\":\"10.1056/NEJMoa2415120\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Transcatheter aortic-valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection (CEP) devices may reduce embolization to the cerebral circulation and hence the incidence of stroke.</p><p><strong>Methods: </strong>We conducted a randomized, controlled trial across 33 centers in the United Kingdom. We randomly assigned 7635 participants with aortic stenosis in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome was stroke within 72 hours after TAVI or before discharge from the hospital (if discharge occurred sooner).</p><p><strong>Results: </strong>A total of 3815 participants were assigned to the CEP group and 3820 to the control group. A primary-outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 participants (2.2%) in the control group (difference, -0.02 percentage points; 95% confidence interval, -0.68 to 0.63; P = 0.94). Disabling stroke occurred in 47 participants (1.2%) in the CEP group and in 53 (1.4%) in the control group. Death occurred in 29 participants (0.8%) in the CEP group and in 26 (0.7%) in the control group. Overall access-site complications appeared to be similar in the two groups (8.1% in the CEP group and 7.7% in the control group). A total of 24 serious adverse events occurred in 22 of 3798 participants (0.6%) in the CEP group, and 13 serious adverse events occurred in 13 of 3803 participants (0.3%) in the control group.</p><p><strong>Conclusions: </strong>Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours. (Funded by the British Heart Foundation and Boston Scientific; BHF PROTECT-TAVI ISRCTN Registry number, ISRCTN16665769.).</p>\",\"PeriodicalId\":54725,\"journal\":{\"name\":\"New England Journal of Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":96.2000,\"publicationDate\":\"2025-03-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"New England Journal of Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1056/NEJMoa2415120\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"New England Journal of Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1056/NEJMoa2415120","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation.
Background: Transcatheter aortic-valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection (CEP) devices may reduce embolization to the cerebral circulation and hence the incidence of stroke.
Methods: We conducted a randomized, controlled trial across 33 centers in the United Kingdom. We randomly assigned 7635 participants with aortic stenosis in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome was stroke within 72 hours after TAVI or before discharge from the hospital (if discharge occurred sooner).
Results: A total of 3815 participants were assigned to the CEP group and 3820 to the control group. A primary-outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 participants (2.2%) in the control group (difference, -0.02 percentage points; 95% confidence interval, -0.68 to 0.63; P = 0.94). Disabling stroke occurred in 47 participants (1.2%) in the CEP group and in 53 (1.4%) in the control group. Death occurred in 29 participants (0.8%) in the CEP group and in 26 (0.7%) in the control group. Overall access-site complications appeared to be similar in the two groups (8.1% in the CEP group and 7.7% in the control group). A total of 24 serious adverse events occurred in 22 of 3798 participants (0.6%) in the CEP group, and 13 serious adverse events occurred in 13 of 3803 participants (0.3%) in the control group.
Conclusions: Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours. (Funded by the British Heart Foundation and Boston Scientific; BHF PROTECT-TAVI ISRCTN Registry number, ISRCTN16665769.).
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