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Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI
The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI). As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT...
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Published in: | JACC. Cardiovascular interventions 2021-07, Vol.14 (13), p.1434-1446 |
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creator | Angiolillo, Dominick J Cao, Davide Baber, Usman Sartori, Samantha Zhang, Zhongjie Dangas, George Mehta, Shamir Briguori, Carlo Cohen, David J Collier, Timothy Dudek, Dariusz Escaned, Javier Gibson, C Michael Gil, Robert Huber, Kurt Kaul, Upendra Kornowski, Ran Krucoff, Mitchell W Kunadian, Vijay Moliterno, David J Ohman, E Magnus Oldroyd, Keith Sardella, Gennaro Sharma, Samin K Shlofmitz, Richard Weisz, Giora Witzenbichler, Bernhard Pocock, Stuart Mehran, Roxana |
description | The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI).
As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age.
The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke.
A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients |
doi_str_mv | 10.1016/j.jcin.2021.04.043 |
format | article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2550264032</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2550264032</sourcerecordid><originalsourceid>FETCH-LOGICAL-c413t-87d15854ee2a9605a51e1ff0879779824252cb4da5103e09c2d5aa48e176b8c53</originalsourceid><addsrcrecordid>eNo9UE1LAzEUDKLYWv0DHiRHL13zuR_HUqoWFAu2Rwlp9m3dspusyfaw_96UVmHgDY-ZYRiE7ilJKKHp0z7Zm9omjDCaEBHBL9CY5lk6zVIiLyMveDrNsyIfoZsQ9oSkpMjYNRpxwXguJR-jr2XbadNjV-HZDrCzuP8G_Kkr6AesbYkXVVUbbYajYh3ZzkPjPH531kWl192Aa4tXuq_B9gFvbAl-52q7w6v58hZdVboJcHe-E7R5Xqznr9O3j5flfPY2NYLyPlYsqcylAGC6iNW1pECrisTqWWzPBJPMbEUZ_4QDKQwrpdYiB5ql29xIPkGPp9zOu58DhF61dTDQNNqCOwTFpCQsFYSzKGUnqfEuBA-V6nzdaj8oStRxVrVXx1nVcVZFRASPpodz_mHbQvlv-duR_wILN3MJ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2550264032</pqid></control><display><type>article</type><title>Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI</title><source>BACON - Elsevier - GLOBAL_SCIENCEDIRECT-OPENACCESS</source><creator>Angiolillo, Dominick J ; Cao, Davide ; Baber, Usman ; Sartori, Samantha ; Zhang, Zhongjie ; Dangas, George ; Mehta, Shamir ; Briguori, Carlo ; Cohen, David J ; Collier, Timothy ; Dudek, Dariusz ; Escaned, Javier ; Gibson, C Michael ; Gil, Robert ; Huber, Kurt ; Kaul, Upendra ; Kornowski, Ran ; Krucoff, Mitchell W ; Kunadian, Vijay ; Moliterno, David J ; Ohman, E Magnus ; Oldroyd, Keith ; Sardella, Gennaro ; Sharma, Samin K ; Shlofmitz, Richard ; Weisz, Giora ; Witzenbichler, Bernhard ; Pocock, Stuart ; Mehran, Roxana</creator><creatorcontrib>Angiolillo, Dominick J ; Cao, Davide ; Baber, Usman ; Sartori, Samantha ; Zhang, Zhongjie ; Dangas, George ; Mehta, Shamir ; Briguori, Carlo ; Cohen, David J ; Collier, Timothy ; Dudek, Dariusz ; Escaned, Javier ; Gibson, C Michael ; Gil, Robert ; Huber, Kurt ; Kaul, Upendra ; Kornowski, Ran ; Krucoff, Mitchell W ; Kunadian, Vijay ; Moliterno, David J ; Ohman, E Magnus ; Oldroyd, Keith ; Sardella, Gennaro ; Sharma, Samin K ; Shlofmitz, Richard ; Weisz, Giora ; Witzenbichler, Bernhard ; Pocock, Stuart ; Mehran, Roxana</creatorcontrib><description>The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI).
As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age.
The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke.
A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (p
= 0.62) and key secondary (p
= 0.77) endpoints and across different age categories.
A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.</description><identifier>ISSN: 1936-8798</identifier><identifier>EISSN: 1876-7605</identifier><identifier>DOI: 10.1016/j.jcin.2021.04.043</identifier><identifier>PMID: 34238553</identifier><language>eng</language><publisher>United States</publisher><subject>Age Factors ; Aged ; Aspirin - adverse effects ; Drug Therapy, Combination ; Humans ; Percutaneous Coronary Intervention ; Platelet Aggregation Inhibitors - adverse effects ; Ticagrelor - adverse effects ; Treatment Outcome</subject><ispartof>JACC. Cardiovascular interventions, 2021-07, Vol.14 (13), p.1434-1446</ispartof><rights>Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-87d15854ee2a9605a51e1ff0879779824252cb4da5103e09c2d5aa48e176b8c53</citedby><cites>FETCH-LOGICAL-c413t-87d15854ee2a9605a51e1ff0879779824252cb4da5103e09c2d5aa48e176b8c53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27922,27923</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34238553$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Angiolillo, Dominick J</creatorcontrib><creatorcontrib>Cao, Davide</creatorcontrib><creatorcontrib>Baber, Usman</creatorcontrib><creatorcontrib>Sartori, Samantha</creatorcontrib><creatorcontrib>Zhang, Zhongjie</creatorcontrib><creatorcontrib>Dangas, George</creatorcontrib><creatorcontrib>Mehta, Shamir</creatorcontrib><creatorcontrib>Briguori, Carlo</creatorcontrib><creatorcontrib>Cohen, David J</creatorcontrib><creatorcontrib>Collier, Timothy</creatorcontrib><creatorcontrib>Dudek, Dariusz</creatorcontrib><creatorcontrib>Escaned, Javier</creatorcontrib><creatorcontrib>Gibson, C Michael</creatorcontrib><creatorcontrib>Gil, Robert</creatorcontrib><creatorcontrib>Huber, Kurt</creatorcontrib><creatorcontrib>Kaul, Upendra</creatorcontrib><creatorcontrib>Kornowski, Ran</creatorcontrib><creatorcontrib>Krucoff, Mitchell W</creatorcontrib><creatorcontrib>Kunadian, Vijay</creatorcontrib><creatorcontrib>Moliterno, David J</creatorcontrib><creatorcontrib>Ohman, E Magnus</creatorcontrib><creatorcontrib>Oldroyd, Keith</creatorcontrib><creatorcontrib>Sardella, Gennaro</creatorcontrib><creatorcontrib>Sharma, Samin K</creatorcontrib><creatorcontrib>Shlofmitz, Richard</creatorcontrib><creatorcontrib>Weisz, Giora</creatorcontrib><creatorcontrib>Witzenbichler, Bernhard</creatorcontrib><creatorcontrib>Pocock, Stuart</creatorcontrib><creatorcontrib>Mehran, Roxana</creatorcontrib><title>Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI</title><title>JACC. Cardiovascular interventions</title><addtitle>JACC Cardiovasc Interv</addtitle><description>The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI).
As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age.
The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke.
A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (p
= 0.62) and key secondary (p
= 0.77) endpoints and across different age categories.
A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.</description><subject>Age Factors</subject><subject>Aged</subject><subject>Aspirin - adverse effects</subject><subject>Drug Therapy, Combination</subject><subject>Humans</subject><subject>Percutaneous Coronary Intervention</subject><subject>Platelet Aggregation Inhibitors - adverse effects</subject><subject>Ticagrelor - adverse effects</subject><subject>Treatment Outcome</subject><issn>1936-8798</issn><issn>1876-7605</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNo9UE1LAzEUDKLYWv0DHiRHL13zuR_HUqoWFAu2Rwlp9m3dspusyfaw_96UVmHgDY-ZYRiE7ilJKKHp0z7Zm9omjDCaEBHBL9CY5lk6zVIiLyMveDrNsyIfoZsQ9oSkpMjYNRpxwXguJR-jr2XbadNjV-HZDrCzuP8G_Kkr6AesbYkXVVUbbYajYh3ZzkPjPH531kWl192Aa4tXuq_B9gFvbAl-52q7w6v58hZdVboJcHe-E7R5Xqznr9O3j5flfPY2NYLyPlYsqcylAGC6iNW1pECrisTqWWzPBJPMbEUZ_4QDKQwrpdYiB5ql29xIPkGPp9zOu58DhF61dTDQNNqCOwTFpCQsFYSzKGUnqfEuBA-V6nzdaj8oStRxVrVXx1nVcVZFRASPpodz_mHbQvlv-duR_wILN3MJ</recordid><startdate>20210712</startdate><enddate>20210712</enddate><creator>Angiolillo, Dominick J</creator><creator>Cao, Davide</creator><creator>Baber, Usman</creator><creator>Sartori, Samantha</creator><creator>Zhang, Zhongjie</creator><creator>Dangas, George</creator><creator>Mehta, Shamir</creator><creator>Briguori, Carlo</creator><creator>Cohen, David J</creator><creator>Collier, Timothy</creator><creator>Dudek, Dariusz</creator><creator>Escaned, Javier</creator><creator>Gibson, C Michael</creator><creator>Gil, Robert</creator><creator>Huber, Kurt</creator><creator>Kaul, Upendra</creator><creator>Kornowski, Ran</creator><creator>Krucoff, Mitchell W</creator><creator>Kunadian, Vijay</creator><creator>Moliterno, David J</creator><creator>Ohman, E Magnus</creator><creator>Oldroyd, Keith</creator><creator>Sardella, Gennaro</creator><creator>Sharma, Samin K</creator><creator>Shlofmitz, Richard</creator><creator>Weisz, Giora</creator><creator>Witzenbichler, Bernhard</creator><creator>Pocock, Stuart</creator><creator>Mehran, Roxana</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20210712</creationdate><title>Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI</title><author>Angiolillo, Dominick J ; Cao, Davide ; Baber, Usman ; Sartori, Samantha ; Zhang, Zhongjie ; Dangas, George ; Mehta, Shamir ; Briguori, Carlo ; Cohen, David J ; Collier, Timothy ; Dudek, Dariusz ; Escaned, Javier ; Gibson, C Michael ; Gil, Robert ; Huber, Kurt ; Kaul, Upendra ; Kornowski, Ran ; Krucoff, Mitchell W ; Kunadian, Vijay ; Moliterno, David J ; Ohman, E Magnus ; Oldroyd, Keith ; Sardella, Gennaro ; Sharma, Samin K ; Shlofmitz, Richard ; Weisz, Giora ; Witzenbichler, Bernhard ; Pocock, Stuart ; Mehran, Roxana</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-87d15854ee2a9605a51e1ff0879779824252cb4da5103e09c2d5aa48e176b8c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Age Factors</topic><topic>Aged</topic><topic>Aspirin - adverse effects</topic><topic>Drug Therapy, Combination</topic><topic>Humans</topic><topic>Percutaneous Coronary Intervention</topic><topic>Platelet Aggregation Inhibitors - adverse effects</topic><topic>Ticagrelor - adverse effects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Angiolillo, Dominick J</creatorcontrib><creatorcontrib>Cao, Davide</creatorcontrib><creatorcontrib>Baber, Usman</creatorcontrib><creatorcontrib>Sartori, Samantha</creatorcontrib><creatorcontrib>Zhang, Zhongjie</creatorcontrib><creatorcontrib>Dangas, George</creatorcontrib><creatorcontrib>Mehta, Shamir</creatorcontrib><creatorcontrib>Briguori, Carlo</creatorcontrib><creatorcontrib>Cohen, David J</creatorcontrib><creatorcontrib>Collier, Timothy</creatorcontrib><creatorcontrib>Dudek, Dariusz</creatorcontrib><creatorcontrib>Escaned, Javier</creatorcontrib><creatorcontrib>Gibson, C Michael</creatorcontrib><creatorcontrib>Gil, Robert</creatorcontrib><creatorcontrib>Huber, Kurt</creatorcontrib><creatorcontrib>Kaul, Upendra</creatorcontrib><creatorcontrib>Kornowski, Ran</creatorcontrib><creatorcontrib>Krucoff, Mitchell W</creatorcontrib><creatorcontrib>Kunadian, Vijay</creatorcontrib><creatorcontrib>Moliterno, David J</creatorcontrib><creatorcontrib>Ohman, E Magnus</creatorcontrib><creatorcontrib>Oldroyd, Keith</creatorcontrib><creatorcontrib>Sardella, Gennaro</creatorcontrib><creatorcontrib>Sharma, Samin K</creatorcontrib><creatorcontrib>Shlofmitz, Richard</creatorcontrib><creatorcontrib>Weisz, Giora</creatorcontrib><creatorcontrib>Witzenbichler, Bernhard</creatorcontrib><creatorcontrib>Pocock, Stuart</creatorcontrib><creatorcontrib>Mehran, Roxana</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Angiolillo, Dominick J</au><au>Cao, Davide</au><au>Baber, Usman</au><au>Sartori, Samantha</au><au>Zhang, Zhongjie</au><au>Dangas, George</au><au>Mehta, Shamir</au><au>Briguori, Carlo</au><au>Cohen, David J</au><au>Collier, Timothy</au><au>Dudek, Dariusz</au><au>Escaned, Javier</au><au>Gibson, C Michael</au><au>Gil, Robert</au><au>Huber, Kurt</au><au>Kaul, Upendra</au><au>Kornowski, Ran</au><au>Krucoff, Mitchell W</au><au>Kunadian, Vijay</au><au>Moliterno, David J</au><au>Ohman, E Magnus</au><au>Oldroyd, Keith</au><au>Sardella, Gennaro</au><au>Sharma, Samin K</au><au>Shlofmitz, Richard</au><au>Weisz, Giora</au><au>Witzenbichler, Bernhard</au><au>Pocock, Stuart</au><au>Mehran, Roxana</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI</atitle><jtitle>JACC. Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2021-07-12</date><risdate>2021</risdate><volume>14</volume><issue>13</issue><spage>1434</spage><epage>1446</epage><pages>1434-1446</pages><issn>1936-8798</issn><eissn>1876-7605</eissn><abstract>The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI).
As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age.
The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke.
A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (p
= 0.62) and key secondary (p
= 0.77) endpoints and across different age categories.
A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.</abstract><cop>United States</cop><pmid>34238553</pmid><doi>10.1016/j.jcin.2021.04.043</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Age Factors Aged Aspirin - adverse effects Drug Therapy, Combination Humans Percutaneous Coronary Intervention Platelet Aggregation Inhibitors - adverse effects Ticagrelor - adverse effects Treatment Outcome |
title | Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI |
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