Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54)
BACKGROUND:In the PEGASUS-TIMI 54 trial (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54), ticagrelor reduced the risk of major adverse cardiovascular events when added to...
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| Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2016-09, Vol.134 (12), p.861-871 |
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| creator | Bonaca, Marc P Goto, Shinya Bhatt, Deepak L Steg, P Gabriel Storey, Robert F Cohen, Marc Goodrich, Erica Mauri, Laura Ophuis, Ton Oude Ruda, Mikhail Špinar, Jindřich Seung, Ki-Bae Hu, Dayi Dalby, Anthony J Jensen, Eva Held, Peter Morrow, David A Braunwald, Eugene Sabatine, Marc S |
| description | BACKGROUND:In the PEGASUS-TIMI 54 trial (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54), ticagrelor reduced the risk of major adverse cardiovascular events when added to low-dose aspirin in stable patients with prior myocardial infarction, resulting in the approval of ticagrelor 60 mg twice daily for long-term secondary prevention. We investigated the incidence of stroke, outcomes after stroke, and the efficacy of ticagrelor focusing on the approved 60 mg twice daily dose for reducing stroke in this population.
METHODS:Patients were followed for a median of 33 months. Stroke events were adjudicated by a central committee. Data from similar trials were combined using meta-analysis.
RESULTS:Of 14 112 patients randomly assigned to placebo or ticagrelor 60 mg, 213 experienced a stroke; 85% of these strokes were ischemic. A total of 18% of strokes were fatal and another 15% led to either moderate or severe disability at 30 days. Ticagrelor significantly reduced the risk of stroke (hazard ratio, 0.75; 95% confidence interval, 0.57–0.98; P=0.034), driven by a reduction in ischemic stroke (hazard ratio, 0.76; 95% confidence interval, 0.56–1.02). Hemorrhagic stroke occurred in 9 patients on placebo and 8 patients on ticagrelor. A meta-analysis across 4 placebo-controlled trials of more intensive antiplatelet therapy in 44 816 patients with coronary disease confirmed a marked reduction in ischemic stroke (hazard ratio, 0.66; 95% confidence interval, 0.54–0.81; P=0.0001).
CONCLUSIONS:High-risk patients with prior myocardial infarction are at risk for stroke, approximately one-third of which are fatal or lead to moderate-to-severe disability. The addition of ticagrelor 60 mg twice daily significantly reduced this risk without an excess of hemorrhagic stroke but with more major bleeding. In high-risk patients with coronary disease, more intensive antiplatelet therapy should be considered not only to reduce the risk of coronary events, but also of stroke.
CLINICAL TRIAL REGISTRATION:URLhttp://www.clinicaltrials.gov. Unique IdentifierNCT01225562. |
| doi_str_mv | 10.1161/CIRCULATIONAHA.116.024637 |
| format | Article |
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METHODS:Patients were followed for a median of 33 months. Stroke events were adjudicated by a central committee. Data from similar trials were combined using meta-analysis.
RESULTS:Of 14 112 patients randomly assigned to placebo or ticagrelor 60 mg, 213 experienced a stroke; 85% of these strokes were ischemic. A total of 18% of strokes were fatal and another 15% led to either moderate or severe disability at 30 days. Ticagrelor significantly reduced the risk of stroke (hazard ratio, 0.75; 95% confidence interval, 0.57–0.98; P=0.034), driven by a reduction in ischemic stroke (hazard ratio, 0.76; 95% confidence interval, 0.56–1.02). Hemorrhagic stroke occurred in 9 patients on placebo and 8 patients on ticagrelor. A meta-analysis across 4 placebo-controlled trials of more intensive antiplatelet therapy in 44 816 patients with coronary disease confirmed a marked reduction in ischemic stroke (hazard ratio, 0.66; 95% confidence interval, 0.54–0.81; P=0.0001).
CONCLUSIONS:High-risk patients with prior myocardial infarction are at risk for stroke, approximately one-third of which are fatal or lead to moderate-to-severe disability. The addition of ticagrelor 60 mg twice daily significantly reduced this risk without an excess of hemorrhagic stroke but with more major bleeding. In high-risk patients with coronary disease, more intensive antiplatelet therapy should be considered not only to reduce the risk of coronary events, but also of stroke.
CLINICAL TRIAL REGISTRATION:URLhttp://www.clinicaltrials.gov. Unique IdentifierNCT01225562.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/CIRCULATIONAHA.116.024637</identifier><identifier>PMID: 27576775</identifier><language>eng</language><publisher>United States: by the American College of Cardiology Foundation and the American Heart Association, Inc</publisher><subject><![CDATA[Adenosine - administration & dosage ; Adenosine - analogs & derivatives ; Adenosine - therapeutic use ; Aged ; Aspirin - administration & dosage ; Aspirin - therapeutic use ; Coronary Artery Disease - drug therapy ; Female ; Hemorrhage - chemically induced ; Humans ; Intracranial Hemorrhages - prevention & control ; Male ; Middle Aged ; Myocardial Infarction - drug therapy ; Myocardial Infarction - prevention & control ; Platelet Aggregation Inhibitors - therapeutic use ; Purinergic P2Y Receptor Antagonists - therapeutic use ; Risk ; Secondary Prevention - methods ; Stroke - drug therapy ; Stroke - prevention & control]]></subject><ispartof>Circulation (New York, N.Y.), 2016-09, Vol.134 (12), p.861-871</ispartof><rights>2016 by the American College of Cardiology Foundation and the American Heart Association, Inc.</rights><rights>2016 American Heart Association, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3157-caa346cb5d1031355248e05a50fa3f75b0ed75725ec4ebefe3ad733db7b888b63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27576775$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bonaca, Marc P</creatorcontrib><creatorcontrib>Goto, Shinya</creatorcontrib><creatorcontrib>Bhatt, Deepak L</creatorcontrib><creatorcontrib>Steg, P Gabriel</creatorcontrib><creatorcontrib>Storey, Robert F</creatorcontrib><creatorcontrib>Cohen, Marc</creatorcontrib><creatorcontrib>Goodrich, Erica</creatorcontrib><creatorcontrib>Mauri, Laura</creatorcontrib><creatorcontrib>Ophuis, Ton Oude</creatorcontrib><creatorcontrib>Ruda, Mikhail</creatorcontrib><creatorcontrib>Špinar, Jindřich</creatorcontrib><creatorcontrib>Seung, Ki-Bae</creatorcontrib><creatorcontrib>Hu, Dayi</creatorcontrib><creatorcontrib>Dalby, Anthony J</creatorcontrib><creatorcontrib>Jensen, Eva</creatorcontrib><creatorcontrib>Held, Peter</creatorcontrib><creatorcontrib>Morrow, David A</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>Sabatine, Marc S</creatorcontrib><title>Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54)</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>BACKGROUND:In the PEGASUS-TIMI 54 trial (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54), ticagrelor reduced the risk of major adverse cardiovascular events when added to low-dose aspirin in stable patients with prior myocardial infarction, resulting in the approval of ticagrelor 60 mg twice daily for long-term secondary prevention. We investigated the incidence of stroke, outcomes after stroke, and the efficacy of ticagrelor focusing on the approved 60 mg twice daily dose for reducing stroke in this population.
METHODS:Patients were followed for a median of 33 months. Stroke events were adjudicated by a central committee. Data from similar trials were combined using meta-analysis.
RESULTS:Of 14 112 patients randomly assigned to placebo or ticagrelor 60 mg, 213 experienced a stroke; 85% of these strokes were ischemic. A total of 18% of strokes were fatal and another 15% led to either moderate or severe disability at 30 days. Ticagrelor significantly reduced the risk of stroke (hazard ratio, 0.75; 95% confidence interval, 0.57–0.98; P=0.034), driven by a reduction in ischemic stroke (hazard ratio, 0.76; 95% confidence interval, 0.56–1.02). Hemorrhagic stroke occurred in 9 patients on placebo and 8 patients on ticagrelor. A meta-analysis across 4 placebo-controlled trials of more intensive antiplatelet therapy in 44 816 patients with coronary disease confirmed a marked reduction in ischemic stroke (hazard ratio, 0.66; 95% confidence interval, 0.54–0.81; P=0.0001).
CONCLUSIONS:High-risk patients with prior myocardial infarction are at risk for stroke, approximately one-third of which are fatal or lead to moderate-to-severe disability. The addition of ticagrelor 60 mg twice daily significantly reduced this risk without an excess of hemorrhagic stroke but with more major bleeding. In high-risk patients with coronary disease, more intensive antiplatelet therapy should be considered not only to reduce the risk of coronary events, but also of stroke.
CLINICAL TRIAL REGISTRATION:URLhttp://www.clinicaltrials.gov. Unique IdentifierNCT01225562.</description><subject>Adenosine - administration & dosage</subject><subject>Adenosine - analogs & derivatives</subject><subject>Adenosine - therapeutic use</subject><subject>Aged</subject><subject>Aspirin - administration & dosage</subject><subject>Aspirin - therapeutic use</subject><subject>Coronary Artery Disease - drug therapy</subject><subject>Female</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>Intracranial Hemorrhages - prevention & control</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - drug therapy</subject><subject>Myocardial Infarction - prevention & control</subject><subject>Platelet Aggregation Inhibitors - therapeutic use</subject><subject>Purinergic P2Y Receptor Antagonists - therapeutic use</subject><subject>Risk</subject><subject>Secondary Prevention - methods</subject><subject>Stroke - drug therapy</subject><subject>Stroke - prevention & control</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNklFv0zAQxwMCsTL4CsiIl_GQEcdx0iLxEKJujdSxiLbiMXKcS2vqxsV2WvXbz1kGbBIPPNk-_-9-Z9_f897j4BLjGH_K8u_Zap4u89tv6SztY5dBGMUkee6NMA0jP6Jk8sIbBUEw8RMShmfea2N-uqPT0FfeWZjQJE4SOnr2odBwgNYK1SLVoIXVagvoKOwGLQVnaw1SaSRaVDArnM4Md4UWLnxzUpzpWjCJ8rZhmvdlPru9EeuNkzZa7VAxvU4Xq4W_zG9yRCN08ZSY9QXUgRneSabR9HAPeQz88Rc4A6YtSq1lfItWRrTrx11mardnGmpkFSok41Ap5CAMfXXytVZdW_fE1OyFFq2_3Lj2KiVPRtwD__ka1_HHN97LhkkDbx_Wc291NV1mM39-e51n6dznBNPE54yRKOYVrXFAMKFuEGMIKKNBw0iT0CqA2v17SIFHUEEDhNUJIXWVVOPxuIrJuXcx1N1r9asDY8udMBykZC2ozpR4HIbYzTeeOOlkkHKtjNHQlHstdkyfShyUvUfKpx7pY-XgEZf77gHTVTuo_2T-NoUTfBkERyUtaLOV3RF0uQEm7eY_AHfmz9HE</recordid><startdate>20160920</startdate><enddate>20160920</enddate><creator>Bonaca, Marc P</creator><creator>Goto, Shinya</creator><creator>Bhatt, Deepak L</creator><creator>Steg, P Gabriel</creator><creator>Storey, Robert F</creator><creator>Cohen, Marc</creator><creator>Goodrich, Erica</creator><creator>Mauri, Laura</creator><creator>Ophuis, Ton Oude</creator><creator>Ruda, Mikhail</creator><creator>Špinar, Jindřich</creator><creator>Seung, Ki-Bae</creator><creator>Hu, Dayi</creator><creator>Dalby, Anthony J</creator><creator>Jensen, Eva</creator><creator>Held, Peter</creator><creator>Morrow, David A</creator><creator>Braunwald, Eugene</creator><creator>Sabatine, Marc S</creator><general>by the American College of Cardiology Foundation and the American Heart Association, Inc</general><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>20160920</creationdate><title>Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54)</title><author>Bonaca, Marc P ; Goto, Shinya ; Bhatt, Deepak L ; Steg, P Gabriel ; Storey, Robert F ; Cohen, Marc ; Goodrich, Erica ; Mauri, Laura ; Ophuis, Ton Oude ; Ruda, Mikhail ; Špinar, Jindřich ; Seung, Ki-Bae ; Hu, Dayi ; Dalby, Anthony J ; Jensen, Eva ; Held, Peter ; Morrow, David A ; Braunwald, Eugene ; Sabatine, Marc S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3157-caa346cb5d1031355248e05a50fa3f75b0ed75725ec4ebefe3ad733db7b888b63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adenosine - administration & dosage</topic><topic>Adenosine - analogs & derivatives</topic><topic>Adenosine - therapeutic use</topic><topic>Aged</topic><topic>Aspirin - administration & dosage</topic><topic>Aspirin - therapeutic use</topic><topic>Coronary Artery Disease - drug therapy</topic><topic>Female</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>Intracranial Hemorrhages - prevention & control</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - drug therapy</topic><topic>Myocardial Infarction - prevention & control</topic><topic>Platelet Aggregation Inhibitors - therapeutic use</topic><topic>Purinergic P2Y Receptor Antagonists - therapeutic use</topic><topic>Risk</topic><topic>Secondary Prevention - methods</topic><topic>Stroke - drug therapy</topic><topic>Stroke - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bonaca, Marc P</creatorcontrib><creatorcontrib>Goto, Shinya</creatorcontrib><creatorcontrib>Bhatt, Deepak L</creatorcontrib><creatorcontrib>Steg, P Gabriel</creatorcontrib><creatorcontrib>Storey, Robert F</creatorcontrib><creatorcontrib>Cohen, Marc</creatorcontrib><creatorcontrib>Goodrich, Erica</creatorcontrib><creatorcontrib>Mauri, Laura</creatorcontrib><creatorcontrib>Ophuis, Ton Oude</creatorcontrib><creatorcontrib>Ruda, Mikhail</creatorcontrib><creatorcontrib>Špinar, Jindřich</creatorcontrib><creatorcontrib>Seung, Ki-Bae</creatorcontrib><creatorcontrib>Hu, Dayi</creatorcontrib><creatorcontrib>Dalby, Anthony J</creatorcontrib><creatorcontrib>Jensen, Eva</creatorcontrib><creatorcontrib>Held, Peter</creatorcontrib><creatorcontrib>Morrow, David A</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>Sabatine, Marc S</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>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bonaca, Marc P</au><au>Goto, Shinya</au><au>Bhatt, Deepak L</au><au>Steg, P Gabriel</au><au>Storey, Robert F</au><au>Cohen, Marc</au><au>Goodrich, Erica</au><au>Mauri, Laura</au><au>Ophuis, Ton Oude</au><au>Ruda, Mikhail</au><au>Špinar, Jindřich</au><au>Seung, Ki-Bae</au><au>Hu, Dayi</au><au>Dalby, Anthony J</au><au>Jensen, Eva</au><au>Held, Peter</au><au>Morrow, David A</au><au>Braunwald, Eugene</au><au>Sabatine, Marc S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54)</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2016-09-20</date><risdate>2016</risdate><volume>134</volume><issue>12</issue><spage>861</spage><epage>871</epage><pages>861-871</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><abstract>BACKGROUND:In the PEGASUS-TIMI 54 trial (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54), ticagrelor reduced the risk of major adverse cardiovascular events when added to low-dose aspirin in stable patients with prior myocardial infarction, resulting in the approval of ticagrelor 60 mg twice daily for long-term secondary prevention. We investigated the incidence of stroke, outcomes after stroke, and the efficacy of ticagrelor focusing on the approved 60 mg twice daily dose for reducing stroke in this population.
METHODS:Patients were followed for a median of 33 months. Stroke events were adjudicated by a central committee. Data from similar trials were combined using meta-analysis.
RESULTS:Of 14 112 patients randomly assigned to placebo or ticagrelor 60 mg, 213 experienced a stroke; 85% of these strokes were ischemic. A total of 18% of strokes were fatal and another 15% led to either moderate or severe disability at 30 days. Ticagrelor significantly reduced the risk of stroke (hazard ratio, 0.75; 95% confidence interval, 0.57–0.98; P=0.034), driven by a reduction in ischemic stroke (hazard ratio, 0.76; 95% confidence interval, 0.56–1.02). Hemorrhagic stroke occurred in 9 patients on placebo and 8 patients on ticagrelor. A meta-analysis across 4 placebo-controlled trials of more intensive antiplatelet therapy in 44 816 patients with coronary disease confirmed a marked reduction in ischemic stroke (hazard ratio, 0.66; 95% confidence interval, 0.54–0.81; P=0.0001).
CONCLUSIONS:High-risk patients with prior myocardial infarction are at risk for stroke, approximately one-third of which are fatal or lead to moderate-to-severe disability. The addition of ticagrelor 60 mg twice daily significantly reduced this risk without an excess of hemorrhagic stroke but with more major bleeding. In high-risk patients with coronary disease, more intensive antiplatelet therapy should be considered not only to reduce the risk of coronary events, but also of stroke.
CLINICAL TRIAL REGISTRATION:URLhttp://www.clinicaltrials.gov. Unique IdentifierNCT01225562.</abstract><cop>United States</cop><pub>by the American College of Cardiology Foundation and the American Heart Association, Inc</pub><pmid>27576775</pmid><doi>10.1161/CIRCULATIONAHA.116.024637</doi><tpages>11</tpages></addata></record> |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete |
| subjects | Adenosine - administration & dosage Adenosine - analogs & derivatives Adenosine - therapeutic use Aged Aspirin - administration & dosage Aspirin - therapeutic use Coronary Artery Disease - drug therapy Female Hemorrhage - chemically induced Humans Intracranial Hemorrhages - prevention & control Male Middle Aged Myocardial Infarction - drug therapy Myocardial Infarction - prevention & control Platelet Aggregation Inhibitors - therapeutic use Purinergic P2Y Receptor Antagonists - therapeutic use Risk Secondary Prevention - methods Stroke - drug therapy Stroke - prevention & control |
| title | Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) |
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