Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients
Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population,...
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| Veröffentlicht in: | The American journal of cardiology 2018-10, Vol.122 (8), p.1287-1296 |
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| creator | Sadjadieh, Golnaz Engstrøm, Thomas Høfsten, Dan Eik Helqvist, Steffen Køber, Lars Pedersen, Frants Laursen, Peter Nørkjær Andersson, Hedvig Bille Nepper-Christensen, Lars Clemmensen, Peter Sørensen, Rikke Jørgensen, Erik Saunamäki, Kari Tilsted, Hans-Henrik Kelbæk, Henning Holmvang, Lene |
| description | Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p 2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p 2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population. |
| doi_str_mv | 10.1016/j.amjcard.2018.07.008 |
| format | Article |
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In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/j.amjcard.2018.07.008</identifier><identifier>PMID: 30115422</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Anemia ; Bleeding ; Clinical trials ; Confidence intervals ; Consortia ; Coronary Angiography ; Coronary vessels ; Denmark - epidemiology ; Diabetes ; Female ; Heart ; Heart attacks ; Heart surgery ; Hemoglobin ; Humans ; Incidence ; Intubation ; Male ; Medical research ; Middle Aged ; Mortality ; Myocardial infarction ; Participation ; Patients ; Percutaneous Coronary Intervention ; Postoperative Hemorrhage - etiology ; Postoperative Hemorrhage - mortality ; Randomization ; Retrospective Studies ; Risk Factors ; ST Elevation Myocardial Infarction - mortality ; ST Elevation Myocardial Infarction - surgery ; Thrombolysis ; Variables ; Veins & arteries</subject><ispartof>The American journal of cardiology, 2018-10, Vol.122 (8), p.1287-1296</ispartof><rights>2018</rights><rights>Copyright © 2018. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited Oct 15, 2018</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-f1c211796afc6e6ae9022106f4b9761653cba86d3221e63c95f8fe2e64abf1ca3</citedby><cites>FETCH-LOGICAL-c393t-f1c211796afc6e6ae9022106f4b9761653cba86d3221e63c95f8fe2e64abf1ca3</cites><orcidid>0000-0001-5436-9194 ; 0000-0002-8865-3107 ; 0000-0002-3905-292X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2120136774?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30115422$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sadjadieh, Golnaz</creatorcontrib><creatorcontrib>Engstrøm, Thomas</creatorcontrib><creatorcontrib>Høfsten, Dan Eik</creatorcontrib><creatorcontrib>Helqvist, Steffen</creatorcontrib><creatorcontrib>Køber, Lars</creatorcontrib><creatorcontrib>Pedersen, Frants</creatorcontrib><creatorcontrib>Laursen, Peter Nørkjær</creatorcontrib><creatorcontrib>Andersson, Hedvig Bille</creatorcontrib><creatorcontrib>Nepper-Christensen, Lars</creatorcontrib><creatorcontrib>Clemmensen, Peter</creatorcontrib><creatorcontrib>Sørensen, Rikke</creatorcontrib><creatorcontrib>Jørgensen, Erik</creatorcontrib><creatorcontrib>Saunamäki, Kari</creatorcontrib><creatorcontrib>Tilsted, Hans-Henrik</creatorcontrib><creatorcontrib>Kelbæk, Henning</creatorcontrib><creatorcontrib>Holmvang, Lene</creatorcontrib><title>Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients</title><title>The American journal of cardiology</title><addtitle>Am J Cardiol</addtitle><description>Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.</description><subject>Aged</subject><subject>Anemia</subject><subject>Bleeding</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Consortia</subject><subject>Coronary Angiography</subject><subject>Coronary vessels</subject><subject>Denmark - epidemiology</subject><subject>Diabetes</subject><subject>Female</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Heart surgery</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Incidence</subject><subject>Intubation</subject><subject>Male</subject><subject>Medical research</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Myocardial infarction</subject><subject>Participation</subject><subject>Patients</subject><subject>Percutaneous Coronary Intervention</subject><subject>Postoperative Hemorrhage - etiology</subject><subject>Postoperative Hemorrhage - mortality</subject><subject>Randomization</subject><subject>Retrospective Studies</subject><subject>Risk Factors</subject><subject>ST Elevation Myocardial Infarction - mortality</subject><subject>ST Elevation Myocardial Infarction - surgery</subject><subject>Thrombolysis</subject><subject>Variables</subject><subject>Veins & arteries</subject><issn>0002-9149</issn><issn>1879-1913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkc1u1DAUhS0EotPCI4AssWGT4J_EiVdoGA1QqQgEU7G0PM5NceTYUzszUnmSPi5OZ8qCDSv7Xp9zrnU_hF5RUlJCxbuh1ONgdOxKRmhbkqYkpH2CFrRtZEEl5U_RghDCCkkreYbOUxpySWktnqMzPl8qxhbo_oMD6Ky_wesD-CnhZT9BxD82RYKbMXfw2sFBTzZ4_OUuzAOtdvjS9zqah671-Ft-fzB_174Lo_0NHZ4C1h4vnStMGHPiyllvTbZu4hywCuNOx6z7aadf-NoncGCmXD9mvUDPeu0SvDydF-j643qz-lxcff10uVpeFYZLPhU9NYzSRgrdGwFCgySMUSL6aisbQUXNzVa3ouO5C4IbWfdtDwxEpbfZq_kFenvM3cVwu4c0qdEmA85pD2GfFCOtbGvOmjZL3_wjHcI--vw7xWimwEXTVFlVH1UmhpQi9GoX7ajjnaJEzejUoE7o1IxOkUZldNn3-pS-347Q_XU9ssqC90cB5HUcLESVTF6Vyfhi3p3qgv3PiD_cEa39</recordid><startdate>20181015</startdate><enddate>20181015</enddate><creator>Sadjadieh, Golnaz</creator><creator>Engstrøm, Thomas</creator><creator>Høfsten, Dan Eik</creator><creator>Helqvist, Steffen</creator><creator>Køber, Lars</creator><creator>Pedersen, Frants</creator><creator>Laursen, Peter Nørkjær</creator><creator>Andersson, Hedvig Bille</creator><creator>Nepper-Christensen, Lars</creator><creator>Clemmensen, Peter</creator><creator>Sørensen, Rikke</creator><creator>Jørgensen, Erik</creator><creator>Saunamäki, Kari</creator><creator>Tilsted, Hans-Henrik</creator><creator>Kelbæk, Henning</creator><creator>Holmvang, Lene</creator><general>Elsevier Inc</general><general>Elsevier Limited</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>3V.</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>M7Z</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5436-9194</orcidid><orcidid>https://orcid.org/0000-0002-8865-3107</orcidid><orcidid>https://orcid.org/0000-0002-3905-292X</orcidid></search><sort><creationdate>20181015</creationdate><title>Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients</title><author>Sadjadieh, Golnaz ; Engstrøm, Thomas ; Høfsten, Dan Eik ; Helqvist, Steffen ; Køber, Lars ; Pedersen, Frants ; Laursen, Peter Nørkjær ; Andersson, Hedvig Bille ; Nepper-Christensen, Lars ; Clemmensen, Peter ; Sørensen, Rikke ; Jørgensen, Erik ; Saunamäki, Kari ; Tilsted, Hans-Henrik ; Kelbæk, Henning ; Holmvang, Lene</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-f1c211796afc6e6ae9022106f4b9761653cba86d3221e63c95f8fe2e64abf1ca3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Anemia</topic><topic>Bleeding</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Consortia</topic><topic>Coronary Angiography</topic><topic>Coronary vessels</topic><topic>Denmark - 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Academic</collection><jtitle>The American journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sadjadieh, Golnaz</au><au>Engstrøm, Thomas</au><au>Høfsten, Dan Eik</au><au>Helqvist, Steffen</au><au>Køber, Lars</au><au>Pedersen, Frants</au><au>Laursen, Peter Nørkjær</au><au>Andersson, Hedvig Bille</au><au>Nepper-Christensen, Lars</au><au>Clemmensen, Peter</au><au>Sørensen, Rikke</au><au>Jørgensen, Erik</au><au>Saunamäki, Kari</au><au>Tilsted, Hans-Henrik</au><au>Kelbæk, Henning</au><au>Holmvang, Lene</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients</atitle><jtitle>The American journal of cardiology</jtitle><addtitle>Am J Cardiol</addtitle><date>2018-10-15</date><risdate>2018</risdate><volume>122</volume><issue>8</issue><spage>1287</spage><epage>1296</epage><pages>1287-1296</pages><issn>0002-9149</issn><eissn>1879-1913</eissn><abstract>Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>30115422</pmid><doi>10.1016/j.amjcard.2018.07.008</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-5436-9194</orcidid><orcidid>https://orcid.org/0000-0002-8865-3107</orcidid><orcidid>https://orcid.org/0000-0002-3905-292X</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-9149 |
| ispartof | The American journal of cardiology, 2018-10, Vol.122 (8), p.1287-1296 |
| issn | 0002-9149 1879-1913 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2089853278 |
| source | MEDLINE; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland |
| subjects | Aged Anemia Bleeding Clinical trials Confidence intervals Consortia Coronary Angiography Coronary vessels Denmark - epidemiology Diabetes Female Heart Heart attacks Heart surgery Hemoglobin Humans Incidence Intubation Male Medical research Middle Aged Mortality Myocardial infarction Participation Patients Percutaneous Coronary Intervention Postoperative Hemorrhage - etiology Postoperative Hemorrhage - mortality Randomization Retrospective Studies Risk Factors ST Elevation Myocardial Infarction - mortality ST Elevation Myocardial Infarction - surgery Thrombolysis Variables Veins & arteries |
| title | Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-26T20%3A26%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Bleeding%20Events%20After%20ST-segment%20Elevation%20Myocardial%20Infarction%20in%20Patients%20Randomized%20to%20an%20All-comer%20Clinical%20Trial%20Compared%20With%20Unselected%20Patients&rft.jtitle=The%20American%20journal%20of%20cardiology&rft.au=Sadjadieh,%20Golnaz&rft.date=2018-10-15&rft.volume=122&rft.issue=8&rft.spage=1287&rft.epage=1296&rft.pages=1287-1296&rft.issn=0002-9149&rft.eissn=1879-1913&rft_id=info:doi/10.1016/j.amjcard.2018.07.008&rft_dat=%3Cproquest_cross%3E2120136774%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2120136774&rft_id=info:pmid/30115422&rft_els_id=S0002914918314267&rfr_iscdi=true |