Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 Registry
Background Questions about the generalizability of randomized trial results to clinical practice have arisen because the overall mortality rate is generally lower in trials, potentially because patients who are at lower risk are enrolled. However, little is known about the characteristics of patient...
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| creator | Bahit, Maria Cecilia Cannon, Christopher P. Antman, Elliott M. Murphy, Sabina A. Gibson, C.Michael McCabe, Carolyn H. Braunwald, Eugene |
| description | Background Questions about the generalizability of randomized trial results to clinical practice have arisen because the overall mortality rate is generally lower in trials, potentially because patients who are at lower risk are enrolled. However, little is known about the characteristics of patients included in clinical trials versus those who are not included.
Methods The Thrombolysis In Myocardial Infarction (TIMI) 9 Registry prospectively evaluated patients with ST-elevation myocardial infarction at 20 hospitals during the TIMI 9 trial, which compared hirudin versus heparin with fibrinolysis. We compared the characteristics, treatment, and outcomes of patients enrolled in TIMI 9B (n = 3002) with other fibrinolytic-eligible patients not enrolled in TIMI 9B (n = 296) and with those not eligible for fibrinolysis by American College of Cardiology/American Heart Association criteria, at the same centers (n = 282), with the latter groups divided by use of reperfusion therapy.
Results Across the groups, ranging from those in the TIMI 9 trial to those ineligible for fibrinolysis, we observed a gradient of higher-risk baseline characteristics, lower use of reperfusion therapy, and higher mortality rates (
P < .001). In addition, comparing fibrinolytic-eligible patients in TIMI 9B versus those not enrolled in the trial, the use of aspirin, β-blockers, and angiotensin-converting enzyme inhibitors was significantly higher in the TIMI 9B trial. Ineligible patients not treated with reperfusion therapy had much lower rates of use of these medications and the highest inhospital mortality rate (24%, adjusted odds ratio 2.8,
P < .0001)
Conclusions In this prospective registry, patients not enrolled in a clinical trial had higher risk characteristics and worse outcomes; however, they also were treated less frequently with guideline-recommended medications, which may have contributed to their higher mortality rates. (Am Heart J 2003;145:109-17.) |
| doi_str_mv | 10.1067/mhj.2003.43 |
| format | Article |
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Methods The Thrombolysis In Myocardial Infarction (TIMI) 9 Registry prospectively evaluated patients with ST-elevation myocardial infarction at 20 hospitals during the TIMI 9 trial, which compared hirudin versus heparin with fibrinolysis. We compared the characteristics, treatment, and outcomes of patients enrolled in TIMI 9B (n = 3002) with other fibrinolytic-eligible patients not enrolled in TIMI 9B (n = 296) and with those not eligible for fibrinolysis by American College of Cardiology/American Heart Association criteria, at the same centers (n = 282), with the latter groups divided by use of reperfusion therapy.
Results Across the groups, ranging from those in the TIMI 9 trial to those ineligible for fibrinolysis, we observed a gradient of higher-risk baseline characteristics, lower use of reperfusion therapy, and higher mortality rates (
P < .001). In addition, comparing fibrinolytic-eligible patients in TIMI 9B versus those not enrolled in the trial, the use of aspirin, β-blockers, and angiotensin-converting enzyme inhibitors was significantly higher in the TIMI 9B trial. Ineligible patients not treated with reperfusion therapy had much lower rates of use of these medications and the highest inhospital mortality rate (24%, adjusted odds ratio 2.8,
P < .0001)
Conclusions In this prospective registry, patients not enrolled in a clinical trial had higher risk characteristics and worse outcomes; however, they also were treated less frequently with guideline-recommended medications, which may have contributed to their higher mortality rates. (Am Heart J 2003;145:109-17.)</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1067/mhj.2003.43</identifier><identifier>PMID: 12514662</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Electrocardiography ; Fibrinolytic Agents - therapeutic use ; Guideline Adherence - statistics & numerical data ; Humans ; Medical sciences ; Myocardial Infarction - diagnosis ; Myocardial Infarction - drug therapy ; Myocardial Reperfusion - utilization ; Pharmacology. Drug treatments ; Prospective Studies ; Randomized Controlled Trials as Topic - statistics & numerical data ; Registries - statistics & numerical data ; Retrospective Studies ; Treatment Outcome</subject><ispartof>The American heart journal, 2003, Vol.145 (1), p.109-117</ispartof><rights>2003 Mosby, Inc.</rights><rights>2003 INIST-CNRS</rights><rights>Copyright Elsevier Limited Jan 2003</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-a6056e4b07479b1cac3b2affe3c19bf02925dc325266b1ff94f2af7d18041b5b3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1504512682?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3548,4022,27922,27923,27924,45994,64384,64386,64388,72240</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14552462$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12514662$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bahit, Maria Cecilia</creatorcontrib><creatorcontrib>Cannon, Christopher P.</creatorcontrib><creatorcontrib>Antman, Elliott M.</creatorcontrib><creatorcontrib>Murphy, Sabina A.</creatorcontrib><creatorcontrib>Gibson, C.Michael</creatorcontrib><creatorcontrib>McCabe, Carolyn H.</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>TIMI 9 Trial and TIMI 9 Registry. Thrombolysis In Myocardial Infarction</creatorcontrib><title>Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 Registry</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Questions about the generalizability of randomized trial results to clinical practice have arisen because the overall mortality rate is generally lower in trials, potentially because patients who are at lower risk are enrolled. However, little is known about the characteristics of patients included in clinical trials versus those who are not included.
Methods The Thrombolysis In Myocardial Infarction (TIMI) 9 Registry prospectively evaluated patients with ST-elevation myocardial infarction at 20 hospitals during the TIMI 9 trial, which compared hirudin versus heparin with fibrinolysis. We compared the characteristics, treatment, and outcomes of patients enrolled in TIMI 9B (n = 3002) with other fibrinolytic-eligible patients not enrolled in TIMI 9B (n = 296) and with those not eligible for fibrinolysis by American College of Cardiology/American Heart Association criteria, at the same centers (n = 282), with the latter groups divided by use of reperfusion therapy.
Results Across the groups, ranging from those in the TIMI 9 trial to those ineligible for fibrinolysis, we observed a gradient of higher-risk baseline characteristics, lower use of reperfusion therapy, and higher mortality rates (
P < .001). In addition, comparing fibrinolytic-eligible patients in TIMI 9B versus those not enrolled in the trial, the use of aspirin, β-blockers, and angiotensin-converting enzyme inhibitors was significantly higher in the TIMI 9B trial. Ineligible patients not treated with reperfusion therapy had much lower rates of use of these medications and the highest inhospital mortality rate (24%, adjusted odds ratio 2.8,
P < .0001)
Conclusions In this prospective registry, patients not enrolled in a clinical trial had higher risk characteristics and worse outcomes; however, they also were treated less frequently with guideline-recommended medications, which may have contributed to their higher mortality rates. (Am Heart J 2003;145:109-17.)</description><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Electrocardiography</subject><subject>Fibrinolytic Agents - therapeutic use</subject><subject>Guideline Adherence - statistics & numerical data</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Myocardial Infarction - diagnosis</subject><subject>Myocardial Infarction - drug therapy</subject><subject>Myocardial Reperfusion - utilization</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Randomized Controlled Trials as Topic - statistics & numerical data</subject><subject>Registries - statistics & numerical data</subject><subject>Retrospective Studies</subject><subject>Treatment Outcome</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</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>eNptkl2L1DAUhoso7rh65b0ERG_cjkmapNPLZf0aWBFkvA5perqToU3GJF3Y_-cP83SnMCDeJOS8z_ngvCmK14yuGVX1x3F_WHNKq7WonhQrRpu6VLUQT4sVpZSXm5pWF8WLlA74VHyjnhcXjEsmlOKr4s8nF8FmYsN4NNGl4Enoid2baGwGDGRn0xXJEUwewecrYnxHwpQxAdLMHk12KCQCPoZhgI7cQ0xTOgs-5LPoPDHEDs47awas6_A02B9JTMOkiB3dnOvvZjjvgey237ekIbsTjP2XwE-4wwHjw8viWW-GBK-W-7L49eXz7uZbefvj6_bm-ra01abJpVFUKhAtrUXdtMwaW7Xc9D1UljVtT3nDZWcrLrlSLev7RvQo1x3bUMFa2VaXxftT3WMMvydIWY8uWRgG4yFMSde8EZWkNYJv_wEPYYoeZ9NMUiEZVxuO1IcTZWNIKUKvj9GNJj5oRvVsrUZr9WytFhXSb5aaUztCd2YXLxF4twAm4W77aLx16cwJKbl45OSJA1zVvYOok0WjLHSPX0F3wf13gL9RkMDg</recordid><startdate>2003</startdate><enddate>2003</enddate><creator>Bahit, Maria Cecilia</creator><creator>Cannon, Christopher P.</creator><creator>Antman, Elliott M.</creator><creator>Murphy, Sabina A.</creator><creator>Gibson, C.Michael</creator><creator>McCabe, Carolyn H.</creator><creator>Braunwald, Eugene</creator><general>Mosby, Inc</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><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>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</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>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>2003</creationdate><title>Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 Registry</title><author>Bahit, Maria Cecilia ; Cannon, Christopher P. ; Antman, Elliott M. ; Murphy, Sabina A. ; Gibson, C.Michael ; McCabe, Carolyn H. ; Braunwald, Eugene</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-a6056e4b07479b1cac3b2affe3c19bf02925dc325266b1ff94f2af7d18041b5b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Biological and medical sciences</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Electrocardiography</topic><topic>Fibrinolytic Agents - therapeutic use</topic><topic>Guideline Adherence - statistics & numerical data</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Myocardial Infarction - diagnosis</topic><topic>Myocardial Infarction - drug therapy</topic><topic>Myocardial Reperfusion - utilization</topic><topic>Pharmacology. 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Thrombolysis In Myocardial Infarction</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 Registry</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2003</date><risdate>2003</risdate><volume>145</volume><issue>1</issue><spage>109</spage><epage>117</epage><pages>109-117</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Questions about the generalizability of randomized trial results to clinical practice have arisen because the overall mortality rate is generally lower in trials, potentially because patients who are at lower risk are enrolled. However, little is known about the characteristics of patients included in clinical trials versus those who are not included.
Methods The Thrombolysis In Myocardial Infarction (TIMI) 9 Registry prospectively evaluated patients with ST-elevation myocardial infarction at 20 hospitals during the TIMI 9 trial, which compared hirudin versus heparin with fibrinolysis. We compared the characteristics, treatment, and outcomes of patients enrolled in TIMI 9B (n = 3002) with other fibrinolytic-eligible patients not enrolled in TIMI 9B (n = 296) and with those not eligible for fibrinolysis by American College of Cardiology/American Heart Association criteria, at the same centers (n = 282), with the latter groups divided by use of reperfusion therapy.
Results Across the groups, ranging from those in the TIMI 9 trial to those ineligible for fibrinolysis, we observed a gradient of higher-risk baseline characteristics, lower use of reperfusion therapy, and higher mortality rates (
P < .001). In addition, comparing fibrinolytic-eligible patients in TIMI 9B versus those not enrolled in the trial, the use of aspirin, β-blockers, and angiotensin-converting enzyme inhibitors was significantly higher in the TIMI 9B trial. Ineligible patients not treated with reperfusion therapy had much lower rates of use of these medications and the highest inhospital mortality rate (24%, adjusted odds ratio 2.8,
P < .0001)
Conclusions In this prospective registry, patients not enrolled in a clinical trial had higher risk characteristics and worse outcomes; however, they also were treated less frequently with guideline-recommended medications, which may have contributed to their higher mortality rates. (Am Heart J 2003;145:109-17.)</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>12514662</pmid><doi>10.1067/mhj.2003.43</doi><tpages>9</tpages></addata></record> |
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| ispartof | The American heart journal, 2003, Vol.145 (1), p.109-117 |
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| subjects | Biological and medical sciences Blood. Blood coagulation. Reticuloendothelial system Electrocardiography Fibrinolytic Agents - therapeutic use Guideline Adherence - statistics & numerical data Humans Medical sciences Myocardial Infarction - diagnosis Myocardial Infarction - drug therapy Myocardial Reperfusion - utilization Pharmacology. Drug treatments Prospective Studies Randomized Controlled Trials as Topic - statistics & numerical data Registries - statistics & numerical data Retrospective Studies Treatment Outcome |
| title | Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 Registry |
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