Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: The INtegrilin plus STenting to Avoid myocardial Necrosis Trial
Background The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. M...
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| creator | Biondi-Zoccai, Giuseppe, MD Valgimigli, Marco, MD, PhD Margheri, Massimo, MD Marzocchi, Antonio, MD Lettieri, Corrado, MD Stabile, Amerigo, MD Petronio, A. Sonia, MD Binetti, Giorgio, MD Bolognese, Leonardo, MD Bellone, Pietro, MD Sardella, Gennaro, MD Contarini, Marco, MD Sheiban, Imad, MD Marra, Sebastiano, MD Piscione, Federico, MD Romeo, Francesco, MD Colombo, Antonio, MD Sangiorgi, Giuseppe, MD |
| description | Background The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. Methods Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase–MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. Results The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase–MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). Conclusions Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies. |
| doi_str_mv | 10.1016/j.ahj.2012.02.009 |
| format | Article |
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Sonia, MD ; Binetti, Giorgio, MD ; Bolognese, Leonardo, MD ; Bellone, Pietro, MD ; Sardella, Gennaro, MD ; Contarini, Marco, MD ; Sheiban, Imad, MD ; Marra, Sebastiano, MD ; Piscione, Federico, MD ; Romeo, Francesco, MD ; Colombo, Antonio, MD ; Sangiorgi, Giuseppe, MD</creator><creatorcontrib>Biondi-Zoccai, Giuseppe, MD ; Valgimigli, Marco, MD, PhD ; Margheri, Massimo, MD ; Marzocchi, Antonio, MD ; Lettieri, Corrado, MD ; Stabile, Amerigo, MD ; Petronio, A. Sonia, MD ; Binetti, Giorgio, MD ; Bolognese, Leonardo, MD ; Bellone, Pietro, MD ; Sardella, Gennaro, MD ; Contarini, Marco, MD ; Sheiban, Imad, MD ; Marra, Sebastiano, MD ; Piscione, Federico, MD ; Romeo, Francesco, MD ; Colombo, Antonio, MD ; Sangiorgi, Giuseppe, MD</creatorcontrib><description>Background The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. Methods Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase–MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. Results The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase–MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). Conclusions Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2012.02.009</identifier><identifier>PMID: 22607870</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Angioplasty ; Angioplasty, Balloon, Coronary - adverse effects ; Angioplasty, Balloon, Coronary - methods ; Angioplasty, Balloon, Coronary - mortality ; Cardiology ; Cardiovascular ; Clinical outcomes ; Coronary Angiography - methods ; Coronary Stenosis - diagnostic imaging ; Coronary Stenosis - mortality ; Coronary Stenosis - therapy ; Coronary vessels ; Drug therapy ; Drug-Eluting Stents ; Female ; Follow-Up Studies ; Heart attacks ; Heparin - administration & dosage ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Myocardial Infarction - pathology ; Myocardial Infarction - prevention & control ; Peptides - administration & dosage ; Platelet Aggregation Inhibitors - administration & dosage ; Proportional Hazards Models ; Risk Assessment ; Severity of Illness Index ; Single-Blind Method ; Statistics, Nonparametric ; Stents ; Survival Analysis ; Treatment Outcome</subject><ispartof>The American heart journal, 2012-05, Vol.163 (5), p.835.e1-835.e7</ispartof><rights>Mosby, Inc.</rights><rights>2012 Mosby, Inc.</rights><rights>Copyright © 2012 Mosby, Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited May 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-337b5f49a9a2824bd7a6396fdf6ff92a957d2da29e9f063e338a4e39134d47ed3</citedby><cites>FETCH-LOGICAL-c436t-337b5f49a9a2824bd7a6396fdf6ff92a957d2da29e9f063e338a4e39134d47ed3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870312000932$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22607870$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Biondi-Zoccai, Giuseppe, MD</creatorcontrib><creatorcontrib>Valgimigli, Marco, MD, PhD</creatorcontrib><creatorcontrib>Margheri, Massimo, MD</creatorcontrib><creatorcontrib>Marzocchi, Antonio, MD</creatorcontrib><creatorcontrib>Lettieri, Corrado, MD</creatorcontrib><creatorcontrib>Stabile, Amerigo, MD</creatorcontrib><creatorcontrib>Petronio, A. Sonia, MD</creatorcontrib><creatorcontrib>Binetti, Giorgio, MD</creatorcontrib><creatorcontrib>Bolognese, Leonardo, MD</creatorcontrib><creatorcontrib>Bellone, Pietro, MD</creatorcontrib><creatorcontrib>Sardella, Gennaro, MD</creatorcontrib><creatorcontrib>Contarini, Marco, MD</creatorcontrib><creatorcontrib>Sheiban, Imad, MD</creatorcontrib><creatorcontrib>Marra, Sebastiano, MD</creatorcontrib><creatorcontrib>Piscione, Federico, MD</creatorcontrib><creatorcontrib>Romeo, Francesco, MD</creatorcontrib><creatorcontrib>Colombo, Antonio, MD</creatorcontrib><creatorcontrib>Sangiorgi, Giuseppe, MD</creatorcontrib><title>Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: The INtegrilin plus STenting to Avoid myocardial Necrosis Trial</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. Methods Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase–MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. Results The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase–MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). Conclusions Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.</description><subject>Aged</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon, Coronary - adverse effects</subject><subject>Angioplasty, Balloon, Coronary - methods</subject><subject>Angioplasty, Balloon, Coronary - mortality</subject><subject>Cardiology</subject><subject>Cardiovascular</subject><subject>Clinical outcomes</subject><subject>Coronary Angiography - methods</subject><subject>Coronary Stenosis - diagnostic imaging</subject><subject>Coronary Stenosis - mortality</subject><subject>Coronary Stenosis - therapy</subject><subject>Coronary vessels</subject><subject>Drug therapy</subject><subject>Drug-Eluting Stents</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart attacks</subject><subject>Heparin - administration & dosage</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - pathology</subject><subject>Myocardial Infarction - prevention & control</subject><subject>Peptides - administration & dosage</subject><subject>Platelet Aggregation Inhibitors - administration & dosage</subject><subject>Proportional Hazards Models</subject><subject>Risk Assessment</subject><subject>Severity of Illness Index</subject><subject>Single-Blind Method</subject><subject>Statistics, Nonparametric</subject><subject>Stents</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9UsFu1DAQjRCIbgsfwAVZ4sIli2M7TgwS0qoqUKkqhy5nyxuPdx2y8WI7RftTfCMTbQGpByRL9ozfe-OZ56J4VdFlRSv5rl-aXb9ktGJLiouqJ8WioqopZSPE02JBKWVl21B-Vpyn1GMoWSufF2eMSdrgxaL4tUoJUvLjluQdkBgGIMEROGTv_MZkb4H4kRzwBGNO5KfPO2K9c1MC0oUYRhOPmEhgMDGNFuI2zGo2TtsShinPQcpIxsN7ssYi17cZttEPs-4wJXK3Pt2SHMjqPnhL9sfQmWi9GcgtdDEkn8g6YviieObMkODlw35RfPt0tb78Ut58_Xx9ubopO8FlLjlvNrUTyijDWiY2tjGSK-msk84pZlTdWGYNU6AclRw4b40AriourGjA8ovi7Un3EMOPCVLWe586GAYzQpiSxvHXTNSiaRH65hG0D1Mc8XW6qqmQvJEtQ1R1Qs3dpAhOH6Lf4-xQalaTutdopp7N1BQXVch5_aA8bfZg_zL-uIeADycA4CjuPUSdOrSpA-sjdFnb4P8r__ERu0NLfGeG73CE9K8LnZCg7-bfNFetGJ3pjP8GhXXHQQ</recordid><startdate>20120501</startdate><enddate>20120501</enddate><creator>Biondi-Zoccai, Giuseppe, MD</creator><creator>Valgimigli, Marco, MD, PhD</creator><creator>Margheri, Massimo, MD</creator><creator>Marzocchi, Antonio, MD</creator><creator>Lettieri, Corrado, MD</creator><creator>Stabile, Amerigo, MD</creator><creator>Petronio, A. 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Sonia, MD ; Binetti, Giorgio, MD ; Bolognese, Leonardo, MD ; Bellone, Pietro, MD ; Sardella, Gennaro, MD ; Contarini, Marco, MD ; Sheiban, Imad, MD ; Marra, Sebastiano, MD ; Piscione, Federico, MD ; Romeo, Francesco, MD ; Colombo, Antonio, MD ; Sangiorgi, Giuseppe, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c436t-337b5f49a9a2824bd7a6396fdf6ff92a957d2da29e9f063e338a4e39134d47ed3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Angioplasty</topic><topic>Angioplasty, Balloon, Coronary - adverse effects</topic><topic>Angioplasty, Balloon, Coronary - methods</topic><topic>Angioplasty, Balloon, Coronary - mortality</topic><topic>Cardiology</topic><topic>Cardiovascular</topic><topic>Clinical outcomes</topic><topic>Coronary Angiography - methods</topic><topic>Coronary Stenosis - diagnostic imaging</topic><topic>Coronary Stenosis - mortality</topic><topic>Coronary Stenosis - therapy</topic><topic>Coronary vessels</topic><topic>Drug therapy</topic><topic>Drug-Eluting Stents</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart attacks</topic><topic>Heparin - administration & dosage</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - pathology</topic><topic>Myocardial Infarction - prevention & control</topic><topic>Peptides - administration & dosage</topic><topic>Platelet Aggregation Inhibitors - administration & dosage</topic><topic>Proportional Hazards Models</topic><topic>Risk Assessment</topic><topic>Severity of Illness Index</topic><topic>Single-Blind Method</topic><topic>Statistics, Nonparametric</topic><topic>Stents</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Biondi-Zoccai, Giuseppe, MD</creatorcontrib><creatorcontrib>Valgimigli, Marco, MD, PhD</creatorcontrib><creatorcontrib>Margheri, Massimo, MD</creatorcontrib><creatorcontrib>Marzocchi, Antonio, MD</creatorcontrib><creatorcontrib>Lettieri, Corrado, MD</creatorcontrib><creatorcontrib>Stabile, Amerigo, MD</creatorcontrib><creatorcontrib>Petronio, A. 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Sonia, MD</au><au>Binetti, Giorgio, MD</au><au>Bolognese, Leonardo, MD</au><au>Bellone, Pietro, MD</au><au>Sardella, Gennaro, MD</au><au>Contarini, Marco, MD</au><au>Sheiban, Imad, MD</au><au>Marra, Sebastiano, MD</au><au>Piscione, Federico, MD</au><au>Romeo, Francesco, MD</au><au>Colombo, Antonio, MD</au><au>Sangiorgi, Giuseppe, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: The INtegrilin plus STenting to Avoid myocardial Necrosis Trial</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2012-05-01</date><risdate>2012</risdate><volume>163</volume><issue>5</issue><spage>835.e1</spage><epage>835.e7</epage><pages>835.e1-835.e7</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. Methods Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase–MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. Results The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase–MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). Conclusions Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>22607870</pmid><doi>10.1016/j.ahj.2012.02.009</doi></addata></record> |
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| language | eng |
| recordid | cdi_proquest_miscellaneous_1015245478 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Aged Angioplasty Angioplasty, Balloon, Coronary - adverse effects Angioplasty, Balloon, Coronary - methods Angioplasty, Balloon, Coronary - mortality Cardiology Cardiovascular Clinical outcomes Coronary Angiography - methods Coronary Stenosis - diagnostic imaging Coronary Stenosis - mortality Coronary Stenosis - therapy Coronary vessels Drug therapy Drug-Eluting Stents Female Follow-Up Studies Heart attacks Heparin - administration & dosage Humans Kaplan-Meier Estimate Male Middle Aged Myocardial Infarction - pathology Myocardial Infarction - prevention & control Peptides - administration & dosage Platelet Aggregation Inhibitors - administration & dosage Proportional Hazards Models Risk Assessment Severity of Illness Index Single-Blind Method Statistics, Nonparametric Stents Survival Analysis Treatment Outcome |
| title | Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: The INtegrilin plus STenting to Avoid myocardial Necrosis Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-03T02%3A05%3A19IST&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=Assessing%20the%20role%20of%20eptifibatide%20in%20patients%20with%20diffuse%20coronary%20disease%20undergoing%20drug-eluting%20stenting:%20The%20INtegrilin%20plus%20STenting%20to%20Avoid%20myocardial%20Necrosis%20Trial&rft.jtitle=The%20American%20heart%20journal&rft.au=Biondi-Zoccai,%20Giuseppe,%20MD&rft.date=2012-05-01&rft.volume=163&rft.issue=5&rft.spage=835.e1&rft.epage=835.e7&rft.pages=835.e1-835.e7&rft.issn=0002-8703&rft.eissn=1097-6744&rft.coden=AHJOA2&rft_id=info:doi/10.1016/j.ahj.2012.02.009&rft_dat=%3Cproquest_cross%3E1015245478%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=1504637682&rft_id=info:pmid/22607870&rft_els_id=1_s2_0_S0002870312000932&rfr_iscdi=true |