Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: Insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial
Identifieur interne : 007823 ( Main/Exploration ); précédent : 007822; suivant : 007824Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: Insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial
Auteurs : Harvey D. White [Nouvelle-Zélande] ; Philip E. Aylward [Australie] ; Richard Gallo [Canada] ; Christoph Bode [Allemagne] ; Gabriel Steg [France] ; Steven R. Steinhubl [États-Unis] ; Gilles Montalescot [France]Source :
- The American heart journal [ 0002-8703 ] ; 2010.
Descripteurs français
- Pascal (Inist)
- Hématome, Pathologie de l'appareil circulatoire, Pronostic, Homme, Malade, Electif, Angioplastie, Artère coronaire, Athérectomie, Stent, Voie percutanée, Sécurité, Complication, Efficacité, Enoxaparine sodique, International, Randomisation, Evaluation, Appareil circulatoire, Cardiologie, Traitement instrumental.
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Background Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention (PCI). No uniform definitions exist for major and minor bleeding. Hematomas ≥5 cm at the femoral puncture site are considered major bleeding events in some trials and minor in others. Limited information is available on the incidence and clinical relevance of hematomas ≥5 cm in PCI patients. Methods Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas >5 cm on ischemic outcomes (mortality, nonfatal myocardial infarction, or urgent target vessel revascularization) up to day 30 and all-cause 1-year mortality. Hematoma data were available for 3,342 of 3,528 patients in STEEPLE. Patients with (n = 103) and without (n = 3,239) hematomas >5 cm were evenly distributed across treatment groups. Results No differences were observed in 30-day ischemic outcomes between patients with and without hematomas (5.8% vs 5.9%, respectively; P= .96). No transfusions were observed in patients with hematomas as compared with patients without hematomas (0% and 0.4%, respectively; P = .52). A greater reduction in hemoglobin was observed (pre- vs post-PCI) in patients with hematomas as compared with patients without hematomas (-0.84 vs -0.35 g/L, P ≤.001). No significant difference in all-cause 1-year mortality was observed between patients with and without hematomas (0.0% vs 1.7%, P = .98). Conclusions After PCI, hematomas ≥5 cm had no effect on 30-day ischemic events or 1-year mortality. Although there is no agreed classification for large hematomas, the lack of a relationship between hematomas ≥5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: Insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial</title><author><name sortKey="White, Harvey D" sort="White, Harvey D" uniqKey="White H" first="Harvey D." last="White">Harvey D. White</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Green Lane Cardiovascular Service, Auckland City Hospital</s1><s2>Auckland</s2><s3>NZL</s3><sZ>1 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Auckland</wicri:noRegion></affiliation></author><author><name sortKey="Aylward, Philip E" sort="Aylward, Philip E" uniqKey="Aylward P" first="Philip E." last="Aylward">Philip E. Aylward</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Flinders Medical Centre</s1><s2>Bedford Park, SA</s2><s3>AUS</s3><sZ>2 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Flinders Medical Centre</wicri:noRegion></affiliation></author><author><name sortKey="Gallo, Richard" sort="Gallo, Richard" uniqKey="Gallo R" first="Richard" last="Gallo">Richard Gallo</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Montreal Heart Institute, Université de Montréal</s1><s2>Montréal, Quebec</s2><s3>CAN</s3><sZ>3 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Montréal, Quebec</wicri:noRegion></affiliation></author><author><name sortKey="Bode, Christoph" sort="Bode, Christoph" uniqKey="Bode C" first="Christoph" last="Bode">Christoph Bode</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Internal Medicine III, Cardiology and Vascular Medicine, Universitätsklinikum Freiburg</s1><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Universitätsklinikum Freiburg</wicri:noRegion><wicri:noRegion>Department of Internal Medicine III, Cardiology and Vascular Medicine, Universitätsklinikum Freiburg</wicri:noRegion></affiliation></author><author><name sortKey="Steg, Gabriel" sort="Steg, Gabriel" uniqKey="Steg G" first="Gabriel" last="Steg">Gabriel Steg</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Service de Cardiologie, Hôpifal Bichat</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R." last="Steinhubl">Steven R. Steinhubl</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>The Adjunct Faculty, Geisinger Clinic, Geisinger Center for Health Research</s1><s2>Danville, PA</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Danville, PA</wicri:noRegion></affiliation></author><author><name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Institut de Cordiologie (AP-HP) and INSERM Unit #856 Centre Hospitalier Universitaire Pitié-Salpêtrière</s1><s2>Paris</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">10-0070231</idno><date when="2010">2010</date><idno type="stanalyst">PASCAL 10-0070231 INIST</idno><idno type="RBID">Pascal:10-0070231</idno><idno type="wicri:Area/PascalFrancis/Corpus">002907</idno><idno type="wicri:Area/PascalFrancis/Curation">003678</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">002363</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">002363</idno><idno type="wicri:doubleKey">0002-8703:2010:White H:hematomas:of:at</idno><idno type="wicri:Area/Main/Merge">007E31</idno><idno type="wicri:Area/Main/Curation">007823</idno><idno type="wicri:Area/Main/Exploration">007823</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: Insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial</title><author><name sortKey="White, Harvey D" sort="White, Harvey D" uniqKey="White H" first="Harvey D." last="White">Harvey D. White</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Green Lane Cardiovascular Service, Auckland City Hospital</s1><s2>Auckland</s2><s3>NZL</s3><sZ>1 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Auckland</wicri:noRegion></affiliation></author><author><name sortKey="Aylward, Philip E" sort="Aylward, Philip E" uniqKey="Aylward P" first="Philip E." last="Aylward">Philip E. Aylward</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Flinders Medical Centre</s1><s2>Bedford Park, SA</s2><s3>AUS</s3><sZ>2 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Flinders Medical Centre</wicri:noRegion></affiliation></author><author><name sortKey="Gallo, Richard" sort="Gallo, Richard" uniqKey="Gallo R" first="Richard" last="Gallo">Richard Gallo</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Montreal Heart Institute, Université de Montréal</s1><s2>Montréal, Quebec</s2><s3>CAN</s3><sZ>3 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Montréal, Quebec</wicri:noRegion></affiliation></author><author><name sortKey="Bode, Christoph" sort="Bode, Christoph" uniqKey="Bode C" first="Christoph" last="Bode">Christoph Bode</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Internal Medicine III, Cardiology and Vascular Medicine, Universitätsklinikum Freiburg</s1><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Universitätsklinikum Freiburg</wicri:noRegion><wicri:noRegion>Department of Internal Medicine III, Cardiology and Vascular Medicine, Universitätsklinikum Freiburg</wicri:noRegion></affiliation></author><author><name sortKey="Steg, Gabriel" sort="Steg, Gabriel" uniqKey="Steg G" first="Gabriel" last="Steg">Gabriel Steg</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Service de Cardiologie, Hôpifal Bichat</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R." last="Steinhubl">Steven R. Steinhubl</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>The Adjunct Faculty, Geisinger Clinic, Geisinger Center for Health Research</s1><s2>Danville, PA</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Danville, PA</wicri:noRegion></affiliation></author><author><name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Institut de Cordiologie (AP-HP) and INSERM Unit #856 Centre Hospitalier Universitaire Pitié-Salpêtrière</s1><s2>Paris</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">The American heart journal</title><title level="j" type="abbreviated">Am. heart j.</title><idno type="ISSN">0002-8703</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The American heart journal</title><title level="j" type="abbreviated">Am. heart j.</title><idno type="ISSN">0002-8703</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Angioplasty</term><term>Atherectomy</term><term>Cardiology</term><term>Cardiovascular disease</term><term>Circulatory system</term><term>Complication</term><term>Coronary artery</term><term>Efficiency</term><term>Elective</term><term>Enoxaparin sodium</term><term>Evaluation</term><term>Hematoma</term><term>Human</term><term>Instrumentation therapy</term><term>International</term><term>Patient</term><term>Percutaneous route</term><term>Prognosis</term><term>Randomization</term><term>Safety</term><term>Stent</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Hématome</term><term>Pathologie de l'appareil circulatoire</term><term>Pronostic</term><term>Homme</term><term>Malade</term><term>Electif</term><term>Angioplastie</term><term>Artère coronaire</term><term>Athérectomie</term><term>Stent</term><term>Voie percutanée</term><term>Sécurité</term><term>Complication</term><term>Efficacité</term><term>Enoxaparine sodique</term><term>International</term><term>Randomisation</term><term>Evaluation</term><term>Appareil circulatoire</term><term>Cardiologie</term><term>Traitement instrumental</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention (PCI). No uniform definitions exist for major and minor bleeding. Hematomas ≥5 cm at the femoral puncture site are considered major bleeding events in some trials and minor in others. Limited information is available on the incidence and clinical relevance of hematomas ≥5 cm in PCI patients. Methods Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas >5 cm on ischemic outcomes (mortality, nonfatal myocardial infarction, or urgent target vessel revascularization) up to day 30 and all-cause 1-year mortality. Hematoma data were available for 3,342 of 3,528 patients in STEEPLE. Patients with (n = 103) and without (n = 3,239) hematomas >5 cm were evenly distributed across treatment groups. Results No differences were observed in 30-day ischemic outcomes between patients with and without hematomas (5.8% vs 5.9%, respectively; P= .96). No transfusions were observed in patients with hematomas as compared with patients without hematomas (0% and 0.4%, respectively; P = .52). A greater reduction in hemoglobin was observed (pre- vs post-PCI) in patients with hematomas as compared with patients without hematomas (-0.84 vs -0.35 g/L, P ≤.001). No significant difference in all-cause 1-year mortality was observed between patients with and without hematomas (0.0% vs 1.7%, P = .98). Conclusions After PCI, hematomas ≥5 cm had no effect on 30-day ischemic events or 1-year mortality. Although there is no agreed classification for large hematomas, the lack of a relationship between hematomas ≥5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>France</li><li>Nouvelle-Zélande</li><li>États-Unis</li></country><region><li>Île-de-France</li></region><settlement><li>Paris</li></settlement></list><tree><country name="Nouvelle-Zélande"><noRegion><name sortKey="White, Harvey D" sort="White, Harvey D" uniqKey="White H" first="Harvey D." last="White">Harvey D. White</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Aylward, Philip E" sort="Aylward, Philip E" uniqKey="Aylward P" first="Philip E." last="Aylward">Philip E. Aylward</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Gallo, Richard" sort="Gallo, Richard" uniqKey="Gallo R" first="Richard" last="Gallo">Richard Gallo</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Bode, Christoph" sort="Bode, Christoph" uniqKey="Bode C" first="Christoph" last="Bode">Christoph Bode</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Steg, Gabriel" sort="Steg, Gabriel" uniqKey="Steg G" first="Gabriel" last="Steg">Gabriel Steg</name></region><name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name></country><country name="États-Unis"><noRegion><name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R." last="Steinhubl">Steven R. Steinhubl</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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