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Effect on Mode of Death of Heart Failure Treatment Started with Bisoprolol Followed by Enalapril, Compared to the Opposite Order: Results of the Randomized CIBIS III Trial

Identifieur interne : 006B58 ( Main/Exploration ); précédent : 006B57; suivant : 006B59

Effect on Mode of Death of Heart Failure Treatment Started with Bisoprolol Followed by Enalapril, Compared to the Opposite Order: Results of the Randomized CIBIS III Trial

Auteurs : Henry Krum [Australie] ; Dirk J. Van Veldhuisen [Pays-Bas] ; Christian Funck-Brentano [France] ; Emilio Vanoli [Italie] ; Bernard Silke [Irlande (pays)] ; Erland Erdmann [Allemagne] ; Ferenc Follath [Suisse] ; Piotr Ponikowski [Pologne] ; Michael Goulder [Royaume-Uni] ; Wilfried Meyer [Allemagne] ; Philippe Lechat [France] ; Ronnie Willenheimer [Suède]

Source :

RBID : Pascal:11-0167396

Descripteurs français

English descriptors

Abstract

Background: Mode of death in chronic heart failure (CHF) may be of relevance to choice of therapy for this condition. Sudden death is particularly common in patients with early and/or mild/moderate CHF. β-Blockade may provide better protection against sudden death than ACE inhibition (ACEI) in this setting. Methods: We randomized 1010 patients with mild or moderate, stable CHF and left ventricular ejection fraction ≤35%, without ACEI, β-blocker or angiotensin-receptor-blocker therapy, to either bisoprolol (n = 505) or enalapril (n = 505) for 6 months, followed by their combination for 6-24 months. The two strategies were blindly compared regarding adjudicated mode of death, including sudden death and progressive pump failure death. Results: During the monotherapy phase, 8 of 23 deaths in the bisoprolol-first group were sudden, compared to 16 of 32 in the enalapril-first group: hazard ratio (HR) for sudden death 0.50; 95% confidence interval (CI) 0.21-1.16; P = 0.107. At 1 year, 16 of 42 versus 29 of 60 deaths were sudden: HR 0.54; 95% CI 0.29-1.00; P = 0.049. At study end, 29 of 65 versus 34 of 73 deaths were sudden: HR 0.84; 95% CI 0.51-1.38; P = 0.487. Comparable figures for pump failure death were: monotherapy, 7 of 23 deaths versus 2 of 32: HR 3.43; 95% CI 0.71-16.53; P = 0.124, at 1 year, 13 of 42 versus 5 of 60: HR 2.57; 95% CI 0.92-7.20; P = 0.073, at study end, 17 of 65 versus 7 of 73: HR 2.39; 95% CI 0.99-5.75; P = 0.053. There were no significant between-group differences in any other fatal events. Conclusion: Initiating therapy with bisoprolol compared to enalapril decreased the risk of sudden death during the first year in this mild systolic CHF cohort. This was somewhat offset by an increase in pump failure deaths in the bisoprolol-first cohort.


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<name sortKey="Funck Brentano, Christian" sort="Funck Brentano, Christian" uniqKey="Funck Brentano C" first="Christian" last="Funck-Brentano">Christian Funck-Brentano</name>
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<title xml:lang="en" level="a">Effect on Mode of Death of Heart Failure Treatment Started with Bisoprolol Followed by Enalapril, Compared to the Opposite Order: Results of the Randomized CIBIS III Trial</title>
<author>
<name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name>
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<s1>Departments of Epidemiology and Preventive Medicine and Medicine, Monash University, Alfred Hospital</s1>
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<sZ>1 aut.</sZ>
</inist:fA14>
<country>Australie</country>
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<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
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<author>
<name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J." last="Van Veldhuisen">Dirk J. Van Veldhuisen</name>
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<s1>Thoraxcenter, Department of Cardiology, University Hospital Groningen</s1>
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<name sortKey="Funck Brentano, Christian" sort="Funck Brentano, Christian" uniqKey="Funck Brentano C" first="Christian" last="Funck-Brentano">Christian Funck-Brentano</name>
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<sZ>3 aut.</sZ>
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<name sortKey="Vanoli, Emilio" sort="Vanoli, Emilio" uniqKey="Vanoli E" first="Emilio" last="Vanoli">Emilio Vanoli</name>
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<s1>Department of Cardiology, University of Pavia and Policlinico di Monza</s1>
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<sZ>4 aut.</sZ>
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<name sortKey="Silke, Bernard" sort="Silke, Bernard" uniqKey="Silke B" first="Bernard" last="Silke">Bernard Silke</name>
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<s1>Department of Pharmacology & Therapeutics, Trinity Centre, St James' Hospital</s1>
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<sZ>5 aut.</sZ>
</inist:fA14>
<country>Irlande (pays)</country>
<wicri:noRegion>Dublin</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Erdmann, Erland" sort="Erdmann, Erland" uniqKey="Erdmann E" first="Erland" last="Erdmann">Erland Erdmann</name>
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<s3>DEU</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>University of Cologne</wicri:noRegion>
<wicri:noRegion>Medizinische Klinik III, University of Cologne</wicri:noRegion>
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<name sortKey="Follath, Ferenc" sort="Follath, Ferenc" uniqKey="Follath F" first="Ferenc" last="Follath">Ferenc Follath</name>
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<s1>Medicine A, University Hospital Zürich</s1>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Medicine A, University Hospital Zürich</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name>
<affiliation wicri:level="1">
<inist:fA14 i1="08">
<s1>Department of Heart Diseases, Medical University</s1>
<s2>Wroclaw</s2>
<s3>POL</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Pologne</country>
<wicri:noRegion>Wroclaw</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Goulder, Michael" sort="Goulder, Michael" uniqKey="Goulder M" first="Michael" last="Goulder">Michael Goulder</name>
<affiliation wicri:level="1">
<inist:fA14 i1="09">
<s1>Worldwide Clinical Trials</s1>
<s2>Nottingham</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Worldwide Clinical Trials</wicri:noRegion>
</affiliation>
</author>
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<name sortKey="Meyer, Wilfried" sort="Meyer, Wilfried" uniqKey="Meyer W" first="Wilfried" last="Meyer">Wilfried Meyer</name>
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<s1>Merck KGaA</s1>
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<s3>DEU</s3>
<sZ>10 aut.</sZ>
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<country>Allemagne</country>
<placeName>
<region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Darmstadt</settlement>
</placeName>
</affiliation>
</author>
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<name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name>
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<s1>Service de Pharmacologie, Hopital Pitié-Salpetriere</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>11 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="Willenheimer, Ronnie" sort="Willenheimer, Ronnie" uniqKey="Willenheimer R" first="Ronnie" last="Willenheimer">Ronnie Willenheimer</name>
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<s2>Malmö</s2>
<s3>SWE</s3>
<sZ>12 aut.</sZ>
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<country>Suède</country>
<wicri:noRegion>Lund University and Heart Health Group</wicri:noRegion>
</affiliation>
</author>
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<series>
<title level="j" type="main">Cardiovascular therapeutics : (Print)</title>
<title level="j" type="abbreviated">Cardiovasc. ther. : (Print)</title>
<idno type="ISSN">1755-5914</idno>
<imprint>
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<idno type="ISSN">1755-5914</idno>
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<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>ACE inhibitor</term>
<term>Antihypertensive agent</term>
<term>Beta blocking agent</term>
<term>Bisoprolol</term>
<term>Cardiocirculatory arrest</term>
<term>Drug</term>
<term>Enalapril</term>
<term>Heart failure</term>
<term>Randomization</term>
<term>Result</term>
<term>Sudden death</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Mort subite</term>
<term>Insuffisance cardiaque</term>
<term>Traitement</term>
<term>Bisoprolol</term>
<term>Enalapril</term>
<term>Résultat</term>
<term>Randomisation</term>
<term>Bloquant β-adrénergique</term>
<term>Inhibiteur angiotensin converting enzyme</term>
<term>Médicament</term>
<term>Arrêt cardiocirculatoire</term>
<term>Antihypertenseur</term>
<term>Arrêt cardiorespiratoire</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Médicament</term>
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<div type="abstract" xml:lang="en">Background: Mode of death in chronic heart failure (CHF) may be of relevance to choice of therapy for this condition. Sudden death is particularly common in patients with early and/or mild/moderate CHF. β-Blockade may provide better protection against sudden death than ACE inhibition (ACEI) in this setting. Methods: We randomized 1010 patients with mild or moderate, stable CHF and left ventricular ejection fraction ≤35%, without ACEI, β-blocker or angiotensin-receptor-blocker therapy, to either bisoprolol (n = 505) or enalapril (n = 505) for 6 months, followed by their combination for 6-24 months. The two strategies were blindly compared regarding adjudicated mode of death, including sudden death and progressive pump failure death. Results: During the monotherapy phase, 8 of 23 deaths in the bisoprolol-first group were sudden, compared to 16 of 32 in the enalapril-first group: hazard ratio (HR) for sudden death 0.50; 95% confidence interval (CI) 0.21-1.16; P = 0.107. At 1 year, 16 of 42 versus 29 of 60 deaths were sudden: HR 0.54; 95% CI 0.29-1.00; P = 0.049. At study end, 29 of 65 versus 34 of 73 deaths were sudden: HR 0.84; 95% CI 0.51-1.38; P = 0.487. Comparable figures for pump failure death were: monotherapy, 7 of 23 deaths versus 2 of 32: HR 3.43; 95% CI 0.71-16.53; P = 0.124, at 1 year, 13 of 42 versus 5 of 60: HR 2.57; 95% CI 0.92-7.20; P = 0.073, at study end, 17 of 65 versus 7 of 73: HR 2.39; 95% CI 0.99-5.75; P = 0.053. There were no significant between-group differences in any other fatal events. Conclusion: Initiating therapy with bisoprolol compared to enalapril decreased the risk of sudden death during the first year in this mild systolic CHF cohort. This was somewhat offset by an increase in pump failure deaths in the bisoprolol-first cohort.</div>
</front>
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<li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Irlande (pays)</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>Suède</li>
</country>
<region>
<li>District de Darmstadt</li>
<li>Hesse (Land)</li>
<li>Victoria (État)</li>
<li>Île-de-France</li>
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<li>Darmstadt</li>
<li>Melbourne</li>
<li>Paris</li>
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<noRegion>
<name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J." last="Van Veldhuisen">Dirk J. Van Veldhuisen</name>
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<region name="Île-de-France">
<name sortKey="Funck Brentano, Christian" sort="Funck Brentano, Christian" uniqKey="Funck Brentano C" first="Christian" last="Funck-Brentano">Christian Funck-Brentano</name>
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<name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name>
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<name sortKey="Vanoli, Emilio" sort="Vanoli, Emilio" uniqKey="Vanoli E" first="Emilio" last="Vanoli">Emilio Vanoli</name>
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