Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial†
Identifieur interne : 003996 ( Main/Exploration ); précédent : 003995; suivant : 003997Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial†
Auteurs : Jean-Claude Tardif ; Christie M. Ballantyne ; Philip Barter ; Jean-Louis Dasseux ; Zahi A. Fayad ; Marie-Claude Guertin ; John J. P. Kastelein ; Constance Keyserling ; Heather Klepp ; Wolfgang Koenig ; Philippe L. L'Allier ; Jacques Lespérance ; Thomas F. Lüscher ; John F. Paolini ; Ahmed Tawakol ; David D. WatersSource :
- European Heart Journal [ 0195-668X ] ; 2014.
Abstract
High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo.
To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA).
A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2–5) weeks after the last study infusion.
Five hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively.
Patients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001.
The primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints.
The nominal change in the total atheroma volume (adjusted means) was −2.71, −3.13, −1.50, and −3.05 mm3 with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo:
CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study.
Name of the trial registry: Clinicaltrials.gov; Registry's URL:
Url:
DOI: 10.1093/eurheartj/ehu171
PubMed: 24780501
PubMed Central: 4258222
Affiliations:
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Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial<sup><xref ref-type="author-notes" rid="AN1">†</xref>
</sup>
</title>
<author><name sortKey="Tardif, Jean Claude" sort="Tardif, Jean Claude" uniqKey="Tardif J" first="Jean-Claude" last="Tardif">Jean-Claude Tardif</name>
</author>
<author><name sortKey="Ballantyne, Christie M" sort="Ballantyne, Christie M" uniqKey="Ballantyne C" first="Christie M." last="Ballantyne">Christie M. Ballantyne</name>
</author>
<author><name sortKey="Barter, Philip" sort="Barter, Philip" uniqKey="Barter P" first="Philip" last="Barter">Philip Barter</name>
</author>
<author><name sortKey="Dasseux, Jean Louis" sort="Dasseux, Jean Louis" uniqKey="Dasseux J" first="Jean-Louis" last="Dasseux">Jean-Louis Dasseux</name>
</author>
<author><name sortKey="Fayad, Zahi A" sort="Fayad, Zahi A" uniqKey="Fayad Z" first="Zahi A." last="Fayad">Zahi A. Fayad</name>
</author>
<author><name sortKey="Guertin, Marie Claude" sort="Guertin, Marie Claude" uniqKey="Guertin M" first="Marie-Claude" last="Guertin">Marie-Claude Guertin</name>
</author>
<author><name sortKey="Kastelein, John J P" sort="Kastelein, John J P" uniqKey="Kastelein J" first="John J. P." last="Kastelein">John J. P. Kastelein</name>
</author>
<author><name sortKey="Keyserling, Constance" sort="Keyserling, Constance" uniqKey="Keyserling C" first="Constance" last="Keyserling">Constance Keyserling</name>
</author>
<author><name sortKey="Klepp, Heather" sort="Klepp, Heather" uniqKey="Klepp H" first="Heather" last="Klepp">Heather Klepp</name>
</author>
<author><name sortKey="Koenig, Wolfgang" sort="Koenig, Wolfgang" uniqKey="Koenig W" first="Wolfgang" last="Koenig">Wolfgang Koenig</name>
</author>
<author><name sortKey="L Allier, Philippe L" sort="L Allier, Philippe L" uniqKey="L Allier P" first="Philippe L." last="L'Allier">Philippe L. L'Allier</name>
</author>
<author><name sortKey="Lesperance, Jacques" sort="Lesperance, Jacques" uniqKey="Lesperance J" first="Jacques" last="Lespérance">Jacques Lespérance</name>
</author>
<author><name sortKey="Luscher, Thomas F" sort="Luscher, Thomas F" uniqKey="Luscher T" first="Thomas F." last="Lüscher">Thomas F. Lüscher</name>
</author>
<author><name sortKey="Paolini, John F" sort="Paolini, John F" uniqKey="Paolini J" first="John F." last="Paolini">John F. Paolini</name>
</author>
<author><name sortKey="Tawakol, Ahmed" sort="Tawakol, Ahmed" uniqKey="Tawakol A" first="Ahmed" last="Tawakol">Ahmed Tawakol</name>
</author>
<author><name sortKey="Waters, David D" sort="Waters, David D" uniqKey="Waters D" first="David D." last="Waters">David D. Waters</name>
</author>
</analytic>
<series><title level="j">European Heart Journal</title>
<idno type="ISSN">0195-668X</idno>
<idno type="eISSN">1522-9645</idno>
<imprint><date when="2014">2014</date>
</imprint>
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<front><div type="abstract" xml:lang="en"><sec><title>Aim</title>
<p>High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo.</p>
</sec>
<sec><title>Objective</title>
<p>To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA).</p>
</sec>
<sec><title>Design and setting</title>
<p>A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2–5) weeks after the last study infusion.</p>
</sec>
<sec><title>Patients</title>
<p>Five hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively.</p>
</sec>
<sec><title>Intervention</title>
<p>Patients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001.</p>
</sec>
<sec><title>Main outcome measures</title>
<p>The primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints.</p>
</sec>
<sec><title>Results</title>
<p>The nominal change in the total atheroma volume (adjusted means) was −2.71, −3.13, −1.50, and −3.05 mm<sup>3</sup>
with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo: <italic>P</italic>
= 0.81). There was also no difference among groups for the nominal change in per cent atheroma volume (0.02, −0.02, 0.01, and 0.19%; nominal <italic>P</italic>
= 0.53 for 12 mg/kg vs. placebo). Change in the coronary artery score was −0.022, −0.036, −0.022, and −0.015 mm (nominal <italic>P</italic>
= 0.25, 0.99, 0.55), and change in the cumulative coronary stenosis score was −0.51, 2.65, 0.71, and −0.77% (compared with placebo, nominal <italic>P</italic>
= 0.85 for 12 mg/kg and nominal <italic>P</italic>
= 0.01 for 3 mg/kg). The number of patients with major cardiovascular events was 10 (8.3%), 16 (13.3%), 17 (13.7%), and 12 (9.8%) in the four groups.</p>
</sec>
<sec><title>Conclusion</title>
<p>CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study.</p>
<p>Name of the trial registry: Clinicaltrials.gov; Registry's URL: <uri xlink:type="simple" xlink:href="http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2">http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2</uri>
; Trial registration number: NCT01201837.</p>
</sec>
</div>
</front>
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<name sortKey="Barter, Philip" sort="Barter, Philip" uniqKey="Barter P" first="Philip" last="Barter">Philip Barter</name>
<name sortKey="Dasseux, Jean Louis" sort="Dasseux, Jean Louis" uniqKey="Dasseux J" first="Jean-Louis" last="Dasseux">Jean-Louis Dasseux</name>
<name sortKey="Fayad, Zahi A" sort="Fayad, Zahi A" uniqKey="Fayad Z" first="Zahi A." last="Fayad">Zahi A. Fayad</name>
<name sortKey="Guertin, Marie Claude" sort="Guertin, Marie Claude" uniqKey="Guertin M" first="Marie-Claude" last="Guertin">Marie-Claude Guertin</name>
<name sortKey="Kastelein, John J P" sort="Kastelein, John J P" uniqKey="Kastelein J" first="John J. P." last="Kastelein">John J. P. Kastelein</name>
<name sortKey="Keyserling, Constance" sort="Keyserling, Constance" uniqKey="Keyserling C" first="Constance" last="Keyserling">Constance Keyserling</name>
<name sortKey="Klepp, Heather" sort="Klepp, Heather" uniqKey="Klepp H" first="Heather" last="Klepp">Heather Klepp</name>
<name sortKey="Koenig, Wolfgang" sort="Koenig, Wolfgang" uniqKey="Koenig W" first="Wolfgang" last="Koenig">Wolfgang Koenig</name>
<name sortKey="L Allier, Philippe L" sort="L Allier, Philippe L" uniqKey="L Allier P" first="Philippe L." last="L'Allier">Philippe L. L'Allier</name>
<name sortKey="Lesperance, Jacques" sort="Lesperance, Jacques" uniqKey="Lesperance J" first="Jacques" last="Lespérance">Jacques Lespérance</name>
<name sortKey="Luscher, Thomas F" sort="Luscher, Thomas F" uniqKey="Luscher T" first="Thomas F." last="Lüscher">Thomas F. Lüscher</name>
<name sortKey="Paolini, John F" sort="Paolini, John F" uniqKey="Paolini J" first="John F." last="Paolini">John F. Paolini</name>
<name sortKey="Tardif, Jean Claude" sort="Tardif, Jean Claude" uniqKey="Tardif J" first="Jean-Claude" last="Tardif">Jean-Claude Tardif</name>
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