Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study
Background: The effect of alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, on coronary plaque burden in patients with familial hypercholesterolemia has not been addressed. Our aim was to assess changes in coronary plaque burden and its characteristics after treatment wi...
| Autores: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | artículo |
| Fecha de publicación: | 2023 |
| País: | España |
| Recursos: | Servizo Galego de Saúde (SERGAS) |
| Repositorio: | RUNA. Repositorio da Consellería de Sanidade e Sergas |
| OAI Identifier: | oai:runa.sergas.gal:20.500.11940/21039 |
| Acesso em linha: | https://portalcientifico.sergas.gal//documentos/647346d1c0b3b1384998827f http://hdl.handle.net/20.500.11940/21039 |
| Access Level: | acceso abierto |
| Palavra-chave: | Humans Female Middle Aged Male Hydroxymethylglutaryl-CoA Reductase Inhibitors Proprotein Convertase 9 Coronary Artery Disease Hypercholesterolemia Plaque, Atherosclerotic Hyperlipoproteinemia Type II Atherosclerosis Acute Coronary Syndrome Treatment Outcome AS A Coruña CHUAC |
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Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study |
| title |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study |
| spellingShingle |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study Perez De Isla, L. Humans Female Middle Aged Male Hydroxymethylglutaryl-CoA Reductase Inhibitors Proprotein Convertase 9 Coronary Artery Disease Hypercholesterolemia Plaque, Atherosclerotic Hyperlipoproteinemia Type II Atherosclerosis Acute Coronary Syndrome Treatment Outcome AS A Coruña CHUAC |
| title_short |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study |
| title_full |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study |
| title_fullStr |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study |
| title_full_unstemmed |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study |
| title_sort |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study |
| dc.creator.none.fl_str_mv |
Perez De Isla, L. Díaz Díaz, José Luis Romero, M.J. Muniz-Grijalvo, O. Mediavilla, J.D. Argueso, R. Sanchez Munoz-Torrero, J.F. Rubio, P. Alvarez-Banos, P. Ponte, P. Manas, D. Suarez Gutierrez, L. Cepeda, J.M. Casanas, M. Fuentes, F. Guijarro, C. Angel Barba, M. Saltijeral Cerezo, A. Padro, T. Mata, P. |
| author |
Perez De Isla, L. |
| author_facet |
Perez De Isla, L. Díaz Díaz, José Luis Romero, M.J. Muniz-Grijalvo, O. Mediavilla, J.D. Argueso, R. Sanchez Munoz-Torrero, J.F. Rubio, P. Alvarez-Banos, P. Ponte, P. Manas, D. Suarez Gutierrez, L. Cepeda, J.M. Casanas, M. Fuentes, F. Guijarro, C. Angel Barba, M. Saltijeral Cerezo, A. Padro, T. Mata, P. |
| author_role |
author |
| author2 |
Díaz Díaz, José Luis Romero, M.J. Muniz-Grijalvo, O. Mediavilla, J.D. Argueso, R. Sanchez Munoz-Torrero, J.F. Rubio, P. Alvarez-Banos, P. Ponte, P. Manas, D. Suarez Gutierrez, L. Cepeda, J.M. Casanas, M. Fuentes, F. Guijarro, C. Angel Barba, M. Saltijeral Cerezo, A. Padro, T. Mata, P. |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Humans Female Middle Aged Male Hydroxymethylglutaryl-CoA Reductase Inhibitors Proprotein Convertase 9 Coronary Artery Disease Hypercholesterolemia Plaque, Atherosclerotic Hyperlipoproteinemia Type II Atherosclerosis Acute Coronary Syndrome Treatment Outcome AS A Coruña CHUAC |
| topic |
Humans Female Middle Aged Male Hydroxymethylglutaryl-CoA Reductase Inhibitors Proprotein Convertase 9 Coronary Artery Disease Hypercholesterolemia Plaque, Atherosclerotic Hyperlipoproteinemia Type II Atherosclerosis Acute Coronary Syndrome Treatment Outcome AS A Coruña CHUAC |
| description |
Background: The effect of alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, on coronary plaque burden in patients with familial hypercholesterolemia has not been addressed. Our aim was to assess changes in coronary plaque burden and its characteristics after treatment with alirocumab by quantification and characterization of atherosclerotic plaque throughout the coronary tree on the basis of a noninvasive analysis of coronary computed tomographic angiography in asymptomatic subjects with familial hypercholesterolemia receiving optimized and stable treatment with maximum tolerated statin dose with or without ezetimibe. Methods: This study is a phase IV, open-label, multicenter, single-arm clinical trial to assess changes in coronary plaque burden and its characteristics after 78 weeks of treatment with alirocumab in patients with familial hypercholesterolemia without clinical atherosclerotic cardiovascular disease. Participants underwent an initial coronary computed tomographic angiography at baseline and another at 78 weeks. Every patient received 150 mg of alirocumab subcutaneiously every 14 days in addition to high-intensity statin therapy. The main outcome was the change on coronary plaque burden and its characteristics by quantification and characterization of atherosclerotic plaque throughout the coronary tree on the basis of analysis of coronary computed tomographic angiography. Results: The study was completed by 104 patients. The median age was 53.3 (46.2-59.4) years. Of these patients, 54 were women (51.9%). Median low-density lipoprotein cholesterol was 138.9 (117.5-175.3) mg/dL at entry and 45.0 (36.0-65.0) mg/dL at follow-up (P<0.001). Coronary plaque burden changed from 34.6% (32.5%-36.8%) at entry to 30.4% (27.4%-33.4%) at follow-up (P<0.001). A significant change in the characteristics of the coronary atherosclerosis was also found: an increase in the proportion of calcified (+0.3%; P<0.001) and mainly fibrous (+6.2%; P<0.001) plaque, accompanied by a decrease in the percentage of fibro-fatty (-3.9%; P<0.001) and necrotic plaque (-0.6%; P<0.001). Conclusions: Treatment with alirocumab in addition to high-intensity statin therapy resulted in significant regression of coronary plaque burden and plaque stabilization on coronary computed tomographic angiography over 78 weeks in these groups of patients with familial hypercholesterolemia without clinical atherosclerotic cardiovascular disease. ARCHITECT (Effect of Alirocumab on Atherosclerotic Plaque Volume, Architecture and Composition) could link and explain ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) results. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05465278. |
| publishDate |
2023 |
| dc.date.none.fl_str_mv |
2023 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| dc.identifier.none.fl_str_mv |
https://portalcientifico.sergas.gal//documentos/647346d1c0b3b1384998827f http://hdl.handle.net/20.500.11940/21039 |
| url |
https://portalcientifico.sergas.gal//documentos/647346d1c0b3b1384998827f http://hdl.handle.net/20.500.11940/21039 |
| dc.language.none.fl_str_mv |
Inglés |
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Inglés |
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https://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
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https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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reponame:RUNA. Repositorio da Consellería de Sanidade e Sergas instname:Servizo Galego de Saúde (SERGAS) |
| instname_str |
Servizo Galego de Saúde (SERGAS) |
| reponame_str |
RUNA. Repositorio da Consellería de Sanidade e Sergas |
| collection |
RUNA. Repositorio da Consellería de Sanidade e Sergas |
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1869411799866015744 |
| spelling |
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT StudyPerez De Isla, L.Díaz Díaz, José LuisRomero, M.J.Muniz-Grijalvo, O.Mediavilla, J.D.Argueso, R.Sanchez Munoz-Torrero, J.F.Rubio, P.Alvarez-Banos, P.Ponte, P.Manas, D.Suarez Gutierrez, L.Cepeda, J.M.Casanas, M.Fuentes, F.Guijarro, C.Angel Barba, M.Saltijeral Cerezo, A.Padro, T.Mata, P.HumansFemaleMiddle AgedMaleHydroxymethylglutaryl-CoA Reductase InhibitorsProprotein Convertase 9Coronary Artery DiseaseHypercholesterolemiaPlaque, AtheroscleroticHyperlipoproteinemia Type IIAtherosclerosisAcute Coronary SyndromeTreatment OutcomeAS A CoruñaCHUACBackground: The effect of alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, on coronary plaque burden in patients with familial hypercholesterolemia has not been addressed. Our aim was to assess changes in coronary plaque burden and its characteristics after treatment with alirocumab by quantification and characterization of atherosclerotic plaque throughout the coronary tree on the basis of a noninvasive analysis of coronary computed tomographic angiography in asymptomatic subjects with familial hypercholesterolemia receiving optimized and stable treatment with maximum tolerated statin dose with or without ezetimibe. Methods: This study is a phase IV, open-label, multicenter, single-arm clinical trial to assess changes in coronary plaque burden and its characteristics after 78 weeks of treatment with alirocumab in patients with familial hypercholesterolemia without clinical atherosclerotic cardiovascular disease. Participants underwent an initial coronary computed tomographic angiography at baseline and another at 78 weeks. Every patient received 150 mg of alirocumab subcutaneiously every 14 days in addition to high-intensity statin therapy. The main outcome was the change on coronary plaque burden and its characteristics by quantification and characterization of atherosclerotic plaque throughout the coronary tree on the basis of analysis of coronary computed tomographic angiography. Results: The study was completed by 104 patients. The median age was 53.3 (46.2-59.4) years. Of these patients, 54 were women (51.9%). Median low-density lipoprotein cholesterol was 138.9 (117.5-175.3) mg/dL at entry and 45.0 (36.0-65.0) mg/dL at follow-up (P<0.001). Coronary plaque burden changed from 34.6% (32.5%-36.8%) at entry to 30.4% (27.4%-33.4%) at follow-up (P<0.001). A significant change in the characteristics of the coronary atherosclerosis was also found: an increase in the proportion of calcified (+0.3%; P<0.001) and mainly fibrous (+6.2%; P<0.001) plaque, accompanied by a decrease in the percentage of fibro-fatty (-3.9%; P<0.001) and necrotic plaque (-0.6%; P<0.001). Conclusions: Treatment with alirocumab in addition to high-intensity statin therapy resulted in significant regression of coronary plaque burden and plaque stabilization on coronary computed tomographic angiography over 78 weeks in these groups of patients with familial hypercholesterolemia without clinical atherosclerotic cardiovascular disease. ARCHITECT (Effect of Alirocumab on Atherosclerotic Plaque Volume, Architecture and Composition) could link and explain ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) results. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05465278.This study was supported by Fundacion Hipercolesterolemia Familiar; grant G03/181, FIS PI12/01289 and ISCIII PI17/01320 from Instituto de Salud Carlos III (ISCIII), grant 08-2008 Centro Nacional de Investigacion Cardiovascular (CNIC), and an unrestricted grant from Sanofi.2023info:eu-repo/semantics/articlehttps://portalcientifico.sergas.gal//documentos/647346d1c0b3b1384998827fhttp://hdl.handle.net/20.500.11940/21039reponame:RUNA. Repositorio da Consellería de Sanidade e Sergasinstname:Servizo Galego de Saúde (SERGAS)Ingléshttps://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:runa.sergas.gal:20.500.11940/210392026-06-12T08:40:47Z |
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15.811543 |