Cargando…

Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial

Background. In patients who underwent cardiac surgery, first-time postoperative atrial fibrillation (POAF) is associated with increased incidence of hospital-acquired complications and mortality. Systemic inflammation is one of confirmed triggers of its development. The anti-inflammatory properties...

Descripción completa

Detalles Bibliográficos
Autores principales: Shvartz, Vladimir, Le, Tatyana, Enginoev, Soslan, Sokolskaya, Maria, Ispiryan, Artak, Shvartz, Elena, Nudel, Daria, Araslanova, Naylyana, Petrosyan, Andrey, Donakanyan, Sergey, Chernov, Igor, Bockeria, Leo, Golukhova, Elena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9604685/
https://www.ncbi.nlm.nih.gov/pubmed/36286314
http://dx.doi.org/10.3390/jcdd9100363
_version_ 1784817876627095552
author Shvartz, Vladimir
Le, Tatyana
Enginoev, Soslan
Sokolskaya, Maria
Ispiryan, Artak
Shvartz, Elena
Nudel, Daria
Araslanova, Naylyana
Petrosyan, Andrey
Donakanyan, Sergey
Chernov, Igor
Bockeria, Leo
Golukhova, Elena
author_facet Shvartz, Vladimir
Le, Tatyana
Enginoev, Soslan
Sokolskaya, Maria
Ispiryan, Artak
Shvartz, Elena
Nudel, Daria
Araslanova, Naylyana
Petrosyan, Andrey
Donakanyan, Sergey
Chernov, Igor
Bockeria, Leo
Golukhova, Elena
author_sort Shvartz, Vladimir
collection PubMed
description Background. In patients who underwent cardiac surgery, first-time postoperative atrial fibrillation (POAF) is associated with increased incidence of hospital-acquired complications and mortality. Systemic inflammation is one of confirmed triggers of its development. The anti-inflammatory properties of colchicine can be effective for the POAF prevention. However, the results of several studies were questionable and required further investigation. Hence, we aimed to evaluate the effectiveness of low-dose short-term colchicine administration for POAF prevention in patients after the open-heart surgery. This double-blind randomized placebo-controlled trial included 267 patients, but 27 of them dropped out in the course of the study. Study subjects received the test drug on the day before the surgery and on postoperative days 2, 3, 4 and 5. The rhythm control was conducted immediately after the operation and until the discharge from the hospital. The final analysis included 240 study subjects: 113 in the colchicine group and 127 in the placebo group. POAF was observed in 21 (18.6%) patients of the colchicine group vs. 39 (30.7%) control patients (OR 0.515; 95% Cl 0.281–0.943; p = 0.029). We observed no statistically significant differences between the patient groups in the secondary endpoints of the study (hospital mortality, respiratory failure, stroke, bleeding, etc.). For other parameters characterizing the severity of inflammation (pericardial effusion, pleural effusion, WBC count, neutrophil count), there were statistically significant differences between the groups in the early postoperative period (days 3 and 5). Also, statistically significant differences between the groups in the frequency of adverse events were revealed: the incidence of diarrhea in the colchicine group was 25.7% vs. 11.8% in the placebo group (OR 2.578; 95% Cl 1.300–5.111; p = 0.005); for abdominal pain, incidence values were 7% vs. 1.6%, correspondingly (OR 4.762; 95% Cl 1.010–22.91; p = 0.028). Thus, there were statistically significant differences between groups in the primary endpoint, thereby confirming the effectiveness of short-term colchicine use for the POAF prevention after coronary artery bypass grafting and/or aortic valve replacement. Also, we detected statistically significant differences between groups in the frequency of side effects to colchicine: diarrhea and abdominal pain were more common in the colchicine group. This clinical trial is registered with ClinicalTrials database under a unique identifier: NCT04224545.
format Online
Article
Text
id pubmed-9604685
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-96046852022-10-27 Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial Shvartz, Vladimir Le, Tatyana Enginoev, Soslan Sokolskaya, Maria Ispiryan, Artak Shvartz, Elena Nudel, Daria Araslanova, Naylyana Petrosyan, Andrey Donakanyan, Sergey Chernov, Igor Bockeria, Leo Golukhova, Elena J Cardiovasc Dev Dis Article Background. In patients who underwent cardiac surgery, first-time postoperative atrial fibrillation (POAF) is associated with increased incidence of hospital-acquired complications and mortality. Systemic inflammation is one of confirmed triggers of its development. The anti-inflammatory properties of colchicine can be effective for the POAF prevention. However, the results of several studies were questionable and required further investigation. Hence, we aimed to evaluate the effectiveness of low-dose short-term colchicine administration for POAF prevention in patients after the open-heart surgery. This double-blind randomized placebo-controlled trial included 267 patients, but 27 of them dropped out in the course of the study. Study subjects received the test drug on the day before the surgery and on postoperative days 2, 3, 4 and 5. The rhythm control was conducted immediately after the operation and until the discharge from the hospital. The final analysis included 240 study subjects: 113 in the colchicine group and 127 in the placebo group. POAF was observed in 21 (18.6%) patients of the colchicine group vs. 39 (30.7%) control patients (OR 0.515; 95% Cl 0.281–0.943; p = 0.029). We observed no statistically significant differences between the patient groups in the secondary endpoints of the study (hospital mortality, respiratory failure, stroke, bleeding, etc.). For other parameters characterizing the severity of inflammation (pericardial effusion, pleural effusion, WBC count, neutrophil count), there were statistically significant differences between the groups in the early postoperative period (days 3 and 5). Also, statistically significant differences between the groups in the frequency of adverse events were revealed: the incidence of diarrhea in the colchicine group was 25.7% vs. 11.8% in the placebo group (OR 2.578; 95% Cl 1.300–5.111; p = 0.005); for abdominal pain, incidence values were 7% vs. 1.6%, correspondingly (OR 4.762; 95% Cl 1.010–22.91; p = 0.028). Thus, there were statistically significant differences between groups in the primary endpoint, thereby confirming the effectiveness of short-term colchicine use for the POAF prevention after coronary artery bypass grafting and/or aortic valve replacement. Also, we detected statistically significant differences between groups in the frequency of side effects to colchicine: diarrhea and abdominal pain were more common in the colchicine group. This clinical trial is registered with ClinicalTrials database under a unique identifier: NCT04224545. MDPI 2022-10-20 /pmc/articles/PMC9604685/ /pubmed/36286314 http://dx.doi.org/10.3390/jcdd9100363 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Shvartz, Vladimir
Le, Tatyana
Enginoev, Soslan
Sokolskaya, Maria
Ispiryan, Artak
Shvartz, Elena
Nudel, Daria
Araslanova, Naylyana
Petrosyan, Andrey
Donakanyan, Sergey
Chernov, Igor
Bockeria, Leo
Golukhova, Elena
Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial
title Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial
title_full Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial
title_fullStr Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial
title_full_unstemmed Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial
title_short Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial
title_sort colchicine in cardiac surgery: the cocs randomized clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9604685/
https://www.ncbi.nlm.nih.gov/pubmed/36286314
http://dx.doi.org/10.3390/jcdd9100363
work_keys_str_mv AT shvartzvladimir colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT letatyana colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT enginoevsoslan colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT sokolskayamaria colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT ispiryanartak colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT shvartzelena colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT nudeldaria colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT araslanovanaylyana colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT petrosyanandrey colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT donakanyansergey colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT chernovigor colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT bockerialeo colchicineincardiacsurgerythecocsrandomizedclinicaltrial
AT golukhovaelena colchicineincardiacsurgerythecocsrandomizedclinicaltrial