Open Access
Open access
Journal of Cardiovascular Development and Disease, volume 9, issue 10, pages 363

Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial

Tatyana Le 1
Soslan Enginoev 2, 3
Maria Sokolskaya 1
Artak Ispiryan 1
Daria Nudel 2
Naylyana Araslanova 2
Andrey Petrosyan 1
Sergey Donakanyan 1
Igor Chernov 2
Leo Bockeria 1
Elena Golukhova 1
1
 
Bakulev Scientific Center for Cardiovascular Surgery, 121552 Moscow, Russia
2
 
Federal Center for Cardiovascular Surgery of the Russian Federation Ministry of Healthcare (Astrakhan), 414011 Astrakhan, Russia
4
 
National Medical Research Center for Therapy and Preventive Medicine, 101990 Moscow, Russia
Publication typeJournal Article
Publication date2022-10-20
scimago Q1
wos Q2
SJR0.621
CiteScore2.6
Impact factor2.4
ISSN23083425
Pharmacology (medical)
General Pharmacology, Toxicology and Pharmaceutics
Abstract

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.

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GOST |
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GOST Copy
Shvartz V. A. et al. Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial // Journal of Cardiovascular Development and Disease. 2022. Vol. 9. No. 10. p. 363.
GOST all authors (up to 50) Copy
Shvartz V. A., Le T., Enginoev S., Sokolskaya M., Ispiryan A., Shvartz E., Nudel D., Araslanova N., Petrosyan A., Donakanyan S., Chernov I., Bockeria L., Golukhova E. Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial // Journal of Cardiovascular Development and Disease. 2022. Vol. 9. No. 10. p. 363.
RIS |
Cite this
RIS Copy
TY - JOUR
DO - 10.3390/jcdd9100363
UR - https://doi.org/10.3390/jcdd9100363
TI - Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial
T2 - Journal of Cardiovascular Development and Disease
AU - Shvartz, Vladimir A.
AU - Le, Tatyana
AU - Enginoev, Soslan
AU - Sokolskaya, Maria
AU - Ispiryan, Artak
AU - Shvartz, Elena
AU - Nudel, Daria
AU - Araslanova, Naylyana
AU - Petrosyan, Andrey
AU - Donakanyan, Sergey
AU - Chernov, Igor
AU - Bockeria, Leo
AU - Golukhova, Elena
PY - 2022
DA - 2022/10/20
PB - MDPI
SP - 363
IS - 10
VL - 9
SN - 2308-3425
ER -
BibTex |
Cite this
BibTex (up to 50 authors) Copy
@article{2022_Shvartz,
author = {Vladimir A. Shvartz and Tatyana Le and Soslan Enginoev and Maria Sokolskaya and Artak Ispiryan and Elena Shvartz and Daria Nudel and Naylyana Araslanova and Andrey Petrosyan and Sergey Donakanyan and Igor Chernov and Leo Bockeria and Elena Golukhova},
title = {Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial},
journal = {Journal of Cardiovascular Development and Disease},
year = {2022},
volume = {9},
publisher = {MDPI},
month = {oct},
url = {https://doi.org/10.3390/jcdd9100363},
number = {10},
pages = {363},
doi = {10.3390/jcdd9100363}
}
MLA
Cite this
MLA Copy
Shvartz, Vladimir A., et al. “Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial.” Journal of Cardiovascular Development and Disease, vol. 9, no. 10, Oct. 2022, p. 363. https://doi.org/10.3390/jcdd9100363.
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