Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation The COPPS-2 Randomized Clinical Trial
2014
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Аутори
Imazio, MassimoBrucato, Antonio
Ferrazzi, Paolo
Pullara, Alberto
Adler, Yehuda
Barosi, Alberto
Caforio, Alida L.
Cemin, Roberto
Chirillo, Fabio
Comoglio, Chiara
Cugola, Diego
Cumetti, Davide
Dyrda, Oleksandr
Ferrua, Stefania
Finkelstein, Yaron
Flocco, Roberto
Gandino, Anna
Hoit, Brian
Innocente, Francesco
Maestroni, Silvia
Musumeci, Francesco
Oh, Jae
Pergolini, Amedeo
Polizzi, Vincenzo
Ristic, Arsen
Simon, Caterina
Spodick, David H.
Tarzia, Vincenzo
Trimboli, Stefania
Valenti, Anna
Belli, Riccardo
Gaita, Fiorenzo
COPPS-2 Investigators
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
IMPORTANCE Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS Patients ...were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients GT = 70 kg or 0.5mg once daily in patients LT 70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES Occurrence of postpericardiotorny syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, -2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, -8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting.
Извор:
Journal of the American Medical Association / JAMA, 2014, 312, 10, 1016-1023Финансирање / пројекти:
- (ASLTO2) within the Italian National Health Service, Acarpia (Madeira, Portugal), FARGIM (Catania, Italy)
DOI: 10.1001/jama.2014.11026
ISSN: 0098-7484; 1538-3598
PubMed: 25172965
WoS: 000341385600019
Scopus: 2-s2.0-84907008557
Колекције
Институција/група
VinčaTY - JOUR AU - Imazio, Massimo AU - Brucato, Antonio AU - Ferrazzi, Paolo AU - Pullara, Alberto AU - Adler, Yehuda AU - Barosi, Alberto AU - Caforio, Alida L. AU - Cemin, Roberto AU - Chirillo, Fabio AU - Comoglio, Chiara AU - Cugola, Diego AU - Cumetti, Davide AU - Dyrda, Oleksandr AU - Ferrua, Stefania AU - Finkelstein, Yaron AU - Flocco, Roberto AU - Gandino, Anna AU - Hoit, Brian AU - Innocente, Francesco AU - Maestroni, Silvia AU - Musumeci, Francesco AU - Oh, Jae AU - Pergolini, Amedeo AU - Polizzi, Vincenzo AU - Ristic, Arsen AU - Simon, Caterina AU - Spodick, David H. AU - Tarzia, Vincenzo AU - Trimboli, Stefania AU - Valenti, Anna AU - Belli, Riccardo AU - Gaita, Fiorenzo AU - COPPS-2 Investigators PY - 2014 UR - https://vinar.vin.bg.ac.rs/handle/123456789/102 AB - IMPORTANCE Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients GT = 70 kg or 0.5mg once daily in patients LT 70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES Occurrence of postpericardiotorny syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, -2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, -8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting. T2 - Journal of the American Medical Association / JAMA T1 - Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation The COPPS-2 Randomized Clinical Trial VL - 312 IS - 10 SP - 1016 EP - 1023 DO - 10.1001/jama.2014.11026 ER -
@article{ author = "Imazio, Massimo and Brucato, Antonio and Ferrazzi, Paolo and Pullara, Alberto and Adler, Yehuda and Barosi, Alberto and Caforio, Alida L. and Cemin, Roberto and Chirillo, Fabio and Comoglio, Chiara and Cugola, Diego and Cumetti, Davide and Dyrda, Oleksandr and Ferrua, Stefania and Finkelstein, Yaron and Flocco, Roberto and Gandino, Anna and Hoit, Brian and Innocente, Francesco and Maestroni, Silvia and Musumeci, Francesco and Oh, Jae and Pergolini, Amedeo and Polizzi, Vincenzo and Ristic, Arsen and Simon, Caterina and Spodick, David H. and Tarzia, Vincenzo and Trimboli, Stefania and Valenti, Anna and Belli, Riccardo and Gaita, Fiorenzo and COPPS-2 Investigators", year = "2014", abstract = "IMPORTANCE Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients GT = 70 kg or 0.5mg once daily in patients LT 70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES Occurrence of postpericardiotorny syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, -2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, -8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting.", journal = "Journal of the American Medical Association / JAMA", title = "Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation The COPPS-2 Randomized Clinical Trial", volume = "312", number = "10", pages = "1016-1023", doi = "10.1001/jama.2014.11026" }
Imazio, M., Brucato, A., Ferrazzi, P., Pullara, A., Adler, Y., Barosi, A., Caforio, A. L., Cemin, R., Chirillo, F., Comoglio, C., Cugola, D., Cumetti, D., Dyrda, O., Ferrua, S., Finkelstein, Y., Flocco, R., Gandino, A., Hoit, B., Innocente, F., Maestroni, S., Musumeci, F., Oh, J., Pergolini, A., Polizzi, V., Ristic, A., Simon, C., Spodick, D. H., Tarzia, V., Trimboli, S., Valenti, A., Belli, R., Gaita, F.,& COPPS-2 Investigators. (2014). Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation The COPPS-2 Randomized Clinical Trial. in Journal of the American Medical Association / JAMA, 312(10), 1016-1023. https://doi.org/10.1001/jama.2014.11026
Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F, COPPS-2 Investigators. Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation The COPPS-2 Randomized Clinical Trial. in Journal of the American Medical Association / JAMA. 2014;312(10):1016-1023. doi:10.1001/jama.2014.11026 .
Imazio, Massimo, Brucato, Antonio, Ferrazzi, Paolo, Pullara, Alberto, Adler, Yehuda, Barosi, Alberto, Caforio, Alida L., Cemin, Roberto, Chirillo, Fabio, Comoglio, Chiara, Cugola, Diego, Cumetti, Davide, Dyrda, Oleksandr, Ferrua, Stefania, Finkelstein, Yaron, Flocco, Roberto, Gandino, Anna, Hoit, Brian, Innocente, Francesco, Maestroni, Silvia, Musumeci, Francesco, Oh, Jae, Pergolini, Amedeo, Polizzi, Vincenzo, Ristic, Arsen, Simon, Caterina, Spodick, David H., Tarzia, Vincenzo, Trimboli, Stefania, Valenti, Anna, Belli, Riccardo, Gaita, Fiorenzo, COPPS-2 Investigators, "Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation The COPPS-2 Randomized Clinical Trial" in Journal of the American Medical Association / JAMA, 312, no. 10 (2014):1016-1023, https://doi.org/10.1001/jama.2014.11026 . .