IRIS UniCatt

Background: Higher levels of inflammatory biomarkers are associated with an increased risk of perioperative atrial fibrillation and myocardial injury after non-cardiac surgery (MINS). Colchicine is an anti-inflammatory drug that might reduce the incidence of these complications. Methods: COP-AF was a randomised trial conducted at 45 sites in 11 countries. Patients aged 55 years or older and undergoing major non-cardiac thoracic surgery were randomly assigned (1:1) to receive oral colchicine 0·5 mg twice daily or matching placebo, starting within 4 h before surgery and continuing for 10 days. Randomisation was done with use of a computerised, web-based system, and was stratified by centre. Health-care providers, patients, data collectors, and adjudicators were masked to treatment assignment. The coprimary outcomes were clinically important perioperative atrial fibrillation and MINS during 14 days of follow-up. The main safety outcomes were a composite of sepsis or infection, and non-infectious diarrhoea. The intention-to-treat principle was used for all analyses. This trial is registered with ClinicalTrials.gov, NCT03310125. Findings: Between Feb 14, 2018, and June 27, 2023, we enrolled 3209 patients (mean age 68 years [SD 7], 1656 [51·6%] male). Clinically important atrial fibrillation occurred in 103 (6·4%) of 1608 patients assigned to colchicine, and 120 (7·5%) of 1601 patients assigned to placebo (hazard ratio [HR] 0·85, 95% CI 0·65 to 1·10; absolute risk reduction [ARR] 1·1%, 95% CI –0·7 to 2·8; p=0·22). MINS occurred in 295 (18·3%) patients assigned to colchicine and 325 (20·3%) patients assigned to placebo (HR 0·89, 0·76 to 1·05; ARR 2·0%, –0·8 to 4·7; p=0·16). The composite outcome of sepsis or infection occurred in 103 (6·4%) patients in the colchicine group and 83 (5·2%) patients in the placebo group (HR 1·24, 0·93–1·66). Non-infectious diarrhoea was more common in the colchicine group (134 [8·3%] events) than the placebo group (38 [2·4%]; HR 3·64, 2·54–5·22). Interpretation: In patients undergoing major non-cardiac thoracic surgery, administration of colchicine did not significantly reduce the incidence of clinically important atrial fibrillation or MINS but increased the risk of mostly benign non-infectious diarrhoea. Funding: Canadian Institutes of Health Research, Accelerating Clinical Trials Consortium, Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario, Population Health Research Institute, Hamilton Health Sciences, Division of Cardiology at McMaster University, Canada; Hanela Foundation, Switzerland; and General Research Fund, Research Grants Council, Hong Kong.

David, C., Michael, K. W., Ekaterine, P., Matthew T V, C., Giovanni, L., Juan P, C., Cara, R., Sean R, M., Sadeesh K, S., Juan Carlos Trujillo, R., Ascension Martín, G., Anna Gonzalez, T., Daniel I, S., Edith, F., Barbara, K., Luca, V., Patrícia, C., Donna E, M., Laura, G., William F, M., Vikas, T., Elisabeth, M., Juan Jose, G., Deborah, D., Randolph H L, W., Anna L, M., Biniam, K., Diego Parise, R., Yaron, S., Jennifer R, W., Sandra N, O., Jessica, V., Lizhen, X., Zhuoru, L., John W, E., Sanjit S, J., Jeff S, H., P J, D., Conen, D., Devereaux, P., Vincent, J., Ke Wang, M., Wells, J. R., Healey, J. S., Landoni, G., Mcintyre, W. F., Popova, E., Sessler, D. I., Srinathan, S. K., Amir, M., Bangdiwala, S. I., Bossard, M., Tv Chan, M., Eikelboom, J. W., Fleischmann, E., Jolly, S., Ramón Montes, F., Reimer, C., Schmartz, D., Yin Wang, C., Ofori, S. N., Blum, S., Alvarez-Garcia, J., Lo Bianco, G., Traquair, H., Andres Guerrero-Pinedo, F., Oleynick, C., Meyre, P. B., Méndez-Zurita, F., Chiarella-Redfern, H., Marcucci, M., Donati, F., Gonzalez-Osuna, A., Minervini, F., Moreno Weidmann, Z., Guerra-Ramos, J. M., Dion, G., Ramos-Pachón, A., Borges, F. K., De Sa Boasquevisque, D., Giulia Mosconi, M., Amarenco, P., Brent Mitchell, L., Wyse, G., Cheng, D., Mcalister, F. A., Wells, G. A., Baskaran, G., Burns, A. T., Gennaccaro, J., Howe, R., Mastrangelo, L., Pettit, S., Popovic, M., Shahbaz, S., Tosh, M., Zucchetto, S. J., Heenan, L., Fu Lee, S., Li, Z., Xu, L., Kabon, B., Hoetzenecker, K., Schweiger, T., Reiterer, C., Zotti, O., Bsuchner, P., Hochreiter, B., Taschner, A., Adamowitsch, N., Horvath, K., Hantáková, N., Bidgoli, J., Huybrechts, I., Cappeliez, S., Neary, J. D., Shargall, Y., Tandon, V., Finley, C., Agzarian, J., Hanna, W., Abdulrahman, M., Lawrence, K., Gregus, K., Quraishi, F., Wikkerink, S., Wallace, C., Prine, M., Gregus, E., Hare, J., Lombardo, K., Fezia, B., Columbus, T., Rushton, J., Dumerton, D., Reid, K., Parlow, J., Chung, W., Karizhenskaia, M., Malik, A., Tanzola, R., Giles, A., Mclean, S. R., Mcguire, A., Lohser, J., Lim, S., Grey, R., Yee, J., Grant, K., Lee, A. L., Choi, J. J., Dewar, L. R., Durkin, C., Schisler, T., Hecht, P., Hughes, B., Kidane, B., Liu, R., Tan, L., Gowing, S., Buduhan, G., Enns, S., Poole, E., Graham, K., Dubik, N., Chin, A., Maziak, D. E., Je Seely, A., Gilbert, S., James Villeneuve, P., Sundaresan, S., Gingrich, M., Fazekas, A., Bucciero, K., Malthaner, R. A., Lewis, D., Fortin, D., Qiabi, M., Nayak, R., Marie Plourde, M., Haider, T., Murphy, R., Sellers, D., Donahoe, L., Lefebvre, M., Lanthier, L., Augustine Ko, M., Parente, D., Cheung, V., Schieman, C., Bessissow, A., Hl Wong, R., Joynt, G. M., Km Lam, C., Wh Lau, R., Yp Wan, I., Underwood, M. J., Kk Wu, W., Tat Wong, W., Ys Choi, G., Lee, E., Yan Hui, K., Fung, B., Sam Chan, C., Kei Ng, F., Hoi Thung, K., Gutiérrez-Soriano, L., Carmenza Castañeda, L., Jaime Téllez, L., Marcela Ortiz-Ramirez, L., Baiardo-Redaelli, M., Belletti, A., Dieci, E., Monaco, F., Muriana, P., Nakhnoukh, C., Novellis, P., Turi, S., Viscardi, S., Veronesi, G., Voltolini, L., Bongiolatti, S., Salvicchi, A., Gatteschi, L., Indino, R., Tombelli, S., Ravasin, A., Salimbene, O., Luca Rosboch, G., Balzani, E., Ceraolo, E., Neitzert, L., Brazzi, L., Londero, F., Grossi, W., Massullo, D., Fiorelli, S., Margaritora, S., Amry Hashim, S., Krishnasamy, S., Shiang See, W., Asghar Nawaz, M., Bilal, H., Carlos Trujillo Reyes, J., Martínez-Téllez, E., Belda Sanchis, J., Planas Canovas, G., Libreros Niño, A., Parera Ruiz, A., Cladellas Gutierrez, E., Guarino, M., Urrutia Cuchi, G., Argilaga Nogues, M., Rovira Juan, A., Medina-Aedo, M., Asunción Turró Castillejo, M., Mª Gil Sanchez, J., Araúz-Sarmiento, I., Herranz Perez, G., Chavarria Murillo, S., Garcia-Osuna, A., Rodriguez-Arias, A., Berga Garrote, N., Martín Grande, A., Parise Roux, D., Gajate Martín, L., De Pablo Pajares, A., Manuel Candela Toha, A., Moreno Mata, N., Muñoz Molina, G., Caballero Silva, U., Cabañero, A., Fra Fernandez, S., Cavestany García-Matres, C., Simón, L., Montenegro, C., Pozo, S., Gonzàlez-Tallada, A., González Suarez, S., Ribas Ball, M., De Nadal Clanchet, M., Pérez Vélez, J., Cruz, P., Sánchez-Pedrosa, G., Duque, P., González, G., Huerta, L., Rodríguez, L., Garutti, I., Ruiz-Villa, L., Del Mar Martí-Ejarque, M., Gili-Bueno, M., Matias Maddio Vieyra, R., Fibla, J. J., Durán, N., De Temple Pla, M., Rodríguez-Fuster, A., Bermejo-Martínez, S., Carramiñana, A., Opitz, I., Etienne, H., Cata, J. P., Jose Guerra-Londono, J., Rajaram, R., Corrales, G., Vaporciyan, A., Mehran, R., Sepesi, B., Walsh, G., Rice, D., Cukierman, D. S., Swisher, S., Marchant, B. E., Harris, L. C., Cusson, B. D., Miller, S. A., Ayad, S., Araujo, J., Marquez-Roa, L., Hofstra, R. L., Wudel, L. J., R., J., Minear, S. C., Teixeira, C., Pimentel, M., Popoff, A. M., Marsack, K., Meehan, S., Chen, T. H., Essandoh, M., Poppers, J. S., Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial, <<THE LANCET>>, 2023; 402 (10413): 1627-1635. [doi:10.1016/S0140-6736(23)01689-6] [https://hdl.handle.net/10807/302138]

Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial

Margaritora, Stefano;
2023

Abstract

Background: Higher levels of inflammatory biomarkers are associated with an increased risk of perioperative atrial fibrillation and myocardial injury after non-cardiac surgery (MINS). Colchicine is an anti-inflammatory drug that might reduce the incidence of these complications. Methods: COP-AF was a randomised trial conducted at 45 sites in 11 countries. Patients aged 55 years or older and undergoing major non-cardiac thoracic surgery were randomly assigned (1:1) to receive oral colchicine 0·5 mg twice daily or matching placebo, starting within 4 h before surgery and continuing for 10 days. Randomisation was done with use of a computerised, web-based system, and was stratified by centre. Health-care providers, patients, data collectors, and adjudicators were masked to treatment assignment. The coprimary outcomes were clinically important perioperative atrial fibrillation and MINS during 14 days of follow-up. The main safety outcomes were a composite of sepsis or infection, and non-infectious diarrhoea. The intention-to-treat principle was used for all analyses. This trial is registered with ClinicalTrials.gov, NCT03310125. Findings: Between Feb 14, 2018, and June 27, 2023, we enrolled 3209 patients (mean age 68 years [SD 7], 1656 [51·6%] male). Clinically important atrial fibrillation occurred in 103 (6·4%) of 1608 patients assigned to colchicine, and 120 (7·5%) of 1601 patients assigned to placebo (hazard ratio [HR] 0·85, 95% CI 0·65 to 1·10; absolute risk reduction [ARR] 1·1%, 95% CI –0·7 to 2·8; p=0·22). MINS occurred in 295 (18·3%) patients assigned to colchicine and 325 (20·3%) patients assigned to placebo (HR 0·89, 0·76 to 1·05; ARR 2·0%, –0·8 to 4·7; p=0·16). The composite outcome of sepsis or infection occurred in 103 (6·4%) patients in the colchicine group and 83 (5·2%) patients in the placebo group (HR 1·24, 0·93–1·66). Non-infectious diarrhoea was more common in the colchicine group (134 [8·3%] events) than the placebo group (38 [2·4%]; HR 3·64, 2·54–5·22). Interpretation: In patients undergoing major non-cardiac thoracic surgery, administration of colchicine did not significantly reduce the incidence of clinically important atrial fibrillation or MINS but increased the risk of mostly benign non-infectious diarrhoea. Funding: Canadian Institutes of Health Research, Accelerating Clinical Trials Consortium, Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario, Population Health Research Institute, Hamilton Health Sciences, Division of Cardiology at McMaster University, Canada; Hanela Foundation, Switzerland; and General Research Fund, Research Grants Council, Hong Kong.
2023
Inglese
THE LANCET
David, C., Michael, K. W., Ekaterine, P., Matthew T V, C., Giovanni, L., Juan P, C., Cara, R., Sean R, M., Sadeesh K, S., Juan Carlos Trujillo, R., Ascension Martín, G., Anna Gonzalez, T., Daniel I, S., Edith, F., Barbara, K., Luca, V., Patrícia, C., Donna E, M., Laura, G., William F, M., Vikas, T., Elisabeth, M., Juan Jose, G., Deborah, D., Randolph H L, W., Anna L, M., Biniam, K., Diego Parise, R., Yaron, S., Jennifer R, W., Sandra N, O., Jessica, V., Lizhen, X., Zhuoru, L., John W, E., Sanjit S, J., Jeff S, H., P J, D., Conen, D., Devereaux, P., Vincent, J., Ke Wang, M., Wells, J. R., Healey, J. S., Landoni, G., Mcintyre, W. F., Popova, E., Sessler, D. I., Srinathan, S. K., Amir, M., Bangdiwala, S. I., Bossard, M., Tv Chan, M., Eikelboom, J. W., Fleischmann, E., Jolly, S., Ramón Montes, F., Reimer, C., Schmartz, D., Yin Wang, C., Ofori, S. N., Blum, S., Alvarez-Garcia, J., Lo Bianco, G., Traquair, H., Andres Guerrero-Pinedo, F., Oleynick, C., Meyre, P. B., Méndez-Zurita, F., Chiarella-Redfern, H., Marcucci, M., Donati, F., Gonzalez-Osuna, A., Minervini, F., Moreno Weidmann, Z., Guerra-Ramos, J. M., Dion, G., Ramos-Pachón, A., Borges, F. K., De Sa Boasquevisque, D., Giulia Mosconi, M., Amarenco, P., Brent Mitchell, L., Wyse, G., Cheng, D., Mcalister, F. A., Wells, G. A., Baskaran, G., Burns, A. T., Gennaccaro, J., Howe, R., Mastrangelo, L., Pettit, S., Popovic, M., Shahbaz, S., Tosh, M., Zucchetto, S. J., Heenan, L., Fu Lee, S., Li, Z., Xu, L., Kabon, B., Hoetzenecker, K., Schweiger, T., Reiterer, C., Zotti, O., Bsuchner, P., Hochreiter, B., Taschner, A., Adamowitsch, N., Horvath, K., Hantáková, N., Bidgoli, J., Huybrechts, I., Cappeliez, S., Neary, J. D., Shargall, Y., Tandon, V., Finley, C., Agzarian, J., Hanna, W., Abdulrahman, M., Lawrence, K., Gregus, K., Quraishi, F., Wikkerink, S., Wallace, C., Prine, M., Gregus, E., Hare, J., Lombardo, K., Fezia, B., Columbus, T., Rushton, J., Dumerton, D., Reid, K., Parlow, J., Chung, W., Karizhenskaia, M., Malik, A., Tanzola, R., Giles, A., Mclean, S. R., Mcguire, A., Lohser, J., Lim, S., Grey, R., Yee, J., Grant, K., Lee, A. L., Choi, J. J., Dewar, L. R., Durkin, C., Schisler, T., Hecht, P., Hughes, B., Kidane, B., Liu, R., Tan, L., Gowing, S., Buduhan, G., Enns, S., Poole, E., Graham, K., Dubik, N., Chin, A., Maziak, D. E., Je Seely, A., Gilbert, S., James Villeneuve, P., Sundaresan, S., Gingrich, M., Fazekas, A., Bucciero, K., Malthaner, R. A., Lewis, D., Fortin, D., Qiabi, M., Nayak, R., Marie Plourde, M., Haider, T., Murphy, R., Sellers, D., Donahoe, L., Lefebvre, M., Lanthier, L., Augustine Ko, M., Parente, D., Cheung, V., Schieman, C., Bessissow, A., Hl Wong, R., Joynt, G. M., Km Lam, C., Wh Lau, R., Yp Wan, I., Underwood, M. J., Kk Wu, W., Tat Wong, W., Ys Choi, G., Lee, E., Yan Hui, K., Fung, B., Sam Chan, C., Kei Ng, F., Hoi Thung, K., Gutiérrez-Soriano, L., Carmenza Castañeda, L., Jaime Téllez, L., Marcela Ortiz-Ramirez, L., Baiardo-Redaelli, M., Belletti, A., Dieci, E., Monaco, F., Muriana, P., Nakhnoukh, C., Novellis, P., Turi, S., Viscardi, S., Veronesi, G., Voltolini, L., Bongiolatti, S., Salvicchi, A., Gatteschi, L., Indino, R., Tombelli, S., Ravasin, A., Salimbene, O., Luca Rosboch, G., Balzani, E., Ceraolo, E., Neitzert, L., Brazzi, L., Londero, F., Grossi, W., Massullo, D., Fiorelli, S., Margaritora, S., Amry Hashim, S., Krishnasamy, S., Shiang See, W., Asghar Nawaz, M., Bilal, H., Carlos Trujillo Reyes, J., Martínez-Téllez, E., Belda Sanchis, J., Planas Canovas, G., Libreros Niño, A., Parera Ruiz, A., Cladellas Gutierrez, E., Guarino, M., Urrutia Cuchi, G., Argilaga Nogues, M., Rovira Juan, A., Medina-Aedo, M., Asunción Turró Castillejo, M., Mª Gil Sanchez, J., Araúz-Sarmiento, I., Herranz Perez, G., Chavarria Murillo, S., Garcia-Osuna, A., Rodriguez-Arias, A., Berga Garrote, N., Martín Grande, A., Parise Roux, D., Gajate Martín, L., De Pablo Pajares, A., Manuel Candela Toha, A., Moreno Mata, N., Muñoz Molina, G., Caballero Silva, U., Cabañero, A., Fra Fernandez, S., Cavestany García-Matres, C., Simón, L., Montenegro, C., Pozo, S., Gonzàlez-Tallada, A., González Suarez, S., Ribas Ball, M., De Nadal Clanchet, M., Pérez Vélez, J., Cruz, P., Sánchez-Pedrosa, G., Duque, P., González, G., Huerta, L., Rodríguez, L., Garutti, I., Ruiz-Villa, L., Del Mar Martí-Ejarque, M., Gili-Bueno, M., Matias Maddio Vieyra, R., Fibla, J. J., Durán, N., De Temple Pla, M., Rodríguez-Fuster, A., Bermejo-Martínez, S., Carramiñana, A., Opitz, I., Etienne, H., Cata, J. P., Jose Guerra-Londono, J., Rajaram, R., Corrales, G., Vaporciyan, A., Mehran, R., Sepesi, B., Walsh, G., Rice, D., Cukierman, D. S., Swisher, S., Marchant, B. E., Harris, L. C., Cusson, B. D., Miller, S. A., Ayad, S., Araujo, J., Marquez-Roa, L., Hofstra, R. L., Wudel, L. J., R., J., Minear, S. C., Teixeira, C., Pimentel, M., Popoff, A. M., Marsack, K., Meehan, S., Chen, T. H., Essandoh, M., Poppers, J. S., Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial, <<THE LANCET>>, 2023; 402 (10413): 1627-1635. [doi:10.1016/S0140-6736(23)01689-6] [https://hdl.handle.net/10807/302138]
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