The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Massimo Imazio - One of the best experts on this subject based on the ideXlab platform.
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colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation the copps 2 randomized clinical trial
JAMA, 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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.
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Colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation : the COPPS-2 randomized clinical trial
'American Medical Association (AMA)', 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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 6570 kg or 0.5 mg once daily in patients
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rationale and design of the colchicine for prevention of the post pericardiotomy Syndrome and post operative atrial fibrillation copps 2 trial a randomized placebo controlled multicenter study on the use of colchicine for the primary prevention of the Postpericardiotomy Syndrome postoperative effusions and postoperative atrial fibrillation
American Heart Journal, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, R. Belli, Davide Patrini, Luigi Martinelli, Vincenzo Polizzi, Anna Leggieri, A.l. CaforioAbstract:Background The efficacy and safety of colchicine for the primary prevention of the Postpericardiotomy Syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
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Postpericardiotomy Syndrome a proposal for diagnostic criteria
Journal of Cardiovascular Medicine, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, David H Spodick, Y. AdlerAbstract:The post-pericardiotomy Syndrome (PPS) affects 10–40% of patients after cardiac surgery, depending on the adopted diagnostic criteria, institution and type of surgery. On this basis, there is a need for standardized criteria for epidemiological and clinical purposes, which we propose on the basis of
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the post pericardiotomy Syndrome
Current Opinion in Pulmonary Medicine, 2012Co-Authors: Massimo ImazioAbstract:Purpose of reviewThe Postpericardiotomy Syndrome (PPS) is a relatively common complication following cardiac surgery, whose epidemiology is not well known because there are no standardized definitions. The aim of the present study is to review more recent updates on the diagnosis, therapy, prognosis
A. Brucato - One of the best experts on this subject based on the ideXlab platform.
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colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation the copps 2 randomized clinical trial
JAMA, 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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.
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Colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation : the COPPS-2 randomized clinical trial
'American Medical Association (AMA)', 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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 6570 kg or 0.5 mg once daily in patients
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rationale and design of the colchicine for prevention of the post pericardiotomy Syndrome and post operative atrial fibrillation copps 2 trial a randomized placebo controlled multicenter study on the use of colchicine for the primary prevention of the Postpericardiotomy Syndrome postoperative effusions and postoperative atrial fibrillation
American Heart Journal, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, R. Belli, Davide Patrini, Luigi Martinelli, Vincenzo Polizzi, Anna Leggieri, A.l. CaforioAbstract:Background The efficacy and safety of colchicine for the primary prevention of the Postpericardiotomy Syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
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Postpericardiotomy Syndrome a proposal for diagnostic criteria
Journal of Cardiovascular Medicine, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, David H Spodick, Y. AdlerAbstract:The post-pericardiotomy Syndrome (PPS) affects 10–40% of patients after cardiac surgery, depending on the adopted diagnostic criteria, institution and type of surgery. On this basis, there is a need for standardized criteria for epidemiological and clinical purposes, which we propose on the basis of
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colchicine reduces postoperative atrial fibrillation results of the colchicine for the prevention of the Postpericardiotomy Syndrome copps atrial fibrillation substudy
Circulation, 2011Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, M.e. Rovere, A. Gandino, S. Ferrua, R. Belli, S. Maestroni, C. SimonAbstract:Background—Inflammation and pericarditis may be contributing factors for postoperative atrial fibrillation (POAF), and both are potentially affected by antiinflammatory drugs and colchicine, which has been shown to be safe and efficacious for the prevention of pericarditis and the Postpericardiotomy Syndrome (PPS). The aim of the Colchicine for the Prevention of the Post-Pericardiotomy Syndrome (COPPS) POAF substudy was to test the efficacy and safety of colchicine for the prevention of POAF after cardiac surgery. Methods and Results—The COPPS POAF substudy included 336 patients (mean age, 65.7±12.3 years; 69% male) of the COPPS trial, a multicenter, double-blind, randomized trial. Substudy patients were in sinus rhythm before starting the intervention (placebo/colchicine 1.0 mg twice daily starting on postoperative day 3 followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, halved doses for patients <70 kg or intolerant to the highest dose). The substudy primary end point w...
R. Cemin - One of the best experts on this subject based on the ideXlab platform.
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colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation the copps 2 randomized clinical trial
JAMA, 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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.
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Colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation : the COPPS-2 randomized clinical trial
'American Medical Association (AMA)', 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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 6570 kg or 0.5 mg once daily in patients
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rationale and design of the colchicine for prevention of the post pericardiotomy Syndrome and post operative atrial fibrillation copps 2 trial a randomized placebo controlled multicenter study on the use of colchicine for the primary prevention of the Postpericardiotomy Syndrome postoperative effusions and postoperative atrial fibrillation
American Heart Journal, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, R. Belli, Davide Patrini, Luigi Martinelli, Vincenzo Polizzi, Anna Leggieri, A.l. CaforioAbstract:Background The efficacy and safety of colchicine for the primary prevention of the Postpericardiotomy Syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
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colchicine reduces postoperative atrial fibrillation results of the colchicine for the prevention of the Postpericardiotomy Syndrome copps atrial fibrillation substudy
Circulation, 2011Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, M.e. Rovere, A. Gandino, S. Ferrua, R. Belli, S. Maestroni, C. SimonAbstract:Background—Inflammation and pericarditis may be contributing factors for postoperative atrial fibrillation (POAF), and both are potentially affected by antiinflammatory drugs and colchicine, which has been shown to be safe and efficacious for the prevention of pericarditis and the Postpericardiotomy Syndrome (PPS). The aim of the Colchicine for the Prevention of the Post-Pericardiotomy Syndrome (COPPS) POAF substudy was to test the efficacy and safety of colchicine for the prevention of POAF after cardiac surgery. Methods and Results—The COPPS POAF substudy included 336 patients (mean age, 65.7±12.3 years; 69% male) of the COPPS trial, a multicenter, double-blind, randomized trial. Substudy patients were in sinus rhythm before starting the intervention (placebo/colchicine 1.0 mg twice daily starting on postoperative day 3 followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, halved doses for patients <70 kg or intolerant to the highest dose). The substudy primary end point w...
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meta analysis of randomized trials focusing on prevention of the Postpericardiotomy Syndrome
American Journal of Cardiology, 2011Co-Authors: Massimo Imazio, A. Brucato, R. Cemin, Rita Trinchero, Gal Markel, David H Spodick, Y. AdlerAbstract:The natural history of Postpericardiotomy Syndrome (PPS), a relatively common complication of cardiac surgery, varies from mild self-limited episodes to cases with protracted courses, recurrences, and readmissions. Preventive strategies may be valuable to decrease morbidity and management costs. We thus aimed to conduct a comprehensive systematic review on available data for pharmacologic primary prevention of PPS. Controlled clinical studies were searched in several databases and were included provided they focused on pharmacologic primary prevention of PPS. Random-effect odds ratios (ORs) were computed for occurrence of PPS. From the initial sample of 343 citations, 4 controlled clinical trials for primary prevention of PPS were finally included (894 patients); 3 studies were double-blind randomized controlled trials (RCTs). Treatment comparisons were colchicine versus placebo (2 RCTs enrolling 471 patients), methylprednisolone versus placebo (1 RCT on 246 pediatric patients), and aspirin versus historical controls (1 nonrandomized study on 177 pediatric patients). Meta-analytic pooling showed that colchicine was associated with decreased risk of PPS (OR 0.38, 0.22 to 0.65). Data on methylprednisolone (OR 1.13, 0.57 to 2.25) or aspirin (OR 1.00, 0.16 to 6.11) were negative but inconclusive because these were based on 1 study and/or a nonrandomized design. In conclusion, clinical evidence for primary prevention of PPS is still limited to few studies of variable quality. Nevertheless, available data suggest a beneficial profile for colchicine and open a new therapeutic strategy for prevention of PPS.
P. Ferrazzi - One of the best experts on this subject based on the ideXlab platform.
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colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation the copps 2 randomized clinical trial
JAMA, 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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.
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Colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation : the COPPS-2 randomized clinical trial
'American Medical Association (AMA)', 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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 6570 kg or 0.5 mg once daily in patients
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rationale and design of the colchicine for prevention of the post pericardiotomy Syndrome and post operative atrial fibrillation copps 2 trial a randomized placebo controlled multicenter study on the use of colchicine for the primary prevention of the Postpericardiotomy Syndrome postoperative effusions and postoperative atrial fibrillation
American Heart Journal, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, R. Belli, Davide Patrini, Luigi Martinelli, Vincenzo Polizzi, Anna Leggieri, A.l. CaforioAbstract:Background The efficacy and safety of colchicine for the primary prevention of the Postpericardiotomy Syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
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Postpericardiotomy Syndrome a proposal for diagnostic criteria
Journal of Cardiovascular Medicine, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, David H Spodick, Y. AdlerAbstract:The post-pericardiotomy Syndrome (PPS) affects 10–40% of patients after cardiac surgery, depending on the adopted diagnostic criteria, institution and type of surgery. On this basis, there is a need for standardized criteria for epidemiological and clinical purposes, which we propose on the basis of
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colchicine reduces postoperative atrial fibrillation results of the colchicine for the prevention of the Postpericardiotomy Syndrome copps atrial fibrillation substudy
Circulation, 2011Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, M.e. Rovere, A. Gandino, S. Ferrua, R. Belli, S. Maestroni, C. SimonAbstract:Background—Inflammation and pericarditis may be contributing factors for postoperative atrial fibrillation (POAF), and both are potentially affected by antiinflammatory drugs and colchicine, which has been shown to be safe and efficacious for the prevention of pericarditis and the Postpericardiotomy Syndrome (PPS). The aim of the Colchicine for the Prevention of the Post-Pericardiotomy Syndrome (COPPS) POAF substudy was to test the efficacy and safety of colchicine for the prevention of POAF after cardiac surgery. Methods and Results—The COPPS POAF substudy included 336 patients (mean age, 65.7±12.3 years; 69% male) of the COPPS trial, a multicenter, double-blind, randomized trial. Substudy patients were in sinus rhythm before starting the intervention (placebo/colchicine 1.0 mg twice daily starting on postoperative day 3 followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, halved doses for patients <70 kg or intolerant to the highest dose). The substudy primary end point w...
A.l. Caforio - One of the best experts on this subject based on the ideXlab platform.
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colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation the copps 2 randomized clinical trial
JAMA, 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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.
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Colchicine for prevention of Postpericardiotomy Syndrome and postoperative atrial fibrillation : the COPPS-2 randomized clinical trial
'American Medical Association (AMA)', 2014Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, A. Pullara, Y. Adler, A. Barosi, A.l. Caforio, R. Cemin, F. Chirillo, C. ComoglioAbstract: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 6570 kg or 0.5 mg once daily in patients
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rationale and design of the colchicine for prevention of the post pericardiotomy Syndrome and post operative atrial fibrillation copps 2 trial a randomized placebo controlled multicenter study on the use of colchicine for the primary prevention of the Postpericardiotomy Syndrome postoperative effusions and postoperative atrial fibrillation
American Heart Journal, 2013Co-Authors: Massimo Imazio, A. Brucato, P. Ferrazzi, R. Cemin, R. Belli, Davide Patrini, Luigi Martinelli, Vincenzo Polizzi, Anna Leggieri, A.l. CaforioAbstract:Background The efficacy and safety of colchicine for the primary prevention of the Postpericardiotomy Syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.