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• W2019912928 abstract "We recognise the controversy involving aspirin use in patients with heart failure, especially when given as a primary prophylaxis for cardiovascular events. In the CHAMPION trial, however, the use of aspirin was not significantly different at 6 months than at randomisation and implantation or between the treatment and control groups. At the time of implantation, 67% of the 550 patients were on aspirin (182 [67%] in the treatment group and 187 [67%] in the control group) and 72% were on the drug at 6-months' follow-up (195 [72%] treatment, 206 [74%] control). All-cause mortality in the CHAMPION trial was 6·4% at 6 months, which is similar to that of other trials involving patients with New York Heart Association class III heart failure, such as the BEST trial1The Beta-Blocker Evaluation of Survival Trial InvestigatorsA trial of the beta-blocker bucindolol in patients with advanced chronic heart failure.N Engl J Med. 2001; 344: 1659-1667Crossref PubMed Scopus (974) Google Scholar in which mortality at 6 months averaged 7·5%. We therefore conclude that aspirin use in this trial had no discernible effect on the primary efficacy outcome.We appreciate the concern about the single-blind design of the CHAMPION trial, but no other trial design was possible since the hypothesis being tested required investigators to have access to pressures in the treatment group. Specifically, patients were instructed that they would periodically receive contact from the investigator team during the duration of the trial. Investigators contacted treatment patients only when pressure information required intervention, and the interaction was carefully scripted to keep the patient from knowing whether the medication changes were random or based on knowledge of the pressures. There were no scheduled calls, but contact with a treatment patient generated a random call to a patient in the control group, again using a script developed by the steering committee before the trial began, designed to maintain masking.An independent committee of experts who were not aware of the patient's randomisation status adjudicated all hospital admission events. A part of the adjudication process recorded the provider responsible for referral to the emergency department or direct hospital admission. 73% (149 of 203) of the admissions came through the emergency department and non-study providers made the clinical decision for hospital admission. Direct admissions from the clinic setting occurred more frequently in the treatment group (25 of 83 events [30%]) than in the control group (29 of 120 events [24%]), which might suggest that knowledge of the pressure data could have lowered the threshold for direct hospital admission, which was also a possibility with this trial design.In summary, several attempts to control bias and maintain the patient's masked status were included in the CHAMPION trial design. We conclude that these important elements of the trial minimised the potential for spurious results.PBA and WTA, in their capacity as Co-Principal Investigators of the CHAMPION trial, received consulting fees from CardioMEMS. JY is an employee of CardioMEMS. We recognise the controversy involving aspirin use in patients with heart failure, especially when given as a primary prophylaxis for cardiovascular events. In the CHAMPION trial, however, the use of aspirin was not significantly different at 6 months than at randomisation and implantation or between the treatment and control groups. At the time of implantation, 67% of the 550 patients were on aspirin (182 [67%] in the treatment group and 187 [67%] in the control group) and 72% were on the drug at 6-months' follow-up (195 [72%] treatment, 206 [74%] control). All-cause mortality in the CHAMPION trial was 6·4% at 6 months, which is similar to that of other trials involving patients with New York Heart Association class III heart failure, such as the BEST trial1The Beta-Blocker Evaluation of Survival Trial InvestigatorsA trial of the beta-blocker bucindolol in patients with advanced chronic heart failure.N Engl J Med. 2001; 344: 1659-1667Crossref PubMed Scopus (974) Google Scholar in which mortality at 6 months averaged 7·5%. We therefore conclude that aspirin use in this trial had no discernible effect on the primary efficacy outcome. We appreciate the concern about the single-blind design of the CHAMPION trial, but no other trial design was possible since the hypothesis being tested required investigators to have access to pressures in the treatment group. Specifically, patients were instructed that they would periodically receive contact from the investigator team during the duration of the trial. Investigators contacted treatment patients only when pressure information required intervention, and the interaction was carefully scripted to keep the patient from knowing whether the medication changes were random or based on knowledge of the pressures. There were no scheduled calls, but contact with a treatment patient generated a random call to a patient in the control group, again using a script developed by the steering committee before the trial began, designed to maintain masking. An independent committee of experts who were not aware of the patient's randomisation status adjudicated all hospital admission events. A part of the adjudication process recorded the provider responsible for referral to the emergency department or direct hospital admission. 73% (149 of 203) of the admissions came through the emergency department and non-study providers made the clinical decision for hospital admission. Direct admissions from the clinic setting occurred more frequently in the treatment group (25 of 83 events [30%]) than in the control group (29 of 120 events [24%]), which might suggest that knowledge of the pressure data could have lowered the threshold for direct hospital admission, which was also a possibility with this trial design. In summary, several attempts to control bias and maintain the patient's masked status were included in the CHAMPION trial design. We conclude that these important elements of the trial minimised the potential for spurious results. PBA and WTA, in their capacity as Co-Principal Investigators of the CHAMPION trial, received consulting fees from CardioMEMS. JY is an employee of CardioMEMS. Wireless pulmonary artery haemodynamic monitoringGiven the huge effect of heart failure on health care, William Abraham and colleagues' finding of a 39% reduction in hospital admissions for patients with New York Heart Association class III heart failure managed with a wireless implantable haemodynamic monitoring system (Feb 19, p 658)1 is very important. Full-Text PDF Wireless pulmonary artery haemodynamic monitoringIn the CHAMPION study,1 William Abraham and colleagues assessed a wireless pulmonary artery monitoring system in patients with heart failure. The study shows a very impressive decrease in 6-month hospital admission rates. Full-Text PDF" @default.
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• W2019912928 title "Wireless pulmonary artery haemodynamic monitoring – Authors' reply" @default.
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