Jondeau G, Neuder Y, Eicher JC, et al. B-CONVINCED: Beta-blocker CONtinuation Vs. INterruption in patients with Congestive heart failure hospitalizED for a decompensation episode. European Heart Journal 2009;30:2186-92
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/19717851
Full text article: https://academic.oup.com/eurheartj/article/30/18/2186/478582
| Methods | Study design: Open-label randomized controlled non-inferiority trial with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 169 randomized
· Active deprescribing group: 78 randomized, 78 completed · Control group: 69 randomized, 69 completed Age: 72.3 ± 11.9 years Sex: 73 female, 96 male Participants with dementia: No Inclusion criteria: · Men and women · Aged 18 years or older · Received a beta-blocker therapy at a stable dosage for more than 1 month · Hospitalized for acute heart failure with pulmonary edema · Respiratory rate had to be > 24 min -1 at some point during the acute heart failure episode before or at the time of inclusion · Left ventricular ejection fraction had to be measured within the preceding 12 months and be lower than 40% Exclusion criteria: · Acute ST elevation myocardial infarction · Clinical indications for dobutamine according to the practicing physician at entry (use of phosphodiesterase inhibitor was not a contraindication) · Second or third degree atrioventricular (AV) block · Heart rate lower than 50 per minute · Up titration phase of beta-blocker therapy · Participation in another research protocol · Pregnancy Country: France Setting: Hospital – Thirty-six cardiology centers in France were invited to participate in the study, 29 participated |
| Interventions | Medicine: Beta-blocker
Withdrawal schedule: Abrupt (information from email correspondence with the author) Comparator: Continued treatment compared to withdrawn treatment |
| Outcomes | Dyspnea and general well-being
BNP plasma levels Duration of hospitalizations Re-hospitalization rate Death rate Successful deprescribing |
| Dates | Dates: October 2004 and October 2008
Follow-up duration: Three months |
| Funding sources | French Ministry of Health (Program Hospitalier de Recherche Clinique). |
| Notes | Authors stated: “Conflict of interest: none declared.”
Additional information sought, and author responsed. The information about how the medication was withdrawn was available (see above). Data on the mean systolic and diastolic heart rates at the completion of the three month follow up was not available. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | Probably done, though method not clearly explained.
“Randomization was performed through a vocal server, accessible through the phone.” |
| Allocation concealment (selection bias) | High risk | Open study |
| Blinding of participants and personnel (performance bias) | High risk | |
| Blinding of outcome assessment (detection bias) | High risk | A blinded physician assessed the outcomes, but otherwise the trial appears to have been un-blinded.
Assessment was by a blinded physician and also by the patient (un-blinded) |
| Incomplete outcome data (attrition bias) | Low risk | As-treated analysis done, and although drop-outs are reported across the study, it is not indicated to which group(s) the drop-outs were allocated. Since no patient stopped beta-blocker for a reason other than an adverse effect or a worsening of heart failure the per-protocol sample was identical to the intention-to-treat sample |
| Selective reporting (reporting bias) | Low risk | The stated objectives are reported in the paper.
The primary end-point was the percentage of patients whose both general well-being and dyspnea had improved at 3 days according to the blinded physician – YES |
| Other bias | Unclear risk | The method of weaning the beta-blocker is not stated, and this is significant as rebound hypertension is a well-known phenomenon with beta-blockers.
Additionally, the baseline use of ACE-inhibitors and diuretics are reported and similar across the two groups. It is unclear if the diuretic is a thiazide, potassium-sparing or loop diuretic. Nor is it stated to what extent this conformed to guidelines for heart failure treatment (e.g. ACE-inhibitors at maximal tolerated dose and loop diuretic). Additionally, it is unclear if the use of ACE-inhibitors and diuretic remain similar at the end of the study. No conflicts of interest declared. Independent funding |
Leave a Reply