Jiménez-Candil J, Bermejo J, Yotti R, et al. Effects of angiotensin converting enzyme inhibitors in hypertensive patients with aortic valve stenosis: A drug withdrawal study. Heart 2005;91:1311-18
Pubmed link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1769141/
Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1769141/pdf/0911311.pdf
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 22 enrolled, 20 completed
Age: 71.6 ± 9.6 years (range 45 to 84 years, median 73) Sex: 7 female, 13 male Participants with dementia: No Inclusion criteria: · Patients referred to our laboratory with moderate or severe aortic valve stenosis · Concomitant treatment with an ACE-inhibitor for at least three months, prescribed for arterial hypertension Exclusion criteria: · Presence of symptoms related to aortic valve stenosis · Existence of any other valvular stenosis or regurgitation other than mild (1+) · Previous cardiac surgery · Absence of a suitable ultrasonic window Country: Spain Setting: Community |
| Interventions | Medicine: Angiotensin-converting enzyme inhibitors (ACE-inhibitors)
Withdrawal Schedule: Withdrawal and re-introduction were progressive, with a daily dose reduction or increase equivalent to 1.25 mg of enalapril. |
| Outcomes | Exercise induced blood pressure response (fall or failure to rise)
Exercise duration Haemodynamic response |
| Dates | Dates: Not described
Follow-up duration: 12 weeks |
| Funding sources | Not described |
| Notes | Authors stated “Potential conflicts of interest: None to disclose.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Descriptive study, not experimental. |
| Allocation concealment (selection bias) | High risk | The design is a case series – not controlled. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Not blinded. |
| Blinding of outcome assessment (detection bias) | 1 out of 5 | The investigators who performed and measured the Doppler echocardiographic and exercise examinations were blinded to this order. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | The two drop-outs were accounted for. |
| Selective reporting (reporting bias) | 1 out of 5 | The study had a pre-specified protocol as they had ethical approval. However, it is unclear neither if this included a detailed analysis plan nor if one existed if the researchers adhered to it. |
| Confounding (non-randomized) | 5 out of 5 | No control group. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Somewhat representative of the average older adult with aortic stenosis and hypertension in the community. |
| Selection of the non-exposed cohort | No concurrent control cohort. | |
| Ascertainment of exposure | Ascertainment of exposure by secure record (e.g. surgical records). | |
| Demonstration that outcome of interest was not present at start of study | Yes. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for ACE-inhibitors deprescribing (select the most important factor). |
| Outcome bias | Assessment of outcome | Assessment of outcomes record linkage. |
| Was follow-up long enough for outcomes to occur | Follow-up not long enough for outcomes to occur, which would need to be one year. | |
| Adequacy of follow-up of cohorts | Subjects lost to follow-up unlikely to introduce bias – small number lost. | |
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