Discrepancy between cardiovascular RCT participants and real-life CKD patients could limit generalisability of RCT results

Participants with chronic kidney disease (CKD) from a real-life population cohort were mostly ineligible for randomised controlled cardiovascular trials (RCTs) that drive contemporary clinical guidelines. The studied real-life population with CKD presented with better cardiovascular risk factor control than participants included in the RCTs.

RCTs often use stringent inclusion criteria, which could limit the applicability of results for routine clinical practice. Julia M.T. Colombijn (University Medical Centre Utrecht, the Netherlands) presented the results of a pilot study which estimated the eligibility of participants with CKD from a real-life population cohort for major routine cardiovascular outcome clinical trials [1].

The eligibility criteria were extracted from 46 trials, selected from KDIGO and ESC clinical guidelines, covering a total of 321674 participants with interventions like renin-angiotensin-aldosterone system inhibitors, beta-blockers, aldosterone receptor antagonists, diuretics, antiplatelets, anticoagulants and sodium-glucose cotransporter-2 inhibitors. The extracted eligibility criteria were modelled on participants from the real-life population cohort, meaning all participants from the Utrecht Patient Oriented Database between 2012 and 2019. From this real-life population, n=9005 participants with CKD were included (eGFR <60 mL/min/1.73 m² or urine albumin-creatinine ratio ≥3 mg/mol) and rates and reasons for ineligibility were determined.

The median rate of ineligibility for clinical trials was 99%. Reasons for ineligibility included demographic characteristics, presence of comorbidities, co-medication use, kidney-related and laboratory or physical examination reasons. Compared with participants in the selected RCTs, participants in the overall Utrecht cohort tended to have fewer comorbidities such as diabetes (27% vs 53%), previous myocardial infarction (3% vs 9%), or heart failure (17% vs 28%). However, Utrecht cohort participants who were eligible for clinical trials had higher rates of common comorbidities such as hypertension, previous myocardial infarction, stroke or heart failure compared to those in the trial populations. Furthermore, participants from the real-life Utrecht population tended to have lower blood pressure, Hb1Ac values, urine albumin-creatinine ratios, and body mass index.

“In Utrecht, we have over 95% ineligibility rates for patients from routine clinical practice for the RCTs on which the KDIGO and ESC guidelines are based. For these trials, the kidney-related criteria were the reasons for ineligibility in about 60%”, concluded Ms Colombijn. “Real-life patients appeared healthier with better cardiovascular risk factor control than the participants included in RCTs.”

1. Colombijn JMT, et al. Generalisability of cardiovascular RCTs to patients with chronic kidney disease in clinical practice: a comparison between RCTs and real-world data. Abstract #615, ERA 2024, 23–26 May, Stockholm, Sweden.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 20 June 202424 June 2024