Trial reportClinical research in cardiology : official journal of the German Cardiac Society2016
External validity of the "all-comers" design: insights from the BIOSCIENCE trial.
Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed, 11 citations in OpenAlex.
- Impact of recruitment and retention on all-cause mortality in a large all-comers randomised controlled trial: insights from the GLOBAL LEADERS trial.Clinical research in cardiology : official journal of the German Cardiac Society · 2020Trial
- Regional differences in health-related quality of life in elderly heart failure patients: results from the CIBIS-ELD trial.Clinical research in cardiology : official journal of the German Cardiac Society · 2017Trial
- Trial
- Eligible-and-enrolled vs. eligible-but-not-enrolled patients with chronic ischaemic heart failure in randomized clinical trials of myocardial regeneration.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2022Article
- Pragmatic Clinical Studies: An Emerging Clinical Research Discipline for Improving Evidence-Based Practice of Cardiovascular Diseases in Asia.Korean circulation journal · 2022Review
- Nomogram for the Individualized Prediction of Survival Among Patients with H7N9 Infection.Risk management and healthcare policy · 2020Article
- SYNTAX score-0 patients: risk stratification in nonobstructive coronary artery disease.Clinical research in cardiology : official journal of the German Cardiac Society · 2016Article
Corrections and comments
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Authors and funding
14 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe sought to systematically evaluate the external validity of a contemporary randomized controlled stent trial (BIOSCIENCE).
methodsBaseline characteristics and clinical outcomes of patients enrolled into the BIOSCIENCE trial at Bern University Hospital (n = 1216) were compared to those of patients included in the CARDIOBASE Bern PCI Registry at the same institution (n = 1045). The primary study endpoint was the rate of target lesion failure (TLF), defined as a composite of cardiac death, target vessel-myocardial infarction (MI) or target lesion revascularization (TLR), at 1 year.
resultsWomen were underrepresented in the RCT compared to the registry (25 vs. 29.4 %, p = 0.020). Non-participants were older compared to study participants (69.2 ± 12.4 vs. 67.0 ± 11.6, p < 0.001), and had a higher prevalence of previous cerebrovascular events (10.8 vs. 5.2 %, p < 0.001), and chronic renal failure (35.5 vs. 15.6 %, p < 0.001). ST-segment elevation myocardial infarction (STEMI) and Killip class IV at presentation were more common among non-participants than participants (30.7 vs. 21.1 %, p < 0.001 and 7.8 vs. 0.4 %, p < 0.001, respectively). At 1 year, non-participants experienced a significantly higher rate of TLF, (15.0 vs. 6.5 %, p < 0.001), and patient-oriented composite endpoint (POCE), including death, MI or any repeat revascularization (21.6 vs. 11.2 %, p < 0.001). There was a significant interaction between POCE and presence or absence of an acute coronary syndrome in participants versus non-participants, respectively (p = 0.009).
conclusionsNon-participants of this all-comers trial had a higher risk profile and adverse prognosis compared to study participants. Further efforts are needed to improve the external validity of contemporary RCTs.
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