Non-efficacy benefits and non-inferiority margins: a scoping review of contemporary high-impact non-inferiority trials in clinical cardiology

Leening, Maarten J.G.; Mahmoud, Karim

doi:10.1007/s10654-021-00820-x

Cited by 3 publications

(1 citation statement)

References 67 publications

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“…Therefore, we used a conservative 15% of the population rate for the DOCE for both intervention and control treatments. We allowed a 10% relative inferiority margin for the investigated treatments (20). The resulting sample size was 158 patients per arm.…”

Section: Sample Size Calculationmentioning

confidence: 99%

The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation – RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial

Kulyassa

Németh

Ehrenberger

et al. 2022

Front. Cardiovasc. Med.

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Introduction and AimRadial artery approach angiography is the current gold standard for coronary status diagnostics and eventual percutaneous revascularization (PCI). Currently, application of adequate, patent hemostasis based physical torniquets are used for puncture site control, to avoid bleeding, radial artery occlusion and damage (RAO and RAD). The Radial Artery Puncture Hemostasis Evaluation (RAPHE) is a prospective, randomized, multicenter clinical trial designed to investigate new, simplified techniques of radial artery hemostasis utilizing physical compression free methods.Methods and ResultsThe RAPHE study has been designed to evaluate the efficacy and safety of two non-compression based radial artery hemostasis methods: a 100% chitosan bioactive hemostatic dressing and a purpose-built radial potassium-ferrate based topical hemostasis disc. These devices will be investigated in a standalone configuration. Control group is a standard pneumatic airbladder-based compression device. A total of 600 patients will be enrolled in a three-way randomization (1:1:1) with two study and one control groups. Safety and efficacy endpoints are RAO, puncture site hematoma formation and RAD respectively, consisting of dissection, (pseudo)aneurism and/or fistula formation, measured post-procedure and at sixty days.ConclusionThe results from this trial will provide valuable information on new, simplified methods of radial artery hemostasis options and possibly simplify post-puncture management of patients.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT04857385].

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Section: Sample Size Calculationmentioning

confidence: 99%