Characteristics and threshold setting of non-inferiority trials for cardiovascular therapeutic medical devices:a systematic review
Objective To systematically review the non-inferiority trials in the cardiovascular domain that utilize medical devices as interventions,and investigate its characteristics and threshold settings.Methods The PubMed,Embase,and CENTRAL databases were electronically searched to collect non-inferiority trials in the cardiovascular field involving medical devices from inception to July 26,2023.Two reviewers independently screened literature and extracted data.The reported information included basic characteristics,features of non-inferiority trials,and threshold-setting features of the included studies.Data analysis was performed using Excel 2020 and R 4.2.1 software.Results A total of 214 studies were included,with 167 studies(78.0％)focusing on interventions related to coronary artery stents.The trials predominantly utilized a two-arm design(92.9％),with a prevalent use of non-inferiority absolute thresholds(96.7％)as the criteria for non-inferiority determination.In 150 studies(70.1％),non-inferiority thresholds were established based on estimated control group effect values,while 33 studies(15.4％)did not report the source of these values.The non-inferiority trial endpoint outcomes exhibited diversity,and there were substantial differences in threshold settings.The three most studied qualitative indicators were target lesion failure rates(2.1％-8.6％),target vessel failure rates(2.5％-19.6％),and major adverse cardiovascular events rates(2.1％-10.0％).Late lumen loss(0.1-0.4 mm)emerged as the most frequently studied quantitative indicator.After converting absolute non-inferiority thresholds for all indicators into relative thresholds,the range was 1.20-3.67.Conclusion Significant variations in non-inferiority threshold settings are observed for identical endpoint outcomes across included studies,highlighting a lack of reporting on the rationale behind threshold settings.
Therapeutic medical devicesCardiovascular medical devicesNon-inferiority trialNon-inferiority thresholdSystematic review
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