Article type
Abstract
Background: Composite end points like major adverse cardiac events (MACEs) are extensively used in coronary stent research despite varied definitions. These end points, combining safety and efficacy indicators, complicate result interpretation.
Objectives: This study evaluates the impact of MACE definition heterogeneity in coronary stent randomized controlled trials (RCTs) on result interpretation to improve research transparency and evidence use.
Methods: We employed a systematic search strategy, retrieving literature on systematic reviews/meta-analyses related to coronary stents from the PubMed and Embase databases from database inception to December 31, 2021. Literature was screened for eligibility using defined criteria. Selected studies were cataloged in a Microsoft Access 2016 database, where we extracted basic details of RCTs included in the studies. We then retrieved full texts to extract MACE definitions, participant counts, and outcome events for each MACE component. RCTs were further screened based on the safety definition of MACE—comprising mortality, myocardial infarction (MI), and stent thrombosis (ST)—to ensure MACE definitions inclusively covered these safety components. Adjustments were made for nonsafety components, recalculating odds ratios (OR) and 95% confidence intervals (CIs) for each study to assess definition impact on study conclusions.
Results: An initial search identified 5197 systematic reviews/meta-analyses related to coronary stent interventions. Inclusion criteria led to the selection of 170 systematic reviews/meta-analyses, from which 8 RCTs were further analyzed. All RCTs included mortality, MI, ST, and revascularization in their MACE definitions, with negative results originally. Adjusting for nonsafety components in one study shifted results from negative to positive, highlighting increased MACE risk in the intervention group (OR = 3.58, 95% CI 1.17 to 10.95) primarily due to MI differences (intervention group 10 occurrences versus control group 3 occurrences).
Conclusions: The variability in MACE definitions can significantly affect study outcomes and interpretations. Particularly, when MACE encompasses both safety and efficacy indicators, careful interpretation is required. Findings underscore the importance of distinguishing between the types of indicators within composite end points to ensure accurate interpretation, emphasizing the need for consistent and transparent MACE definitions in clinical research.
Objectives: This study evaluates the impact of MACE definition heterogeneity in coronary stent randomized controlled trials (RCTs) on result interpretation to improve research transparency and evidence use.
Methods: We employed a systematic search strategy, retrieving literature on systematic reviews/meta-analyses related to coronary stents from the PubMed and Embase databases from database inception to December 31, 2021. Literature was screened for eligibility using defined criteria. Selected studies were cataloged in a Microsoft Access 2016 database, where we extracted basic details of RCTs included in the studies. We then retrieved full texts to extract MACE definitions, participant counts, and outcome events for each MACE component. RCTs were further screened based on the safety definition of MACE—comprising mortality, myocardial infarction (MI), and stent thrombosis (ST)—to ensure MACE definitions inclusively covered these safety components. Adjustments were made for nonsafety components, recalculating odds ratios (OR) and 95% confidence intervals (CIs) for each study to assess definition impact on study conclusions.
Results: An initial search identified 5197 systematic reviews/meta-analyses related to coronary stent interventions. Inclusion criteria led to the selection of 170 systematic reviews/meta-analyses, from which 8 RCTs were further analyzed. All RCTs included mortality, MI, ST, and revascularization in their MACE definitions, with negative results originally. Adjusting for nonsafety components in one study shifted results from negative to positive, highlighting increased MACE risk in the intervention group (OR = 3.58, 95% CI 1.17 to 10.95) primarily due to MI differences (intervention group 10 occurrences versus control group 3 occurrences).
Conclusions: The variability in MACE definitions can significantly affect study outcomes and interpretations. Particularly, when MACE encompasses both safety and efficacy indicators, careful interpretation is required. Findings underscore the importance of distinguishing between the types of indicators within composite end points to ensure accurate interpretation, emphasizing the need for consistent and transparent MACE definitions in clinical research.