IMPORTANCE Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS). OBJECTIVE To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents. DESIGN, SETTING, AND PARTICIPANTS A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019. INTERVENTIONS Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529). MAIN OUTCOMES AND MEASURES The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events. RESULTS Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, −1.98% [95% CI, −3.50% to −0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). CONCLUSIONS AND RELEVANCE Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial.
Traditionally, two approaches have been employed for structural equation modeling: covariance structure analysis and partial least squares. A third alternative, generalized structured component analysis, was introduced recently in the psychometric literature. The authors conduct a simulation study to evaluate the relative performance of these three approaches in terms of parameter recovery under different experimental conditions of sample size, data distribution, and model specification. In this study, model specification is the only meaningful condition in differentiating the performance of the three approaches in parameter recovery. Specifically, when the model is correctly specified, covariance structure analysis tends to recover parameters better than the other two approaches. Conversely, when the model is misspecified, generalized structured component analysis tends to recover parameters better. Finally, partial least squares exhibits inferior performance in parameter recovery compared with the other approaches. In particular, this tendency is salient when the model involves cross-loadings. Thus, generalized structured component analysis may be a good alternative to partial least squares for structural equation modeling and is recommended over covariance structure analysis unless correct model specification is ensured.
Compared with 12-month DAPT, 6-month DAPT did not increase the composite events of cardiac death, myocardial infarction, stroke, or TIMI major bleeding at 1 year in patients who underwent everolimus-eluting stent implantation. (Impact of Intravascular Ultrasound Guidance on Outcomes of XIENCE PRIME Stents in Long Lesions [IVUS-XPL Study]; NCT01308281).
Important differences were found among children in a number of areas as a function of overall physical health status. The findings emphasize the importance of measuring activity limitations distinctly from chronic conditions and impairments, and, perhaps, of measuring impairments distinctly from chronic conditions, and of comparing children with such health problems to children without health problems in order to obtain a more accurate picture of the impact of health on children's lives. The World Health Organization's distinct definitions of health condition and disability facilitate a dimensional approach for describing child health that can serve to clarify this field of study and improve comparability of data across countries.
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