ABSTRACT
OBJECTIVE: To estimate the frequency and critically appraise the use and reporting of composite outcomes in randomized clinical trials on pharmacological interventions for coronary artery disease. DESIGN: A meta-research study. A search strategy was developed to retrieve references from MEDLINE. We considered articles, published from 1st January 2020 to December 31, 2021, reporting results of clinical primary outcomes from randomized clinical trials which assessed pharmacological interventions, used alone or in combination, for the treatment or secondary prevention (previous coronary event) of coronary artery disease. RESULTS: From the 34 included studies, 28 (82.35%) had a primary composite outcome. Thirteen unique composite primary outcomes were used with the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term MACE (major adverse cardiac events) was used for five distinct composite primary outcomes. A combination of 12 different components resulted in the 28 primary composite outcomes, with stroke being the most frequent component present in 96.43% (27/28) of the primary composite outcomes. From the included studies, 60.71% (17/28) reported the estimates for each individual component and the direction of the effect was consistent between all components and the composite outcomes in 58.82% (10/17) of them. Additionally, no included study discussed potential limitations and/or related advantages of the composite outcomes. CONCLUSIONS: In randomized clinical trials on pharmacological interventions for coronary artery disease, composite outcomes are frequently used, but the definition of their components is very heterogeneous. The estimate for individual components within the composite outcome is often not fully reported, which prevents a complete analysis of their adequacy for clinical practice. The term MACE was used inconsistently and to refer to different set of components, which can also be misleading and confusing.
ABSTRACT
The objective of this study was to evaluate the existence of hemodynamic arterial flow correlation between preoperative duplex scanning (DS) and intraoperative direct outflow resistance (IDOR) measurements in ischemic lower limb revascularization. Sixty-eight ischemic lower limbs were submitted to preoperative DS. Anatomic and hemodynamic arterial characteristics of the outflow system were recorded, and the results were considered in the distal anastomosis placement site decision making. IDOR measurements were obtained at the same arterial segment, and Pearson's correlation coefficient test was performed to study the preoperative DS power in predicting the intraoperative outflow resistance. DS was technically satisfactory and helped define the distal anastomosis site in 93.2% of the cases (supragenicular popliteal artery, 19 [27.9%]; infragenicular popliteal artery, 10 [14.7%]; crural artery, 31 [57.4%]). A positive correlation could be found between preoperative DS and IDOR (0.450; p < .001). This correlation was particularly powerful in the crural artery (0.715; p < .001) when compared with the popliteal arterial segment (0.237; p = .192). Preoperative DS may help define the best distal arterial and outflow segment to be revascularized based on anatomic and hemodynamic parameters. There is a positive flow correlation between preoperative DS and IDOR that seems to be stronger in crural revascularization surgery.
