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Open in new tab Download slide OBJECTIVES Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America [294 (39.4%)], Europe [264 (35.4%)] or Asia [141 (18.9%)]. Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3 and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because of lack of funding. Left ventricular assist device trials [odds ratio (OR) 3.65, 95% confidence interval (CI) (1.65–8.00) P  = 0.001], valve surgery trials [OR 4.30, 95% CI (2.33–8.00) P  < 0.001], aortic surgery trials [OR 2.86 95% CI (1.22–6.43) P  = 0.012], phase 2 [OR 3.02, 95% CI (1.31–7.93) P  = 0.015] and phase 4 trials [OR 3.62, 95% CI (1.43–10.23) P  = 0.010] were at higher risk of premature termination while trials performed in Asia [OR 0.18, 95% CI (0.07–0.39) P  ≤ 0.001] and Europe [OR 0.49, 95% CI (0.30–0.80) P  = 0.004] were less likely to be terminated prematurely. CONCLUSIONS Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on left ventricular assist device, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely. [ABSTRACT FROM AUTHOR]

OBJECTIVES The association between obesity and graft failure after coronary artery bypass grafting has not been previously investigated. METHODS We pooled individual patient data from randomized clinical trials with systematic postoperative coronary imaging to evaluate the association between obesity and graft failure at the individual graft and patient levels. Penalized cubic regression splines and mixed-effects multivariable logistic regression models were performed. RESULTS Six trials comprising 3928 patients and 12 048 grafts were included. The median time to imaging was 1.03 (interquartile range 1.00–1.09) years. By body mass index (BMI) category, 800 (20.4%) patients were normal weight (BMI 18.5–24.9), 1668 (42.5%) were overweight (BMI 25–29.9), 983 (25.0%) were obesity class 1 (BMI 30–34.9), 344 (8.8%) were obesity class 2 (BMI 35–39.9) and 116 (2.9%) were obesity class 3 (BMI 40+). As a continuous variable, BMI was associated with reduced graft failure [adjusted odds ratio (aOR) 0.98 (95% confidence interval (CI) 0.97–0.99)] at the individual graft level. Compared to normal weight patients, graft failure at the individual graft level was reduced in overweight [aOR 0.79 (95% CI 0.64–0.96)], obesity class 1 [aOR 0.81 (95% CI 0.64–1.01)] and obesity class 2 [aOR 0.61 (95% CI 0.45–0.83)] patients, but not different compared to obesity class 3 [aOR 0.94 (95% CI 0.62–1.42)] patients. Findings were similar, but did not reach significance, at the patient level. CONCLUSIONS In a pooled individual patient data analysis of randomized clinical trials, BMI and obesity appear to be associated with reduced graft failure at 1 year after coronary artery bypass grafting. [ABSTRACT FROM AUTHOR]

The external stenting of saphenous vein grafts (SVGs) during coronary artery bypass grafting (CABG) has been proven to reduce intimal hyperplasia (IH) in animal models, paving the way for human randomized controlled trials (RCTs) to be conducted. Herein, we performed a study-level meta-analysis to assess the impact of the Venous External SupporT (VEST) device, an external stent, on the outcomes of SVGs. A systematic search was conducted to identify all RCTs comparing VEST-stented to non-stented SVGs in patients undergoing CABG. The primary outcome was graft occlusion. The main secondary outcomes were repeat revascularization, SVG IH area, and intimal-medial thickness. Two RCTs totaling 407 patients were included. At a mean follow-up of 1.5 years, there was no difference in graft occlusion between groups (incidence rate ratio: 1.11; 95% confidence interval (CI): 0.80–1.53). The rate of repeat revascularization was also similar (odds ratio: 0.66; 95% CI: 0.27–1.64). The IH area (standardized mean difference (SMD): −0.45; 95% CI: −0.79 to −0.10) and intimal-medial thickness (SMD: −0.50; 95% CI: −0.90 to −0.10) were significantly reduced in the VEST group. Our findings show that significant reductions in the IH area and the intimal-medial thickness in VEST-stented SVGs do not currently translate into a lesser need for repeat revascularization or less graft occlusion events compared to non-stented SVGs at 1.5 years after CABG. [ABSTRACT FROM AUTHOR]

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The aim of this study was to assess whether the Harris Hip Score (HHS) and the Oxford Hip Score (OHS) were comparable in normal, healthy, pathology-free individuals of different age, gender, ethnicity, handedness and nationality. The purpose of this study was to establish normal population values for the HHS and OHS using an electronic data collection system.~Background~Background~317 Australian and 310 Canadian citizens with no active hip pain, injury or pathology in the ipsilateral hip corresponding to their dominant arm, were evaluated. Participants completed an electronically-administered questionnaire and were assessed clinically. Chi-square tests, Fisher's exact test and Poisson regression models were used where appropriate, to investigate the association between hip scores, ethnicity, nationality, gender, handedness and age.~Methods~Methods~There was a statistically significant association between the OHS and age (p<0.0001) and the HHS and age (p = 0.0006); demonstrating that as age increased, normal hip scores decreased. There was no statistically significant association between the HHS and gender (p = 0.1389); or HSS and nationality, adjusting for age (p = 0.5698) and adjusting for gender (p = 0.6997). There was no statistically significant association between the OHS and gender (p = 0.1350). Australians reported a statistically significant 4.2% higher overall OHS value compared to Canadians (p = 0.0490). There was no statistically significant association between the OHS and nationality in age groups 18-79 years. Participants >80 years reported a statistically significant association between the OHS and nationality (p<0.0001).~Results~Results~Studies using an electronic control group should consider differences in gender, age, ethnicity and nationality when using the HHS and OHS to assess patient outcomes. This study has established an electronic, normal control group for studies using the HHS and OHS. When using the OHS, the control group should be sourced from the same country of origin. When using the HHS, the control group should be sourced from a pre-established control group within a database, without necessarily being sourced from the same country of origin.~Conclusions~Conclusions [ABSTRACT FROM AUTHOR]

Background: Postoperative bleeding requiring re-exploration is a serious complication that occurs in 2.8-4.6% of patients undergoing cardiac surgery. Re-exploration has previously been associated with a higher risk of short-term mortality. However, a comprehensive analysis of long-term outcomes after re-exploration for bleeding has not been published., Materials and Methods: The authors performed a systematic, three databases search to identify studies reporting long-term outcomes in patients who required re-exploration for bleeding after cardiac surgery compared to patients who did not, with at least 1-year of follow-up. Long-term survival was the primary outcome. Secondary outcomes were operative mortality, myocardial infarction, stroke, renal and respiratory complications, and hospital length of stay. Random-effects models was used. Individual patient survival data was extracted from available survival curves and reconstructed using restricted mean survival time., Results: Six studies totaling 135 456 patients were included. The average follow-up was 5.5 years. In the individual patient data, patients who required re-exploration had a significantly higher risk of death compared with patients who did not [hazard ratio (HR): 1.21; 95% CI: 1.14-1.27; P <0.001], which was confirmed by the study-level survival analysis (HR: 1.32; 95% CI: 1.12-1.56; P <0.01). Re-exploration was also associated with a higher risk of operative mortality [odds ratio (OR): 5.25, 95% CI: 4.74-5.82, P <0.0001], stroke (OR: 2.05, 95% CI: 1.72-2.43, P <0.0001), renal (OR: 4.13, 95% CI: 3.43-4.39 P <0.0001) respiratory complications (OR: 3.91, 95% CI: 2.96-5.17, P <0.0001), longer hospital length of stay (mean difference: 2.69, 95% CI: 1.68-3.69, P <0.0001), and myocardial infarction (OR: 1.85, 95% CI: 1.30-2.65, P =0.0007)., Conclusion: Postoperative bleeding requiring re-exploration is associated with lower long-term survival and increased risk of short-term adverse events including operative mortality, stroke, renal and respiratory complications, and longer hospital length of stay. To improve both short-term and long-term outcomes, strategies to prevent the need for re-exploration are necessary., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)