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Background: The relative efficacy and safety of more potent P2Y12 inhibitors in patients with acute coronary syndrome and high bleeding risk (HBR) undergoing percutaneous coronary intervention remains unclear. We aimed to study the treatment effect of ticagrelor and prasugrel in percutaneous coronary intervention patients presenting with acute coronary syndrome and HBR. Methods: This post hoc analysis of the ISAR-REACT 5 trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) included patients with acute coronary syndrome undergoing percutaneous coronary intervention, randomized to ticagrelor or prasugrel, in whom HBR was defined as per Academic Research Consortium criteria. The primary (efficacy) end point was the composite of all-cause death, myocardial infarction, or stroke. The secondary (safety) end point was Bleeding Academic Research Consortium type 3 to 5 bleeding. Outcomes were assessed 12 months after randomization. Results: Out of the 3239 patients included in this analysis, 486 fulfilled the criteria for Academic Research Consortium-HBR definition (HBR group; ticagrelor, n=230 and prasugrel, n=256), while 2753 did not (non-HBR group; ticagrelor, n=1375 and prasugrel, n=1378). Compared with the non-HBR group, the HBR group had a higher risk for the primary (hazard ratio [HR]=3.57 [95% CI, 2.79–4.57]; P <0.001) and secondary end point (HR=2.94 [2.17–3.99]; P <0.001). In the HBR group, the primary (HR=1.09 [0.73–1.62]) and secondary (HR=1.18 [0.67–2.08]) end points were not significantly different between patients assigned to ticagrelor and prasugrel. In the non-HBR group, the primary end point (HR=1.62 [1.19–2.20]) occurred more frequently in patients assigned to ticagrelor as compared to patients assigned to prasugrel, without difference in safety (HR=1.08 [0.74–1.58]). There was no significant treatment allocation-by-HBR status interaction with respect to the primary (P for interaction=0.12) or secondary (P for interaction=0.80) end points. Conclusions: In patients with acute coronary syndrome undergoing percutaneous coronary intervention, HBR status increased both ischemic and bleeding risk without significant impact on the relative efficacy and safety of either ticagrelor or prasugrel. These results warrant confirmation in larger cohorts. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800. [ABSTRACT FROM AUTHOR]

Background: Restoration of biomechanics is a major goal in THA. Imageless navigation enables intraoperative control of leg length equalization and offset reconstruction. However, the effect of navigation compared with intraoperative fluoroscopy is unclear. Questions/purposes: We asked whether intraoperative use of imageless navigation (1) improves the relative accuracy of leg length and global and femoral offset restoration; (2) increases the absolute precision of leg length and global and femoral offset equalization; and (3) reduces outliers in a reconstruction zone of ± 5 mm for leg length and global and femoral offset restoration compared with intraoperative fluoroscopy during minimally invasive (MIS) THA with the patient in a lateral decubitus position. Methods: In this prospective study a consecutive series of 125 patients were randomized to either navigation-guided or fluoroscopy-controlled THA using sealed, opaque envelopes. All patients received the same cementless prosthetic components through an anterolateral MIS approach while they were in a lateral decubitus position. Leg length, global or total offset (representing the combination of femoral and acetabular offset), and femoral offset differences were restored using either navigation or fluoroscopy. Postoperatively, residual leg length and global and femoral offset discrepancies were analyzed on magnification-corrected radiographs of the pelvis by an independent and blinded examiner using digital planning software. Accuracy was defined as the relative postoperative difference between the surgically treated and the unaffected contralateral side for leg length and offset, respectively; precision was defined as the absolute postoperative deviation of leg length and global and femoral offset regardless of lengthening or shortening of leg length and offset throughout the THA. All analyses were performed per intention-to-treat. Results: Analyzing the relative accuracy of leg length restoration we found a mean difference of 0.2 mm (95% CI, −1.0 to +1.4 mm; p = 0.729) between fluoroscopy and navigation, 0.2 mm (95 % CI, −0.9 to +1.3 mm; p = 0.740) for global offset and 1.7 mm (95 % CI, +0.4 to +2.9 mm; p = 0.008) for femoral offset. For the absolute precision of leg length and global and femoral offset equalization, there was a mean difference of 1.7 ± 0.3 mm (p < 0.001) between fluoroscopy and navigation. The biomechanical reconstruction with a residual leg length and global and femoral offset discrepancy less than 5 mm and less than 8 mm, respectively, succeeded in 93% and 98%, respectively, in the navigation group and in 54% and 95%, respectively, in the fluoroscopy group. Conclusions: Intraoperative fluoroscopy and imageless navigation seem equivalent in accuracy and precision to reconstruct leg length and global and femoral offset during MIS THA with the patient in the lateral decubitus position. Level of Evidence: Level I, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: Differentiation between septic and aseptic loosening of joint replacements is essential for successful revision surgery, but reliable markers for the diagnosis of low-grade infection are lacking. The present study was performed to assess intra-articular and systemic levels of antimicrobial peptides and proinflammatory cytokines as diagnostic markers for periprosthetic joint infection. Methods: Fifteen consecutive patients with staphylococcal periprosthetic joint infections and twenty control patients with aseptic loosening of total hip and knee replacements were included in this prospective, single-center, controlled clinical trial. Expression of the antimicrobial peptides human 3-defensin-2 (HBD-2), human 3-defensin-3 (HBD-3), and cathelicidin LL-37 (LL-37) was determined by ELISA (enzyme-linked immunosorbent assay) in serum and joint aspirates. Proinflammatory cytokines were assessed in serum and joint aspirates with use of cytometric bead arrays. C-reactive protein in serum, microbiology, and histopathology of periprosthetic tissue served as the "gold standard" for the diagnosis of infection. Results: The antimicrobial peptides HBD-3 and LL-37 were significantly elevated in joint aspirates from patients with periprosthetic joint infection compared with patients with aseptic loosening, and the area under the curve (AUC) in a receiver operating characteristic curve analysis was equal to 0.745 and 0.875, respectively. Additionally, significant local increases in the proinflammatory cytokines interleukin (IL)-1β, IL-4, IL-6, IL-17A, interferon (IFN)-γ, and tumor necrosis factor (TNF)-α were observed to be associated with infection. Logistic regression analysis indicated that the combination of an antimicrobial peptide with another synovial fluid biomarker improved diagnostic accuracy; the AUC value was 0.916 for LL-37 and IL-4, 0.895 for LL-37 and IL-6, 0.972 for HBD-3 and IL-4, and 0.849 for HBD-3 and IL-6. In contrast, the only antimicrobial peptides and cytokines in serum that showed a significant systemic increase in association with infection were HBD-2, IL-4, and IL-6 (all of which had an AUC value of <0.75). Conclusions: The present study showed promising results for the use of antimicrobial peptides and other biomarkers in synovial fluid for the diagnosis of periprosthetic joint infection, and analysis of the levels in synovial fluid was more accurate than analysis of serum. Level of Evidence: Diagnostic Level IV. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: Whether bleeding and myocardial infarction (MI) improve the performance of risk prediction models for mortality in patients with acute coronary syndromes (ACS) treated with percutaneous coronary intervention (PCI) remains unknown., Methods: This study included 3377 patients with ACS who underwent PCI in the setting of the ISAR-REACT 5 trial. Patients with bleeding, MI or those dying at 1 year after PCI were characterized in terms of baseline characteristics, risk estimates and C-statistic of the risk prediction models for these outcomes., Results: Major bleeding (Bleeding Academic Research Consortium types 3-5), MI and mortality occurred in 195 patients (5.8%), 143 patients (4.3%) and 143 patients (4.3%), respectively. After adjustment, bleeding [hazard ratio = 5.08; 95% confidence interval (CI), 3.03-8.53; P < 0.001] and MI [hazard ratio = 5.90; 95% CI, (3.00-11.65); P < 0.001) remained independently associated with the risk for 1-year mortality. The C-statistic (with 95% CI) of the model for bleeding, MI and mortality was, 0.755 (0.722-0.786), 0.752 (0.717-0.789) and 0.868 (0.837-0.896), respectively. The inclusion of bleeding [C-statistic: 0.892 (0.867-0.913); delta C-statistic 0.024 (-0.014 to 0.065); P = 0.200] or MI [C-statistic: 0.878 (0.851-0.903); delta C-statistic 0.011 (-0.030 to 0.053); P = 0.635] in the risk prediction models for mortality alongside baseline demographical and clinical variables did not improve prediction for mortality., Conclusions: In patients with ACS treated with PCI, mortality is the most accurately predicted outcome. Bleeding and MI did not improve risk discrimination for mortality when added in the risk prediction models for mortality suggesting that these outcomes do not provide incremental prognostic information on top of baseline demographical and clinical data., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)