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Direct oral anticoagulants (DOACs) are widely employed for antithrombotic prophylaxis in patients with atrial fibrillation (AF). However, there is still uncertainty about their risk-benefit profile in older patients. Here, we evaluated the efficacy, safety, and dose appropriateness of DOACs in a real-world population of outpatients with non-valvular AF, with a specific focus on subjects aged over 80 years and/or with reduced renal function. Single-center retrospective study including patients who had been prescribed a DOAC between May 2014 and May 2021 for long-term anticoagulation in non-valvular AF. Patients anticoagulated for <4 weeks were excluded. The primary efficacy outcome was a composite of cardiovascular (CV) death, stroke, or systemic embolism. The primary safety outcome was major bleeding. A total of 1154 patients (median age 84 yrs., range 57–100 yrs.), among which 862 were 80 years and older, were included. In the subgroup of subjects ≥80 yrs., a subtherapeutic dose of DOAC was associated with an increased incidence of CV mortality, stroke, or systemic embolism (multivariable Cox regression, HR = 2.09, 95 % CI: 1.09–4.02), with no benefit in terms of prevalence of bleeding events (21.5 % vs. 18.6 %, p = 0.428), and the incidence of adverse safety and efficacy outcomes was not increased in patients with a reduced renal function (eGFR ≤30 mL/min). Plasma concentration of DOACs, assessed in a subset of 367 patients, did not increase with advanced age (≥ 80 yrs., two-way ANOVA, p = 0.656) nor with declining eGFR (≤30 mL/min, two-way ANOVA, p = 0.643) and was not associated with adverse safety and efficacy outcomes. Data from our study support the use of DOACs in populations of older adults and remark on the risks associated with inappropriate prescriptions in terms of CV mortality and adverse events. [ABSTRACT FROM AUTHOR]

Administratively coded data are frequently used in observational research to identify outcome events. With the transition to the new International Classification of Diseases coding system's 10th version (ICD-10), information is needed about the coding accuracy for bleeding events in anticoagulated patients. We aimed to determine ICD-10 code accuracy for bleeding events in anticoagulated patients admitted to the hospital. This cross-sectional study retrospectively examined charts of anticoagulated patients who were admitted to the University of Utah Hospital between October 1, 2017 and December 31, 2017. Two trained chart abstractors blinded to ICD-10 code status independently reviewed medical charts to determine the presence or absence of bleeding events. ICD-10 code status in any diagnosis position was unblinded and code accuracy was assessed using sensitivity, specificity, positive predictive value (PPV), and negative predictive values (NPV) along with 95% confidence intervals (CI). Out of 661 admissions, 487 unique patients and 71 bleeding events were identified. Gastrointestinal tract bleeding and intracranial hemorrhage comprised 32.4% and 19.7% of bleeding events respectively. ICD-10 code sensitivity was 91.4% (95% CI, 82.3–96.8), specificity was 90.2% (87.5–92.5), PPV was 52.5% (43.2–61.6) and NPV 98.9% (97.6–99.6). Individual codes for intracranial hemorrhages and gastrointestinal tract bleeding had similar accuracy as the overall set of bleeding codes. Our results demonstrate that ICD-10 codes can reliably rule-out hospitalizations for bleeding events in patients receiving anticoagulation therapy. Due to unacceptable false positive rates ICD-10 codes should not be used for identifying bleeding complications without confirmatory chart review. • ICD-10 codes indicative of bleeding events appropriately excluded patients without clinical bleeding (high negative predictive value). • ICD-10 codes in "any" diagnostic position capture the majority of bleeding events (few false negatives). • Unverified ICD-10 codes erroneously identify a large number of bleeding events (false positives). • ICD-10 codes used for identifying acute bleeding complications in anticoagulated patients require confirmatory chart review. [ABSTRACT FROM AUTHOR]

Introduction Using International Classification of Diseases, 9th edition (ICD-9) diagnosis codes to identify potential warfarin-related bleeding events from administrative datasets is highly efficient but may be prone to identifying non-events. The objective of this study was to evaluate the ability of bleeding-related ICD-9 codes to identify true bleeding events in patients who were receiving warfarin therapy at the time of hospitalization. Methods This was a cross-sectional study conducted in an integrated healthcare delivery system. Anticoagulated patients aged ≥ 18 years and hospitalized between January 1, 2014 and March 31, 2014 were identified using administrative data queries. All hospitalizations were manually chart reviewed by a trained abstractor blinded to hospitalization diagnoses to assess for true bleeding events. Identification of the presence or lack of bleeding-related ICD-9 diagnosis code(s) for each hospitalization was then performed. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each ICD-9 code present. Results There were 486 hospitalizations in 468 anticoagulated patients with 57 true bleeding events identified. Patients had a mean age of 73.4 years and 50% were female. For codes in the principal position, sensitivity, specificity, PPV, and NPV were 7.0%, 99.8%, 80.0%, and 89.0%, respectively. For codes in any position, sensitivity, specificity, PPV, and NPV were 94.7%, 90.9%, 58.1%, and 99.2%, respectively. For major bleeding, sensitivity, specificity, PPV, and NPV were 100%, 83.1%, 14.0%, and 100%, respectively. Conclusions While the absence of a bleeding ICD-9 code reliably ruled-out hospitalization for warfarin-related bleeding, bleeding ICD-9 codes in the principal position were rarely used and undesirable false positive rates were identified when ICD-9 codes when recorded in any position and for major bleeding. Manual chart review is recommended to validate bleeding events from administrative data. [ABSTRACT FROM AUTHOR]

Abstract: Background: The bleeding time is frequently used to screen primary haemostasis before surgical procedures, although it poorly predicts the risk of hemorrhage. The platelet function analyzer (PFA), which is also used to screen primary haemostasis, has a higher sensitivity and other advantages, like patient friendliness, higher degree of objectivity and analytical reliability, but needs more extensive clinical validation. Methods: We compared the predictive values of the PFA-CTs (closure times) and bleeding time for bleeding events after renal biopsy. We prospectively evaluated the complications in patients that underwent a renal biopsy and were screened with PFA in advance (n=170). For comparison we used a historical cohort of patients screened with the bleeding time (n=132). Results: When the PFA-CTs were normal, 26.0% of the patients had a mild bleeding event after the biopsy, which did not differ from the event rate with a normal bleeding time (29.4%). When one or both PFA-CTs were prolonged, 51.3% of the patients had post-biopsy bleeding events independently of the measures to correct the closure time(s), significantly more than with either a prolonged bleeding time (26.7%) or normal PFA-CTs (26.0%). Conclusion: For bleeding events, the PFA has a higher positive and similar negative predictive value compared to the bleeding time. Taken into account the additional advantages of the PFA like patient friendliness and better analytical qualities, we prefer the PFA over the bleeding time as a screening tool for primary haemostasis before performing a renal biopsy. [Copyright &y& Elsevier]