Sex-Related Differences in the Prevalence and Prognostic Value of the Academic Research Consortium for High Bleeding Risk Criteria

Abstract

Background: Bleeding events after percutaneous coronary intervention are associated with substantial morbidity and mortality. Female patients undergoing percutaneous coronary intervention are often older and present with a higher burden of comorbidities, which in turn increases their risk of adverse events, including bleeding complications. The Academic Research Consortium (ARC) have proposed a list of clinical criteria to define high bleeding risk (HBR). Our aim was to evaluate the prevalence and predictive value of the ARC-HBR criteria according to sex in a contemporary cohort of patients undergoing percutaneous coronary intervention. Methods: All consecutive patients receiving coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they fulfilled at least 1 major or 2 minor ARC-HBR criteria. The primary bleeding end point was the composite of periprocedural in-hospital or postdischarge bleeding up to 1 year. Individual components of the primary bleeding end point, all-cause mortality, and myocardial infarction were also evaluated. Results: Of the total 9623 patients, 6979 (72.5%) were male and 2644 (27.5%) female. The prevalence of HBR was significantly higher in females compared with males (56.5% versus 39.9%, P <0.001). With regard to the individual criteria, moderate/severe anemia and moderate chronic kidney disease were more common in females, while oral anticoagulation and mild anemia were more frequent among males. The presence of HBR was associated with an increased risk of bleeding in both females (10.0% versus 4.4%; hazard ratio, 2.57 [95% CI, 1.80–3.67]; P <0.001) and males (8.7% versus 2.9%; hazard ratio, 3.19 [95% CI, 2.50–4.08]; P <0.001)(p interaction =0.344).The ARC-HBR criteria associated with the highest bleeding risk at 1 year were severe/end-stage chronic kidney disease and thrombocytopenia in females, and moderate/severe anemia in males. Conclusions: In a real-world cohort of percutaneous coronary intervention patients, females were more often at HBR than males. The prognostic value of the ARC-HBR definition was consistent between female and male patients, despite sex-related differences in the prevalence and bleeding risk associated with individual ARC-HBR criteria.

Sex-Related Differences in the Bleeding Trade-Off for Patients Undergoing Percutaneous Coronary Intervention

“…Females were more likely to present with moderate-severe anemia, have chronic kidney disease, and fulfill the ARC-HBR definition multiple times, while males were more likely to have an indication for anticoagulation. 9 There were minor differences between the study definitions of HBR and ARC-HBR definitions, as a result of the study collection period occurring before the development of the ARC-HBR criteria. 4,9 For example, there was unavailability of data on recent trauma or surgery and liver cirrhosis.…”

“…9 There were minor differences between the study definitions of HBR and ARC-HBR definitions, as a result of the study collection period occurring before the development of the ARC-HBR criteria. 4,9 For example, there was unavailability of data on recent trauma or surgery and liver cirrhosis. The primary study end point was bleeding events at 1 year post-PCI.…”

“…8 As long as females continue to be underrepresented in clinical trials, scrutiny will be necessary to evaluate for sex-specific differences that could influence applicability to females. In this issue of the journal, Mehran et al 9 explore the predictive value of the ARC-HBR criteria according to sex, testing if the recently proposed ARC-HBR criteria can be applied to both males and females with confidence. 4 The ARC-HBR criteria have previously been validated in real-world cohorts, but none have specifically compared the performance of the criteria in male versus female patients.…”

Reply to Kielb et al. Untapped Potential for Female Patients? Comment on “Lucà et al. Update on Management of Cardiovascular Diseases in Women. J. Clin. Med. 2022, 11, 1176”

“…Being female has frequently been assessed as a predictor of both ischemic and bleeding risks [ 20 ]. For example, it has recently been included by the European Society of Cardiology in the SCORE2 risk [ 21 ] (a composite model to predict 10-year fatal and non-fatal CVD risk in patients aged 40–69 years without previous CVD or diabetes); in addition, the Academic Research Consortium (ARC) criteria for high bleeding risk (HBR) were evaluated in patients undergoingpercutaneous coronary intervention (PCI) according to sex: in terms of both prevalence and predictive value, females who undergo PCI are more likely to be at ARC-HBR status than males [ 22 ].…”