Study weighs up discordance between bleeding risk calculation tools

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A study assessing the performance of two commonly used definitions for determining which patients are at high risk of bleeding after percutaneous coronary intervention (PCI) has found a “substantial discordance” in categorisation between the two tools.

Writing in JACC: Cardiovascular Interventions, Carl-Emil Lim (Karolinska Institutet, Stockholm, Sweden) and colleagues outline their analysis of the ARC-HBR and PRECISE-DAPT score definitions for high bleeding risk, which are two methodologies that can be used by clinicians to help determine if patients would benefit from shorter or less intensive antiplatelet therapy after coronary stenting.

ARC-HBR—the Academic Research Consortium for High Bleeding Risk—is based upon expert opinion and bleeding rates from clinical trials of dual antiplatelet therapy (DAPT) after PCI, taking in criteria such as prior stroke and severe kidney disease.

PRECISE-DAPT—Predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy—on the other hand, is based upon pooled data from eight randomised trials and includes variables such as age, creatinine clearance, haemoglobin count and previous bleeding.

Lim and colleagues used data from several Swedish registries, including SWEDEHEART, the national registry recording outcomes of patients hospitalised for acute coronary syndrome or undergoing coronary or valvular intervention, to assess all patients who were discharged after coronary stenting with DAPT between January 2013 and July 2018. The study’s primary outcome was bleeding type predicted by each risk tool: BARC type 3 to 5 bleeding in the analyses of the ARC-HBR definition and TIMI major or minor bleeding in the analyses of the PRECISE-DAPT score.

Of the 7,562 patients, 27% (2,004) were categorised as high bleeding risk using the ARC-HBR definition, whereas 38% (1,696) were classified as being high bleeding risk when using the PRECISE-DAPT score. Overall, the numbers indicate a discordance in 22% of patients—1,696 of those included in the study.

Additionally, the study noted that patients at high bleeding risk were also at increased ischaemic risk and that observed risks for bleeding risk were higher than those predicted by the PRECISE-DAPT score.

“Our analyses indicate a need for the refinement of tools to guide personalised antiplatelet therapy after coronary stenting,” Lim and colleagues write in their report of the results in JACC: Cardiovascular Interventions. “Instead of attempts to predict the absolute risks under the assumption that the impact of DAPT on bleeding is a function of the patient’s risk, using clinical trial data to directly model heterogenous treatment effects may be possible. Specifically, if a score can identify patients who experience no ischaemic benefit or no bleeding harm from longer DAPT duration (regardless of their absolute risk for the outcomes), calibration would not be crucial when it is applied in new populations.”

The authors go on to state that their study highlights the uncertain generalisability of guideline-recommended high bleeding risk definitions and decision rules across patient populations seen in routine clinical practice, indicating a need for “more refined” scoring systems.


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