An updated bleeding model to predict the risk of post-procedure bleeding among patients undergoing percutaneous coronary intervention: a report using an expanded bleeding definition from the National Cardiovascular Data Registry CathPCI Registry.
OBJECTIVE
This study sought to develop a model that predicts bleeding complications using an expanded bleeding definition among patients undergoing percutaneous coronary intervention (PCI) in contemporary clinical practice.


BACKGROUND
New knowledge about the importance of periprocedural bleeding combined with techniques to mitigate its occurrence and the inclusion of new data in the updated CathPCI Registry data collection forms encouraged us to develop a new bleeding definition and risk model to improve the monitoring and safety of PCI.


METHODS
Detailed clinical data from 1,043,759 PCI procedures at 1,142 centers from February 2008 through April 2011 participating in the CathPCI Registry were used to identify factors associated with major bleeding complications occurring within 72 h post-PCI. Risk models (full and simplified risk scores) were developed in 80% of the cohort and validated in the remaining 20%. Model discrimination and calibration were assessed in the overall population and among the following pre-specified patient subgroups: females, those older than 70 years of age, those with diabetes mellitus, those with ST-segment elevation myocardial infarction, and those who did not undergo in-hospital coronary artery bypass grafting.


RESULTS
Using the updated definition, the rate of bleeding was 5.8%. The full model included 31 variables, and the risk score had 10. The full model had similar discriminatory value across pre-specified subgroups and was well calibrated across the PCI risk spectrum.


CONCLUSIONS
The updated bleeding definition identifies important post-PCI bleeding events. Risk models that use this expanded definition provide accurate estimates of post-PCI bleeding risk, thereby better informing clinical decision making and facilitating risk-adjusted provider feedback to support quality improvement.
Duke Clinical Research Institute, Durham, North Carolina. Electronic address: sunil.rao@duke.edu.
Sunil V
SV
Rao
Lisa A
LA
McCoy
John A
JA
Spertus
Ronald J
RJ
Krone
Mandeep
M
Singh
Susan
S
Fitzgerald
Eric D
ED
Peterson
D000368:Aged; D003661:Decision Support Techniques; D005260:Female; D006470:Hemorrhage / Q000145:classification / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D012042:Registries; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D009626:Terminology as Topic; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
BARC; BAS; BMI; Bleeding Academic Research Consortium; NCDR; National Cardiovascular Data Registry; bleeding avoidance strategies; bleeding complications; bleeding risk models; body mass index; percutaneous coronary intervention; quality improvement