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Clinical Trial
. 2015 Mar 24:350:h1302.
doi: 10.1136/bmj.h1302.

Precision medicine to improve use of bleeding avoidance strategies and reduce bleeding in patients undergoing percutaneous coronary intervention: prospective cohort study before and after implementation of personalized bleeding risks

John A Spertus  1 , Carole Decker  2 , Elizabeth Gialde  3 , Philip G Jones  3 , Edward J McNulty  4 , Richard Bach  5 , Adnan K Chhatriwalla  2
Affiliations
Clinical Trial

Precision medicine to improve use of bleeding avoidance strategies and reduce bleeding in patients undergoing percutaneous coronary intervention: prospective cohort study before and after implementation of personalized bleeding risks

John A Spertus et al. BMJ. .

Abstract

Objective: To examine whether prospective bleeding risk estimates for patients undergoing percutaneous coronary intervention could improve the use of bleeding avoidance strategies and reduce bleeding.

Design: Prospective cohort study comparing the use of bleeding avoidance strategies and bleeding rates before and after implementation of prospective risk stratification for peri-procedural bleeding.

Setting: Nine hospitals in the United States.

Participants: All patients undergoing percutaneous coronary intervention for indications other than primary reperfusion for ST elevation myocardial infarction.

Main outcome measures: Use of bleeding avoidance strategies, including bivalirudin, radial approach, and vascular closure devices, and peri-procedural bleeding rates, stratified by bleeding risk. Observed changes were adjusted for changes observed in a pool of 1135 hospitals without access to pre-procedural risk stratification. Hospital level and physician level variability in use of bleeding avoidance strategies was examined.

Results: In a comparison of 7408 pre-intervention procedures with 3529 post-intervention procedures, use of bleeding avoidance strategies within intervention sites increased with pre-procedural risk stratification (odds ratio 1.81, 95% confidence interval 1.44 to 2.27), particularly among higher risk patients (2.03, 1.58 to 2.61; 1.41, 1.09 to 1.83 in low risk patients, after adjustment for control sites; P for interaction = 0.05). Bleeding rates within intervention sites were significantly lower after implementation of risk stratification (1.0% v 1.7%; odds ratio 0.56, 0.40 to 0.78; 0.62, 0.44 to 0.87, after adjustment); the reduction in bleeding was greatest in high risk patients. Marked variability in use of bleeding avoidance strategies was observed across sites and physicians, both before and after implementation.

Conclusions: Prospective provision of individualized bleeding risk estimates was associated with increased use of bleeding avoidance strategies and lower bleeding rates. Marked variability between providers highlights an important opportunity to improve the consistency, safety, and quality of care. Study registration Clinicaltrials.gov NCT01383382.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: this study was funded by grants from the American Heart Association and the National Heart Lung and Blood Institute; JAS owns several patents on the ePRISM technology used to deliver the pre-procedural estimates of bleeding and has an economic interest in Health Outcomes Sciences, the company the distributes and supports the ePRISM software to hospitals; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Unadjusted rates of bleeding before and after ePRISM implementation, as a function of bleeding risk. PCI=percutaneous coronary intervention
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Fig 2 Individual physicians’ variability in use of bivalirudin, as a function of bleeding risk, before and after PRISM. Each line represents a physician in the study
See this image and copyright information in PMC

Comment in

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