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.

Background While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making. Methods We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models. Results Site-adjusted analyses revealed more frequent review (72% for ePRISM vs. 45% for original consents) and better understanding of the ePRISM consents (odds ratios (ORs)=1.8–3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference (MRD) in the ORs of ePRISM's effect = 2–3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9–3.9, MRDs=1.1–6.2), engaged more in shared decision-making (proportional OR=2.1 [95%CI=1.02–4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often. Conclusions A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment.

There was an increase in bivalirudin use and a lower incidence of bleeding after the incorporation of individualized bleeding risk estimates into clinical practice. This implementation led to a reversal of the risk-treatment paradox, through a rational increase in bivalirudin use in patients at intermediate and high bleeding risk and decreased use in lower-risk patients.

Background Appropriate Use Criteria (AUC) for coronary revascularization have been developed by selected experts. Objective To compare the consistency in AUC ratings among a broader range of practicing cardiologists and the AUC Technical Panel. Methods Prior to AUC publication, 85 cardiologists from 10 U.S. institutions assessed the appropriateness of coronary revascularization for 68 indications that had been evaluated by the Technical Panel. Each indication was classified as appropriate, uncertain, or inappropriate, based on the physician group’s median rating. Rates of concordance between the physician group and the AUC Technical Panel (i.e., same appropriateness category assignment) and rates of non-agreement within the physician group (≥25% of panelists’ ratings outside the group’s appropriateness category assessment) were determined. Results Overall concordance between the 2 groups was 84%. Among indications classified as appropriate by the Technical Panel, concordance between the 2 groups was excellent (94% [34/36]); however, non-agreement within the physician group was 44% (16/36). Among indications classified as uncertain, there was 73% (16/22) concordance between the 2 groups. Among inappropriate indications, concordance was moderate (70% [7/10]), but non-agreement occurred frequently (70% [7/10]). Moreover, there was substantial variation in appropriateness ratings between individual physicians and the Technical Panel (weighted kappa range: 0.05–0.76). Conclusions While there was good concordance in assessments of appropriateness for coronary revascularization between physicians and the AUC Technical Panel, non-agreement within the physician group was common and there was marked variation in ratings between individual physicians and the Technical Panel.