Use of prasugrel and clinical outcomes in African-American patients treated with percutaneous coronary intervention for acute coronary syndromes.

OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P < 0.0001). AA race was independently associated with a significantly higher risk of MI at 90-days and 1 year after PCI. CONCLUSIONS: Despite higher risk clinical presentation and worse 1-year ischemic outcomes, AA race was an independent predictor of lower prasugrel prescription in a contemporary population of ACS patients undergoing PCI.

Beneficial effects of a point-of-care bleeding risk calculator on anticoagulant selection in the coronary catheterization laboratory.

STUDY OBJECTIVES: To estimate periprocedural bleeding risk before elective percutaneous coronary intervention (PCI) by using a point-of-care bleeding risk calculator and to document changes in anticoagulant use and bleeding complications after implementation of use of this calculator. DESIGN: Prospective observational pilot study with a historical control cohort. SETTING: Tertiary care medical center. PATIENTS: The pilot cohort consisted of 100 patients undergoing ad hoc PCI during elective cardiac catheterization procedures between January and May 2013, whose bleeding risk and accompanying PCI anticoagulant recommendations were determined by the use of a pre-PCI point-of-care bleeding risk calculator. The historical control cohort consisted of all patients who underwent elective PCI at the same facility between April 1, 2011, and March 31, 2012, before implementation of use of the bleeding risk calculator. MEASUREMENTS AND MAIN RESULTS: The pre-PCI bleeding risk calculator distinguished patients in the pilot cohort as high risk (score 12 or higher) or low risk (lower than 12) for bleeding after a PCI procedure. The primary outcome was bivalirudin use in the pilot cohort compared with its use in the historical control cohort. Implementation of the bleeding risk calculator significantly decreased bivalirudin use compared with bivalirudin use in the historical control cohort (87% in the control cohort vs 60% in the pilot cohort, p<0.01). Bivalirudin use remained high in patients at high bleeding risk (82.2% in the pilot cohort vs 87.4% in the control cohort, p=0.3) and its use was decreased in patients at low bleeding risk (41.8% in the pilot cohort vs 87.1% in the control cohort, p<0.01). The incidence of bleeding complications in the pilot cohort was comparable with that in the control cohort (1% vs. 0.4%, p=0.37), although this pilot study was underpowered to potentially detect a significant change in the incidence of bleeding complications. CONCLUSION: A simple bleeding risk calculator can substantially reduce overall bivalirudin use by specifically decreasing its use among patients at low bleeding risk while maintaining its use among patients at high bleeding risk. The incidence of bleeding complications remained unchanged despite decreasing bivalirudin use among patients undergoing elective coronary catheterization who were at low risk for bleeding.

Impact of prior admissions on 30-day readmissions in medicare heart failure inpatients.

OBJECTIVE: To determine how all-cause hospitalizations within 12 months preceding an index heart failure (HF) hospitalization affect risk stratification for 30-day all-cause readmission. PATIENTS AND METHODS: Early readmission of inpatients with HF is challenging to predict, yet this outcome is used to compare hospital performance and guide reimbursement. Most risk models do not consider the potentially important variable of prior admissions. We analyzed Medicare inpatients with HF aged 66 years or older admitted to 14 Michigan community hospitals from October 1, 2002, to March 31, 2003, and from January 1 to June 30, 2004. Clinical data were obtained from admission charts, hospitalization dates from Centers for Medicare & Medicaid Services (CMS) claims, and mortality dates from the Social Security Death Index. We used mixed-effects logistic regression and reclassification indices to evaluate the ability of a CMS chart-based readmission risk model, prior admissions, and their combination to predict 30-day readmission in survivors of the index HF hospitalization. RESULTS: Of 1807 patients, 43 (2.4%) died during the index admission; 476 of 1764 survivors (27%) were readmitted 30 or fewer days after discharge. Adjusted for the CMS readmission model, prior admissions significantly increased the odds of 30-day readmission (1 vs 0: odds ratio, 4.67; 95% CI, 3.37-6.46; ≥2 vs 0: odds ratio, 6.49; 95% CI, 4.93-8.55; both P<.001), improved model discrimination (c statistic, 0.61-0.74, P<.001), and reclassified many patients (net reclassification index, 0.40; integrated discrimination index, 0.12). CONCLUSION: In Medicare inpatients with HF, prior all-cause admissions strongly increase all-cause readmission risk and markedly improve risk stratification for 30-day readmission.

Monitoring platelet inhibition after clopidogrel with the VerifyNow-P2Y12(R) rapid analyzer: the VERIfy Thrombosis risk ASsessment (VERITAS) study.

INTRODUCTION: Clopidogrel inhibits platelet P2Y12 ADP receptors, while ADP, as an inductor of aggregation, stimulates both P2Y12 and P2Y1 platelet receptors. Despite a clinical loading dose routine with clopidogrel, some patients still experience coronary stent thrombosis suggesting persistent platelet activation. The VerifyNow-P2Y12 is a rapid assay that test platelet activity over 3 min and uses of the combination of ADP and prostaglandin E1 (PGE1) to directly measure the effects of clopidogrel on the P2Y12 receptor. ADP is used to maximally activate the platelets by binding to the P2Y1 and P2Y12 platelet receptors, while PGE1 is used to suppress the ADP-induced P2Y1-mediated increase in intracellular calcium levels. OBJECTIVE: The VERIfy Thrombosis risk ASsessment (VERITAS) was a prospective study designed to measure platelet response to clopidogrel therapy in subjects with multiple risk factors or history of vascular disease using this novel point-of-care assay. METHODS: 166 participants were enrolled in 4 participating sites. Data from 147 participants were analyzed after exclusion of 19 patients due to protocol violations. Platelets were assessed twice at baseline (before clopidogrel) and at 24 h post-loading 450 mg (110 participants) or 7 days after chronic clopidogrel treatment (75 mg/day) (37 patients). All participants received aspirin 81-325 mg for at least 2 days before the study enrollment. Results from the VerifyNow-P2Y12 assay are reported in P2Y12 reaction units (PRU). RESULTS: Clopidogrel therapy resulted in a mean 64.0+/-25.3% PRU reduction. No participant reached PRU inhibition below 10% of baseline. Distribution of PRU values for the VerifyNow-P2Y12 assay shows a separation from baseline to post-clopidogrel assay values with some overlap due to high inter-individual variations in response. CONCLUSIONS: VerifyNow-P2Y12 is a reliable, fast and sensitive device suitable for monitoring of platelet inhibition during clopidogrel therapy.

Guideline-based standardized care is associated with substantially lower mortality in medicare patients with acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice (GAP) Projects in Michigan.

OBJECTIVES: We sought to assess the impact of the American College of Cardiology's Guidelines Applied in Practice (GAP) project for acute myocardial infarction (AMI) care, encompassing 33 acute-care hospitals in southeastern Michigan, on rates of mortality in Medicare patients treated in Michigan. BACKGROUND: The GAP project increases the use of evidence-based therapies in patients with AMI. It is unknown whether GAP also can reduce the rate of mortality in patients with AMI. METHODS: Using a before (n = 1,368) and after GAP implementation (n = 1,489) cohort study, 2,857 Medicare patients with AMI were studied to assess the influence of the GAP program on mortality. Multivariate models tested the independent impact of GAP after controlling for other conditions on in-hospital, 30-day, and one-year mortality. RESULTS: Average patient age was 76 years, 48% were women, and 16% represented non-white minorities. The rate of mortality decreased after GAP for each interval studied: hospital, 10.4% versus 13.6%; 30-day, 16.7% versus 21.6%; and one-year, 33.2% versus 38.3%; all p < 0.02. After multivariate adjustment, GAP correlated with a 21% to 26% reduction in mortality, particularly at 30 days (odds ratio of GAP to baseline 0.74; 95% confidence interval [CI] 0.59 to 0.94; p = 0.012) and one year (odds ratio 0.78; 95% CI 0.64 to 0.95; p = 0.013), particularly in the patients for whom a standard discharge tool was used (1-year mortality, odds ratio 0.53; 95% CI 0.36 to 0.76; p = 0.0006). CONCLUSIONS: Embedding AMI guidelines into practice was associated with improved 30-day and one-year mortality. This benefit is most marked when patients are cared for using standardized, evidence-based clinical care tools.