Chewed Versus Swallowed Ticagrelor in P2Y12 Inhibitor-Naïve Patients Undergoing Percutaneous Coronary Intervention.

Purpose: Dual antiplatelet therapy is standard for patients undergoing percutaneous coronary intervention (PCI) with stents. Traditionally, patients swallow the loading dose of a P2Y12 inhibitor before or during PCI. Time to achieve adequate platelet inhibition after swallowing the loading dose varies significantly. Chewed tablets may allow more rapid inhibition of platelet aggregation. However, data for this strategy in patients with stable ischemic heart disease or non-ST-elevation acute coronary syndrome (NSTE-ACS) are less robust. Methods: In this single-center prospective trial, 112 P2Y12-naïve patients with stable ischemic heart disease or NSTE-ACS on aspirin therapy and who received ticagrelor after coronary angiography but before PCI were randomized to chewing (n=55) or swallowing (n=57) the ticagrelor loading dose (180 mg). Baseline variables were compared using 2-sample t-test and chi-squared/Fisher's exact tests as appropriate, with alpha set at 0.05. P2Y12 reaction units (PRU) were compared at baseline, 1 hour, and 4 hours using Wilcoxon rank-sum test. Patients then received standard ticagrelor dosing. Results: After exclusions, P2Y12 PRU in the chewed and swallowed groups at baseline, 1 hour, and 4 hours after ticagrelor loading dose were 243 vs 256 (P=0.75), 143 vs 210 (P=0.09), and 28 vs 25 (P=0.89), respectively. No differences were found in major adverse cardiac events (MACE) or major bleeding at 30 days and 1 year. Conclusions: In patients with stable ischemic heart disease or NSTE-ACS, chewing rather than swallowing ticagrelor may lead to slightly faster inhibition of platelet aggregation at 1 hour with no increase in MACE or major bleeding.

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.

A randomized controlled trial of angiography versus intravascular ultrasound-directed bare-metal coronary stent placement (the AVID Trial).

BACKGROUND: AVID (Angiography Versus Intravascular ultrasound-Directed stent placement) is a multicenter, randomized controlled trial designed to assess the effect of intravascular ultrasound (IVUS)-directed stent placement on the 12-month rate of target lesion revascularization (TLR). METHODS AND RESULTS: After elective coronary stent placement and an optimal angiographic result (<10% stenosis), 800 patients were randomized to Angiography- or IVUS-directed therapy. Blinded IVUS was performed in the Angiography group without further therapy. In the IVUS group, IVUS criteria for optimal stent placement (<10% area stenosis, apposition, and absence of dissection) were applied. Final minimum stent area was 6.90+/-2.43 mm(2) in the Angiography group and 7.55+/-2.82 mm(2) in the IVUS group (P=0.001). In the IVUS group, only 37% with inadequate expansion (<90%) received further therapy. The 12-month TLR rate was 12.0% in the Angiography group and 8.1% in the IVUS group (P=0.08, 95% confidence level [CI], [-8.3% to 0.5%]). When vessels with a distal reference diameter <2.5 mm by core laboratory angiography measurement were excluded from analysis, the 12-month TLR rate was 10.1% in the Angiography group and 4.3% in the IVUS group (P=0.01, 95% CI, [-10.6% to -1.2%]). With a pre-stent angiographic stenosis of > or =70%, the TLR rate was lower in the IVUS group compared with the Angiography group (3.1% versus 14.2%; P=0.002; 95% CI, [-18.4% to -4.2%]). CONCLUSIONS: IVUS-directed bare-metal stent placement results in larger acute stent dimensions without an increase in complications and a significantly lower 12-month TLR rate for vessels > or =2.5 mm by angiography and for vessels with high-grade pre-stent stenosis. However, for the entire sample analyzed on an intention-to-treat basis, IVUS-directed bare-metal stent placement does not significantly reduce the 12-month TLR rate when compared with stent placement guided by angiography alone. In addition, IVUS evaluation of adequate stent expansion is underutilized by experienced operators.

Recommendation of low-salt diet and short-term outcomes in heart failure with preserved systolic function.

BACKGROUND: Dietary sodium indiscretion frequently contributes to hospitalizations in elderly heart failure patients. Animal models suggest an important role for dietary sodium intake in the pathophysiology of heart failure with preserved systolic function. The documentation and effects of hospital discharge recommendations, particularly for sodium-restricted diet, have not been extensively investigated in heart failure with preserved systolic function. METHODS: We analyzed 1700 heart failure admissions to Michigan community hospitals. We compared documentation of guideline-based discharge recommendations between preserved systolic function and systolic heart failure patients with chi-squared testing, and used logistic regression to identify predictors of 30-day death and hospital readmission in a prespecified follow-up cohort of 443 patients with preserved systolic function. We hypothesized that patients who received a documented discharge recommendation for sodium-restricted diet would have lower 30-day adverse event rates. RESULTS: Heart failure patients with preserved systolic function were significantly less likely than systolic heart failure patients to receive discharge recommendations for weight monitoring (33% vs 43%) and sodium-restricted diet (42% vs 53%). Upon propensity score-adjusted multivariable analysis, patients with preserved systolic function who received a documented sodium-restricted diet recommendation had decreased odds of 30-day combined death and readmission (odds ratio 0.43, 95% confidence interval, 0.24-0.79; P=.007). No other discharge recommendations predicted 30-day outcomes. CONCLUSIONS: Clinicians document appropriate discharge instructions less frequently in heart failure with preserved systolic function than systolic heart failure. Selected heart failure patients with preserved systolic function who receive advice for sodium-restricted diet may have improved short-term outcomes after hospital discharge.

Sex differences in the application of evidence-based therapies for the treatment of acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice projects in Michigan.

BACKGROUND: Studies have shown that women with acute myocardial infarction (AMI) are less likely to receive evidence-based care compared with men. The American College of Cardiology's AMI Guidelines Applied in Practice (GAP) program has been shown to increase the rates of evidence-based medicine use and reduce mortality in patients with AMI. The objective of this study was to investigate the relative benefits of the GAP program in men and women. METHODS: By using a predesign-postdesign, standard orders, and a discharge tool to improve evidence-based indicator rates and long-term mortality in patients with AMI in Michigan, this study compared the success of GAP in men vs women. Logistic regression was used to develop predictive models for death at 30 days and 1 year in men and women. RESULTS: Use of evidence-based care, including use of beta-blockers and aspirin in men and women at hospital discharge and lipid-lowering agent use in men, was higher in the post-GAP sample (P<.01 for all). Use of the discharge tool promoted by the GAP program was independently protective against death at 1 year in women (adjusted odds ratio, 0.46; 95% confidence interval, 0.27-0.79), and a trend existed for similar results in men (adjusted odds ratio, 0.62; 95% confidence interval, 0.36-1.06). However, the tool was used slightly less often with women (27.9% vs 33.96%; P=.003). CONCLUSIONS: The GAP program increased the use of evidence-based therapies in male and female patients. In addition, the GAP discharge tool may decrease mortality rates at 1 year in patients with AMI; however, the tool was used less often with women. Greater use of the GAP discharge tool in women might narrow the post-MI sex mortality gap.

Association between blood glucose and long-term mortality in patients with acute coronary syndromes in the OPUS-TIMI 16 trial.

Hyperglycemia in the context of acute coronary syndrome (ACS) is a common observation, and existing data suggest that high glucose levels are associated with increased in-hospital mortality. We assessed the relation between random glucose and long-term mortality in 9,020 patients with ACS who were enrolled in the OPUS-TIMI 16 trial. A significant relation between glucose level and 10-month mortality was observed (2.7% in quartile 1 vs 7.0% in quartile 4, p <0.0001). After multivariable adjustment for co-morbidity, which included history of diabetes, this relation remained significant (quartile 4 vs 1, hazard ratio 1.70, 95% confidence interval 1.16 to 2.50, p = 0.006). These observations were similar in the TACTICS-TIMI 18 trial. In addition, we observed that B-type natriuretic peptide and troponin I levels increased across glucose quartiles in the OPUS-TIMI 16 trial (p values for trend = 0.002 and 0.0001, respectively) and the TACTICS-TIMI 18 trial (p values for trend = 0.006 and 0.0001, respectively). High blood glucose during ACS is an independent predictor of long-term mortality and is significantly correlated with prognostic biomarkers. Glucose levels during ACS may be an important addition to the risk stratification of patients with ACS and a potentially important target for 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.

Relationship between operator volume and adverse outcome in contemporary percutaneous coronary intervention practice: an analysis of a quality-controlled multicenter percutaneous coronary intervention clinical database.

OBJECTIVES: The aim of our study was to evaluate the volume-outcome relationship in a large, quality-controlled, contemporary percutaneous coronary interventions (PCI) database. BACKGROUND: Whether the relationship between physician volume of PCI and outcomes still exists in the era of coronary stents is unclear. METHODS: Data on 18,504 consecutive PCIs performed by 165 operators in calendar year 2002 were prospectively collected in a regional consortium. Operators' volume was divided into quintiles (1 to 33, 34 to 89, 90 to 139, 140 to 206, and 207 to 582 procedures/year). The primary end point was a composite of major adverse cardiovascular events (MACE) including death, coronary artery bypass grafting, stroke or transient ischemic attack, myocardial infarction, and repeat PCI at the same site during the index hospital stay. RESULTS: The unadjusted MACE rate was significantly higher in quintiles one and two of operator volume when compared with quintile five (7.38% and 6.13% vs. 4.15%, p = 0.002 and p = 0.0001, respectively). A similar trend was observed for in-hospital death. After adjustment for comorbidities, patients treated by low volume operators had a 63% increased odds of MACE (adjusted odds ratio [OR] 1.63, 95% confidence interval [CI] 1.29 to 2.06, p < 0.0001 for quintile [Q]1; adjusted OR 1.63, 95% CI 1.34 to 1.90, p < 0.0001 for Q2 vs. Q5), but not of in-hospital death. Overall, high volume operators had better outcomes than low volume operators in low-risk and high-risk patients. CONCLUSIONS: Although the relationship between operator volume and in-hospital mortality is no longer significant, the relationship between volume and any adverse outcome is still present. Technological advancements have not yet completely offset the influence of procedural volume on proficiency of PCIs.

Prognostic implication of anemia on in-hospital outcomes after percutaneous coronary intervention.

BACKGROUND: Although prior studies have shown a relationship between anemia and in-hospital mortality after coronary artery bypass grafting and acute myocardial infarction (MI), the prognostic implication of anemia in patients undergoing percutaneous coronary intervention (PCI) is unknown. Therefore, we evaluated the relationship between anemia and outcomes of PCI. METHODS AND RESULTS: Clinical and outcome data on 48,851 consecutive PCIs were prospectively collected. Patients were classified as anemic using the World Health Organization definition (<12.0 g/dL in women and <13.0 g/dL in men). A total of 6471 men (21.7%) and 4659 women (30.4%) were anemic. Anemic men and women were older and had a higher percentage of comorbidities compared with their nonanemic cohorts (P<0.0001 for all comparisons). When compared with nonanemic patients, anemic patients had higher in-hospital mortality (3.0% versus 0.8% in men; 2.4% versus 1.5% in women; P< or =0.0001) and postprocedural MI (2.0% versus 1.6% in men; 2.4% versus 1.6% in women; P< or =0.02) and a higher combined major cardiovascular events end point, including death, MI, and cerebrovascular event (5.0% versus 2.6% in men; 5.1% versus 3.5% in women; P<0.0001). After adjustment for comorbidities, anemia was associated with a higher risk of in-hospital mortality (odds ratio [OR], 2.29; 95% CI, 1.79 to 2.92; P<0.0001) and MI (OR, 1.34; 95% CI, 1.05 to 1.72; P=0.02) and major cardiovascular events (OR, 1.2; 95% CI, 1.05 to 1.34). Significant gender interactions were observed for death in men and for MI in women. CONCLUSIONS: Preprocedural anemia is associated with increased adverse in-hospital outcomes after PCI. Whether optimization of hemoglobin before PCI is of clinical benefit will need to be determined in a randomized clinical trial.

Nephropathy requiring dialysis after percutaneous coronary intervention and the critical role of an adjusted contrast dose.

This study was undertaken to determine the incidence, risk factors, and in-hospital outcome of nephropathy requiring dialysis (NRD) after percutaneous coronary intervention (PCI), and to evaluate the role of a weight- and creatinine-adjusted maximum radiographic contrast dose (MRCD) on NRD. Data were obtained from a registry of 16,592 PCIs. The data were divided into development and test sets. Univariate predictors were identified and a multivariate logistic regression model was developed. The MRCD was calculated for each patient as: MRCD = 5 ml x body weight (kilograms)/serum creatinine (milligrams per deciliter). Predictive accuracy was assessed by receiver-operating characteristic curve analysis. In the development set, 41 patients (0.44%) developed NRD with a subsequent in-hospital mortality rate of 39.0%. NRD increased with worsening baseline renal dysfunction. Other risk factors included peripheral vascular disease, diabetes mellitus, congestive heart failure, and cardiogenic shock. There was a direct relation between the number of risk factors and NRD. After adjustment for baseline risk factors, MRCD was the strongest independent predictor of NRD (adjusted odds ratio 6.2, 95% confidence interval 3.0 to 12.8). NRD and in-hospital mortality were both significantly higher in patients who exceeded the MRCD compared with patients who did not (p <0.001). In conclusion, NRD following PCI is a rare complication with a poor prognosis. Baseline clinical characteristics identify patients at greatest risk for NRD. Optimization of procedural variables such as timing of the intervention relative to the diagnostic catheterization, staging coronary procedures, or dosing within the MRCD may help reduce the risk of this complication in high-risk patients. A risk prediction tool for NRD with guidelines for prevention is presented.