Disease-State Understanding and Experience of Patients Receiving Continuous Intravenous Inotropic Support as Palliative Therapy: A Multicenter Survey.

Background: The use of continuous intravenous inotropic support (CIIS) as palliative therapy in patients with advanced heart failure (HF) has increased over the past decade. CIIS improves New York Heart Association (NYHA) functional class but does not impact survival. Objective: The objective of this study was to examine patients' understanding of the therapeutic intent of CIIS, prognostic awareness, and quality of life with CIIS. Design: We conducted a prospective, cross-sectional, multicenter study of patients with advanced HF receiving CIIS as palliative therapy between 2020 and 2022. Settings/Subjects: An investigator-developed survey instrument was administered to outpatients on CIIS in the United States via telephone. Measurements: Survey data were analyzed using descriptive and inferential statistics. Results: Forty-eight patients, 63% male, 81% African American/Black, with a mean age of 68.9 (standard deviation 12.3) years, participated in this study. The majority of patients responded that they expected CIIS to make them feel better (79%) and increase longevity (75%), but few expected that CIIS would cure their HF (19%). Patients described their overall quality of life on CIIS as not better/worse (19%), somewhat better (46%), and significantly better (35%) and reported high treatment satisfaction (87% were at least somewhat satisfied). Conclusions: In this study, patients report improved quality of life with CIIS as palliative therapy. Patients on CIIS as palliative therapy expected increased survival on CIIS, which is incongruent with current evidence. Further studies on how we can improve care processes so that patients have accurate prognostic and disease-state awareness, and receive goal concordant care, are warranted.

Reduced heart failure-related healthcare costs with Furoscix versus in-hospital intravenous diuresis in heart failure patients: the FREEDOM-HF study.

Aim: Compare heart failure (HF) costs of Furoscix use at home compared with inpatient intravenous (IV) diuresis. Patients & methods: Prospective, case control study of chronic HF patients presenting to emergency department (ED) with worsening congestion discharged to receive Furoscix 80 mg/10 ml 5-h subcutaneous infusion for ≤7 days. 30-day HF-related costs in Furoscix group derived from commercial claims database compared with matched historical patients hospitalized for <72 h. Results: Of 24 Furoscix patients, 1 (4.2%) was hospitalized in 30-day period. 66 control patients identified and were well-matched for age, sex, ejection fraction (EF), renal function and other comorbidities. Furoscix patients had reduced mean per patient HF-related healthcare cost of $16,995 (p < 0.001). Conclusion: Furoscix use was associated with significant reductions in 30-day HF-related healthcare costs versus matched hospitalized controls.

What is this article about? In heart failure (HF), the heart cannot pump as well as it should. This causes blood to back up in the vessels that return blood to the heart. Fluid leaks from these vessels and collects in vital organs such as the lungs. This fluid build-up is called congestion. Congestion causes symptoms such as shortness of breath, tiredness and leg swelling. Furoscix is a prescription medicine, a diuretic, that treats congestion. Diuretics help get rid of extra fluid by increasing urination. Congestion is usually managed with oral diuretics, but sometimes congestion cannot be controlled by oral diuretics and patients may have to spend several days at a clinic or hospital to receive diuretics given through a vein (intravenous or iv.). Furoscix is a new formulation of furosemide, a common diuretic, and is delivered into the skin (subcutaneous) by a self-administered pump instead of through an iv. Our investigation aimed to answer two questions Can Furoscix be given to patients at home instead of in the hospital with iv. diuretics? Is there a cost savings to using Furoscix? Instead of being admitted to the hospital for iv. diuretics, HF patients with worsening congestion who came to the emergency department were sent home to receive Furoscix 80 mg/10 ml 5-h subcutaneous infusion for ≤7 days. 30-day costs related to HF in these patients were compared with costs from similar group of patients previously hospitalized for iv. diuretics. What were the results & what do they mean? In patients who needed to be admitted to the hospital for iv. diuretics, Furoscix given at home instead reduced congestion and resulted in significant cost savings. Patients with heart failure, who are not getting relief with oral diuretics, can be treated with Furoscix at home without having to be admitted to the hospital for iv. diuretics. Use of Furoscix instead of iv. furosemide can save money to the healthcare system.

Comparison of Outcomes of Invasive or Conservative Management of Chronic Coronary Disease in Four Randomized Controlled Trials.

Revascularization and medical therapy for chronic coronary disease have both evolved significantly over the last 50 years. A total of 4 contemporary randomized controlled trials- Clinical Outcomes Utilizing Revascularization and Aggressive drug Evaluation (COURAGE), Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D), Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2 (FAME 2), and International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)-have assessed the incremental benefit of revascularization when added to secondary prevention with intensive pharmacologic and lifestyle intervention. We reviewed these 4 seminal studies with the objective of marshaling evidence to better frame how these results should apply to clinical decision making. These studies differed in study design, end points, intensity of treatment, and revascularization techniques. Nevertheless, they all demonstrate similar rates of "hard" clinical events with invasive and conservative management, and varying degrees of benefit in angina-related quality of life with revascularization. In conclusion, although controversy persists concerning the role of revascularization because of differing interpretations of the clinical trial evidence, we contend that instead of being competing management strategies, invasive and conservative approaches are complementary.

Machine learning evaluation of LV outflow obstruction in hypertrophic cardiomyopathy using three-chamber cardiovascular magnetic resonance.

Left ventricular outflow tract obstruction (LVOTO) is common in hypertrophic cardiomyopathy (HCM), but relationships between anatomical metrics and obstruction are poorly understood. We aimed to develop machine learning methods to evaluate LVOTO in HCM patients and quantify relationships between anatomical metrics and obstruction. This retrospective analysis of 1905 participants of the HCM Registry quantified 11 anatomical metrics derived from 14 landmarks automatically detected on the three-chamber long axis cine CMR images. Linear and logistic regression was used to quantify strengths of relationships with the presence of LVOTO (defined by resting Doppler pressure drop of > 30 mmHg), using the area under the receiver operating characteristic (AUC). Intraclass correlation coefficients between the network predictions and three independent observers showed similar agreement to that between observers. The distance from anterior mitral valve leaflet tip to basal septum (AML-BS) was most highly correlated with Doppler pressure drop (R2 = 0.19, p < 10-5). Multivariate stepwise regression found the best predictive model included AML-BS, AML length to aortic valve diameter ratio, AML length to LV width ratio, and midventricular septal thickness metrics (AUC 0.84). Excluding AML-BS, metrics grouped according to septal hypertrophy, LV geometry, and AML anatomy each had similar associations with LVOTO (AUC 0.71, 0.71, 0.68 respectively, p = ns), significantly less than their combination (AUC 0.77, p < 0.05 for each). Anatomical metrics derived from a standard three-chamber CMR cine acquisition can be used to highlight risk of LVOTO, and suggest further investigation if necessary. A combination of geometric factors is required to provide the best risk prediction.

National trends and 30-day readmission rates for next-day-discharge transcatheter aortic valve replacement: An analysis from the Nationwide Readmissions Database, 2012-2016.

Transcatheter aortic valve replacement (TAVR) has evolved toward a minimalist approach, resulting in shorter hospital stays. Real-world trends of next-day discharge (NDD) TAVR are unknown. This study aimed to evaluate underlying trends and readmissions of NDD TAVR. METHODS: This study was derived from the Nationwide Readmissions Database from 2012 to 2016. International Classification of Diseases, Ninth and Tenth Revisions, codes were used to identify patients. Any discharge within 1 day of admission was identified as NDD. NDD TAVR trends over the years were analyzed, and any admissions within 30 days were considered readmissions. A hierarchical logistic regression model was used to identify predictors of readmission. RESULTS: Of 49,742 TAVR procedures, 3,104 were NDD. The percentage of NDD TAVR increased from 1.5% (46/3,051) in 2012 to 12.2% (2,393/19,613) in 2016. However, the 30-day readmission rate remained the same over the years (8.6%). The patients' mean age was 80.3 ±â€¯8.4 years. Major readmission causes were heart-failure exacerbation (16%), infections (9%), and procedural complications (8%). In 2016, there were significantly higher late conduction disorder and gastrointestinal bleeding readmission rates than in 2012-2015. Significant predictors of readmission were anemia, baseline conduction disease, cardiac arrhythmias, heart failure, chronic kidney disease, chronic obstructive pulmonary disease, neoplastic disorders, and discharge to facility. CONCLUSIONS: The percentage of NDD TAVR increased over the years; however, readmission rates remained the same, with a higher rate of conduction abnormality-related hospitalizations in 2016. Careful discharge planning that includes identification of baseline factors that predict readmission and knowledge of etiologies may further prevent 30-day readmissions.

Optimizing Monotherapy Selection, Aspirin Versus P2Y12 Inhibitors, Following Percutaneous Coronary Intervention.

Dual antiplatelet therapy (DAPT) reduces ischemic and thrombotic events after percutaneous coronary intervention (PCI). Initial reports of higher myocardial infarction and mortality rates prompted guideline committees to choose 12-month duration of DAPT after PCI. However, higher bleeding rates with DAPT remain a major concern. Since these guidelines were published, there have been improvements in stent design, deployment techniques, and antiplatelet therapies, which have reduced ischemic events. To address bleeding concerns, trials were performed to evaluate the effectiveness of short-duration DAPT. Two main strategies were employed: (1) aspirin monotherapy after a short-duration DAPT, and (2) P2Y12 inhibitor monotherapy after a short-duration DAPT. In this review, we outline all the major trials on short-duration DAPT that have examined the previously mentioned strategies and propose a new individualized treatment algorithm for which monotherapy to choose or remove after PCI. In conclusion, while removing the P2Y12 inhibitor after a short DAPT appears to be safe in the low-risk population, removing aspirin and continuing the P2Y12 inhibitor as monotherapy would be the preferred strategy in intermediate- to high-risk patients to mitigate the bleeding risk.

The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.

Admissions Rate and Timing of Revascularization in the United States in Patients With Non-ST-Elevation Myocardial Infarction.

Clinical trials have shown improved outcomes with an early invasive approach for non-ST-elevation myocardial infarction (NSTEMI). However, real-world data on clinical characteristics and outcomes based on time to revascularization are lacking. We aimed to analyze NSTEMI rates, revascularization timing, and mortality using the 2016 Nationwide Readmissions Database. We identify patients who underwent diagnostic angiography and subsequently received either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Finally, revascularization timing and mortality rates (in-hospital and 30-day) were extracted. Our analysis included 748,463 weighted NSTEMI hospitalizations in 2016. Of these hospitalizations, 50.3% (376,695) involved diagnostic angiography, with 34.1% (255,199) revascularized. Of revascularized patients, 77.6% (197,945) underwent PCI and 22.4% (57,254) underwent CABG. Patients with more comorbidities tended to have more delayed revascularization. PCI was most commonly performed on the day of admission (32.9%; 65,155). This differs from CABG, which was most commonly performed on day 3 after admission (13.7%; 7,823). The in-hospital mortality rate increased after day 1 for PCI patients and after day 4 for CABG patients, whereas 30-day in-hospital mortality for both populations increased as revascularization was delayed. Our study shows that patients undergoing early revascularization differ from those undergoing later revascularization. Mortality is generally high with delayed revascularization, as these are sicker patients. Randomized clinical trials are needed to evaluate whether very early revascularization (<90 minutes) is associated with improved long-term outcomes in high-risk patients.

Risk Prediction Tool for Assessing the Probability of Death or Myocardial Infarction in Patients With Stable Coronary Artery Disease.

Several risk scores in acute coronary syndromes are available, but few models exist for stable coronary artery disease to guide decision-making and prognosis. A multivariate model was developed using 23 baseline candidate variables from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Therapy EvaluationTrial (n = 2,287 patients). Discrimination of the model was evaluated by the concordance c-index. The procedure was validated using 100 random half samples. We identified 9 independent predictors of death or myocardial infarction (MI) during a 5-year follow-up. The following predictors and points contributing to the risk score were: heart failure (3), number of diseased coronary arteries (1 for each vessel), diabetes (1), age (1 for each 15 years ≥ age 45), previous revascularization (1), current smoking (1), female (1), previous MI (1), and high-density lipoprotein cholesterol (1: 31 to 40 mg/dL; 2: <30 mg/dL). The risk tool had a potential range from 0 to 15, corresponding to 5-year event rates of 5.8% to 56%. C-indices ranged from 0.67 for the full data set to 0.62 for the validating subsamples. Respective observed versus predicted 5-year event rates for 3 predefined risk strata revealed: 30% had a low-risk score of 0 to 3 (9.3% vs 9.3%, or 1.9%/year); 59% had an intermediate-risk score of 4-6 (18.0% vs 18.1%, or 3.6%/year); and 11% had a high-risk score of 7-11 (36% vs 36.5%, or 7.2%/year). This stable coronary artery disease risk score permitted a prognostic assessment of 5-year probability of death or MI with an approximate 4-fold range in event rates from the lowest (9.3%) to the highest (36%) terciles, thus enabling better clinical practice decisions that allow physicians to tailor the intensity of treatment to the level of risk.

Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease.

BACKGROUND: In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients. METHODS: We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency. RESULTS: At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina). CONCLUSIONS: In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review.

Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain high. Non-stent-based local drug delivery by a drug-coated balloon (DCB) has been investigated, as it leaves no metallic mesh. A DCB consists of a semicompliant balloon coated with antiproliferative agents encapsulated in a polymer matrix, which is released into the wall after inflation and contact with the intima. DCB have demonstrated effectiveness in treating in-stent restenosis. Clinical studies using DCB in de novo coronary artery disease have shown mixed results, with a major benefit in small-vessel disease. Differences in study results are not only due to variations in DCB technology but also to disparity in procedural approach, "leave nothing behind" or "combination therapy," and vessel size. This review focuses on the available evidence from randomized trials and proposes a design for future clinical trials.

Incidence, predictors and impact of stroke on mortality among patients with acute coronary syndromes following percutaneous coronary intervention-Results from the PROMETHEUS registry.

BACKGROUND: Stroke represents a potentially calamitous complication among patients with acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI). Data on the distribution of stroke occurrence post-PCI and its impact on mortality are scarce. OBJECTIVES: We sought to determine the incidence, predictors and impact of stroke on mortality in ACS patients undergoing PCI. METHODS: A total of 19,914 ACS patients underwent PCI in the PROMETHEUS multicenter observational study. We calculated the cumulative stroke incidence at 30 days and 1 year using the Kaplan Meier method. We also compared the distribution of stroke, myocardial infarction (MI), and bleeding across time and evaluated their overlap. Predictors of stroke were identified through multivariable Cox-regression. Stroke, MI, and bleeding were assessed as time-updated covariates to estimate how each impacts subsequent mortality. RESULTS: We found that 244 patients had a stroke within 1 year, a cumulative incidence of 1.5%. Previous cerebrovascular disease was the strongest predictor for post-PCI stroke, followed by ST-elevation MI presentation, hypertension, non-ST-elevation MI presentation, smoking, female sex, and age. Mortality risk was significantly higher among those who had a stroke versus those who did not (adjusted HR 4.84, p < .0001). However, the association attenuated over time with a much larger effect in the first 30 days of its occurrence (adjusted HR 17.7; 95% CI: 12.3-25.4, p < .0001) versus beyond 30 days (adjusted HR 1.22; 95% CI: 0.6-2.46, p = .58). CONCLUSIONS: Stroke occurrence within 1 year was not uncommon for ACS patients undergoing PCI. When compared with MI and bleeding, stroke had a substantial impact on mortality that attenuated rapidly over time.

Safety gaps in medical team communication: Results of quality improvement efforts in a cardiac catheterization laboratory.

OBJECTIVES: To assess closed-loop communications (readback), a fundamental aspect of effective communication, among cardiovascular teams and assess improvement efforts. BACKGROUND: Effective communication within teams is essential to assure safety and optimal outcomes. Readback of verbal physician orders is a hospital and national requirement. METHODS: Single-center observational study, where the readback responses to physician verbal orders in the catheterization laboratory were characterized over three distinct time intervals from 2015 to 2017. Performance feedback and focused education on the value of readbacks was provided to the teams in two waves, with subsequent remeasurement. Responses to verbal orders were characterized as complete (all important parameters of the order repeated for verification), partial, acknowledgement only, or no response. Changes in readback performance after quality interventions were assessed. RESULTS: During the first-observational period of 101 cases, complete readback occurred in 195 of 515 (38%) medication orders and 136 of 235 (58%) equipment orders. After initial quality improvement efforts, 102 cases were observed. In these, 298 of 480 (62%) medication orders had complete readback, and 210 of 420 (50%) equipment orders had complete readback. After additional quality improvement efforts, 168 cases were observed. In these, 506 of 723 (70%) medication orders had complete readback, and 630 of 1,061 (59%) equipment orders had complete readback. Overall, medication order readback improved over time (correlation = 0.26 [-0.30, -0.21]; p < 0.001), but equipment order readback did not (correlation = 0.02 [-0.07, 0.03]; p = 0.44). CONCLUSIONS: Closed-loop communication of physician verbal orders was used infrequently in this medical team setting and proved difficult to fully improve. This is an important safety gap.

Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis and Prior External Chest Radiation.

BACKGROUND/PURPOSE: Surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (AS) and prior chest radiation is associated with poor outcomes in comparison with patients without prior radiation. Our objective was to compare clinical outcomes of patients with and without prior chest radiation undergoing transcatheter aortic valve replacement (TAVR) for symptomatic severe AS. METHODS/MATERIALS: Between January 2003 and January 2017, 1150 patients underwent TAVR at our institution. Of these, 44 had prior chest radiation. Baseline demographic and clinical characteristics, procedural details, and clinical outcomes were prospectively collected. RESULTS: Patients with prior chest radiation were younger, 76 ±â€¯13 years, compared with those without prior chest radiation, 82 ±â€¯8 years (p = 0.002). Median Society of Thoracic Surgeons score for chest radiation patients was 7 ±â€¯4, compared to 8 ±â€¯5 in those without prior radiation. Despite higher prevalence of complete heart block, there was no significant difference between the 2 groups with regard to the need for permanent pacemaker implantation. There was a trend toward longer length of intensive care unit stay in chest radiation patients, but there was no significant difference in 30-day or 1-year mortality. CONCLUSIONS: Thus, TAVR appears to be a safe treatment option in the short and medium term for patients with symptomatic severe AS and prior chest radiation.

Lifestyle, Glycosylated Hemoglobin A1c, and Survival Among Patients With Stable Ischemic Heart Disease and Diabetes.

BACKGROUND: The importance of glycosylated hemoglobin A1c (A1c) control as part of comprehensive risk factor management in patients with stable ischemic heart disease (SIHD) and diabetes mellitus (DM) is controversial. OBJECTIVES: The purpose of this study was to determine whether a greater number of controlled risk factors at 1 year, including A1c, affects survival in patients with DM and SIHD. METHODS: Of 690 patients with DM followed in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, 592 (86%) had complete ascertainment of 7 pre-specified risk factors at baseline and after 1 year: systolic blood pressure, low-density lipoprotein cholesterol, nonsmoking, physical activity, diet adherence, body mass index, and A1c. The primary outcome measure was mortality beyond 1 year after randomization. RESULTS: During a mean follow-up of 7.0 ± 4.2 years beyond 1 year after randomization, 186 subjects died (31.4% overall, 4.5%/year). The greater the number of risk factors controlled at 1 year, the higher the probability of survival (unadjusted log rank p = 0.002). Compared with 0 to 1 controlled risk factors, attaining 3 to 7 goals predicted progressively lower mortality (hazard ratio for control of 6 or 7 risk factors was 0.13; 95% confidence interval: 0.05 to 0.40). Importantly, only 10.3% of subjects achieved control of 6 or 7 risk factors. In multivariate analysis, the strongest predictors of improved survival were no smoking, regular physical activity, dietary adherence, and A1c <7%. CONCLUSIONS: In this high-risk subset of SIHD patients with DM, the number of controlled risk factors, particularly lifestyle behaviors and A1c, were associated with improved survival. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657).

Relation of Sex and Race to Outcomes in Patients Undergoing Percutaneous Intervention With Drug-Eluting Stents.

Cardiovascular disease is the leading cause of death in men and women, black and white. However, there exists limited outcomes data for women and blacks after percutaneous coronary intervention (PCI). The aim of this study was to evaluate the 1-year major cardiovascular events in patients who underwent PCI based on gender and race. We retrospectively analyzed data that were prospectively collected over 13 years at a large tertiary hospital in the United States. There were 12,050 patients who underwent PCI for both stable disease and acute coronary syndrome from 2003 to 2016. Of those, 1,952 were black men, 6,013 white men, 1,619 black women, and 2,466 white women. Major cardiovascular events at 1 year were assessed, and proportional Cox hazard model analyses were performed to assess outcome adjusted for confounding factors (i.e., age, body mass index, presentation with acute myocardial infarction, diabetes, smoking, history of coronary artery disease, family history of coronary artery disease, hyperlipidemia, hypertension, previous cardiovascular intervention, and chronic kidney disease). At 1 year, white men had significantly lower major cardiovascular events driven by lower rate of death compared with the other groups. Adjusted for confounders, major cardiovascular events were 1.3 to 1.5 times more likely to occur in black men and women and white women than in white men. There was a significant race by gender interaction (p <0.001).

Use of prasugrel vs clopidogrel and outcomes in patients with and without diabetes mellitus presenting with acute coronary syndrome undergoing percutaneous coronary intervention.

BACKGROUND: Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear. METHODS: PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS: We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabetic patients both at 90 days and 1 year. CONCLUSIONS: Use of prasugrel in diabetic patients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel.