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Background The hybrid approach to chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has significantly increased procedural success rates, yet some cases still fail. We sought to evaluate the causes of failure in a contemporary CTO PCI registry. Methods We examined 380 consecutive patients who underwent CTO-PCI at 4 high volume CTO PCI centers in the United States using the “hybrid” approach. Clinical, angiographic, complication, and efficiency outcomes were compared between successful and failed cases. Failed cases were individually reviewed by an independent reviewer to determine the cause of failure. Results Procedural success was 91.3%. Compared with patients in whom CTO PCI was successful, those in whom CTO PCI failed had similar baseline clinical characteristics, but were more likely to have longer occlusion length, more tortuosity, more proximal cap ambiguity and blunt stump, and higher mean J-CTO scores (2.8 ± 1.1 vs. 3.5 ± 1.0, P

Objectives To examine the impact of transradial access on the procedural outcomes of chronic total occlusion (CTO) percutaneous coronary interventions (PCI). Background The efficacy and safety of transradial access in CTO PCI has received limited study. Methods We compared the technique and outcomes of transradial vs. transfemoral access among 650 CTO PCI cases performed between January 2012 and March 2014 at 6 US centers. Results Most patients were men (87%) with high frequency of diabetes mellitus (42%) and prior coronary artery bypass graft surgery (36%). The CTO target vessel was the right coronary (59%), left anterior descending (20%), or circumflex (17%) artery. TR access was used in 110 (17%) of the 650 cases, as follows: bilateral radial access (63%); bilateral radial access plus unilateral or bilateral femoral access (7%); unilateral radial access plus unilateral or bilateral femoral access (26%); and unilateral radial access (4%). Six and eight French guide catheters were used through the radial and femoral artery, respectively. Compared to transfemoral, transradial cases had similar technical (92.6% vs. 93.0%, P = 0.87) and procedural (91.1% vs. 90.0%, P = 0.95) success and major complication rates (1.7% vs 1.8%, P = 0.99). However, transradial access was associated with higher mean procedure (142 ± 83 vs. 120 ± 60 min, P = 0.008) and fluoroscopy (58 ± 40 vs. 49 ± 31 min, P

We investigated the relation between overall atheroma burden and clinical events in the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study. In PROSPECT, 660 patients (3,229 nonculprit lesions with a plaque burden >= 40% and complete intravascular ultrasound data) were divided into tertiles according to baseline percent atheroma volume (PANT: total plaque/vessel volume). Patients were followed for 3.4 years (median); major adverse cardiac events (MACE: death from cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization because of unstable or progressive angina) were adjudicated to either culprit or nonculprit lesions. Compared with patients in low or intermediate PAV tertiles, patients in the high PAY tertile had the greatest prevalence of plaque rupture and radiofrequency thin-cap fibroatheroma (VH-TCFA) and the highest percentage of necrotic core volume; they were also more likely to have high-risk lesion characteristics: lesion with minimal luminal area 70%, and/or VH-TCFA. Three-year cumulative nonculprit lesion-related MACE was greater in the intermediate and high tertiles than in the low tertile (6.3% vs 14.7% vs 15.1%, low vs intermediate vs high tertiles, p = 0.009). On Cox multivariable analysis, insulin-dependent diabetes (hazard ratio [HR] 3.98, p = 0.002), PAY (HR 1.06, p = 0.03), and the presence of >= 1 VH-TCFA (HR 1.80, p = 0.02) were independent predictors of nonculprit MACE. In conclusion, increasing baseline overall atheroma burden was associated with more advanced, complex, and vulnerable intravascular ultrasound lesion morphology and independently predicted nonculprit lesion-related MACE in patients with acute coronary syndromes after successful culprit lesion intervention. (C) 2015 Elsevier Inc. All rights reserved.

OBJECTIVE In the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) cardiovascular (CV) outcomes trial (NCT01179048), liraglutide significantly reduced the risk of CV events (by 13%) and hypoglycemia versus placebo. This post hoc analysis examines the associations between hypoglycemia and CV outcomes and death. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and high risk for CV disease (n = 9,340) were randomized 1:1 to liraglutide or placebo, both in addition to standard treatment, and followed for 3.5–5 years. The primary end point was time to first major adverse cardiovascular event (MACE) (1,302 first events recorded), and secondary end points included incidence of hypoglycemia. We used Cox regression to analyze time to first MACE, CV death, non-CV death, or all-cause death with hypoglycemia as a factor or time-dependent covariate. RESULTS A total of 267 patients experienced severe hypoglycemia (liraglutide n = 114, placebo n = 153; rate ratio 0.69; 95% CI 0.51, 0.93). These patients had longer diabetes duration, higher incidence of heart failure and kidney disease, and used insulin more frequently at baseline than those without severe hypoglycemia. In combined analysis (liraglutide and placebo), patients with severe hypoglycemia were more likely to experience MACE, CV death, and all-cause death, with higher risk shortly after hypoglycemia. The impact of liraglutide on risk of MACE was similar in patients with and without severe hypoglycemia (P-interaction = 0.90). CONCLUSIONS Patients experiencing severe hypoglycemia were at greater risk of CV events and death, particularly shortly after the hypoglycemic episode. While causality remains unclear, reducing hypoglycemia remains an important goal in diabetes management.

The Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) was a double-blind, randomised, event-driven, treat-to-target prospective trial comparing the cardiovascular safety of insulin degludec with that of insulin glargine U100 (100 units/ml) in patients with type 2 diabetes at high risk of cardiovascular events. This paper reports a secondary analysis investigating associations of day-to-day fasting glycaemic variability (pre-breakfast self-measured blood glucose [SMBG]) with severe hypoglycaemia and cardiovascular outcomes. In DEVOTE, patients with type 2 diabetes were randomised to receive insulin degludec or insulin glargine U100 once daily. The primary outcome was the first occurrence of an adjudicated major adverse cardiovascular event (MACE). Adjudicated severe hypoglycaemia was the pre-specified secondary outcome. In this article, day-to-day fasting glycaemic variability was based on the standard deviation of the pre-breakfast SMBG measurements. The variability measure was calculated as follows. Each month, only the three pre-breakfast SMBG measurements recorded before contact with the site were used to determine a day-to-day fasting glycaemic variability measure for each patient. For each patient, the variance of the three log-transformed pre-breakfast SMBG measurements each month was determined. The standard deviation was determined as the square root of the mean of these monthly variances and was defined as day-to-day fasting glycaemic variability. The associations between day-to-day fasting glycaemic variability and severe hypoglycaemia, MACE and all-cause mortality were analysed for the pooled trial population with Cox proportional hazards models. Several sensitivity analyses were conducted, including adjustments for baseline characteristics and most recent HbA1c. Day-to-day fasting glycaemic variability was significantly associated with severe hypoglycaemia (HR 4.11, 95% CI 3.15, 5.35), MACE (HR 1.36, 95% CI 1.12, 1.65) and all-cause mortality (HR 1.58, 95% CI 1.23, 2.03) before adjustments. The increased risks of severe hypoglycaemia, MACE and all-cause mortality translate into 2.7-, 1.2- and 1.4-fold risk, respectively, when a patient’s day-to-day fasting glycaemic variability measure is doubled. The significant relationships of day-to-day fasting glycaemic variability with severe hypoglycaemia and all-cause mortality were maintained after adjustments. However, the significant association with MACE was not maintained following adjustment for baseline characteristics with either baseline HbA1c (HR 1.19, 95% CI 0.96, 1.47) or the most recent HbA1c measurement throughout the trial (HR 1.21, 95% CI 0.98, 1.49). Higher day-to-day fasting glycaemic variability is associated with increased risks of severe hypoglycaemia and all-cause mortality. ClinicalTrials.gov NCT01959529

Aims/hypothesis The double-blind Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) assessed the cardiovascular safety of insulin degludec. The incidence and rates of adjudicated severe hypoglycaemia, and all-cause mortality were also determined. This paper reports a secondary analysis investigating associations of severe hypoglycaemia with cardiovascular outcomes and mortality. Methods In DEVOTE, patients with type 2 diabetes were randomised to receive either insulin degludec or insulin glargine U100 (100 units/ml) once daily (between dinner and bedtime) in an event-driven, double-blind, treat-to-target cardiovascular outcomes trial. The primary outcome was the first occurrence of an adjudicated major adverse cardiovascular event (MACE; cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). Adjudicated severe hypoglycaemia was the pre-specified secondary outcome. In the present analysis, the associations of severe hypoglycaemia with both MACE and all-cause mortality was evaluated in the pooled trial population using time-to-event analyses, with severe hypoglycaemia as a time-dependent variable and randomised treatment as a fixed factor. An investigation with interaction terms indicated that the effect of severe hypoglycaemia on the risk of MACE and all-cause mortality were the same for both treatment arms, and so the temporal association for severe hypoglycaemia with subsequent MACE and all-cause mortality is reported for the pooled population. Results There was a non-significant difference in the risk of MACE for individuals who had vs those who had not experienced severe hypoglycaemia during the trial (HR 1.38, 95% CI 0.96, 1.96; p = 0.080) and therefore there was no temporal relationship between severe hypoglycaemia and MACE. There was a significantly higher risk of all-cause mortality for patients who had vs those who had not experienced severe hypoglycaemia during the trial (HR 2.51, 95% CI 1.79, 3.50; p

This study sought to accurately describe the success rate, risks, and patient-reported benefits of contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI).In light of the evolving techniques to successfully revascularize CTO lesions, there remains a compelling need to more accurately quantify the success rates, risks, and benefits of these complex procedures.Using a uniquely comprehensive, core-lab adjudicated, single-arm, multicenter registry of 1,000 consecutive patients undergoing CTO PCI by the hybrid approach, we evaluated the technical success rates, complication rates, and raw and adjusted health status benefits at 1 month among successfully as compared to unsuccessfully treated patients.Technical success was high (86%). In-hospital and 1-month mortality was 0.9% and 1.3%, respectively, and perforations requiring treatment occurred in 48 patients (4.8%). Among those who survived and completed the 1-month interview (n = 947), mean ± SEM Seattle Angina Questionnaire quality of life scores improved from 49.4 ± 0.9 to 75.0 ± 0.7 (p 0.01), mean Rose Dyspnea Scale scores improved (decreased) from 2.0 ± 0.1 to 1.1 ± 0.1 (p 0.01), and physician health questionnaire (for depression) scores improved (decreased) from 6.2 ± 0.2 to 3.5 ± 0.1 (p 0.01) at 1 month. After adjusting for baseline differences the mean group difference in Seattle Angina Questionnaire quality of life between successful and unsuccessful CTO PCI was 10.8 (95% confidence interval: 6.3 to 15.3; p 0.001).Clarifying the success rates, risks, and benefits of CTO PCI will help to more accurately contextualize the informed consent process for these procedures so that patients with appropriate indications for CTO PCI can more effectively share in the decision to pursue this or other therapeutic options.

Technical advances and the development of the Hybrid algorithm have been associated with higher success rates in chronic total occlusion percutaneous coronary intervention (CTO-PCI). Nevertheless, there are still intraprocedural obstacles that result in failure or prolonged procedure time. The Excimer coronary laser (EL) has been repurposed in CTO-PCI to overcome such obstacles. This case series illustrates the use of the EL in four technically complex scenarios including the balloon resistant lesion, the impenetrable proximal cap, device resistance in stent restenosis, and difficulty with device tracking in the subintima. © 2014 Wiley Periodicals, Inc.

In this issue of the Journal , Dangas et al. [(1)][1] report on an important subgroup of patients from the FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial, a trial in which patients with type 2 diabetes mellitus (T2DM) and

Background Blood transfusion is controversial for anemic patients with acute myocardial infarction (AMI), with some previous studies reporting increased risk of transfusion-associated mortality. Objectives The goal of this study was to examine variability in blood transfusions across hospitals and the relationship between blood transfusion and in-hospital mortality in a large, contemporary cohort of consecutive AMI patients. Methods Among 34,937 AMI hospitalizations from 57 centers, patients receiving at least 1 packed red blood cell transfusion were compared with those who were not transfused. Using 45 disease severity, comorbidity, laboratory, and in-hospital treatment variables, we propensity matched patients who did and did not receive a packed red blood cell transfusion. A conditional logistic regression model was used to identify the association between transfusion and in-hospital mortality. Results A total of 1,778 patients (5.1%) had at least 1 transfusion. In unadjusted analyses, transfusion was associated with higher in-hospital mortality (odds ratio: 2.05 [95% confidence interval: 1.76 to 2.40]). The vast majority of patients (91.1%) with and without transfusion had nonoverlapping propensity scores, reflecting incomparable clinical profiles. Thus, they were excluded from the propensity-matched analyses. After propensity matching those with overlapping scores, blood transfusion was associated with a reduced risk of in-hospital death (odds ratio: 0.73 [95% confidence interval: 0.58 to 0.92]). Conclusions The majority of patients undergoing blood transfusion in clinical practice cannot be matched with nontransfused patients due to their markedly different clinical profiles. Among comparable patients, blood transfusion was associated with a lower risk of in-hospital mortality. These findings suggest that previous observational reports of increased mortality with transfusion may have been influenced by selection bias, and they highlight the need for randomized trials to establish the role of transfusion during AMI.

Objectives The present study aimed to assess the pharmacodynamic response of a prasugrel 60-mg loading dose (LD) alone compared with prasugrel 60 mg added to clopidogrel 600 mg. Background Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) commonly receive a clopidogrel LD prior to angiography. Switching these patients to prasugrel may be desirable because higher platelet inhibition is expected. Methods In this open-label, multicenter, nonrandomized trial, 75 patients were categorized into 2 treatment strategies: Those who received a clopidogrel 600-mg LD and received a reloading dose of prasugrel 60 mg (clopidogrel/prasugrel group) and those who did not receive a clopidogrel LD and received a prasugrel 60-mg LD (prasugrel group). Platelet reactivity was assessed using VerifyNow P2Y12 reaction units (PRU) and Platelet Reactivity Index vasodilator-stimulated phosphoprotein phosphorylation (PRI-VASP) at 3 different times: at the sheath insertion prior to prasugrel LD, 4 hours after prasugrel LD, and at discharge. Results Four hours after prasugrel LD, platelet reactivity did not differ between the clopidogrel/prasugrel group and the prasugrel group according to the VerifyNow assay (median PRU 23 [5–71] vs. 54 [5–91], respectively; P = 0.18) and the VASP assay (median PRI 8.67 [4.51–16.85] versus 8.03 [4.82–21.72], respectively; P = 1.0). No significant differences in PRU and PRI were observed at discharge. Few bleeding events were reported without any significant differences between the 2 groups. Conclusions Platelet reactivity with prasugrel 60 mg added to a clopidogrel 600-mg LD was not significantly different compared with prasugrel 60 mg alone in ACS patients undergoing PCI. (J Interven Cardiol 2014;27:365–372)

ObjectivesGlagov proposed that remodeling delayed development of significant coronary artery stenoses until plaque occupied, on average, 40% of arterial area (40% plaque burden). The aim of the current study was to confirm the previously proposed concept of coronary remodeling as first described by Glagov who studied postmortem left main coronary arteries (LMCAs).MethodsUsing the in-vivo intravascular ultrasound data from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study, we evaluated 552 LMCAs in 552 patients.ResultsExternal elastic membrane cross-sectional areas (CSAs) increased in proportion to the increase in plaque and media CSAs (r=0.61, P40% plaque burden), there was an inverse relationship between lumen CSA and plaque burden (r=-0.57, P

Despite increasing complexity of contemporary procedures at tertiary care hospitals, the relationship between interventional cardiology fellows-in-training (ICFITs) and complications of percutaneous coronary intervention (PCI) has not been reported. We compiled logbooks of 6 ICFITs at an academic hospital and evaluated patient and procedural characteristics of PCIs performed with and without presence of an ICFIT. The primary end point was the composite of all in-hospital PCI complications defined by the American College of Cardiology's National Cardiovascular Data Registry: (1) catheterization laboratory events such as no-reflow and dissection/perforation, (2) general clinical events such as stroke or cardiogenic shock, (3) vascular and bleeding complications, and (4) miscellaneous complications such as peak troponin or creatinine levels. Logistic regression adjusted for differences in measured confounders between patients treated with and without presence of an ICFIT. All analyses were repeated after excluding PCI for ST-elevation myocardial infarction. Of 2,605 PCI procedures at the academic hospital between July 2007 and April 2010, an ICFIT was present for 1,638 procedures (63%). Despite having worse clinical and procedural characteristics, patients in the ICFIT group experienced similar rates of the composite end point (12.9% vs 14.5% without ICFIT, p = 0.27). Longer mean fluoroscopy times and greater number of stents were noted in the ICFIT group; however, hospital length of stay was shorter and no individual adverse events were increased in the ICFIT procedures. Presence of an ICFIT remained unrelated to the composite end point after multivariable adjustment (odds ratio 0.92, 95% confidence interval 0.71 to 1.20; p = 0.53), and findings were similar after excluding PCI for ST-elevation myocardial infarction. In conclusion, in contemporary practice at a large academic medical center, PCI complication rates were not adversely affected by the presence of an ICFIT.

Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality. The retrograde approach has been reported to have higher complication rates than the antegrade approach. However, these

Background Several percutaneous coronary intervention (PCI) trials have established that the use of bivalirudin (BIV) is associated with improved patient outcomes and substantial hospital cost savings, relative to heparin (HEP)-based regimens ± glycoprotein IIb/IIIa inhibitors (GPIs). Whether these benefits persist with the use of prasugrel, a new third-generation oral thienopyridine, has not been previously evaluated. Methods Using the Premier hospital database, 6986 patients treated with prasugrel who underwent elective, urgent, or primary PCI between quarter 3, 2009 and quarter 4, 2010 from 166 US hospitals were identified. These patients received either BIV (n = 3377) or HEP ± GPI (n = 3609) as procedural anticoagulation. Outcomes of interest included bleeding, transfusions, death, and hospital length of stay (LOS). To control for patient and hospital-level characteristics, propensity score-matching (PSM) analyses were performed. Results Mortality, clinically apparent bleeding, clinically apparent bleeding requiring transfusion, any transfusions, and LOS were all lower in patients treated with BIV as compared with patients treated with HEP ± GPI. After PSM, the rate of transfusion was significantly lower with BIV (odds ratio: 0.57, 95% confidence interval: 0.34-0.96), and the hospital LOS was significantly shorter in patients treated with BIV compared with those treated with HEP ± GPI (0.9 ± 2.0 vs 1.2 ± 2.3 days, P < 0.0001). Conclusions In patients undergoing PCI and treated with prasugrel, the use of BIV rather than HEP ± GPI is associated with significantly lower transfusion rate and LOS. These results suggest that the previously documented safety and cost-effectiveness benefits of BIV remain applicable when prasugrel is used.

Background— Bleeding is a common, noncardiac, preventable complication of percutaneous coronary intervention. We compared the relative safety of radial access and bivalirudin in percutaneous coronary intervention. Methods and Results— From CathPCI Registry, we determined the association between the site of arterial access, bivalirudin, and periprocedural bleeding rates in 501 017 patients. Radial access patients receiving heparin (radial group) were compared with those receiving bivalirudin (radial combination group). Femoral access patients who had bivalirudin and a vascular closure device served as a reference group (femoral group). An inverse probability weighting analysis incorporating propensity scores was used to compare groups. The overall rate of bleeding was 2.59%. It was 2.71% in the femoral group, 2.5% in the radial group, and 1.82% in the radial combination groups ( P Conclusions— In this observational analysis, the combination of bivalirudin and radial access was associated with reduced bleeding event rate. This benefit was present across the entire spectrum of preprocedural risk of bleeding, with or without exposure to IIb/IIIa inhibitors. These data support an adequately powered randomized trial comparing bleeding avoidance strategies.

Objectives The purpose of this study was to examine use and describe outcomes of radial access for percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Background Transradial PCI (TRI) is associated with reduced risk of bleeding and vascular complications, as compared with femoral access PCI (FPCI). Studies have suggested that TRI may reduce mortality among patients with STEMI. Methods We examined 294,769 patients undergoing PCI for STEMI at 1,204 hospitals in the CathPCI Registry between 2007 and 2011. Patients were grouped according to access site used for PCI. The temporal trend in the rate of radial versus femoral approach was determined. For minimization of confounding, an inverse probability weighting analysis incorporating propensity scores was used to compare procedural success, post-PCI bleeding, door-to-balloon times, and in-hospital mortality between radial and femoral access. Results Over the 5-year period, the use of TRI versus FPCI in STEMI increased from 0.9% to 6.4% (p Conclusions In this large national database, use of radial access for PCI in STEMI increased over the study period. Despite longer door-to-balloon times, the radial approach was associated with lower bleeding rate and reduced in-hospital mortality. These data provide support to execute an adequately powered randomized controlled trial comparing radial and femoral approaches for PCI in STEMI.

Objectives The authors sought to study the characteristics and outcomes of patients with contralateral carotid artery occlusions (CCOs) undergoing elective carotid artery stenting (CAS). Background CCOs are associated with adverse neurological events following carotid endarterectomy. Methods In-hospital outcomes were examined in patients with and without CCO undergoing elective CAS in the Carotid Artery Revascularization and Endarterectomy (CARE) registry. A CCO was defined as a 100% occlusion of the contralateral internal carotid artery. To minimize differences in measured comorbidities, a 3:1 propensity matching analysis was performed comparing 42 clinical and demographic variables between CCO and non-CCO patients from the CARE registry. The primary endpoint was a composite of in-hospital death, nonfatal myocardial infarction, and nonfatal stroke. Results Between April 2005 and January 2012, 13,993 eligible patients underwent elective CAS, of whom 1,450 (10%) had CCO. There were 5,500 CAS procedures (1,375 CCO and 4,125 non-CCO) identified in the propensity analysis. The primary composite endpoint occurred in 29 (2.1%) and 107 (2.6%) patients with and without CCO, respectively (adjusted odds ratio: 0.81, 95% confidence interval: 0.53 to 1.23, p = 0.316). Conclusions In the CARE registry, there was no evidence that the presence of a CCO was associated with an increased risk of in-hospital death, nonfatal myocardial infarction, or nonfatal stroke in patients undergoing elective CAS. These findings may have implications on the selection of carotid revascularization procedures for such patients.

To evaluate the feasibility, effectiveness, and safety of intravenous exenatide to control hyperglycemia in the cardiac intensive care unit (CICU).A prospective, single-center, open-label, nonrandomized pilot study. Forty patients admitted to the CICU with glucose levels of 140 to 400 mg/dL received intravenous exenatide as a bolus followed by a fixed dose infusion for up to 48 hours. Exenatide effectiveness was benchmarked to two historical insulin infusion cohorts, one (INT) with a target glucose of 90 to 119 mg/dL (n = 84) and the other (MOD) with a target of 100 to 140 mg/dL (n = 71).Median admission glucose values were 185.5 mg/dL (161.0, 215.5), 259.0 mg/dL (206.0, 343.0), and 189.5 mg/dL (163.5, 245.0) in the exenatide, MOD, and INT groups, respectively (P.001). Steady state glucose values were similar between the exenatide (132.0 mg/dL [110.0, 157.0]) and the MOD groups (127.0 mg/dL [105.0, 161.0], P = .15), but lower in the INT group (105.0 mg/dL [92.0, 128.0], P.001 for exenatide versus INT). Median (IQR) time to steady state was 2.0 hours (1.5, 5.0) in the exenatide group compared to 12.0 hours (7.0, 15.0) in the MOD group (P.001) and 3.0 hours (1.0, 5.0) in the INT group (P = .80 for exenatide versus INT). Exenatide was discontinued in 3 patients after failure to achieve glycemic control. No episodes of severe hypoglycemia (50 mg/dL) occurred in patients who received exenatide. Nausea was reported by 16 patients and vomiting by 2 patients.Intravenous exenatide is effective in lowering glucose levels in CICU patients, but its use may be limited by nausea.

Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure.To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs.Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar.OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.

The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous coronary intervention (PCI), on hospital costs.PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown.In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed.Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval [CI]: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p 0.0001). Shifting current practice from transfemoral intervention non-same-day discharge to TRI SDD by 30% could potentially save a hospital performing 1,000 PCIs each year $1 million and the country $300 million annually.Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs.

The authors performed a meta-analysis of randomized controlled trials to compare the efficacy of initial endovascular treatment with or without supervised exercise training (SET) versus SET alone in patients with intermittent claudication.Current guidelines recommend SET as the initial treatment modality for patients with intermittent claudication, in addition to optimal medical therapy. The role of endovascular therapy as primary treatment for claudication has been controversial.The primary outcome was treadmill-measured maximal walk distance at the end of follow-up. Secondary outcomes included resting ankle brachial index (ABI) and treadmill-measured ischemic claudication distance on follow-up. Risk of revascularization or amputations was also compared. Pooled estimates of the difference in outcomes between endovascular therapy with or without SET and SET-only groups were calculated using fixed and random effects models.A total of 987 patients from 7 trials were included. In pooled analysis, compared with SET only (reference group), patients that underwent combined endovascular therapy and SET had significantly higher maximum walk distance (standardized mean difference 0.79 [95% confidence interval (CI): 0.18 to 1.39]; weighted mean difference 98.9 [95% CI: 31.4 to 166.4 feet], and lower risk of revascularization or amputation (odds ratio 0.19 [95% CI: (0.09 to 0.40]; p 0.0001, number needed to treat = 8) over a median follow-up of 12.4 months. By contrast, revascularization was not associated with significant improvement in exercise capacity or risk of future revascularization or amputation, compared with SET alone. Follow-up ABI was significantly higher among patients that underwent endovascular therapy with or without SET as compared with SET alone.Compared with initial SET only, endovascular therapy in combination with SET is associated with significant improvement in total walking distance, ABI, and risk of future revascularization or amputation. By contrast, endovascular therapy-only was not associated with any improvement in functional capacity or clinical outcomes over an intermediate duration of follow-up.

Doctor, “you gotta let me know. Should I stay or should I go?” This (modified) version of The Clash’s song is a fundamental question for physicians and patients after elective percutaneous coronary intervention (PCI). In the current paradigm, third-party payers dictate that the vast majority of patients irrespective of risk should go. The driving force behind this is almost entirely financial. We think this care paradigm must evolve. The Centers for Medicare and Medicaid Services (CMS) is the largest payer for PCI procedures in the United States. In recent years, CMS has made several modifications to reimbursement for PCI procedures.1,2 An important aspect of reimbursement is whether PCI is performed in an inpatient or outpatient setting. Although these are fairly intuitive terms, they are in fact not related to duration of hospitalization and historically have carried different implications for reimbursement purposes. Overall, there appeared to be a significant financial advantage to institutions for performing inpatient PCI: reimbursement under the more lucrative Diagnostic-Related Group system rather than the Ambulatory Payment Classification system, as also illustrated by Vora et al in this issue of Circulation: Cardiovascular Interventions .3 What is interesting is that, in this construct, an outpatient PCI could in fact be in the hospital for several days after, whereas an inpatient PCI could be discharged the next day. See Article by Vora et al Recognizing that cardiovascular services, particularly inpatient procedures, contributed heavily to escalating healthcare costs, CMS pursued several measures to rein in costs and reduce overpayments. One of them was …

DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued. The primary end point was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Patients with T2D at high risk of cardiovascular complications were randomized 1:1 to receive either IDeg or IGlar, each added to background therapies. This trial was designed to demonstrate statistical noninferiority of IDeg vs IGlar for the primary end point. DEVOTE enrolled 7,637 patients between October 2013 and November 2014 at 436 sites in 20 countries. Of these, 6,506 patients had prior cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors. DEVOTE was designed to provide conclusive evidence regarding the cardiovascular safety of IDeg relative to IGlar in a high-risk population of patients with T2D.

To explore the association of health status change and long-term survival among patients with symptomatic peripheral artery disease (PAD).Early gains in health status after successful endovascular therapy (EVT) for symptomatic PAD can be maintained up to 1 year. Whether such health status improvements are associated with long-term survival benefits is unknown.Between February 2001 and August 2004, 258 patients with symptomatic PAD treated with EVT participated in a prospective study evaluating baseline and 1 year health status using the Peripheral Artery Questionnaire (range 0-100, higher scores = better). All-cause mortality was assessed for all patients at a median of 9.4 years following EVT.The mean age at enrollment was 68 ± 11 years; 61% were male, 97% were Caucasian, and 38% had diabetes. Patients with a clinically meaningful health status improvement (≥8 points) 1 year after their index procedure (79%) were identified as responders. Responders had a significantly better 10 year survival compared with nonresponders (60% vs 38%, p = 0.025). Responder status was associated with a survival advantage that persisted in risk-adjusted analysis (adjusted hazard ratio for long-term mortality, 0.66 [95% CI, 0.45-0.97]; p = 0.036).Among patients with symptomatic PAD undergoing EVT, improvement of PAD-specific health status at 1 year follow-up was associated with improved long-term survival. Whether additional treatment for patients with poor response to EVT could improve long-term survival warrants further investigation. © 2016 Wiley Periodicals, Inc.

Contains fulltext : 170859.pdf (Publisher’s version ) (Open Access) AIMS: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity. METHODS: Baseline data, stratified for prior cardiovascular disease (CVD), were compared using multivariable logistic regression analysis to establish whether region is an independent determinant of achieved targets for glycated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL)-cholesterol. RESULTS: Independent of CVD history, US participants were more often of non-White origin and had a longer history of type 2 diabetes, higher body weight, and higher baseline HbA1c. They had substantially lower systolic and diastolic BP, and a marginally lower LDL-cholesterol level. Fewer US participants were diagnosed with left ventricular dysfunction. In the largest group of patients, those with prior CVD and the highest cardiovascular risk, US participants were more often female, had a higher waist circumference, and had a decreased estimated glomerular filtration rate, but less frequently prior myocardial infarction or angina pectoris. CONCLUSIONS: There were baseline differences between US and European participants. These differences may result from variation in regional targets for cardiovascular risk factor management, and should be considered in the analysis and reporting of the trial results. Clinical trial identifier: ClinicalTrials.gov, NCT01179048.

There remains a pressing need in the interventional cardiology community to narrow the existing gap in the success rates, safety, and efficiency of chronic total occlusion percutaneous coronary intervention (CTO-PCI) relative to non CTO-PCI. Success rates for non CTO-PCI are high (>98 %). The success rates of CTO-PCI at experienced CTO-PCI centers are catching up (>90 %) but are likely much lower (50–70 %) at the vast majority of other PCI centers. Complication rates appear to be equal between CTO and non-CTO procedures at experienced CTO centers but may not be at others. CTO-PCI is associated with higher procedural time, contrast use, radiation exposure and supply cost than non CTO PCI even at experienced CTO-PCI centers. Thus, a wide variability in the CTO-PCI cases being attempted persists in large part due to these gaps. This chapter provides an overview of the new expanded hybrid approach, commonly employed by successful CTO operators.

Thin cap fibroatheroma (TCFA) in coronary arteries is believed to be associated with plaque rupture leading to cardiovascular death and non-fatal myocardial infarction. Catheter-based imaging platforms can identify TCFAs but detection algorithms lack specificity. Here we report results of an exploratory study of the variability in TCFA plaque attributes and effects on peak von Mises stress of TCFA using idealized finite element models. A total of 1272 idealized TCFA finite element models were developed by strategically varying attribute dimensions – external elastic membrane diameter, lumen diameter, necrotic core thickness, fibrous cap thickness, and necrotic core angle – obtained from a global registry of subjects undergoing percutaneous coronary intervention with Virtual Histology intravascular ultrasound. Peak stress exhibited parabolic or higher order proportionality with lumen diameter, sigmoidal proportionality with necrotic core thickness, inverse hyperbolic proportionality with fibrous cap thickness, and skewed sinusoidal proportionality with necrotic core angle. Each of these relationships was governed by highly sensitive, complex, and interdependent influences of various attributes on plaque stress. An over 7-fold increase in peak stress from 101 to 788 kPa was observed in models of coronary dimensions commonly encountered in clinical practice. Peak stress of intramural TCFA within this common coronary artery subset did not exceed 300 kPa for fibrous cap thickness greater than 100 μm and necrotic core angle outside 90–120° range, indicating low risk of rupture. This exploratory study demonstrated the complex and interdependent influence of plaque attributes on the peak stress of TCFA.

Objectives This study sought to investigate the long-term effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS). Background Improved recanalization techniques have increased interest in percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). The long-term effectiveness of DES and BMS is not known. Methods We used data from 10,261 stable patients age ≥65 years at 889 U.S. hospitals who underwent CTO PCI from January 1, 2005, to December 31, 2008, in the NCDR (National Cardiovascular Data Registry) CathPCI Registry with linked Medicare inpatient claims for follow-up. Patient and procedural characteristics, and 30-month death, myocardial infarction, revascularization, and hospitalization for bleeding were evaluated by stent type. Outcomes following stenting were adjusted and compared using propensity score matching. Results DES were used for CTO PCI in 8,218 (80%) and BMS in 2,043 (20%). DES patients were younger (74.0 vs. 75.5 years, p Conclusions Compared with BMS, DES use in stable patients undergoing CTO PCI was associated with lower mortality, as well as similar myocardial infarction and repeat revascularization rates without an increase in subsequent bleeding requiring hospitalization.

Objectives The purpose of this study was to examine temporal trends in post-percutaneous coronary intervention (PCI) bleeding among patients with elective PCI, unstable angina (UA)/non–ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI). Background The impact of bleeding avoidance strategies on post-PCI bleeding rates over time is unknown. Methods Using the CathPCI Registry, we examined temporal trends in post-PCI bleeding from 2005 to 2009 among patients with elective PCI (n = 599,524), UA/NSTEMI (n = 836,103), and STEMI (n = 267,632). We quantified the linear time trend in bleeding using 3 sequential logistic regression models: 1) clinical factors; 2) clinical + vascular access strategies (femoral vs. radial, use of closure devices); and 3) clinical, vascular strategies + antithrombotic treatments (anticoagulant ± glycoprotein IIb/IIIa inhibitor [GPI]). Changes in the odds ratio for time trend in bleeding were compared using bootstrapping and converted to risk ratio. Results An approximate 20% reduction in post-PCI bleeding was seen (elective PCI: 1.4% to 1.1%; UA/NSTEMI: 2.3% to 1.8; STEMI: 4.9% to 4.5%). Radial approach remained low ( Conclusions The nearly 20% reduction in post-PCI bleeding over time was largely due to temporal changes in antithrombotic strategies. Further reductions in bleeding complications may be possible as bleeding avoidance strategies evolve, especially in STEMI.

Objectives The purpose of this study was to correlate adverse events at long-term follow-up in patients after an acute coronary syndrome with coronary plaque characteristics derived from simultaneous evaluation of their mechanical and compositional properties using virtual histology (intravascular ultrasound virtual histology) and palpography. Background Fibroatheroma is the plaque morphology with the highest risk of causing adverse cardiac events. Palpography can potentially assess the local mechanical plaque properties with the possibility of identifying fibroatheroma with the highest risk of rupture. Methods A total of 114 patients with acute coronary syndrome from the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) trial underwent a single ultrasound imaging investigation of their 3 coronary vessels with the co-registration of intravascular ultrasound virtual histology and palpography. Major adverse cardiac events (MACE) (cardiac death, cardiac arrest, myocardial infarction, or unstable or progressive angina) were collected up to a median follow-up of 3.4 years and adjudicated to originally treated culprit versus untreated nonculprit lesions. Results In total, 488 necrotic core–rich plaques were identified and subclassified as thin-cap fibroatheroma (n = 111), calcified thick-cap fibroatheroma (n = 213), and noncalcified thick-cap fibroatheroma (n = 164) and matched to their co-registered palpography data. A total of 16 MACE, adjudicated to untreated nonculprit lesions, were recorded at follow-up. In patients in whom MACE developed, fibroatheroma were larger (plaque area 10.0 mm 2 [range: 8.4 to 11.6 mm 2 ] vs. 8.2 mm 2 [range: 7.7 to 8.8 mm 2 ] (p = 0.03) compared with patients who were MACE free. By palpography, the maximum and the density strain values did not differ between the varying subtypes of fibroatheroma of patients with or without MACE during follow-up. Conclusions In acute coronary syndromes, patients treated with stents and contemporary pharmacotherapy, palpography did not provide additional diagnostic information for the identification of fibroatheroma with a high risk of rupture and MACE during long-term follow-up. ( Providing Regional Observations to Study Predictors of Events in the Coronary Tree [PROSPECT]: An Imaging Study in Patients With Unstable Atherosclerotic Lesions; NCT00180466 )

Appropriate utilization of percutaneous coronary intervention (PCI) and medical therapy is deservedly a national healthcare policy priority for the United States. Because PCI is both common and costly, appraisal of appropriateness is warranted. The initial appropriate use criteria (AUC) have been developed for coronary revascularization procedures and investigators recently reported the appropriateness for the approximately 500,000 PCI procedures performed at centers participating in the National Cardiovascular Data Registry. The AUC have broad implications for both healthcare providers and our patients and will be used as the basis for indications, referral patterns, treatment options, physician education, shared decision-making, and reimbursement for years to come. While we acknowledge the importance of thoughtfully assessing appropriateness for all medical procedures including PCI, there are a number of concerns with the current AUC and methods used to report appropriateness that warrant expanded commentary.

Background In some prior studies, patients with ST-elevation myocardial infarction (STEMI) as compared with patients with non-STEMI (NSTEMI) tended to have a higher early mortality but similar long-term outcomes. We compared the angiographic and intravascular ultrasound (IVUS) characteristics of patients with STEMI and NSTEMI in the PROSPECT study to evaluate the independent prognostic value of clinical presentation on long-term outcome. Methods After successful revascularization, patients had 3-vessel quantitative coronary angiography, gray scale, and radiofrequency intravascular ultrasound (IVUS) imaging. The primary end point was the occurrence of major adverse cardiac events (MACE) (cardiac death, myocardial infarction, or rehospitalization for unstable or progressive angina). Results There were 211 patients (31.6%) with STEMI and 457 (68.4%) with NSTEMI. Patients with STEMI and NSTEMI had similar angiographic and IVUS morphologic characteristics. At 3 years, MACE occurred in 22.1% and 19.6%, respectively (hazard ratio [HR] 1.16 [0.81, 1.68], P = .42). There was a higher overall mortality (HR 2.16 [0.94, 4.99], P = .06) and a significantly higher incidence of probable stent thrombosis (HR 4.34 [1.09, 17.36], P = .02) in the STEMI cohort. There were no significant differences between the 2 groups with respect to events related to culprit or to nonculprit lesions. ST-elevation myocardial infarction presentation was not an independent predictor of 3-year MACE (HR 1.14 [0.77, 1.67], P = .52). Conclusion Patients with STEMI and NSTEMI did not differ with respect to residual nonculprit lesion angiographic or IVUS characteristics and had similar rates of MACE at 3 years, without late "catch-up" in NSTEMI. However, probable stent thrombosis and mortality were higher in the STEMI cohort.

The assumption that atherosclerosis accumulates in the proximal coronary arteries and that distal segments are spared has yet to be systematically shown in vivo.We used intravascular ultrasound to analyze complete proximal, mid, and distal segments from 75 diseased left anterior descending arteries (LADs) and 61 diseased right coronary arteries (RCAs) (including either the posterolateral [PLA; n = 38] or posterior descending artery [PDA; n = 23]) to document that distal coronary arteries are more often free of disease vs proximal vessels. External elastic membrane, lumen, and plaque and media areas were measured every 0.4 mm (median), and plaque burden (plaque and media/external elastic membrane) and percentage of normal (plaque and media thickness0.3 mm) cross sections/segment were determined.Left anterior descending artery plaque was heaviest in proximal and mid segments, diminishing significantly in distal segments; plaque burden was 46% ± 9% in proximal, 39% ± 8% in mid, and 31% ± 9% in distal LAD (P.0001), with 93% (median) of distal LAD cross sections being normal compared with 21% of mid and 0% of proximal cross sections (P.0001). Right coronary artery plaque gradient was less pronounced vs the LAD; plaque burden was 37% ± 13% in proximal, 40% ± 10% in mid, and 36% ± 10% in distal RCA, followed by 31% ± 11% in PDA and 33% ± 10% in PLA. This was supported by the median percentage of normal cross sections/segment: 0% proximal, 0% mid, and 23% distal RCA sections plus 100% PDA and 48% PLA sections.Intravascular ultrasound data indicated a proximal-to-distal LAD plaque gradient; significant disease was uncommon in the distal LAD. Conversely, the proximal-to-distal RCA plaque gradient was less distinct than the LAD, although disease in the PDA was still reduced compared with proximal segments.

Objectifs L’objectif de cette analyse post-hoc de l’etude LEADER etait de caracteriser les infarctus du myocarde (IDM) survenus en cours d’etude. Patients et methodes Au total, 9340 diabetiques de type 2 a haut risque cardiovasculaire randomises pour recevoir du liraglutide ou un placebo sur une duree de 3,5 a 5 ans. Analyse des patients ayant presente un IDM. Resultats Au total, 780 IDM (de novo ou recidive) ont ete observes : 359 (liraglutide) et 421 (placebo) (p = 0,02), dont 17,8 % d’ IDM silencieux. Numeriquement moins d’IDM fatals ont ete rapportes sous liraglutide versus. placebo (n = 17 versus 28). Davantage de patients du groupe liraglutide avec IDM presentaient des antecedents de pontages coronariens (30,8 % versus 21,5 % ; p = 0,008) et d’angioplasties percutanees (47,6 % versus 40,4 % ; p = 0,070), tandis qu’ils presentaient moins d’antecedents de dysfonction ventriculaire gauche (13,4 % versus 18, 9 % ; p = 0,061), d’AOMI (9,9 % versus 17,7 % ; p = 0,005) ou de stenoses superieures a 50 % des coronaires, carotides ou autres arteres (33,2 % versus 41,0 % ; p = 0,044). Six cent quarante et un IDM symptomatiques (dont 555 NSTEMI–86,6 %) ont ete observes : 297 (liraglutide) et 344 (placebo). Pour les patients avec un dosage disponible, le nombre presentant des niveaux de troponine > 5 × la valeur limite de la normale est moindre dans le bras liraglutide versus. placebo (139 versus 189). Discussion L’incidence des IDM et des IDM fatals est plus faible dans le bras liraglutide. Ces resultats suggerent une moindre severite de l’IDM et de sa taille, avec le liraglutide.

Background— Creatine kinase-MB (CK-MB) elevation after percutaneous coronary intervention (PCI) has been associated with increased risk for mortality. Although most studies have defined periprocedural myocardial infarction (pMI) as an elevation in CK-MB >3× upper limit of normal (ULN), use of different CK-MB assays and variation in site-specific definitions of the ULN may limit the value of such relative thresholds. Methods and Results— We used data from the multicenter Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry to examine the impact of variations in site-specific thresholds for CK-MB elevation on the incidence of pMI as well as the relationship between absolute peak levels of CK-MB after PCI and 1-year mortality. The study cohort consisted of 6347 patients who underwent nonemergent PCI and had normal CK-MB at baseline. Across the 59 study centers, the ULN for CK-MB ranged from 2.6 to 10.4 ng/mL (median, 5.0 ng/mL), and there was an inverse relationship between the site-specific ULN and the incidence of pMI (defined as CK-MB elevation >3× ULN). Although any postprocedure elevation of CK-MB was associated with an adverse prognosis, in categorical analyses, only CK-MB ≥50 ng/mL was independently associated with increased 1-year mortality (hazard ratio, 4.71; 95% confidence interval, 2.42 to 9.13; P Conclusions— Among unselected patients undergoing PCI, there is a graded relationship between CK-MB elevation after PCI and 1-year mortality that is particularly strong for large CK-MB elevations (>30 to 50 ng/mL). Future studies that include pMI as a clinical end point should consider using a core laboratory to assess CK-MB (to ensure consistency) and raising the threshold for defining pMI above current levels (to enhance clinical relevance).

Aims: To characterise plaque phenotypes in the left main stem (LMS) and the proximal left anterior descending (LAD) coronary artery using virtual histology assisted intravascular ultrasound (VH-IVUS). Methods and results: Patients with IVUS pullbacks including no less than the proximal 30 mm of the LAD and through the ostium of the left main were identified from a global IVUS registry. Plaque composition and phenotype frequency in the LMS and five consecutive non-overlapping 6 mm segments in the LAD were studied, resulting in six analysed segments per patient. There were 74 patients (72% male, mean age 65 years). The median LMS length was 5.4 mm (IQR 2.8-8.7 mm). The percent of fibrofatty plaque was greater in the LMS compared to the proximal LAD segments (27.9% [20.0-39.2] vs. 17.3% [12.2-23.1], p

We assessed the cardiovascular safety of liraglutide, a glucagon-like peptide-1 receptor agonist, using existing clinical data. Patient-level results from all completed phase 2 and 3 studies from the liraglutide clinical development programme were pooled to determine rates of major adverse cardiovascular events (MACE): cardiovascular death, myocardial infarction, stroke. MACE were identified by querying the study database using Medical Dictionary for Regulatory Activities (MedDRA) terms combined with serious adverse events recorded by study investigators. Broad, narrow, and custom groups of MedDRA queries were used. Candidate events from each query were independently adjudicated post hoc. In 15 studies (6638 patients; 4257 liraglutide treated), there were 114 patients with MACE identified using the broad MedDRA query. Of these, 44 were classified as serious adverse events and 39 were adjudicated as MACE. The incidence ratio for adjudicated broad/serious MACE associated with liraglutide was 0.73 (95% CI 0.38—1.41) versus all comparator drugs (metformin, glimepiride, rosiglitazone, insulin glargine, placebo), within cardiovascular safety limits defined by the United States Food & Drug Administration for diabetes therapies under current investigation.

Item does not contain fulltext OBJECTIVES: The aim of this study was to evaluate the relative frequency of access and nonaccess site bleeding, the association of these events with 1-year mortality, and the impact of randomized antithrombotic therapy. BACKGROUND: Post-percutaneous coronary intervention (PCI) bleeding has been strongly associated with subsequent mortality. The extent to which access versus nonaccess site bleeding contributes to this poor prognosis and the role of antithrombotic therapies remains poorly understood. METHODS: The incidence and impact of Thrombolysis In Myocardial Infarction (TIMI) major/minor 30-day bleeding and randomized antithrombotic therapy were examined in a combined dataset from the REPLACE-2 (Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events), Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY), and HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trials in 17,393 PCI patients. RESULTS: The TIMI major/minor bleeding occurred in 5.3% of patients, 61.4% of which (3.3%) were nonaccess site bleeds. After multivariable adjustment, TIMI bleeding was associated with an increased risk of 1-year mortality (hazard ratio [HR]: 3.17, 95% confidence interval [CI]: 2.51 to 4.00, p < 0.0001). The HR of a nonaccess site bleed was approximately 2-fold that of an access site bleed: HR: 3.94, 95% CI: 3.07 to 5.15, p < 0.0001 versus HR: 1.82, 95% CI: 1.17 to 2.83, p = 0.008, respectively. Randomization to bivalirudin versus heparin + a glycoprotein IIb/IIIa inhibitor resulted in 38% and 43% relative reductions in TIMI major/minor and TIMI major bleeding, respectively (p < 0.0001 for both), with significant reductions in both access and nonaccess site bleeding. CONCLUSIONS: Nonaccess site bleeding after PCI is common, representing approximately two-thirds of all TIMI bleeding events, and is associated with a 4-fold increase in 1-year mortality. Use of bivalirudin rather than heparin + a glycoprotein IIb/IIIa inhibitor significantly decreases both nonaccess site as well as access site bleeding events by approximately 40%.

Depressive symptoms are known to compromise health status in cardiac disease, but this relationship has not been described in peripheral artery disease (PAD). Depressive symptoms (PHQ-9) and disease-specific health status (Peripheral Artery Questionnaire, PAQ) were assessed in 242 PAD patients undergoing percutaneous transluminal angioplasty (PTA) at baseline and 1 year. Patients were classified by baseline and follow-up depression status (moderate–severe depressive symptoms = PHQ ≥ 10). Changes were categorized as no depression/improvement of depression versus persistent/worsened depression. At baseline, 20% of patients were depressed; at 1 year, 17% of patients experienced persistent/worsened depression. Although this group improved on most PAQ subscales, they improved to a significantly lesser degree than those without depressive symptoms or those who improved by 1 year ( p-values < 0.05). Baseline depressive symptoms (Bper 5-point increment = −11.9, 95% CI −15.3, −8.5, p < 0.0001) and changes in depression were independently associated with a decrease in 1-year health status (Bper 5-point increment = −11.7, 95% CI −14.3, −9.2, p < 0.0001). In conclusion, depressive symptoms are associated with less improvement in health status 1 year after undergoing a peripheral endovascular revascularization (PER) as compared with those having no depression or whose depressive symptoms improve. Efforts to improve depression detection and treatment among patients with PAD may improve the health status outcomes of these patients.

Objectifs Analyse post-hoc de l’etude LEADER selon la presence ou non d’antecedents d’insuffisance cardiaque (IC) NYHA II–III. Methodes Dans LEADER, 9340 DT2 a haut risque CV ont ete randomises (1 :1) pour recevoir liraglutide ou un placebo (plus traitement standard) et suivis pendant 3,5 a 5 ans. Etaient exclus les stades NYHA IV. Resultats A l’inclusion, 18 % des patients dans les deux bras de traitement presentaient des antecedents d’IC NYHA I–III (14 % NYHA II–III). Moins de patients ont ete hospitalises pour IC dans le bras liraglutide (4,7 vs 5,3 % ; p = 0,14) et ce, qu’ils aient ou non des antecedents d’IC NYHA II–III (respectivement 13,3 vs 13,8 % ; 3,3 vs 3,9 % ; p interaction = 0,45). Pour le critere principal (evenements cardiovasculaires majeurs : deces CV, IDM ou AVC non fatals), le benefice du liraglutide est observe qu’ils aient ou non des antecedents d’IC NYHA II–III (respectivement 17,2 vs 18,3 % ; 12,4 vs 14,3 % ; p interaction = 0,53). Discussion Des reductions non significatives du risque d’hospitalisation pour IC ou de survenue d’evenements cardiovasculaires majeurs ont ete observees sous liraglutide chez les patients avec des antecedents d’IC NYHA II–III.

Background— Anemia is common among patients hospitalized with acute myocardial infarction and is associated with poor outcomes. Less is known about the incidence, correlates, and prognostic implications of acute, hospital-acquired anemia (HAA). Methods and Results— We identified 2909 patients with acute myocardial infarction who had normal hemoglobin (Hgb) on admission in the multicenter TRIUMPH registry and defined HAA by criteria proposed by Beutler and Waalen. We used hierarchical Poisson regression to identify independent correlates of HAA and multivariable proportional hazards regression to identify the association of HAA with mortality and health status. At discharge, 1321 (45.4%) patients had HAA, of whom 348 (26.3%) developed moderate-severe HAA (Hgb Conclusions— HAA develops in nearly half of acute myocardial infarction hospitalizations among patients treated medically or with percutaneous coronary intervention, commonly in the absence of documented bleeding, and is associated with worse mortality and health status. Better understanding of how HAA can be prevented and whether its prevention can improve patient outcomes is needed.

Some type 2 diabetes (T2D) therapies are associated with an increased risk of heart failure (HF).1 In the LEADER trial ([NCT01179048][1]), liraglutide significantly reduced the risk of major adverse cardiovascular (CV) events (MACE) by 13% vs placebo (PBO) when added to standard care in people with

Cardiovascular risk factors such as elevated serum lipid levels are important in the development of coronary atherosclerosis. Radiofrequency (RF) analysis of intravascular ultrasound [IVUS, Virtual histology (TM) (VH)] offers a unique tool to study the composition of coronary atherosclerotic plaque in vivo. We used data from the multicentre VH registry to assess the association between cardiovascular risk factors and coronary plaque volume and composition. Between August 2004 and July 2006, 990 patients in 42 centres were enrolled in a prospective, multicentre, non-randomized global VH registry. Coronary artery imaging was performed by conventional IVUS and RF-IVUS. The four RF-IVUS plaque components [dense calcium (DC), necrotic core (NC), fibrous (F) tissue, and fibro fatty (FF)] were analysed in every recorded frame. The results were expressed as mean cross-sectional areas, absolute volume, and percentage of total plaque volume. Risk factor assessment included evaluation of family history of previous myocardial infarction (MI), past or current smoking, diabetes mellitus, hypertension, and the laboratory measurements. Patients with diabetes had an increased relative proportion of NC (6.47 +/- 0.28 vs. 5.86 +/- 0.14%, P = 0.037) and DC (4.58 +/- 0.27 vs. 3.90 +/- 0.14%, P = 0.017), and patients with hypertension had an increased relative proportion of FF, DC (4.35 +/- 0.16 vs. 3.57 +/- 0.17%, P = 0.02) and NC (6.24 +/- 0.17 vs. 5.60 +/- 0.19%, P = 0.01). Compared with patients with LDL-C < 100 mg/dL, patients with LDL-C > 160 mg/dL had higher plaque volume (342.1 +/- 26.2 vs. 318.6 +/- 10.7 mm(3)). Linear regression analysis showed a correlation between the level of HDL-C and F (r = -0.149, P < 0.01), FF (r = -0.106, P < 0.01), and NC (r = -0.90, P < 0.05). The level of LDL correlated with F (r = 0.110, P < 0.01). Patients with prior MI have an increased percentage of F (30.03 +/- 0.59 vs. 28.20 +/- 0.37%, P = 0.009). Smoking had no relevant effect on plaque composition. Treatment with acetylsalicylacid and statins reduced FF with altering plaque volume. Radiofrequency-IVUS detects marked differences in coronary plaque composition related to the risk factor profile with particular focus on lipid levels. Greater amounts of NC were associated with diabetes, hypertension, MI, and low HDL-C. The effects of treatment of changes related to plaque composition are underway.

Background— Coronary plaque classified as thin-cap fibroatheroma (TCFA) is believed to be associated with plaque rupture and coronary heart disease–related events. Although an association between duration of diabetes and increased coronary heart disease risk has been demonstrated, the relationship between TCFA and diabetes duration is unknown. Methods and Results— Prospective registry of diabetic patients undergoing diagnostic coronary angiography and intravascular ultrasound (IVUS) enrolled in a diabetic gene and biomarker banking registry. Plaque composition in the most diseased 10-mm segment of a single coronary artery was assessed using IVUS virtual histology and was classified by phenotype as IVUS-defined adaptive intimal thickening, pathological intimal thickening, TCFA, fibroatheroma, or fibrocalcific. Patients (n=54) were stratified by duration of diabetes (P =0.008). The proportion of IVUS-defined TCFA in the ≥10-year group was greater than the P =0.009). This association persisted after adjustment for multiple comparisons, clinical characteristics, and diabetes treatment. Conclusions— In this cohort, longer duration of diabetes was associated with IVUS-defined TCFA, a plaque phenotype associated with risk of rupture and coronary heart disease events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00428961.