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To determine the diagnostic performance of cardiac computed tomography (CT)–based modalities including coronary CT angiography (CTA), stress myocardial CT perfusion (stress CTP), computer simulation of fractional flow reserve by CT (FFRCT), and transluminal attenuation gradients (TAG), for the diagnosis of hemodynamic significant coronary artery disease (CAD), using invasive fractional flow reserve as the reference standard. PubMed and Cochrane databases were searched for original articles until July 2018. Diagnostic accuracy results were pooled at per-patient and per-vessel level using random effect models. Fifty articles were included in the meta-analysis (3024 subjects). The per-patient analysis per imaging modality demonstrated a pooled positive likelihood ratio (PLR) of 1.78 (95% confidence interval CI 1.49–2.11), 4.58 (95% CI 3.54–5.91), and 3.45 (95% CI 2.38–5.00) for CTA, stress CTP, and FFRCT respectively. Per-patient specificity of stress CTP (82%, 95% CI 76–86) and FFRCT (72%, 95% CI 68–76) were higher than for CTA (48%, 95% CI 44–51). At the vessel level, PLR was 2.42 (95% CI 1.93–3.02), 7.72 (95% CI 5.50–10.83), 3.50 (95% CI 2.73–4.78), 1.97 (95% CI 1.32–2.93) for CTA, stress CTP, FFRCT, and TAG respectively. With improved PLR and specificity, stress CTP and FFRCT have incremental value over CTA for the detection of functionally significant CAD. • New functional CT imaging techniques, such as stress CTP and FFRCT, improve diagnostic accuracy of coronary CTA to predict hemodynamically relevant stenosis. • TAG yields poor diagnostic performance. • Combination of CTA and some functional CT techniques (stress CTP and FFRCT) might become a “must” to improve diagnostic accuracy of CAD and to reduce unnecessary invasive coronary angiography.

Objectives The authors sought to describe the incidence, determinants, and outcome of elective coronary revascularization (ECR) in patients with stable coronary artery disease (CAD). Background Observational data are lacking regarding the practice of ECR in patients with stable CAD receiving modern secondary prevention. Methods The authors analyzed coronary revascularization procedures performed during a 5-year follow-up in 4,094 stable CAD outpatients included in the prospective multicenter CORONOR (Suivi d'une cohorte de patients COROnariens stables en region NORd-Pas-de-Calais) registry. Results Secondary prevention medications were widely prescribed at inclusion (antiplatelet agents 96.4%, statins 92.2%, renin-angiotensin system antagonists 81.8%). A total of 481 patients underwent ≥1 coronary revascularization procedure (5-year cumulative incidences of 3.6% [0.7% per year] for acute revascularizations and 8.9% [1.8% per year] for ECR); there were 677 deaths during the same period. Seven baseline variables were independently associated with ECR: prior coronary stent implantation (p Conclusions These real-life data show that ECR is performed at a rate of 1.8% per year in stable CAD patients widely treated by secondary medical prevention. ECR procedures performed in patients without noninvasive stress tests are not rare. Having an ECR was not associated with the risk of ischemic adverse events.

PURPOSE: To assess the comparative diagnostic accuracy of cardiac CT and transesophageal echocardiography (TEE) in the detection of valvular and perivalvular complications in infective endocarditis. MATERIALS AND METHODS: PubMed and Embase databases were systematically searched until July 2019 for original articles published in English. Studies were included if (a) they used CT and/or TEE as an index test, (b) data were provided as infective endocarditis valvular complications (classified as abscess or pseudoaneurysm, vegetation, leaflet perforation, and paravalvular leakage), and (c) they used surgical findings as the reference standard. RESULTS: Eight studies fulfilled the inclusion criteria. The sensitivity was higher for CT than TEE for abscess or pseudoaneurysm detection, 78% (95% confidence interval [CI]: 70%, 85%) (112 of 142) versus 69% (95% CI: 62%, 76%) (94 of 135) (P = .052) and increased to 87% (95% CI: 78%, 93%) (70 of 79) when restricted to multiphase CT studies, the difference being significant (P = .04). The sensitivity was significantly higher for TEE than CT for vegetation detection, 94% (95% CI: 92%, 96%) (363 of 383) versus 64% (95% CI: 57%, 70%) (151 of 237) (P < .001) and leaflet perforation detection, 81% (95% CI: 71%, 88%) (74 of 91) versus 41% (95% CI: 25%, 59%) (14 of 35) (P = .02).The sensitivity for paravalvular leakage was 69% (95% CI: 58%, 79%) (56 of 80) versus 44% (95% CI: 30%, 59%) (21 of 48) for TEE and CT, respectively (P = .27). CONCLUSION: CT performs better than TEE in the detection of abscess or pseudoaneurysm whereas TEE gives superior results for vegetation detection, leaflet perforation, and paravalvular leakage. Supplemental material is available for this article. © RSNA, 2020

Associations of early creatine phosphokinase-MB (CK-MB) elevation and new Q waves and their association with cardiovascular death (CVD) after coronary artery bypass grafting (CABG) have been reported, but this association has not been studied in a large population of patients with diabetes mellitus. In this study, we examine the association of periprocedural CK-MB elevations and new Q waves with CVD in the Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease trial. Cox proportional hazards regression was used to assess the relation of CK-MB elevations and new Q waves in the first 24 hours after procedure and their relation to CVD; logistic regression was used to assess odds ratios of these variables. Hazard ratios, 95% confidence intervals, and p values associated with Wald chi-square test are reported. CK-MB elevation in first 24 hours after procedure was independently associated with CVD. CVD hazard increased by 6% (p0.001) with each multiple of CK-MB above the upper reference limit (URL); odds of new post-CABG Q waves increased by a factor of 1.08 (p0.001); at 7× CK-MB URL, HR was2. CK-MB URL multiples of 7, 12, and 15 were associated with new Q-wave odds ratios of 9, 16, and 27 times, respectively (p ≤0.001, C-statistic0.70). New Q waves were independently associated with survival in the multivariate model only when CK-MB was excluded (p = 0.01). In conclusion, independent associations included (1) CVD and early post-CABG CK-MB elevation; (2) new Q waves with early post-CABG CK-MB elevation; (3) CVD with new Q waves only when CK-MB elevation is excluded from analysis.

SummaryBackground Ticagrelor and prasugrel have shown superiority over clopidogrel. However, it remains unclear if one is superior to another regarding on-treatment platelet reactivity. Objectives To compare the impact of ticagrelor and prasugrel on high on-treatment platelet reactivity (HTPR). Methods The PubMed and Cochrane databases were searched for eligible studies in December 2014. Studies were eligible if they compared ticagrelor and prasugrel regarding high on-treatment platelet reactivity (HTPR). Pooled estimates were calculated by using a random-effects model with 95% confidence intervals. Results We included 14 studies and 1822 patients: 805 and 1017 in the ticagrelor and prasugrel groups, respectively. The rate of HTPR was significantly lower in the ticagrelor group: 1.5% vs. 9.8% (RR = 0.27 [0.14–0.50]). The pre-specified analysis focusing on randomized trials (n = 10) showed consistent results (RR = 0.27 [0.12–0.60]). Conclusion Our results suggest that ticagrelor allows a higher platelet reactivity inhibition as compared with prasugrel and leads to a further decrease in the rate of HTPR.

Objectives: This study sought to determine clinical, procedural, and treatment factors associated with acute stent thrombosis (AST) in the EUROMAX (European Ambulance Acute Coronary Syndrom...

Importance Uncertainty exists regarding potential survival benefits of bivalirudin compared with heparin with routine or optional use of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with ST-segment elevation myocardial infarction (STEMI). Few data are available regarding long-term mortality in the context of contemporary practice with frequent use of radial access and novel platelet adenosine diphosphate P2Y12 receptor inhibitors. Objective To assess the effect of bivalirudin monotherapy compared with unfractionated or low-molecular-weight heparin plus optional GPIs on 1-year mortality. Design, Setting, and Participants This international, randomized, open-label clinical trial (EUROMAX [European Ambulance Acute Coronary Syndrome Angiography]) included 2198 patients with STEMI undergoing transport for primary percutaneous coronary intervention from March 10, 2010, through June 20, 2013, and followed up for 1 year. Patients were randomized (1:1) in ambulance to bivalirudin monotherapy vs unfractionated or low-molecular-weight heparin plus optional GPIs (control group). Analysis was based on intention to treat. Main Outcomes and Measures The primary outcome of this prespecified analysis was 1-year mortality. All deaths were adjudicated as cardiac or noncardiac by an independent, blinded clinical events committee. One-year mortality was assessed and examined across multiple prespecified subgroups. Results Of the 2198 patients enrolled (1675 men [76.2%] and 523 women [23.8%]; median [interquartile range] age, 62 [52-72] years), complete 1-year follow-up data were available for 2164 (98.5%). All-cause 1-year mortality occurred in 118 patients (5.4%). The number of all-cause deaths was the same for both treatment groups (59 deaths; relative risk [RR], 1.02; 95% CI, 0.72-1.45; P = .92). No differences were noted in the rates of 1-year cardiac death (44 [4.0%] for the bivalirudin group vs 48 [4.3%] for the control group; RR, 0.93; 95% CI, 0.63-1.39; P = .74) or noncardiac death (15 [1.4%] for the bivalirudin group vs 11 [1.0%] for the control group; RR, 1.39; 95% CI, 0.64-3.01; P = .40). Results were consistent across the prespecified patient subgroups. The rate of deaths occurring from 30 days to 1 year was also similar (27 [2.5%] in the bivalirudin group vs 25 [2.3%] in the control group; RR, 1.10; 95% CI, 0.64-1.88; P = .73). Conclusions and Relevance In patients with STEMI who were being transported for primary percutaneous coronary intervention, treatment with bivalirudin or with heparin with optional use of GPI resulted in similar 1-year mortality. The reduced composite end point of death and/or major bleeding at 30 days in the bivalirudin arm of the EUROMAX trial did not translate into reduced cardiovascular or all-cause death at 1 year. Trial Registration clinicaltrials.gov Identifier:NCT01087723

There are limited data on the impact of anemia on clinical outcomes in unstable angina and non-ST-segment elevation myocardial infarction treated with an early invasive strategy. We sought to determine the short- and long-term clinical events among patients with and without anemia enrolled in the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Anemia was defined as baseline hemoglobin of13 g/dl for men and12 g/dl for women. The primary end points were composite ischemia (death, myocardial infarction, or unplanned revascularization for ischemia) and major bleeding assessed in-hospital, at 1 month, and at 1 year. Among the 13,819 patients in the ACUITY trial, information regarding anemia was available in 13,032 (94.3%), 2,199 of whom (16.9%) had anemia. Patients with anemia compared with those without anemia had significantly increased adverse event rates in-hospital (composite ischemia 6.6% vs 4.8%, p = 0.0004; major bleeding 7.3% vs 3.3%, p 0.0001), at 1 month (composite ischemia 10% vs 7.2%, p0.0001, major bleeding 8.8% vs 3.9%, p0.0001), and 1 year (composite ischemia 21.7% vs 15.3%, p0.0001). Anemia was an independent predictor of death at 1 year (hazard ratio 1.77, 95% confidence interval [CI] 1.29 to 2.44, p = 0.0005). Composite ischemia was significantly more common among patients who developed in-hospital non-coronary artery bypass surgery major bleeding compared with those who did not (anemic patients 1-year relative risk 2.19, 95% CI 1.67 to 2.88, p0.0001; nonanemic patients relative risk 2.16, 95% CI 1.76 to 2.65, p0.0001). In conclusion, in the ACUITY trial, baseline anemia was strongly associated with adverse early and late clinical events, especially in those who developed major bleeding.

Although lesion complexity is predictive of outcomes after balloon angioplasty, it is unclear whether complex lesions continue to portend a worse prognosis in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with contemporary interventional therapies. We sought to assess the impact of angiographic lesion complexity, defined by the modified American College of Cardiology/American Heart Association classification, on clinical outcomes after PCI in patients with ACS and to determine whether an interaction exists between lesion complexity and antithrombin regimen outcomes after PCI. Among the 3,661 patients who underwent PCI in the Acute Catheterization and Urgent Intervention Triage strategy study, patients with type C lesions (n = 1,654 [45%]) had higher 30-day rates of mortality (1.2% vs 0.6%, p = 0.049), myocardial infarction (9.2% vs 6.3%, p = 0.0006), and unplanned revascularization (4.3% vs 3.1%, p = 0.04) compared with those without type C lesions. In multivariate analysis, type C lesions were independently associated with myocardial infarction (odds ratio [95% confidence interval] = 1.37 [1.04 to 1.80], p = 0.02) and composite ischemia (odds ratio [95% confidence interval] = 1.49 [1.17 to 1.88], p = 0.001) at 30 days. Bivalirudin monotherapy compared with heparin plus a glycoprotein IIb/IIIa inhibitor reduced major bleeding complications with similar rates of composite ischemic events, regardless of the presence of type C lesions. There were no interactions between antithrombotic regimens and lesion complexity in terms of composite ischemia and major bleeding (p [interaction] = 0.91 and 0.80, respectively). In conclusion, patients with ACS with type C lesion characteristics undergoing PCI have an adverse short-term prognosis. Treatment with bivalirudin monotherapy reduces major hemorrhagic complications irrespective of lesion complexity with comparable suppression of adverse ischemic events as heparin plus glycoprotein IIb/IIIa inhibitor.

Purpose The prospective EUROVISION Registry was designed to capture patterns of use and short term outcomes in consecutive patients undergoing PCI with bivalirudin (BIV) in European centres. Methods A total of 2018 consecutive BIV-treated patients were included from 58 sites in 5 countries (Germany, Italy, France, Austria, United Kingdom). In-hospital and 30-day outcomes were prospectively collected and included: death, myocardial infarction (MI), stroke, urgent revascularization (URV), major and minor bleeding, stent thrombosis (ST) and thrombocytopenia (TCP). Results In this all-comer population, indication for PCI included STEMI (34%), NSTEMI (25%), unstable angina (16%) and stable angina (26%). Diabetes was present in 24% of patients and 30% of cases were performed via radial access. Preloading with a P2Y12 inhibitor was frequent (74%) while procedural glycoprotein inhibitor (GPI) use was low at 4.2%. Almost half (45%) of patients had received at least one additional anticoagulant prior to receiving BIV for PCI. The overall 30-day mortality was 1.0%, with low rates of MI (1.1%), URV (0.8%), ST (0.3%) and stroke (0.2%). The rate of ACUITY major bleeding was 1.6% and no TCP was reported. Dosing variations representing possible under- or over-dosing of BIV were frequent at 35%. Conclusion In this prospective registry of consecutive patients intended for PCI, use of BIV was associated with low rates of ischemic complications and excellent safety.

Objectives: This study evaluated the impact of nonculprit vessel myocardial perfusion on outcomes of non–ST-segment elevation acute coronary syndromes (NSTE-ACS) patients.Background: ST-segment ele...

Objectives The aim of this review is to discuss different methods of working through radial artery (RA) and brachial artery (BA) vascular complexities to increase the success rate of transradial approach (TRA). Background Anatomical complexities of RA and BA vasculature are an important reason for failure of TRA. There are few current data describing methods to overcome these challenges and reduce TRA failure. Methods A series of the primary RA and BA anatomical complexities are identified and management techniques to overcome these variants are discussed. Results RA and BA vascular complexities can be divided into three subsets including (1) radial artery spasm (RAS); (2) variant anatomy including tortuosity, loops, and anomalous origin of RA; (3) acquired abnormalities including perforations, atherosclerotic lesions, and calcification of RA. In-depth discussion with supportive examples for the identification and management of these challenges are provided. A classification of RAS and perforations is shown and simple algorithms that have been developed for management of RAS, perforations and loops are explained. Conclusions Despite lower rates of bleeding and vascular complications as compared to transfemoral approach (TFA), the adoption has been relatively slow particularly due to higher failure rates. Anatomical complexities of RA and BA vasculature play an important role for TRA failure cases. Using a simply framework to classify the anatomical or functional problem, and then approach these challenges in a logical sequence should facilitate management and increase success rate for TRA. © 2013 Wiley Periodicals, Inc.

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.

Radial access use has been growing steadily but, despite encourag- ing results, still varies greatly among operators, hospitals, countries and continents. Twenty years from its introduction, it was felt that the time had come to develop a common evidence-based view on the technical, clinical and organisational implications of using the radial approach for coronary angiography and interventions. The European Association of Percutaneous Cardiovascular Interven- tions (EAPCI) has, therefore, appointed a core group of European and non-European experts, including pioneers of radial angioplasty and operators with different practices in vascular access supported by experts nominated by the Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology (ESC). Their goal was to define the role of the radial approach in modern interventional practice and give advice on technique, training needs, and optimal clinical indications.

The clinical equipoise, or lack thereof, between radial and femoral access site in patients undergoing coronary angiography and/or percutaneous coronary intervention has been extensively debated over the last two decades. Registries, randomized trials and meta-analyses have reported the benefit of the radial use with respect to vascular access site complications and bleeding. As result, expert opinion paper and European and American guidelines have endorsed the preferential use of radial over femoral access, in order to allow minimization of periprocedural bleeding events. Whether trans-radial intervention is also associated to improved patient outcomes beyond vascular and bleeding complications has been a matter of ongoing debate. The RIVAL study failed to provide unquestionable evidence of benefit in favor of radial approach. However, more recently the MATRIX study, which is the largest randomized comparison between radial versus femoral intervention in patients with acute coronary syndromes, provided clear evidence that radial, as compared to femoral intervention, reduces vascular and site-related major bleeding complications, transfusion, need for surgical repair of the arterial access and improves survival at 30 days.

To report the four-month and nine-month angiographic results as well as one-year clinical follow-up from the first-in-man study with the silicon carbide and sirolimus-eluting bioabsorbable polymer (poly-L-lactic acid (PLLA) polymer) -coated cobalt-chromium Orsiro stent.A group of 30 patients with documented myocardial ischaemia related to a single de novo coronary stenosis up to 22 mm in length, in vessels with a 2.5 to 3.5 mm reference diameter, and between50% and90% diameter stenosis were enrolled at two sites. The primary endpoint of the study was in-stent late lumen loss at nine months. The secondary endpoints included major adverse cardiac events (MACE) at one year defined as the composite of cardiac death, ischaemia-driven target lesion revascularisation (TLR) and target vessel myocardial infarction (MI). Procedural success was 100%. Angiographic late lumen loss was 0.12±0.19 mm and 0.05±0.22 mm at four and nine months respectively. At one-year clinical follow-up, the composite MACE was 10% with one patient who died from cardiac death and two patients who had ischaemia-driven target lesion revascularisation. There was no report of MI or stent thrombosis.The Orsiro drug-eluting stent demonstrated potency with low rates of in-stent neointimal hyperplasia and cardiovascular events but warrants further evaluation in a larger population cohort with longer follow-up time points.

The occurrence of clinically silent cerebral infarcts (SCIs) in individuals affected by cardiac disease and after invasive cardiac procedures is frequently reported. Indeed, atrial fibrillation, left ventricular thrombus formation, cardiomyopathy, and patent foramen ovale have all been associated with SCIs. Furthermore, postprocedural SCIs have been observed after left cardiac catheterization, transcatheter aortic valve implantation, CABG surgery, pulmonary vein isolation, and closure of patent foramen ovale. Such SCIs are often described as precursors to symptomatic stroke and are associated with cognitive decline, dementia, and depression. Increased recognition of SCIs might advance our understanding of their relationship with heart disease and invasive cardiac procedures, facilitate further improvement of therapies or techniques aimed at preventing their occurrence and, therefore, decrease the risk of adverse neurological outcomes. In this Review, we provide an overview of the occurrence and clinical significance of, and the available diagnostic modalities for, SCIs related to cardiac disease and associated invasive cardiac procedures.

Objectives The objective of this study is to investigate the incidence and clinical implications of thrombus on baseline angiography among patients presenting with non–ST-segment elevation acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). Background Given current advances in the pharmacological and mechanical treatment of ACS patients managed with an early invasive strategy, the incidence and prognostic importance of pre-procedural lesion thrombus is warranted. Methods In the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial, a total of 3,627 patients with moderate- and high-risk ACS undergoing PCI had their baseline and final post-PCI angiograms analyzed by an independent angiographic core laboratory. Results Patients with thrombus (n = 530 [15%]) compared with those without thrombus had higher rates of impaired final epicardial coronary flow (final Thrombolysis In Myocardial Infarction [TIMI] flow grade 3: 89.6% vs. 97.1%, p Conclusions Pre-procedural thrombus was present in 15% of moderate- and high-risk ACS patients undergoing PCI in the ACUITY trial. Baseline thrombus predicts increased ischemic complications at 30 days including a 3-fold increased risk of death as well as MI up to 1 year. Further evaluation of adjunctive pharmacotherapy is needed in this high-risk population.

AIMS The aim of the present study was to examine the impact of the transradial approach (TRA), in comparison to the transfemoral approach (TFA), on PCI-related bleeding and patient outcomes in acute coronary syndrome patients who underwent PCI in the OASIS-5 trial. METHODS AND RESULTS The primary outcome (death, myocardial infarction, refractory ischaemia) at nine days was similar in both groups (7.1% in 872 TRA and 7.7% in 7,013 TFA). Major bleeding was significantly lower in patients who underwent PCI with TRA by comparison to TFA (1.6% vs 3.5%, p

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%.

Left ventricular (LV) remodeling after myocardial infarction (MI) indicates a high risk of heart failure and death. However, LV remodeling is difficult to predict, and limited information is available on the association of cardiac biomarkers with LV remodeling. Our aim was to study the association of B-type natriuretic peptide (BNP), cardiac troponin I (cTnI), and C-reactive protein with LV remodeling after MI. We designed a prospective multicenter study including 246 patients with a first anterior Q-wave MI. Serial echocardiographic studies were performed at hospital discharge and 3 months and 1 year after MI; quantitative analysis was performed at a core echocardiographic laboratory. Blood samples for determination of BNP, cTnI, and C-reactive protein levels were obtained at hospital discharge and the 1-month, 3-month, and 1-year follow up visits. One-year echocardiographic follow-up was obtained in 226 patients. End-diastolic volume increased from 52.3 ± 13.8 ml/m(2) at baseline to 62.3 ± 18.4 ml/m(2) at 1 year (p0.0001); LV remodeling (20% increase in end-diastolic volume) was observed in 87 patients (38%). At baseline, we found significant univariate relations between LV remodeling and the 3 biomarkers. During follow-up, high BNP levels and persistently detectable levels of cTnI were associated with LV remodeling. In multivariate analysis, none of the 3 biomarkers at baseline was independently predictive of LV remodeling. In contrast, during follow-up, high BNP and positive cTnI were independently associated with LV remodeling. In conclusion, circulating cardiac biomarkers may reflect pathophysiologic processes implicated in LV remodeling after MI. Determination of BNP and cTnI during follow-up can help refine risk stratification.

Objectives The aim of this study was to evaluate practice of transradial approach (TRA). Background TRA has been adopted as an alternative access site for coronary procedures. Methods A questionnaire was distributed worldwide with Internet-based software. Results The survey was conducted from August 2009 to January 2010 among 1,107 interventional cardiologists in 75 countries. Although pre-TRA dual hand circulation testing is not uniform in the world, >85% in the U.S. perform Allen or oximetry testing. Right radial artery is used in almost 90%. Judkins catheters are the most popular for left coronary artery angiographies (66.5%) and right coronary artery angiographies (58.8%). For percutaneous coronary intervention (PCI), 6-F is now standard. For PCI of left coronary artery, operators use standard extra back-up guiding catheters in >65% and, for right coronary artery 70.4% use right Judkins catheters. Although heparin remains the routine antithrombotic agent in the world, bivalirudin is frequently used in the U.S. for PCI. The incidence of radial artery occlusion before hospital discharge is not assessed in >50%. Overall, approximately 50% responded that their TRA practice will increase in the future (68.4% in the U.S.). Conclusions TRA is already widely used across the world. Diagnostic and guiding-catheters used for TRA remain similar to those used for traditional femoral approach, suggesting that specialized radial catheters are not frequently used. However, there is substantial variation in practice as it relates to specific aspects of TRA, suggesting that more data are needed to determine the optimal strategy to facilitate TRA and optimize radial artery patency after catheterization.

Background— Contemporary adjunctive pharmacology and revascularization strategies have improved the prognosis of patients with acute coronary syndromes (ACSs). We sought to identify the clinical and angiographic predictors of cardiac ischemic events in patients with ACSs treated with an early invasive strategy. Methods and Results— Multivariable logistic regression was used to analyze the relation between baseline characteristics and 30-day and 1-year composite ischemia (death, myocardial infarction, or unplanned revascularization) among the 6921 ACS patients included in the prespecified angiographic substudy of the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial. Of the 6921 patients, 3826 (55.3%) were treated with percutaneous coronary intervention, 755 (10.9%) with coronary artery bypass grafting, and 2340 (33.8%) with medical therapy. Composite ischemia occurred in 595 (8.6%) patients at 30 days and in 1153 (17.4%) at 1 year. Renal insufficiency, biomarker elevation, ST-segment deviation, nonuse of aspirin or thienopyridine, insulin-treated diabetes, older age, baseline lower hemoglobin value, history of percutaneous coronary intervention, and current smoking were independently associated with 30-day or 1-year ischemic events. Angiographic characteristics predicting ischemic events included number of diseased vessels, moderate/severe calcification, worst percent diameter stenosis, jeopardy score, lower left ventricular ejection fraction, lesion eccentricity, and thrombus. With use of receiver operating characteristic methodology, the c statistic improved for the predictive model by adding angiographic to clinical parameters for the 30-day composite ischemia (from 0.62 to 0.68) and myocardial infarction (from 0.64 to 0.71) and 1-year composite ischemia (from 0.61 to 0.65) and myocardial infarction (from 0.63 to 0.69) end points. Conclusions— Among ACS patients managed with an early invasive strategy, baseline angiographic markers of disease burden, calcification, lesion severity, lower left ventricular ejection fraction, and morphological characteristics provided important added independent predictive value for 30-day and 1-year ischemic outcomes, beyond the well-recognized clinical risk factors. These findings emphasize the prognostic importance of the diagnostic angiogram in the risk stratification of patients presenting with ACSs. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00093158.

Background— Outcomes of patients presenting with acute coronary syndromes are improved with an early invasive approach; however, approximately one third of these patients are treated medically after angiographic screening. We sought to assess the predictors of adverse cardiac events in patients with acute coronary syndrome assigned to medical management. Methods and Results— This substudy of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial included 4491 acute coronary syndrome patients treated medically after angiographic triage. Rates of bleeding and composite ischemia (death, myocardial infarction, revascularization) were compared among the 3 antithrombotic treatment arms. Composite ischemia occurred in 399 patients (9.5%) at 1 year. Treatment with bivalirudin glycoprotein IIb/IIIa inhibitors significantly reduced major bleeding at 30 days (2.5% bivalirudin monotherapy; P =0.005, 2.0% bivalirudin plus glycoprotein IIb/IIIa inhibitors; P =0.0002 versus 4.4% heparin with glycoprotein IIb/IIIa inhibitors). Composite ischemic events at 1 year were not significantly different in the 3 groups (bivalirudin monotherapy, 9.6%; bivalirudin plus glycoprotein IIb/IIIa inhibitors, 9.7%; heparin plus glycoprotein IIb/IIIa inhibitors, 9.1%). Independent predictors of composite ischemia were mostly angiographic factors at 30 days, including jeopardy score and coronary ectasia, and at 1 year, including previous percutaneous coronary intervention, jeopardy score, coronary ectasia, and increasing number of diseased vessels. Conclusions— Among the ACUITY acute coronary syndrome patients treated medically after angiographic triage, bivalirudin therapy significantly reduced bleeding complications compared with heparin without any negative impact on ischemic outcomes at 1 year. The most powerful predictors of ischemic outcomes were angiographic rather than traditional clinical parameters, supporting the early use of angiographic screening in the moderate- and high-risk but medically treated acute coronary syndrome population. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00093158.

Background— The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial demonstrated that bivalirudin monotherapy significantly reduces major bleeding compared with heparin (unfractionated or enoxaparin) or bivalirudin plus a glycoprotein IIb/IIIa inhibitor in acute coronary syndromes. Whether vascular closure devices (VCD) impact these results is unknown. Therefore, this study sought to determine whether VCD impact major access site bleeding (ASB) in patients with acute coronary syndromes undergoing early invasive management by the femoral approach. Methods and Results— Major ASB in ACUITY was defined as ASB requiring interventional or surgical correction, hematoma ≥5 cm at the access site, retroperitoneal bleeding, or hemoglobin drop ≥3 g/dL with ecchymosis or hematoma 30 minutes) at the access site. Stepwise logistical regression was performed to identify the independent determinants of ASB. Of 11 621 patients undergoing angiography with or without percutaneous coronary intervention by the femoral approach, 4307 (37.1%) received a VCD and 7314 (62.9%) did not. Rates of major ASB were lower with VCD compared with no VCD (2.5% versus 3.3%, relative risk, 0.76; 95% CI, 0.61 to 0.94; P =0.01) and were lowest in patients treated with bivalirudin monotherapy and a VCD (0.7%). Stepwise logistic regression revealed that a VCD (odds ratio, 0.78; 95% CI, 0.61 to 0.99; P =0.04) and bivalirudin monotherapy (odds ratio, 0.35; 95% CI, 0.25 to 0.49; P Conclusion— In patients with acute coronary syndromes undergoing an early invasive management strategy by the femoral approach, the use of a VCD, bivalirudin monotherapy, or both minimizes rates of major ASB. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique Identifier: NCT00093158.

The prevalence of coronary artery disease in end-stage liver disease is only now being recognized. Liver transplant patients are a high risk subgroup for coronary artery disease, even if asymptomatic. Coronary artery disease is a predictor of poor outcomes; therefore, identification of those at risk must be a key clinical priority. However, risk assessment is particularly difficult as many of the available diagnostic tools have either proven to be unhelpful or remain to be validated. Risk factor profiling has been unable to identify those at risk and commonly underestimates risk. The high negative predictive value of Dobutamine stress echo, when target heart rates are achieved, allows it to be used to identify a low risk group. For all other patients, proceeding to invasive coronary angiography is often necessary, and the risks of the procedure can be reduced by a transradial approach. Pharmacological reduction of the consequences of coronary artery disease can be limited by the underlying liver disease. Revascularization pre-transplantation is recommended in international guidelines but has demonstrated little evidence of benefit. Surgical revascularization carries an increased risk in these patients and is commonly performed pre-transplantation, although combined liver and cardiac surgery has been described. Percutaneous coronary intervention is increasingly used with patients requiring anti-platelet medication for up to one year after intervention. We present a review of all these issues and the evidence for assessing and managing these high-risk patients.

Background and Purpose— Pulmonary embolism is thought to be associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). Although neurological complications are infrequent, the incidence of clinically silent brain infarction is unknown. We assessed the rate of clinically apparent and silent cerebral embolism in patients with pulmonary embolism in relation to the presence or not of a PFO. Methods— We used diffusion-weighted MRI in patients hospitalized for a pulmonary embolism to assess cerebral embolic events. Sixty consecutive patients were evaluated at diffusion-weighted MRI. All patients underwent neurological assessment before diffusion-weighted MRI and a contrast echocardiography to detect PFO the next day. Results— Diffusion-weighted MRI showed bright lesions in 6 patients among the 60 consecutive patients with pulmonary embolism in a pattern consistent with embolic events. There was only one patient with a neurological deficit. After contrast echocardiography, a PFO was diagnosed in 15 patients (25%). The frequency of silent brain infarcts in patients with a PFO was significantly higher than in patients without PFO (5 [33.3%] of 15 versus one [2.2%] of 45 patients, P =0.003). By logistic regression analysis, PFO was identified as an independent predictor of silent brain infarcts (OR, 34.9 [3.1 to 394.3]; P =0.004). Conclusions— In pulmonary embolism, cerebral embolic events are more frequent than the apparent neurological complication rate. The prevalence of silent brain infarcts is closely related to the presence of a PFO suggesting a high incidence of unsuspected paradoxical emboli in those patients.

Femoral arterial access site complications are responsible for a substantial proportion of the bleeding complications that occur in patients undergoing percutaneous coronary intervention (PCI). Because bleeding is associated with an increase in morbidity and mortality, pharmacologic and nonpharmacologic strategies associated with lower bleeding risk may improve outcomes. From this perspective, radial artery access, which is associated with a similar rate of success as femoral artery access with lower rates of bleeding, might become the "gold standard" for PCI. Although transradial technique requires a specific skill set and significant learning curve, success rates comparable to those of the femoral approach may be achieved. The benefits of radial access may be further enhanced by using antithrombotic strategies that maintain efficacy but limit bleeding risk. Indeed, a substantial proportion of bleeding complications unrelated to the access site occur, a finding that supports the use of safer antithrombotic regimens to optimize patient outcomes.

BACKGROUND Previous studies have suggested that the activity of enzymes involved in the urea cycle may modulate nitric oxide (NO) production, arterial vasomotion, and hypertension. Our aim was to determine whether hypertension and coronary vasomotion could be associated with polymorphisms within the ornithine transcarbamylase (OTC) gene, located on chromosome X and coding for a key-enzyme of the urea cycle. METHODS Among 11 OTC polymorphisms that were originally selected from databases, the tag single-nucleotide polymorphism (SNP) rs5963409 and the independent SNP rs1800321 were tested for association with hypertension in two independent population samples recruited in Northern (Multinational MONItoring of trends and determinants in CArdiovascular disease (MONICA) study, n = 1,138) and Western (Etude du Vieillissement Arteriel (EVA) study, n = 1,166) France. The vasomotor response of coronary arteries to methylergonovine maleate and isosorbide dinitrate was also evaluated in an independent sample (the vasomotion study, n = 121). RESULTS In males, the frequency of the rs5963409 minor allele was consistently higher in hypertensive (HT) than in normotensive subjects in the MONICA and EVA studies. In the combined sample, the rs5963409 minor allele was associated with an increased risk of hypertension (odds ratio (OR) (95% confidence interval (CI)) = 1.45 (1.10-1.90); P = 0.008). This association was independent of classical confounding factors. Consistently, rs5963409 minor allele was associated with a greater susceptibility to vasoconstriction in response to methylergonovine maleate (P = 0.0072). In contrast, no significant association between rs5963409 and hypertension could be detected in females. CONCLUSION Our results suggest that the OTC rs5963409 polymorphism may be associated with hypertension and coronary vasomotion in males.

Background— Inhibition of platelet aggregation after aspirin or clopidogrel intake varies greatly among patients, and previous studies have suggested that poor response to oral antiplatelet agents may increase the risk of thrombotic events, especially after coronary angioplasty. Whether this reflects suboptimal platelet inhibition per se, which might benefit from more potent antiplatelet agents such as tirofiban, is unknown. Methods and Results— We screened 1277 patients to enroll 93 aspirin, 147 clopidogrel, and 23 dual poor responders, based on a point-of-care assay, who underwent elective coronary angioplasty at 10 European sites for stable or low-risk unstable coronary artery disease. Patients were randomly assigned in a double-blind manner to receive either tirofiban (n=132) or placebo (n=131) on top of standard aspirin and clopidogrel therapy. The primary end point, consisting of troponin I/T elevation at least 3 times the upper limit of normal, was attained in 20.4% (n=27) in the tirofiban group compared with 35.1% (n=46) in the placebo group (relative risk, 0.58; 95% confidence interval, 0.39 to 0.88; P =0.009). The rate of major adverse cardiovascular events within 30 days in the tirofiban group also was reduced (3.8% versus 10.7%; P =0.031). The overall incidence of bleeding was low, likely explained by a substantial use of the transradial approach, and did not differ between the 2 groups. Conclusions— In low-risk patients according to clinical presentation who had poor responsiveness to standard oral platelet inhibitors via a point-of-care assay, intensified platelet inhibition with tirofiban lowers the incidence of myocardial infarction after elective coronary intervention.

Case presentation : During cardiac catheterization, a 65-year-old man suddenly complained of nuchal pain, vertigo, and nausea and rapidly became unconscious, presumably from a stroke. The operator was unsure what type of imaging and management should be undertaken in this infrequent clinical setting. He paged the neurologist, asking him to urgently provide a strategy for diagnosis and management. Although the overall rate of stroke after left heart catheterization or percutaneous coronary intervention (PCI) is low, ranging from 0.2% to 0.4% (Tables 1 and 2⇓),1–5 it is the most debilitating complication from the patient’s perspective, associated with a high rate of morbidity and mortality (Figure 1).1–8 In 20 679 consecutive patients who underwent PCI in a large-volume center, stroke occurred in 0.44%.4 Multivariate analysis has shown that the occurrence of stroke was more frequently associated with diabetes mellitus, hypertension, prior stroke, or renal failure and was independently associated with in-hospital death. Patients who suffered a stroke had previously undergone longer cardiac catheterization procedures, using more contrast, were more likely to have had the procedure for urgent reasons, and to have had intraaortic balloon counterpulsation, a procedure that is itself known to increase the risk of stroke.9 Possible explanations for this latter characteristic include the greater propensity for hemodynamic compromise in these patients, which may increase the risk of ischemic stroke, and less meticulous care in advancing the catheter through the aorta during urgent PCI, which increases the risk of embolization by scraping of aortic plaques with subsequent embolization of debris to the brain. Indeed, scraping of aortic plaques occurs in >50% of PCI cases and more frequently with large than with small catheters.10 Cerebral microembolism is thought to be the main mechanism of periprocedural ischemic stroke occurring with PCI. This finding is supported …

Among patients undergoing coronary procedures, patients with coronary artery bypass grafts represent an important, high risk subgroup. Routine transradial approach may be successfully adopted in these patients to reduce access-site complications. However, transradial cannulation of the grafts may result technically demanding. In this article we discuss the specific technical issues and we present a series of tips and tricks which may facilitate angiography and interventions on both internal mammary and aorto-coronary grafts.

Resume L’elevation des marqueurs de necrose myocardique apres une angioplastie coronaire est frequente (jusqu’a 40 % des cas) et de mauvais pronostic. Un traitement prealable par statines pourrait reduire l’incidence de ces infarctus periproceduraux. Les bases de donnees Medline et Cochrane Library ont permis de selectionner des articles publies jusqu’en mars 2007. Les 16 etudes prospectives et retrospectives selectionnees portent sur l’interet ou non d’un pretraitement par statines en terme d’infarctus periproceduraux et de morbimortalite, chez les patients hospitalises en vue d’une intervention coronaire percutanee. Parmi les etudes selectionnees, 12 mentionnent le nombre d’infarctus periproceduraux. Le risque relatif global d’infarctus periprocedural est de 0,50 (95 % IC : 0,40–0,63) chez les patients pretraites par statines. Parmi les 5409 patients suivis a six mois, le risque relatif de deces dans le groupe pretraite par statines avant angioplastie coronaire est de 0,64 (95 % IC : 0,44–0,93). Les etudes selectionnees sont heterogenes, regroupant des patients stables et instables ; les analyses de sensibilite retrouvent un risque relatif d’infarctus periproceduraux comparable dans ces deux groupes. Cette meta-analyse confirme l’interet d’initier un traitement par statines avant toute intervention coronaire percutanee afin de diminuer le nombre d’infarctus periproceduraux et suggere une reduction de la mortalite a six mois associee a cette strategie therapeutique.

AIMS: The incidence of obesity is increasing continuously in industrial countries. Vascular complications after the transfemoral approach (TF) for either coronary angiography (CA) or angioplasty (PCI) are more frequent in this population. The transradial approach may decrease the risk of such complications. METHODS AND RESULTS: We undertook a prospective, multicentre, European registry of overweight patients (BMI >/=35), undergoing CA and/or PCI in centres with broad experience in the transradial approach (TR). The vascular approach was left to the operator's discretion. The primary end point was the occurrence of access related complications resulting in delayed hospital discharge 555 patients, (age 60.8+/-10.9 years; males 57.3%; BMI: 38.5+/-3.6 kg/m2) were included in the study. Of these, 157 underwent the transfemoral approach and 398 the transradial. Total procedure time was significantly shorter for the transradial approach in these morbidly obese patients (TR: 35.5+/-25.8 min versus TF: 52.4+/-25.2 min, p=0.0001), and hospital stay after CA or PCI was significantly shorter in the transradial group (TR: 1.8+/-2.3 days versus TF: 2.5+/-4.3 days, p=0.04). Vascular complications delaying hospital discharge occurred in 0.8% of TR patients vs 5.1% TF patients. p=0.0009). CONCLUSIONS: The rate of vascular complications in overweight patients after CA or PCI can be significantly decreased by the use of the transradial approach in centres with a large experience.

Background Current treatment standards for patients undergoing primary percutaneous coronary intervention support early infusion of abciximab, followed by bare-metal stent (BMS) implantation. Whether the use of sirolimus-eluting stent (SES) would result in a further improvement of clinical outcomes remains to be proven. Similarly, whether tirofiban administered at high-bolus dose (HBD) followed by standard infusion is a valuable alternative to abciximab in the setting of ST-segment elevation myocardial infarction remains uncertain. Study Design Multicentre evaluation of single high-bolus dose tirofiban versus abciximab and sirolimus-eluting versus bare metal stent in acute myocardial infarction (MULTI-STRATEGY) is a phase III, open-label, multinational investigator-driven clinical trial evaluating, with a 2-by-2 factorial design, the safety/efficacy profile of 4 interventional strategies of reperfusion: tirofiban given at HBD (bolus of 25 μg/kg over 3 minutes), followed by an infusion of 0.15 μg/kg per minute for 18 to 24 hours versus abciximab and SES, as compared to BMS implantation in primary percutaneous coronary intervention. The coprimary objectives are (i) the evaluation of the effect of SES versus BMS on the incidence of major adverse cardiac events within 8 months of the index procedure and (ii) the degree of ST-segment resolution obtained after the mechanical intervention for the comparison of HBD tirofiban versus abciximab. The protocol mandates clinical follow-up for 5 years. Conclusions MULTI-STRATEGY will evaluate the role of SES and HBD tirofiban versus BMS and abciximab in the acute management of patients presenting with ST-segment elevation myocardial infarction.

Background and Purpose— The primary objective of this study was to assess the incidence of new cerebral infarcts related to cardiac catheterization in patients explored through the right transradial approach. Methods— This prospective study involved 41 consecutive patients with severe aortic valve stenosis. To assess the incidence of cerebral infarction, all patients underwent cerebral diffusion-weighted MRI before and after cardiac catheterization through the right transradial approach. Results— We detected only two patients (4.9%) with new, small, isolated acute cerebral diffusion abnormalities postcatheterization. All patients remained asymptomatic. Conclusions— New cerebral lesions on diffusion-weighted MRI are infrequent in patients explored through the right transradial approach. Randomized studies are warranted to confirm for potential advantages of transradial approach versus the femoral approach in cardiac catheterization.

Objectives The purpose of this study was to determine the predictors of major bleeding and the impact of major bleeding on outcomes, including mortality, in acute coronary syndromes (ACS). Background Whether major bleeding independently predicts mortality in patients with ACS undergoing an early invasive strategy is undefined. Methods Patients (n = 13,819) with moderate- and high-risk ACS were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy (plus provisional GPI). Logistic regression was used to determine predictors of 30-day major bleeding and mortality. Results Major bleeding rates in patients treated with heparin plus GPI were higher versus bivalirudin monotherapy (5.7% vs. 3.0%, p Conclusions Major bleeding is a powerful independent predictor of 30-day mortality in patients with ACS managed invasively. Several factors independently predict major bleeding, including treatment with heparin plus GPI compared with bivalirudin monotherapy. Knowledge of these findings might be useful to reduce bleeding risk and improve outcomes in ACS.

The overall impact of post percutaneous coronary intervention (PCI) bleeding on long term prognosis after acute coronary syndromes (ACS) has been established, but it may differ between access and non-access related bleeding events. The impact of antithrombin choice on bleeding may also differ according to the origin of the bleed. We sought to determine the origin of bleeding relative to the access site, its prognostic significance and the respective impact of antithrombin therapy in the EUROMAX trial.We performed a blinded review of the case records of all TIMI major or minor bleeds in the EUROMAX trial and assigned them in one of 2 categories: access site bleeds (ASB), or rest of bleeds (ROB). Incidence of bleeding for each category was assessed according to randomization to antithrombotic treatment.A total of 231 out of 2198 patients suffered a TIMI major/minor bleed (10.5%) and ASB accounted for 48.5%, while ROB for 51.5% of the bleeds. Thirty day mortality was 2.5% (50/1967) for patients without a bleed, 2.7% (3/112, p=0.76 vs. no bleed) for patients with ASB, and 10.9% (13/119, p0.0001 vs. no bleed) for ROB patients. The use of bivalirudin reduced both ASB and ROB with relative risk reductions of 34% and 46% respectively.In contemporary primary PCI, bleeding originates with equal frequency either at or away from the access site. Access site bleeds were not associated with an excess in 30day mortality, but the rest of the bleeds were. Bivalirudin is associated with a lower risk of bleeding irrespective of origin.ClinicalTrials.gov identifier NCT01087723.

Background— In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. Methods and Results— In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33–1.03; P =0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37–0.93; P =0.022; interaction P =0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27–0.74; P =0.002). Conclusions— In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01087723.

Objective: To compare bleeding complications and results of percutaneous coronary intervention (PCI) between patients treated by radial and femoral approaches for acute myocardial infarction (AMI,) and using abciximab and 5 French guiding-catheters. Patients: 114 consecutive patients with AMI were prospectively randomised. Exclusion criteria were a history of coronary artery bypass graft, cardiogenic shock, atrioventricular block, and contraindication to abciximab or a negative Allen test. Local haemostasis was achieved by manual compression. Results: Baseline characteristics were similar between the two groups. Peripheral arterial complication rates and delays to patient ambulation were significantly lower in the radial group than in the femoral group, whereas in-hospital stay was similar between the two groups. A cross over was more often necessary in the radial group than in the femoral group. Coronary angiography duration and fluoroscopy time were significantly longer in the radial group than in the femoral group, whereas PCI duration was similar in both groups. Conclusions: The FARMI trial showed that the radial route lowered peripheral arterial complication rates and allowed earlier ambulation, despite no significant benefit on the duration of hospitalisation.

Background and Purpose— Cerebral microembolism detected by transcranial Doppler occurs systematically during cardiac catheterization, but its clinical relevance remains unknown. Studies suggest that asymptomatic embolic cerebral infarction detectable by diffusion-weighted (DW) MRI might exist after percutaneous cardiac interventions, especially after retrograde catheterization of the aortic valve in patients with valvular aortic stenosis, with a frequency as high as 22% of cases. We investigated the incidence of new ischemic lesions on serial cerebral DW MRI after cardiac catheterization. Methods— This prospective study involved 46 patients with severe aortic valve stenosis. To assess the occurrence of cerebral infarction, all patients underwent cerebral DW MRI and neurological assessment within 24 hours before and 48 hours after cardiac catheterization and retrograde catheterization of the aortic valve. A subgroup was monitored by transcranial power M-mode Doppler during cardiac catheterization to observe cerebral blood flow and track emboli. Results— One patient had a focal diffusion abnormality on DW MRI before cardiac catheterization. After catheterization, we detected only 1 additional acute cerebral diffusion abnormality in a single case (2.2%), although cerebral microemboli were detected in all transcranial Doppler-monitored patients during cardiac catheterization, as expected. All patients remained asymptomatic. Based on these results a mid-point incidence of 5.9% (95% CI, 0.01 to 12.5) for abnormalities on DW MRI in asymptomatic cardiac catheterization patients in our center can be assigned. Conclusions— Unsuspected cerebral infarctions can be detected by DW MRI after cardiac catheterization, but this phenomenon remains unfrequent in our series. Further studies are needed to identify factors explaining the discrepancy between these results and those of previous studies.

Objectives This study was designed to define the current role of multislice spiral computed tomography (MSCT) for the diagnosis of coronary artery disease (CAD) using a meta-analytic process. Background Multislice spiral computed tomography has recently been proposed as an alternative to conventional coronary angiography (CA) for the diagnosis of CAD. Methods Using Medline, we identified 29 studies (2,024 patients) evaluating CAD by means of both MSCT (≥16 slices) and conventional CA before July 2006. After data extraction the analysis was performed according to a random-effects model. Results The per-segment analysis pooled the results from 27 studies corresponding to a cumulative number of 22,798 segments. Among unassessable segments, 4.2% were excluded from the analysis and 6.4% were classified at the discretion of the investigators, underscoring the shortcomings of MSCT. With this major limitation, the per-segment sensitivity and specificity were 81% (95% confidence interval [CI] 72% to 89%) and 93% (95% CI 90% to 97%), respectively, with positive and negative likelihood ratios of 21.5 (95% CI 13.1 to 35.5) and 0.11 (95% CI 0.06 to 0.21), respectively, and positive and negative predictive values of 67.8% (95% CI 57.6% to 78.0%) and 96.5% (95% CI 94.7% to 98.3%), respectively. As expected, the per-patient analysis has shown an increased sensitivity of 96% (95% CI 94% to 98%) but a decreased specificity of 74% (95% CI 65% to 84%). Conclusions Multislice spiral computed tomography has shortcomings difficult to overcome in daily practice and, at the more clinically relevant per-patient analysis, continues to have moderate specificity in patients with high prevalence of CAD. Studies evaluating the diagnostic performance of the newest generation of MSCT, including patients with low to moderate CAD prevalence, will be critical in establishing the clinical role of this emerging technology as an alternative to CA.

Background The survival of patients after prolonged cardiac arrest is still inadequate. Extracorporeal life support (ECLS) represents an alternative therapeutic method for patients who do not respond to conventional cardiopulmonary cerebral resuscitation. This technology is used to support the circulation of a patient with severe cardiac failure. Methods Between June 1997 and January 2003, 40 ECLS procedures were performed in patients who presented with refractory cardiac arrest. During external cardiac massage, the patient was connected to an extracorporeal circuit by the insertion of an arterial and venous cannula through the femoral vessels. The extracorporeal circuit included a centrifugal pump and an oxygenator. Mean age was 42 ± 15 years; the average time of external cardiac massage was 105 ± 44 minutes. Results Once the circulation was restored, 22 patients were disconnected from the extracorporeal circulation because of brain death or multiorgan failure; after 24 hours, among the 18 survivors, 6 were weaned off the pump, 9 were bridged to a ventricular assist device, and 2 patients were directly bridged to cardiac transplantation. Eight patients are alive and without any sequelae at 18 month's follow-up. Conclusions In prolonged cardiac arrest with failing conventional measures, rescue by extracorporeal support provides an ultimate therapeutic option with a good outcome in survivors. Our results encourage the wider application of ECLS for refractory cardiocirculatory arrest in selected patients. The high rate of neurologic death needs further improvements in the early phase of resuscitation maneuvers.

This prospective multicenter study was conducted to compare the incidence of significant vascular complications delaying hospital discharge after coronary angiography and percutaneous coronary intervention (PCI) between the radial approach (n = 192) and the femoral approach (n = 185) in octogenarians, a rapidly growing population with numerous risk factors for complications. By intention-to-treat analysis, the incidence of vascular complications was found to be significantly less in the radial group (1.6% vs 6.5%, p = 0.03), without any decrease in the efficacy of PCI and only a slight increase in procedure duration for coronary angiography. All vascular complications, except for 1, occurred in patients treated with the transfemoral approach.

Objectives We sought to compare, through a meta-analytic process, the transradial and transfemoral approaches for coronary procedures in terms of clinical and procedural outcomes. Background The radial approach has been increasingly used as an alternative to femoral access. Several trials have compared these two approaches, with inconclusive results. Methods The MEDLINE, CENTRAL, and conference proceedings from major cardiologic associations were searched. Random-effect odds ratios (ORs) for failure of the procedure (crossover to different entry site or impossibility to perform the planned procedure), entry site complications (major hematoma, vascular surgery, or arteriovenous fistula), and major adverse cardiovascular events (MACE), defined as death, myocardial infarction, emergency revascularization, or stroke, were computed. Results Twelve randomized trials (n = 3,224) were included in the analysis. The risk of MACE was similar for the radial versus femoral approach (OR 0.92, 95% confidence interval [CI] 0.57 to 1.48; p = 0.7). Instead, radial access was associated with a significantly lower rate of entry site complications (OR 0.20, 95% CI 0.09 to 0.42; p Conclusions The radial approach for coronary procedures appears as a safe alternative to femoral access. Moreover, radial access virtually eliminates local vascular complications, thanks to a time-sparing hemostasis technique. However, gaining radial access requires higher technical skills, thus yielding an overall lower success rate. Nonetheless, a clear ongoing trend toward equalization of the two procedures, in terms of procedural success, is evident through the years, probably due to technologic progress of materials and increased operator experience.

This study assesses demographic and clinical variables associated with perioperative and late stroke in diabetes mellitus patients after multivessel coronary artery bypass grafting (CABG). Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) is the largest randomized trial of diabetic patients undergoing multivessel CABG. FREEDOM patients had improved survival free of death, myocardial infarction, or stroke and increased overall survival after CABG compared to percutaneous intervention. However, the stroke rate was greater following CABG than percutaneous intervention. We studied predictors of stroke in CABG-treated patients analyzing separately overall, perioperative (≤30 days after surgery), and late (>30 days after surgery) stroke. For long-term outcomes (overall stroke and late stroke), Cox proportional hazards regression was used, accounting for time to event, and logistic regression was used for perioperative stroke. Independent perioperative stroke predictors were previous stroke (odds ratio [OR] 6.96, 95% confidence interval [CI] 1.43 to 33.96; p = 0.02), warfarin use (OR 10.26, 95% CI 1.10 to 96.03; p = 0.02), and surgery outside the United States or Canada (OR 9.81, 95% CI 1.28 to 75.40; p = 0.03). Independent late stroke predictors: renal insufficiency (hazard ratio [HR] 3.57, 95% CI 1.01 to 12.64; p = 0.048), baseline low-density lipoprotein ≥105 mg/dl (HR 3.28, 95% CI 1.19 to 9.02; p = 0.02), and baseline diastolic blood pressure (each 1 mm Hg increase reduces stroke hazard by 5%; HR 0.95, 95% CI 0.91 to 0.99; p = 0.03). There was no overlap between predictors of perioperative versus late stroke. In conclusion, late post-CABG strokes were associated with well-described risk factors. Nearly half of the strokes were perioperative. Independent risk factors for perioperative stroke: previous stroke, previous warfarin use, and CABG performed outside the United States or Canada.

The purpose of this study was to compare the effects of stent placement with and without balloon predilatation on duration of the procedure, reduction of procedure-related costs, and clinical outcomes. Although preliminary trials of direct coronary stenting have demonstrated promising results, the lack of randomized studies with long-term follow-up has limited the critical evaluation of the role of direct stenting in the treatment of obstructive coronary artery disease. Between January and September 1999, 338 patients were randomly assigned to either direct stent implantation (DS+; 173 patients) or standard stent implantation with balloon predilatation (DS-; 165 patients). Baseline clinical and angiographic characteristics were similar in the 2 groups. Procedural success was achieved in 98.3% of patients assigned to DS+ and 97.5% of patients assigned to DS- (p = NS), with a crossover rate of 13.9%. Compared with DS-, DS+ conferred a dramatic reduction in procedure-related cost ($956.4 +/- $352.2 vs $1,164.6 +/- $383.9, p

To determine the relation between the concentration of Lp(a), LpAI, immunological markers of LDL oxidation (antioxidized-LDL autoantibodies (LDL-AB), LDL immune complexes (LDL-IC)) and restenosis after percutaneous transluminal coronary angioplasty (PTCA) in a Caucasian population (France), we studied 77 consecutive patients who successfully underwent PTCA. All were evaluated by follow-up angiography at an average of 6 months after PTCA and were divided into two groups: existence of restenosis (32 patients, group (G+)) and absence of restenosis (45 patients, negative group (G-)). The prevalence of diabetes mellitus was higher in the restenosis positive group than in the negative group (28% versus 2% respectively, P=0.001). Before and after adjustment in diabetes mellitus frequency there was no difference in the usual lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, phospholipids, apolipoprotein AI, apolipoprotein B) between the two groups of patients nor in the other parameters (Before adjustment: Lp(a): 0.306+/-0.352 g/l (G+) vs. 0.263+/-0.270 g/l (G-); LpAI: 0.414+/-0.126 g/l (G+) vs. 0.390+/-0.092 g/l (G-); LDL-AB: arbitrary unit (AU) 3.75+/-1.91 (G+) vs. 3.67+/-1.24 (G-); LDL-IC: (AU) 0.93+/-0.82 (G+) vs. 0.86+/-0.44 (G-)). Spearman correlation coefficients did not report any correlation between late loss, loss index, gain and the above mentioned plasma parameters. In conclusion, usual tested plasma lipids, Lp(a), LpAI and in vivo markers of LDL oxidation (LDL-AB and LDL-IC) are not risk factors for restenosis after PTCA in this French population.