Hypertension, microvascular obstruction and infarct size in patients with STEMI undergoing PCI: Pooled analysis from 7 cardiac magnetic resonance imaging studies.

BACKGROUND: Mortality after ST-segment elevation myocardial infarction (STEMI) is increased in patients with hypertension. The mechanisms underlying this association are uncertain. We sought to investigate whether patients with STEMI and prior hypertension have greater microvascular obstruction (MVO) and infarct size (IS) compared with those without hypertension. METHODS: We pooled individual patient data from 7 randomized trials of patients with STEMI undergoing primary percutaneous coronary intervention (PCI) in whom cardiac magnetic resonance imaging was performed within 1 month after reperfusion. The associations between hypertension and MVO, IS, and mortality were assessed in multivariable adjusted models. RESULTS: Among 2174 patients (61.3 ± 12.6 years, 76% male), 1196 (55.0%) had hypertension. Patients with hypertension were older, more frequently diabetic and had more extensive coronary artery disease than those without hypertension. MVO and IS measured as percent LV mass were not significantly different in patients with and without hypertension (adjusted differences 0.1, 95% CI -0.3 to 0.6, P = .61 and -0.2, 95% CI -1.5 to 1.2, P = .80, respectively). Hypertension was associated with a higher unadjusted risk of 1-year death (hazard ratio [HR] 2.28, 95% CI 1.44-3.60, P < .001), but was not independently associated with higher mortality after multivariable adjustment (adjusted HR 1.04, 95% CI 0.60-1.79, P = .90). CONCLUSION: In this large-scale individual patient data pooled analysis, hypertension was not associated with larger IS or MVO after primary PCI for STEMI.

Developmental or Procedural Vena Cava Interruption and Venous Thromboembolism: A Review.

The inferior vena cava (IVC) and superior vena cava are the main conduits of the systemic venous circulation into the right atrium. Developmental or procedural interruptions of vena cava might predispose to stasis and deep vein thrombosis (DVT) distal to the anomaly and may impact the subsequent rate of pulmonary embolism (PE). This study aimed to review the various etiologies of developmental or procedural vena cava interruption and their impact on venous thromboembolism. A systematic search was performed in PubMed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines per each clinical question. For management questions with no high-quality evidence and no mutual agreements between authors, Delphi methods were used. IVC agenesis is the most common form of congenital vena cava interruption, is associated with an increased risk of DVT, and should be suspected in young patients with unexpected extensive bilateral DVT. Surgical techniques for vena cava interruption (ligation, clipping, and plication) to prevent PE have been largely abandoned due to short-term procedural risks and long-term complications, although survivors of prior procedures are occasionally encountered. Vena cava filters are now the most commonly used method of procedural interruption, frequently placed in the infrarenal IVC. The most agreed-upon indication for vena cava filters is for patients with acute venous thromboembolism and coexisting contraindications to anticoagulation. Familiarity with different forms of vena cava interruption and their local and systemic adverse effects is important to minimize complications and thrombotic events.

High-Sensitivity vs Conventional Troponin Cutoffs for Risk Stratification in Patients With Acute Pulmonary Embolism.

Importance: High-sensitivity troponin tests can detect even milder cardiac troponin elevations in plasma, beyond the threshold of conventional troponin tests. Whether detection of low-grade cardiac troponin elevation is associated with outcomes of patients with hemodynamically stable pulmonary embolism (PE) and helps with risk stratification is unknown. Objective: To determine the association between high-sensitivity cardiac troponin I (hs-cTnI) compared with conventional cardiac troponin I (cTnI) and PE risk designations according to the European Society of Cardiology (ESC) 2019 classification scheme and clinical outcomes in patients with hemodynamically stable PE. Design, Setting, and Participants: This is a post hoc analysis of data from the prospective Prognostic Value of Computed Tomography (PROTECT) multicenter cohort study enrolling patients from 12 hospital emergency departments in Spain. In this analysis, cTnI and hs-cTnI were compared with respect to ESC risk designation, and the association between troponin values and a complicated course after PE diagnosis was evaluated. Of 848 patients enrolled in PROTECT, 834 (98.3%) had hsTnI and cTnI values available and were included in the present analysis. Data were analyzed from May to December 2022. Exposures: Troponin blood testing with cTnI (threshold of >0.05 ng/mL) vs hs-cTnI (threshold of >0.029 ng/mL) assays at the time of PE diagnosis. Main Outcomes: Complicated course, defined as hemodynamic collapse, recurrent PE, or all-cause death, within 30 days after PE. Results: Of 834 patients (mean [SEM] age, 67.5 [0.6] years; 424 [50.8%] female), 139 (16.7%) had elevated cTnI and 264 (31.7%) elevated hs-TnI, respectively. During follow-up, 62 patients (7.4%; 95% CI, 5.7-9.4) had a complicated course. Analyzing troponin elevation as a binary variable, elevated cTnI (odds ratio [OR], 2.84; 95% CI, 1.62-4.98) but not hs-cTnI (OR, 1.12; 95% CI, 0.65-1.93) was associated with increased odds of a complicated course. Of 125 patients who had elevated hs-cTnI but normal cTnI, none (0; 95% CI, 0.0-2.9) developed a complicated course. Using the 2019 ESC risk stratification scheme, hs-TnI classified fewer patients as low risk compared with cTnI. Among 78 patients designated as ESC low risk when using cTnI but not with hsTnI, none (0; 95% CI, 0.0-4.6) had a complicated course. Conclusions and Relevance: In this study of patients with hemodynamically stable PE, hs-cTnI identified modest elevations in cardiac troponin levels. However, the results did not provide additive clinical value compared with cTnI. These findings suggest that use of hs-cTnI may result in overestimation of the risk in patients with stable PE.

Bivalirudin Versus Heparin During PCI in NSTEMI: Individual Patient Data Meta-Analysis of Large Randomized Trials.

BACKGROUND: The benefit:risk profile of bivalirudin versus heparin anticoagulation in patients with non-ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) is uncertain. Study-level meta-analyses lack granularity to provide conclusive answers. We sought to compare the outcomes of bivalirudin and heparin in patients with non-ST-segment-elevation myocardial infarction undergoing PCI. METHODS: We performed an individual patient data meta-analysis of patients with non-ST-segment-elevation myocardial infarction in all 5 trials that randomized ≥1000 patients with any myocardial infarction undergoing PCI to bivalirudin versus heparin (MATRIX [Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox], VALIDATE-SWEDEHEART [Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial], ISAR-REACT 4 [Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4], ACUITY [Acute Catheterization and Urgent Intervention Triage Strategy], and BRIGHT [Bivalirudin in Acute Myocardial Infarction vs Heparin and GPI Plus Heparin Trial]). The primary effectiveness and safety end points were 30-day all-cause mortality and serious bleeding. RESULTS: A total of 12 155 patients were randomized: 6040 to bivalirudin (52.3% with a post-PCI bivalirudin infusion), and 6115 to heparin (53.2% with planned glycoprotein IIb/IIIa inhibitor use). Thirty-day mortality was not significantly different between bivalirudin and heparin (1.2% versus 1.1%; adjusted odds ratio, 1.24 [95% CI, 0.86-1.79]; P=0.25). Cardiac mortality, reinfarction, and stent thrombosis rates were also not significantly different. Bivalirudin reduced serious bleeding (both access site-related and non-access site-related) compared with heparin (3.3% versus 5.5%; adjusted odds ratio, 0.59; 95% CI, 0.48-0.72; P<0.0001). Outcomes were consistent regardless of use of a post-PCI bivalirudin infusion or routine lycoprotein IIb/IIIa inhibitor use with heparin and during 1-year follow-up. CONCLUSIONS: In patients with non-ST-segment-elevation myocardial infarction undergoing PCI, procedural anticoagulation with bivalirudin and heparin did not result in significantly different rates of mortality or ischemic events, including stent thrombosis and reinfarction. Bivalirudin reduced serious bleeding compared with heparin arising both from the access site and nonaccess sites.

Sex-Related Differences in Patient Characteristics, Risk Factors, and Symptomatology in Older Adults with Pulmonary Embolism: Findings from the SERIOUS-PE Study.

Sex-specific factors are implicated in pulmonary embolism (PE) presentation in young patients, as indicated by increased risk in pregnancy. Whether sex differences exist in PE presentation, comorbidities, and symptomatology in older adults, the age group in which most PEs occur, remains unknown. We identified older adults (aged ≥65 years) with PE in a large international PE registry replete with information about relevant clinical characteristics (RIETE registry, 2001-2021). To provide national data from the United States, we assessed sex differences in clinical characteristics and risk factors of Medicare beneficiaries with PE (2001-2019). The majority of older adults with PE in RIETE (19,294/33,462, 57.7%) and in the Medicare database (551,492/948,823, 58.7%) were women. Compared with men, women with PE less frequently had atherosclerotic diseases, lung disease, cancer, or unprovoked PE, but more frequently had varicose veins, depression, prolonged immobility, or history of hormonal therapy (p < 0.001 for all). Women less often presented with chest pain (37.3 vs. 40.6%) or hemoptysis (2.4 vs. 5.6%) but more often with dyspnea (84.6 vs. 80.9%) (p < 0.001 for all). Measures of clot burden, PE risk stratification, and use of imaging modalities were comparable between women and men. PE is more common in elderly women than in men. Cancer and cardiovascular disease are more common in men, whereas transient provoking factors including trauma, immobility, or hormone therapy are more common in elderly women with PE. Whether such differences correlate with disparities in treatment or differences in short- or long-term clinical outcomes warrants further investigation.

Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism: Rationale and design of the SERIOUS-PE study.

BACKGROUND: Sex is an important factor associated with pulmonary embolism (PE) disease presentation and outcomes, which may be related to pathobiological, social, and treatment-based differences. We are seeking to illuminate sex differences in pulmonary embolism presentation, care, and outcomes using an international registry and a national US database of people 65 years and older, the age group in which the majority of these events occur. METHODS: The Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism (SERIOUS-PE) study has been designed to address knowledge gaps in this area. This study will use data from the Registro Informatizado Enfermedad TromboEmbolica (RIETE) registry and the US Medicare Fee-For-Service beneficiaries. RIETE is a large international registry of patients with venous thromboembolism with data collected on PE presentation, risk factors, co-morbidities, drug and interventional therapies, as well as 30-day and 1-year outcomes (including recurrent VTE, major bleeding, and mortality). Data from US Medicare Fee-For-Service beneficiaries will be used to understand the sex differences in PE hospitalizations, advanced therapies, and outcomes at 30-day and 1-year follow-up. Assessment of outcomes in both databases will be performed in unadjusted models, as well as those adjusted for demographics, co-morbidities, and treatments, to understand whether the potential sex differences in outcomes are related to differences in risk factors and co-morbidities, potential disparities in treatment, or a plausible biological difference in women versus men. Linear trends will be assessed over time. RESULTS: RIETE data from March 2001 through March 2021 include 33,462 elderly patients with PE, of whom 19,294 (57.7%) were women and 14,168 (42.3%) were men. In the Medicare Fee-For-Service database, between January 2001 and December 31, 2019, 1,030,247 patients were hospitalized with a principal discharge diagnosis of PE, of whom 599,816 (58.2%) were women and 430,431 (41.8%) were men. CONCLUSIONS: Findings from the SERIOUS-PE study will help address important knowledge gaps related to sex differences in presentation and risk factors, treatment patterns, and outcomes of older adults with PE. The results may guide changes in prognostic prediction rules based on sex-specific findings, identify sex-based disparities in care delivery that should be addressed by quality improvement, or uncover potential differences in response to available therapies that warrant testing in dedicated randomized trials.

Imaging modalities for confirming pulmonary embolism during pregnancy: results from a multicenter international study.

OBJECTIVES: We explored the variations in use of imaging modalities for confirming pulmonary embolism (PE) according to the trimester of pregnancy. METHODS: We included all pregnant patients with confirmed acute PE from RIETE, a prospective registry of patients with PE (03/2001-02/2020). Imaging modalities included computed tomography pulmonary angiography (CTPA), ventilation-perfusion (V/Q) scan, or presence of signs of acute PE along with imaging-confirmed proximal deep vein thrombosis (pDVT) without pulmonary vascular imaging. We compared the imaging modalities to postpartum patients with PE, and other non-pregnant women with PE. RESULTS: There were 157 pregnant patients (age: 32.7 ± 0.5), 228 postpartum patients (age: 33.9 ± 0.5), and 23,937 non-pregnant non-postpartum women (age: 69.5 ± 0.1). CTPA was the most common modality for confirming PE, from 55.7% in first trimester to 58.3% in second trimester, and 70.0% in third trimester. From first trimester to third trimester, V/Q scanning was used in 21.3%, 16.7%, and 18.3% of cases, respectively. Confirmed pDVT along with the presence of signs/symptoms of PE was the confirmatory modality for PE in 21.3% of patients in first trimester, 19.4% in second trimester, and 6.7% in third trimester. The proportion of postpartum patients confirmed with CTPA (85.5%) was comparable to that of non-pregnant non-postpartum women (83.2%). From the first trimester of pregnancy to postpartum period, there was a linear increase in the proportion of patients with PE diagnosed with CTPA (p = 0.039). CONCLUSION: CTPA was the primary modality for confirming PE in all trimesters of pregnancy, although its proportional use was higher in later stages of pregnancy. KEY POINTS: • Computed tomography pulmonary angiography (CTPA) was the primary modality of diagnosis in all trimesters of pregnancy among patients with confirmed pulmonary embolism, even in the first trimester. • From the first trimester of pregnancy to postpartum period, there was a linear increase in the proportion of patients with pulmonary embolism who were diagnosed based on CTPA. • In the postpartum period, use of CTPA as the modality to confirm pulmonary embolism was comparable to non-pregnant patients.

Ventilation/perfusion (V/Q) scanning in contemporary patients with pulmonary embolism: utilization rates and predictors of use in a multinational study.

Ventilation/perfusion (V/Q) imaging and computed tomography pulmonary angiography (CTPA) are common tools for acute pulmonary embolism (PE) diagnosis. Limited contemporary data exist about the utilization of each modality, including the predictors of using V/Q versus CTPA. We used the data from patients diagnosed with PE using V/Q or CTPA from 2007 to 2019 in Registro Informatizado Enfermedad ThromboEmbolica, an international prospective registry of patients with venous thromboembolism. Outcomes was to determine the trends in utilization of V/Q vs. CTPA and, in a contemporary subgroup fitting with current practices, to evaluate predictors of V/Q use with multivariable logistic regression. Among 26,540 patients with PE, 89.2% were diagnosed with CTPA, 7.1% with V/Q and 3.7% with > 1 thoracic imaging modality. Over time, the proportional use of V/Q scanning declined (13.9 to 3.3%, P < 0.001). In multivariable analysis, heart failure history (odds ratio [OR]:1.5; 95% confidence interval [CI] 1.14-1.98), diabetes ([OR 1.71; 95% CI 1.39-2.10]), moderate and severe renal failure (respectively [OR 1.87; 95% CI 1.47-2.38] and [OR 9.36; 95% CI 6.98-12.55]) were the patient-level predictors of V/Q utilization. We also observed an influence of geographical and institutional factors, partly explained by time-limited V/Q availability (less use over weekends) and regional practices. Use of V/Q for the diagnosis of PE decreased over time, but it still has an important role in specific situations with an influence of patient-related, institution-related and logistical factors. Local and regional resources should be evaluated to improve V/Q accessibility than could benefit for this population.

Relationship between primary percutaneous coronary intervention time of day, infarct size, microvascular obstruction and prognosis in ST-segment elevation myocardial infarction.

BACKGROUND: Whether the time of day of primary percutaneous coronary intervention (pPCI) in patients with ST-segment elevation myocardial infarction (STEMI) is associated with infarct size, microvascular obstruction (MVO), and prognosis is uncertain. We compared infarct size assessed by cardiac MRI (CMR) and clinical outcomes in STEMI patients according to the pPCI time of day from a large, individual patient-data pooled database. METHODS: We pooled patient-level data from five randomized pPCI trials in which infarct size was measured within 1 month by CMR. Patients were categorized according to the pPCI time of day. RESULTS: Among 1519 patients with STEMI, 794 (52.2%) underwent pPCI between 8:00 h and 15:59 h, 431 (28.4%) between 16:00 h and 23:59 h, and 294 (19.4%) between 24:00 h and 7:59 h. Infarct size was assessed in 1331 patients at a median of 3.0 days (interquartile range 2.0-5.0) after pPCI. Compared with patients who underwent PCI between 8:00 h and 15:59 h, infarct size was not significantly different for patients undergoing PCI from 16:00 h to 23:59 h [adjusted difference -0.7%, 95% confidence interval (CI) -3.1 to 1.7%, P = 0.46] or 24:00 h to 7:59 h (adjusted difference 0.9%, 95% CI -1.2 to 3.1%, P = 0.29). The time of day of pPCI was also unrelated to MVO and the 1-year risks of death or heart failure hospitalization. CONCLUSION: In this large-scale, individual patient data pooled analysis, no association was found between the time of day of pPCI and infarct size, MVO, or prognosis after STEMI.

Prognostic significance of computed tomography-assessed right ventricular enlargement in low-risk patients with pulmonary embolism: Systematic review and meta-analysis.

BACKGROUND: For patients with acute low-risk pulmonary embolism (PE), determined by a validated clinical prognostic score, the additive prognostic significance of computed tomography (CT)-assessed right ventricular (RV) enlargement is uncertain. METHODS: We performed a systematic review and meta-analysis of studies that enrolled patients with acute low-risk PE to assess the prognostic value of concomitant CT-assessed RV enlargement for 30-day all-cause mortality and PE-related death. We conducted unrestricted searches of PubMed and Embase through December 2019. We used a random-effects model to pool study results; Begg rank correlation method to evaluate for publication bias; and I2 testing to assess for heterogeneity. RESULTS: Of the 7 cohorts with 2197 participants who had low-risk PE and provided results on the primary outcome, 743 (34%; 95% confidence interval [CI], 32-36%) patients had concomitant RV enlargement. Six of 743 (0.8%; 95% CI, 0.3-1.8%) patients with concomitant RV enlargement died 30-days after the diagnosis of PE compared with 3 of 1454 (0.2%, 95% CI, 0-0.6%) without RV enlargement. CT-assessed RV enlargement did not have a significant association with 30-day all-cause mortality (odds ratio [OR], 2.6; 95% CI, 0.7-9.4; I2 = 0%; P = 0.15) or PE-related mortality (OR, 2.8; 95% CI, 0.7-12.1; I2 = 0%; P = 0.16). CONCLUSIONS: CT-assessed RV enlargement occurs in a third of PE patients identified as low-risk by clinical scores. Mortality rate in these patients is low, and CT-assessed RV enlargement was not associated with a significantly increased risk of death within 30 days of PE diagnosis.

Cardiac structural changes after transcatheter aortic valve replacement: systematic review and meta-analysis of cardiovascular magnetic resonance studies.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly used to treat patients with severe aortic stenosis (AS). Cardiovascular magnetic resonance imaging (CMR) provides reliable and reproducible estimates for assessment of cardiac structure and function after TAVR. The goal of this study was to conduct a systematic review and meta-analysis of the literature to assess left ventricular (LV) volumes, mass and function by CMR after TAVR. METHODS: Using Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines, we searched PubMed and Embase for studies reporting CMR findings before and at least 1 month after TAVR. Main factors of interest were LV end-diastolic volume index (LVEDVi), LV end-systolic volume index (LVESVi), LV mass index (LVMi), and left ventricular ejection fraction (LVEF). Standardized mean differences (SMD) were pooled by random effects meta-analytic techniques. RESULTS: Of 453 screened publications, 10 studies (published between 2012 and 2018) were included. A total of 305 patients completed pre- and post-TAVR follow-up CMR (mean age range 78.6-85.0 years, follow-up range 6-15 months). Random effects analysis showed TAVR resulted in reduced LVEDVi (SMD: -0.25, 95% CI: - 0.43 to - 0.07, P = 0.006), LVESVi (SMD: -0.24, 95% CI: - 0.44 to - 0.05, P = 0.01), LVMi (SMD: -0.82, 95% CI: - 1.0 to - 0.63, P < 0.001) and increased LVEF (SMD: 22, 95% CI: 6 to 38%, P = 0.006). Heterogeneity across studies was low (I2: 0%, Pheterogeneity > 0.05 for all). The median reduction was 4 ml/m2 (IQR: 3.1 to 8.2) for LVEDVi, 5 ml/m2 (IQR: 3.0 to 6.0) for LVESVi, and 15.1 g/m2 (IQR: 11.8 to 18.3) for LVMi. The median increase for LVEF was 3.4% (IQR 1.0 to 4.6%). CONCLUSIONS: CMR demonstrates reverse LV remodeling occurrs within 6-15 months after TAVR, with reductions in LVEDVi, LVESVi and LVMi, and increased LVEF.

Patient-Level, Institutional, and Temporal Variations in Use of Imaging Modalities to Confirm Pulmonary Embolism.

BACKGROUND: The choice of the imaging modality for diagnosis of pulmonary embolism (PE) could be influenced by provider, patient or hospital characteristics, or over time. However, little is known about the choice of the diagnostic modalities in practice. The aim of this study was to evaluate the variations in the use of imaging modalities for patients with acute PE. METHODS: Using the data from Registro Informatizado Enfermedad TromboEmbolica (RIETE), a prospective international registry of patients with venous thromboembolism (March 2001-January 2019), we explored the imaging modalities used in patients with acute PE. The imaging modalities included computed tomography pulmonary angiography, ventilation/perfusion scanning, pulmonary angiography, a combination of these tests, or PE signs and symptoms plus imaging-confirmed proximal deep vein thrombosis but no chest imaging. RESULTS: Among 38 025 patients with confirmed PE (53.1% female, age: 67.3±17 years), computed tomography pulmonary angiography was the dominant modality of diagnosis in all RIETE enrollees (78.2% [99% CI, 77.6-78.7]); including pregnant patients (58.9% [99% CI, 47.7%-69.4%]) and patients with severe renal insufficiency (62.5% [99% CI, 59.9-65.0]). A greater proportion of patients underwent ventilation/perfusion scanning in larger hospitals compared with smaller hospitals (13.1% versus 7.3%, P<0.001). The use of computed tomography pulmonary angiography varied between 13.3% and 98.3% across the countries, and its use increased over time (46.5% in 2002 to 91.7% in 2018, P<0.001). CONCLUSIONS: In a large multinational PE registry, variations were observed in the use of imaging modalities according to patient or institutional factors and over time. However, computed tomography pulmonary angiography was the dominant modality of diagnosis, even in pregnancy and severe renal insufficiency. The safety, costs, and downstream effects of these tests on PE-related and non-PE-related outcomes warrant further investigation.

Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction: Rationale and Methodology.

BACKGROUND: Individual randomized controlled trials (RCTs) of periprocedural anticoagulation with bivalirudin versus heparin during percutaneous coronary intervention (PCI) have reported conflicting results. Study-level meta-analyses lack granularity to adjust for confounders, explore heterogeneity, or identify subgroups that may particularly benefit or be harmed. OBJECTIVE: To overcome these limitations, we sought to develop an individual patient-data pooled database of RCTs comparing bivalirudin versus heparin. METHODS: We conducted a systematic review to identify RCTs in which ≥1,000 patients with acute myocardial infarction (AMI) undergoing PCI were randomized to bivalirudin versus heparin. RESULTS: From 738 identified studies, 8 RCTs met the prespecified criteria. The principal investigators of each study agreed to provide patient-level data. The data were pooled and checked for accuracy against trial publications, with discrepancies addressed by consulting with the trialists. Consensus-based definitions were created to resolve differing antithrombotic, procedural, and outcome definitions. The project required 3.5 years to complete, and the final database includes 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin). CONCLUSION: We have created a large individual patient database of bivalirudin versus heparin RCTs in patients with AMI undergoing PCI. This endeavor may help identify the optimal periprocedural anticoagulation regimen for patient groups with different relative risks of adverse ischemic versus bleeding events, including those with ST-segment and non-ST-segment elevation MI, radial versus femoral access, use of a prolonged bivalirudin infusion or glycoprotein inhibitors, and others. Adherence to standardized techniques and rigorous validation processes should increase confidence in the accuracy and robustness of the results.

Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score.

BACKGROUND: The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial. METHODS: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression. RESULTS: A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (Pinteraction=0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P=0.01), a difference which rose progressively with increasing SS (Pinteraction=0.03). CONCLUSIONS: In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.

Does an occluded RCA affect prognosis in patients undergoing PCI or CABG for left main coronary artery disease? Analysis from the EXCEL trial.

AIMS: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92). CONCLUSIONS: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.

Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-Individual patient data pooled analysis from 6 randomized controlled trials.

BACKGROUND: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. METHODS: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. RESULTS: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF. CONCLUSIONS: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.

Imaging manifestations of Behcet's disease: Key considerations and major features.

Behcet's disease is an autoimmune disease most commonly seen in the Middle East. Although primarily known with painful oral and genital ulcers, it can lead to vasculitis. Therefore, several associated complications such as thrombotic syndromes, aneurysmal arterial disease may arise. In many cases, it might be difficult to make the diagnosis purely based on clinical grounds; however, imaging plays an important role for both diagnosis and assessment of the disease's complications. We provide a comprehensive review of the most notable imaging findings of Behcet's disease.

Survey of practitioners' competency for diagnosis of acute diseases manifest on chest X-ray.

BACKGROUND: Chest X-ray (CXR) is a common imaging modality that could impact immediate decision-making for acute chest pathologies. We sought to examine the non-radiologists proficiency of diagnosing acute pathologies manifest on CXR. METHODS: We selected 9 clinical vignettes, each associated with a CXR, wherein only a single acute chest pathology was manifest. We also added a low-risk vignette associated with a normal CXR. We built an electronic survey with the CXR-embedded vignettes and also inquired about the participants' confidence in the diagnosis, and prior exposure to the topics. We distributed the survey to senior medical students and general practitioners (GPs) in Tehran, Iran. We scored each correct answer per each vignette as 1 and each incorrect answer as 0; leading into a sum score from 0 to10 for the entire survey for each participant. RESULTS: Of the 136 candidates, 100 had legible survey results (67 medical students and 33 GPs). The overall score (mean [standard error]) was 3.57 [0.20], with no significant difference between the students and GPs (P = 0.15). The lowest rate of correct response occurred for acute respiratory distress syndrome (8%), foreign body (12%), and normal CXR (15%), while the best-answered vignettes were diaphragmatic herniation (77%) and pneumoperitoneum (67%). Self-reported confidence was associated with correct response for pneumoperitoneum, tension pneumothorax, and pulmonary edema (P < 0.05 for all). CONCLUSIONS: Diagnostic proficiency of practitioners for acute chest pathologies in our study was poor, including for distinction of a normal CXR. Such dramatic knowledge deficiencies for common or life-threatening chest pathologies should be prioritized in the educational and continuous education curricula. Secure electronic tools for transferring the CXRs to specialists in case of acute pathologies would be an interim pragmatic alternative.