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Although transfemoral transcatheter aortic valve replacement (TAVR) is the gold standard, this approach is not be feasible in approximately 15% of the patients. Trans-carotid TAVR may be less invasive than transthoracic routes for TAVR, and has been associated with encouraging results. Further prospective studies comparing alternative access routes in patients with whom transfemoral TAVR is not feasible are warranted, to propose an evidence-based algorithm guiding the physician decision.

OBJECTIVES We sought to identify clinical, electrocardiographic (ECG), and angiographic characteristics that are predictive of 3-year mortality after primary percutaneous coronary intervention (PCI) in patients with non-anterior ST-elevation myocardial infarction (NA-STEMI) from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. BACKGROUND Which patients with NA-STEMI undergoing PCI have a poor prognosis is uncertain. METHODS NA-STEMI was defined as ST-segment elevation in lateral (V5, V6, I, aVL), inferior (II, III, aVF), or inferolateral (I, II, III, aVF, and V5-V6) ECG leads or posterior myocardial infarction with ST-segment depression of ≥1 mm in ≥2 contiguous anterior leads. Cox regression was used to identify independent predictors of 3-year mortality. Missing data were imputed using multiple imputation. RESULTS In HORIZONS-AMI, 2,578/3,602 patients had no prior coronary artery bypass grafting, underwent single-vessel PCI, and had baseline ECG data assessed in an independent core laboratory. Among them, 1,495 (58.0%) had NA-STEMI. Patients with NA-STEMI had lower 3-year mortality risk than those with anterior STEMI (4.5% versus 7.1%, P = 0.004). The independent predictors of increased 3-year mortality in NA-STEMI were older age (median > 59.0 years), diabetes, reduced LVEF (≤50%), Killip class ≥2, post-procedure TIMI flow 0-2 versus 3, renal insufficiency, and ST-resolution

Objectives: To investigate the prevalence, predictors and associations between guideline-directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States. Background: Evidence for GDMT in patients with AMI comes from randomized controlled trials. The use of GDMT in clinical practice is unknown in this setting. Methods: PROMETHEUS is a multicenter observational registry comprising 19,914 patients with acute coronary syndrome (ACS) undergoing PCI. Patients with AMI were divided into two groups based on the prescription of GDMT or not (non-GDMT) at discharge. GDMT was defined according to American College of Cardiology/American Heart Association (ACC/AHA) class I recommendations, specifically, dual antiplatelet therapy, statin and beta-blocker for all AMI patients, and additional ACEI/ARB in patients with left ventricular ejection fraction (LVEF) less than 40%, hypertension, diabetes mellitus (DM) or chronic kidney disease (CKD). The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause death, MI, stroke or unplanned target vessel revascularization (TVR) at 1 year. Results: Out of 4,834 patients with AMI, 3,356 (69.4%) patients were discharged on GDMT. Patients receiving GDMT were more often younger and male. Compared with non-GDMT patients, GDMT patients had a significantly lower frequency of comorbidities. Predictors of greater GDMT prescription at discharge were ST-segment elevation myocardial infarction (STEMI), and increased body mass index (BMI), whereas hypertension, prior PCI, anemia and CKD were associated with less GDMT prescription. At 1 year, the use of GDMT was associated with a significantly lower incidence of MACE (13.7% vs. 22.5%; adjusted HR 0.68; 95%CI 0.58–0.80; P < 0.001), death (3.7% vs. 9.4%; adjusted HR 0.61; 95%CI 0.46–0.80; P < 0.001), and unplanned TVR (8.4% vs. 11.3%; adjusted HR 0.76; 95%CI 0.61–0.96; P = 0.020). However, there were no significant differences in the incidence of MI (4.3% vs. 7.0%; adjusted HR 0.75; 95%CI 0.56–1.01; P = 0.056), stroke (1.5% vs. 2.0%; adjusted HR 0.79; 95%CI 0.47–1.34; P = 0.384) between the two groups. Conclusion: In a contemporary practice setting in the United States, GDMT was utilized in just over two-thirds of AMI patients undergoing PCI. Predictors of GDMT prescription at discharge included STEMI, BMI and absence of hypertension, CKD, anemia or prior PCI. Use of GDMT was associated with significantly lower risk of 1-year MACE and mortality.

Objectives To assess the safety and efficacy of the novel Resolute (R-) Onyx drug-eluting stent (DES). Background The R-Onyx DES consists of a composite wire with an outer shell of cobalt chromium alloy and a platinum-iridium inner core to enhance radiopacity, with thinner, swaged struts and modified stent geometry compared with the predicate Resolute DES, resulting in a slightly lower total drug load in most sizes. Methods This was a prospective, single-arm non-inferiority trial compared with a historical control. Patients with stable angina/ischemia and up to 2 de novo target lesions ≤35 mm long with reference vessel diameter (RVD) of 2.25–4.2 mm were enrolled. The primary endpoint was late lumen loss at 8-month follow-up. Propensity-score adjusted outcomes from the single-arm RESOLUTE-US trial served as the control. Results Seventy-five patients (85 lesions) were enrolled. Mean patient age was 66 ± 9 years, 73% were male, and 32% had diabetes. Mean lesion length was 14.28 ± 6.68 mm, mean RVD was 2.57 ± 0.48 mm, and 86% of lesions were class B2/C. In-stent late lumen loss at 8 months was 0.24 ± 0.39 mm with R-Onyx DES compared with 0.36 ± 0.52 mm with Resolute DES (P

Objectives We sought to determine the prevalence, predictors, and clinical impact of target lesion calcification in patients undergoing percutaneous coronary intervention (PCI) with newer generation drug-eluting stents (DES) and devices. Background Coronary calcification is independently associated with adverse outcomes following PCI. While newer DES and contemporary devices are considered safer and more efficacious, their influence on outcomes following PCI of heavily calcified lesions is unknown. Methods We performed a retrospective analysis of a large, multiethnic cohort of patients undergoing PCI with new generation DES at an academic center between 2009 and 2013. Coronary calcification was qualitatively assessed as none/mild, moderate, or severe. Independent demographic, clinical, and anatomic predictors of moderate/severe calcification were identified using logistic regression. Associations between coronary calcification and 1-year MACE (death, myocardial infarction, or target vessel revascularization) were examined using Cox modeling. Results Compared to patients with none/mild (n = 10,180; 82.0%), those with moderate (n = 1,271; 10.0%) or severe (n = 994; 8.0%) calcification were older, more often Caucasian, had more complex target lesions, and worse renal function. The strongest demographic, clinical, and anatomic correlates of moderate/severe calcification were age, Caucasian race, renal dysfunction, lesion length, and left main location. Unadjusted MACE rates among those with none/mild, moderate, and severe calcification were 8.3, 14.6, and 17.8%, respectively (P

Objective To examine the relationship between occupational exposure to ionizing radiation and the prevalence of lens changes in interventional cardiologists (ICs) and catheterization laboratory (“cath-lab”) staff. Background Exposure to ionizing radiation is associated with the development of lens opacities. ICs and cath-lab staff can receive high doses of ionizing radiation without protection, and may thus be at risk for lens opacity formation. Methods We conducted a cross-sectional study at an interventional cardiology conference. Study participants completed a questionnaire pertaining to occupational exposure to radiation and potential confounders for the development of cataracts, followed by slit-lamp examination and grading of lens findings. Results A total of 117 attendees participated in the study, including 99 (85%; 49 ± 11 years-old; 82% male) with occupational exposure to ionizing radiation and 18 (15%; 39 ± 12 years-old; 61% male) unexposed controls. The prevalence of overall cortical and posterior subcapsular lens changes (including subclinical findings) was higher in exposed participants compared with controls (47 vs. 17%, P = 0.015). Occupational exposure and age over 60 were independent predictors of lens changes (odds ratio [95% CI]: 6.07 [1.38–43.45] and 7.72 [1.60–43.34], respectively). The prevalence of frank opacities was low and similar between the two groups (14 vs. 6%, P = 0.461). Most lens findings consisted of subclinical changes in the periphery of the lens without impact on visual acuity. Conclusions Compared with unexposed controls, ICs and cath-lab staff had a higher prevalence of lens changes that may be attributable to ionizing radiation exposure. While most of these changes were subclinical, they are important due to the potential to progress to clinical symptoms, highlighting the importance of minimizing staff radiation exposure.

Ascertaining risk of contrast induced acute kidney injury (CI-AKI) in ST-segment elevation myocardial infarction (STEMI) patients undergoing multi-vessel percutaneous coronary intervention (MV-PCI).Complete revascularization may improve outcomes in STEMI patients with multi-vessel disease. However, a practice of MV-PCI may be associated with a higher risk of CI-AKI. We aimed to evaluate the risk of CI-AKI in patients with STEMI and MV-PCI and examine the accuracy of a validated risk score.We searched PubMed, Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from inception through August 31, 2016 for randomized studies comparing CI-AKI rates with MV-PCI and infarct-related artery (IRA) only PCI during index hospitalization. A random effects model was used to estimate the risk ratio (RR) and respective 95% confidence intervals (CI). We queried the Nationwide Inpatient Sample (NIS) to assess the ability of the Mehran risk score to accurately predict the incidence of CI-AKI in patients undergoing MV-PCI.Four randomized studies (N = 1,602) were included in the final analysis. The risk of CI-AKI was low and no difference was observed with MV-PCI (1.45%) compared with IRA-only (1.94%) (RR 0.73, 95% CI 0.34-1.57; P = 0.57). From 2009 to 2012, excluding shock, there were 11,454 MV-PCI for STEMI patients in the NIS. The Mehran risk score accurately discriminated 78% of the patients who developed CI-AKI in this cohort (c-statistic of 0.78, P = 0.002).MV-PCI in STEMI is not associated with a higher risk of CI-AKI and the Mehran risk score can identify patients at higher risk for this complication. © 2017 Wiley Periodicals, Inc.

The impact of arterial hypertension, one of the most common comorbidities in CAD patients, on bleeding risk after PCI must not be underestimated. More rigorous control of blood pressure during PCI procedure, radial artery access and alternative anticoagulant strategy may be considered in these patients. Further investigation in a more contemporary setting of PCI procedure is warranted.

Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater adverse events than men, potentially due to under-treatment. We sought to compare the 1-year outcomes by sex in patients ≤55 years of age from a contemporary PCI cohort.PROMETHEUS was a retrospective multicenter observational US study comparing outcomes in clopidogrel and prasugrel treated patients following ACS PCI. MACE was defined as a composite of death, myocardial infarction, stroke or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Hazard ratios were generated using multivariable Cox proportional hazards regression.The study cohort included 4,851 patients of which 1,162 (24.0%) were women and 3,689 (76.0%) were men. In this cohort, the prevalence of diabetes (41.0 vs. 27.9%) and chronic kidney disease (12.7 vs. 7.2%) was higher among women compared with men. Irrespective of sex, prasugrel was used in less than one-third of patients (31.8% in men vs. 28.1% in women, P = 0.01). Unadjusted, 1-year MACE (21.1% vs. 16.2%, P 0.001) and bleeding (3.6% vs. 2.2%, P = 0.01) was significantly higher in women compared with men, but these results were no longer significant after adjustment for risk (HR 1.13, 95% CI 0.94-1.36 for MACE and HR 1.31, 95% CI 0.85-2.04 for bleeding).Women ≤ 55 years of age undergoing ACS PCI have significantly greater comorbidities than young men. Despite a higher risk clinical phenotype in women, prasugrel use was significantly lower in women than men. Female sex was associated with a significantly higher risk of 1-year MACE and bleeding than male sex, findings that are attributable to baseline differences. © 2016 Wiley Periodicals, Inc.

Target lesion revascularization (TLR) for BRS failure is burdened with a high rate of adverse events. DES implantation appears to be the safest treatment option following BRS failure. A real world observational study with a minimum of 2-year follow-up would be required to investigate the long-term clinical outcomes in patients with a BRS failure and to assess the best treatment option in case of TLR.

The goal of the present study was to survey the Society of Cardiovascular Angiography and Intervention (SCAI) member cardiologists to evaluate contemporary practice patterns with regards to contrast use, acute kidney injury (AKI) risk assessment, and prevention in patients undergoing invasive angiography. We sought to compare the physician responses against guideline statements and evidence-based data from clinical studies.A 20-question online survey based on a modified Likert scale was sent out via email to the Society of Cardiovascular Angiography and Intervention (SCAI) member cardiologists. The survey questions focused on prophylaxis methods, medication management, risk assessment, contrast agent use, and postprocedure care. A scoring system was developed which examined the individual responses to analyze the 10 questions with the greatest strength of evidence in the literature and guidelines.The survey was completed by 506 individuals. Selected responses of note included the use of standardized volume expansion protocols: 64.8%, use of iso-osmolar contrast (iodixanol) in the majority of patients at risk of AKI: 55%, and 27% of individuals reported diluting contrast with saline for patients at risk of AKI during coronary angiography. For questions with support from guideline documents, 56.9% of the responses were scored as concordant with evidence-based data. Individuals who reported that the risk of AKI was often or always important in planning angiography for "at risk patients" were more likely to closely monitor renal function (76.7% vs. 40.0%, P = 0.003), obtain nephrology consultation (45.2% vs. 13.3%, P = 0.016) and use iso-osmolar contrast agents (56.0% vs. 26.7%, P = 0.033).The majority of cardiologists participating in this survey, reported practice patterns consistent with guideline and evidence-based recommendations. However, over 40% of responses to questions were inconsistent with these recommendations, suggesting continued opportunities for education and quality improvement concerning AKI prevention. © 2016 Wiley Periodicals, Inc.

We sought to identify angiographic predictors of 2-year stent thrombosis (ST) in the ADAPT-DES study.A strong relationship between platelet reactivity and ST after implantation of drug-eluting stents (DES) was recently confirmed in the prospective, multicenter ADAPT-DES study.In a pre-specified analysis of patients enrolled in ADAPT-DES, an independent angiographic core laboratory performed detailed angiographic analyses for all cases of ST. Patients with Academic Research Consortium definite/probable target-lesion ST were matched with controls in a 1:2 ratio, and multivariable Cox regression models identified angiographic predictors of 2-year ST.Among 8,582 patients who had successful percutaneous coronary intervention (PCI) and were included in the ADAPT-DES study, 92 (1.1%) patients had ST at 2-year follow-up. Target lesion-related ST was identified in 77 patients (82 lesions) who were clinically matched with 153 patients (196 lesions) without ST. Patients with ST were more likely to have longer target lesions, thrombus, moderate/severe calcification, American College of Cardiology/American Heart Association (ACC/AHA) type C lesions, and saphenous vein grafts. After adjustment for clinical covariates the angiographic variables that predicted ST were lesion complexity (ACC/AHA type C lesion, adjusted HR: 1.97, 95% CI: 1.19 to 3.26, P = 0.01) and presence of thrombus on index PCI (HR: 2.25, 95% CI: 1.40 to 3.59, P 0.01).Anatomically complex lesions and the presence of thrombus are strong predictors of 2-year ST in the DES era. © 2016 Wiley Periodicals, Inc.

The aim of this study was to identify the predictors of side branch (SB) ostial stenosis developed after provisional stenting of the main vessel (MV) using optical coherence tomography (OCT).Provisional stenting remains the main approach to treatment of bifurcation lesions; however, it may result in the narrowing of SB ostium. There is little information about underlying plaque morphology of the MV lesion and its potential impact on the SB after provisional stenting.Patients with stable coronary disease with angiographic MV lesion not involving SB were included in a prospective single center study. The primary outcome was significant SB ostium stenosis (SBOS), defined as residual stenosis of50% after MV stenting.Thirty bifurcation lesions in 30 patients were analyzed in the study. Poststenting significant SBOS was observed in 30% of patients. The MV lesions with SBOS 50% were characterized by a higher prevalence of lipid rich plaques (100 vs. 64%, p = 0.040) and spotty calcifications (60 vs. 0%, p = 0.005). Maximal lipid arcs were greater (257° vs. 132°, p = 0.001) and lipid volume index was higher (1380 vs. 574, p = 0.012) in the SBOS50% group. Multivariate logistic regression analysis identified maximal lipid arc (odds ratio (OR): 1.014, p = 0.038) and the presence of lipid plaque contralateral to SB ostium (OR: 8.14, p = 0.046) before stenting as independent predictors of significant SBOS after PCI.High lipid content of the MV lesion and a contralateral location of lipid in the bifurcation area may contribute to SBOS after provisional stenting. © 2016 Wiley Periodicals, Inc.

In the drug eluting stent (DES) era, repeat in-stent restenosis (ISR) of the same coronary lesion, despite percutaneous coronary intervention (PCI), is a rare but challenging problem that has not been reported. We aim to describe what we propose as the occurrence of "resistant"-ISR (R-ISR) in the DES era, including angiographic patterns and outcomes.We defined R-ISR as the recurrence of an ISR episode after successful treatment of the same lesion. We identified 276 consecutive patients with 291 lesions who had R-ISR between May 2003 and June 2012. Quantitative coronary angiography (QCA) was performed for the first and second ISR episodes. Outcomes at one year, including death, myocardial infarction (MI), and target lesion failure (TLF), were analyzed.Patients with R-ISR had a high frequency of diabetes (62%), chronic kidney disease (39%), bifurcation lesions (51%), and moderate to severe calcified lesions (52%). The most common pattern of R-ISR was focal (77%). R-ISR lesions were treated with DES implantation (55%) or balloon-only strategy (45%). The mortality rate and TLF at 2-years were 9.3% and 51% respectively. The overall 2-year TLF rate did not vary with the originally implanted stent, angiographic pattern (focal versus diffuse), or revascularization strategy.R-ISR appears to consist predominantly of focal lesions and occurs in patients at high clinical and angiographic risk, conceivably owing to their unique diabetic and coronary calcification profile. Clinical outcomes are suboptimal irrespective of angiographic pattern or treatment strategy, indicating the recalcitrant nature of the disease, and need for aggressive treatment of cardiovascular risk factors and novel interventional approaches. © 2016 Wiley Periodicals, Inc.

As more patients become eligible for transcatheter aortic valve implantation (TAVI), resource allocation and early discharge planning require careful consideration. TAVI centers must develop locally appropriate and systematic strategies to facilitate early discharge and seamless post-discharge care. While ongoing studies examine pacing requirements post-TAVI, trials comparing general anesthesia and monitored analgesia care are desired. Future technologies for co-registration of computed tomography with fluoroscopy may reduce the need for intra-operative transesophageal echo and general anesthesia. A tailored patient-centered approach is essential to optimize in-hospital stay and overall patient experience.

Frailty assessment aids appropriate patient selection for transcatheter aortic valve implantation (TAVI). An uncumbersome and easy to use evaluation tool is needed to facilitate wider uptake among TAVI teams. Mobility assessment by the euroSCORE definition can be utilized as a one-point measure and may be indicative of short- and long-term outcomes post TAVI. Frailty is an evolving concept and further data are warranted, with validation across regions to determine a gold standard.

To evaluate the impact of antithrombotic regimens during the medical phase of treatment among 13,819 patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) treated with an early invasive strategy in the acute catheterization and urgent intervention triage strategy (ACUITY) trial.Endpoints included composite major adverse cardiac events (MACE), major bleeding, and net adverse clinical events (NACE; MACE or major bleeding). The median (interquartile range) duration of antithrombin use in the medical only treatment phase was 6.5 (1.8-22.5) hours. MACE, major bleeding, and NACE during the medical only phase occurred in 63 (0.5%), 117 (0.9%), and 178 (1.3%) patients, respectively. MACE rates in the medical-treatment-only phase were not significantly different between the four randomized medical regimens used (heparin alone, bivalirudin alone, heparin plus a glycoprotein IIb/IIIa inhibitor [GPI], and bivalirudin plus GPI) (Ptrend = 0.65). The lowest rates of major bleeding and NACE during the medical treatment phase occurred in patients treated with bivalirudin alone (Ptrend = 0.0006 and Ptrend = 0.0004, respectively).In patients with NSTE-ACS undergoing an early invasive strategy, treatment with bivalirudin alone significantly reduced major bleeding and improved net clinical outcomes during the upstream medical management phase with comparable rates of MACE. © 2015 Wiley Periodicals, Inc.

We aimed to construct a predictive model for one-year mortality in patients undergoing invasive coronary evaluation and to examine the impact of bivalirudin on survival according to the level of baseline risk.Compared to heparin plus GP IIb/IIIa inhibitors (HEP/GPI), bivalirudin decreases bleeding complications in a range of clinical presentations. The impact of preprocedural risk assessment on survival and whether this is modified by bivalirudin, has not been investigated in detail.We examined patient-level data from the REPLACE-2, ACUITY, and HORIZONS-AMI trials (n = 18,819) to construct a risk-adjusted mortality model using baseline clinical variables.One-year mortality occurred in 287 patients (3.1%) assigned to bivalirudin and 336 patients (3.6%) assigned to HEP/GPI (HR 0.85; 95% CI, 0.73-1.00; P = 0.048). Using 11 highly significant predictors of mortality, we developed an integer-risk score to classify patients into risk tertiles. High-risk patients had a rate of 1-year mortality over 9-fold greater than low-risk patients. Consequently, the absolute mortality reduction attributed to bivalirudin was more marked in high-risk patients: 3.1% (-0.8% to 7.0%) in the overall cohort, 4.8% (0.5% to 9.2%) in the PCI cohort (P-interaction versus intermediate and low risk categories, 0.09 and P = 0.02, respectively).In patients undergoing invasive coronary evaluation, 1-year mortality can be predicted using baseline variables. Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit.

To examine the practice patterns and outcomes of percutaneous coronary intervention (PCI) procedures performed by female interventional cardiologists in the United States (U.S.).Little is known about the prevalence, volume, case mix, and outcomes of PCI procedures performed by female interventional cardiologists.Using data from the National Cardiovascular Data Registry(®) , we performed a retrospective study of 2,465,685 PCI procedures performed at 1,431 U.S. hospitals between July 1, 2009 and June 30, 2013. Interventionalist sex was ascertained from the National Provider Identifier number of each operator.Women accounted for only 4% (412/9,179) of interventional cardiologists in the U.S., and performed 3% (n = 70,009) of all PCI procedures during the time period studied. Forty-one percent of female interventionalists operated at an institution with no other female operators. Female interventionalists performed a median of 48 PCI procedures per year (interquartile range: 22-87). Of the cases performed by female interventionalists, 77% were performed on patients with acute coronary syndrome, 3% on patients with cardiogenic shock, and 16% on call. In-hospital mortality was low (1.8%), and was not significantly different between female operators with high (≥50 cases/year) versus low (1.95% vs. 1.75%, unadjusted P = 0.12, adjusted OR: 1.03, 95% CI: 0.84-1.27) annual procedure volume.Female interventional cardiologists remain uncommon in contemporary U.S. practice. Performing only a very small proportion of PCI cases, female interventionalists are often low-volume operators, yet no significant differences in patient mortality were observed in low- versus high-volume operators.

The AVERT(TM) Contrast Modulation System (AVERT) (Osprey Medical, MN) is designed to reduce contrast volume administration during angiography. The AVERT provides an adjustable resistance circuit which decreases the pressure head delivering contrast towards the patient. The AVERT has not been previously studied in patients undergoing peripheral digital subtraction angiography (DSA). The purpose of this study was (1) to evaluate contrast savings with the AVERT and (2) to evaluate the ability to generate clinically acceptable DSA images in the process. To better define the mechanism of action in the peripheral circulation, we also developed a bench model to study the effects of the AVERT on the hydrodynamics of contrast delivery.Patients undergoing lower extremity DSA (diagnostic or intervention, sheath or catheter) were studied. The following variables were recorded for each injection: starting control syringe contrast volume, contrast volume injected towards patient, contrast volume returned to AVERT reservoir, net contrast administered to the patient and % savings. The AVERT resistance was adjusted manually based on operator's discretion--balancing image quality and contrast savings.About 408 DSA angiographic sequences were obtained in 22 patients undergoing 29 procedures. Almost 68% of the patients had chronic kidney disease. An 82% presented with critical limb ischemia, 18% had claudication. There was an overall 37% ± 14% savings of contrast (31% for diagnostic DSA, 40% for interventional procedures). Overall 91% of all images were acceptable for clinical decision making. Specifically, 94% of diagnostic and 87% of interventional images were acceptable. Injection through a 4 Fr catheter (77% acceptable) resulted in poorer image quality as compared to a 5 Fr catheter (96% acceptable). Image quality for 5, 6, and 7 Fr sheath injections was 86%, 91%, 98%, respectively. The bench model of peripheral angiography demonstrated a significant reduction in reflux of contrast proximal to the end of the catheter without loss of antegrade image quality - confirming the in vivo findings.We demonstrate that the use of the AVERT device during peripheral angiography results in significant contrast savings without compromising image quality.

Long-term clinical outcomes after exposure to non-ionic iso-osmolar contrast medium (IOCM) or ionic low-osmolar CM (LOCM) in patients with chronic kidney disease (CKD) undergoing coronary angiography are unclear.The ICON trial was a prospective, double-blinded, multicentre study that randomly assigned 146 patients with CKD undergoing coronary angiography with or without percutaneous coronary intervention to the non-ionic IOCM Iodixanol or the ionic LOCM Ioxaglate. We report the 1-year clinical outcomes.After randomization, baseline and procedural characteristics were well-matched between the two groups. At 1 year, three deaths (4.1%) occurred in the ioxaglate and nine deaths in the iodixanol group (13.6%, P = 0.07). The cardiac death rate at 1 year was 2.7% in the ioxaglate group and 9.1% in the iodixanol group (P = 0.07). There were no significant differences in the rates of myocardial infarction (1.4% vs. 1.5%; P = 1.00) and repeated revascularization (6.8% vs. 9.1%; P = 0.75).The use of ionic LOCM ioxaglate was associated with a numerically lower mortality at 1 year as compared to iodixanol in patients who underwent cardiac catheterization. Future studies evaluating long-term safety following exposure to different types of CM are warranted.

We sought to estimate the direct costs (in-hospital and 30-day) associated with an intraprocedural thrombotic event (IPTE) among patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing percutaneous coronary intervention (PCI).Patients with IPTE have higher rates of in-hospital and 30-day major adverse cardiac events than patients without IPTE. The extent to which IPTE also add to medical costs is unknown.Hospital costs for patients in the ACUITY Trial were compared between patients with and without IPTE. Adjusted comparisons were performed using generalized linear models (GLMs). All costs are reported in 2012 US dollars.A total of 1,307 patients with both core laboratory-based angiographic assessment and detailed economic data were included in the final study population. IPTE occurred in 52 patients (4.0%). Median in-hospital costs were higher in patients with IPTE than in those without IPTE ($23,719 vs. $18,419, P = 0.01). Thirty-day median costs were also higher for IPTE patients ($23,719 vs. $19,556, P = 0.05). After adjusting for baseline differences, IPTE was associated with 19.5% (95% CI: [2.8-38.8%], P = 0.02) and 18.9% (95% CI: [1.2-39.7%], P = 0.04) increases in in-hospital and 30-day costs, respectively. These relative differences represent median increases of $3,592 in initial hospital costs and $3,696 in 30-day costs.The occurrence of IPTE during the index PCI in patients with NSTEACS is associated with substantial increases in-hospital and 30-day costs. These findings suggest that strategies to prevent IPTE may be associated with important cost offsets as well as improved clinical outcomes.

We evaluated the ability of post-procedural myocardial blush grade (MBG) to stratify outcomes of patients undergoing percutaneous coronary intervention (PCI) for non-ST segment elevation acute coronary syndromes (NSTE-ACS).MBG strongly correlates with survival after reperfusion therapy in patients with ST-segment elevation myocardial infarction (STEMI).Of 13,819 NSTE-ACS patients randomized in the ACUITY trial, 3,115 patients underwent PCI and had MBG analyzed by an independent angiographic core laboratory. We examined net adverse clinical events (NACE; composite ischemia or bleeding), composite ischemia (death, MI or ischemia-driven revascularization) and non-CABG major bleeding according to final MBG.At 30 days, patients with MBG-0/1 had higher rates of NACE (25.1% vs. 13.9%, P = 0.002) and composite ischemia (19.1% vs. 9.4%, P = 0.002) than patients with MBG-2/3. At 1-year follow-up, MBG-0/1 patients had significantly higher rates of composite ischemia compared to other patients (27.8% vs. 19.8%, P = 0.02). By multivariable analysis, MBG-0/1 was an independent predictor of 30-day ischemia-driven revascularization (OR 5.74 [2.63, 12.54], P 0.0001) in the total population and among patients with normal post-PCI epicardial TIMI-3 flow (OR 6.39 [2.06, 19.78], P = 0.001). However, 1-year outcomes were similar between patients with and without normal myocardial perfusion.In conclusion, MBG is a predictor of 30-day revascularization in the overall population and in patients with normal epicardial flow but fails to stratify 1-year outcomes. Thus, unlike in STEMI patients, the prognostic value of MBG in NSTE-ACS patients appears to be limited to the short-term. © 2015 Wiley Periodicals, Inc.

To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies.It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation.We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year.Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30%) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7% vs. 10.8%, HR: 0.61, 95% CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0% vs. 8.1%, HR: 0.61, 95% CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84).In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy.

Studies have shown sex-based disparities in ST-segment elevation myocardial infarction (STEMI) management and prognosis. We sought to compare women and men undergoing primary percutaneous coronary intervention (PCI) for STEMI in a large, prospective, contemporary context.The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial randomized 3,602 patients (23.4% women and 76.6% men) with STEMI presenting within 12 hr of onset of symptoms to bivalirudin or heparin plus glycoprotein IIb/IIIa inhibitors and to PCI with drug-eluting or bare metal stents.Compared with men, women presented later after symptom onset and were more often treated with medical management alone (6.9% vs. 4.7%; P = 0.01). Women had significantly higher rates of 3-year major adverse cardiac events (MACE) and major bleeding. After adjusting for baseline differences, female sex remained an independent predictor of major bleeding (hazard ratio [HR] 1.81, 95% confidence interval [CI] 1.41-2.33; P 0.0001) but not of MACE (HR 1.09; 95% CI 0.91-1.32; P = 0.35).This study found that women with STEMI are at increased risk of bleeding as compared to men. While female sex may not directly contribute to increased risk of MACE, it is, however, associated with the presence of comorbidities that increase the risk of ischemic events long-term. Further dedicated studies are needed to confirm these findings and to assess strategies to optimize both the initial emergent treatment and long-term management in this high-risk subset. © 2014 Wiley Periodicals, Inc.

The aim of this study was to compare long-term clinical outcomes in patients treated with new-generation drug-eluting stent (DES) or early-generation DES in a real-world registry.New-generation DESs have proved to be more effective and safer than early-generation DES in randomized trials. However, the effects of new-generation DES versus early-generation DES in everyday clinical practice deserve further verification.A propensity-score and inverse-probability weighted analysis of 5,332 patients undergoing DES implantation (2,557 new-generation and 2,775 early-generation) between January 1, 2007 and June 30, 2011 was performed, with a median follow-up of 3 years. We assessed the incidence of major adverse cardiovascular events (MACE: all-cause death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), and angiographic stent thrombosis (ST) during follow-up.At 3-years, new-generation DES in comparison with early-generation DES were associated with a reduced risk of MI (5% versus 7.4%, hazard ratio [HR]=0.65, 95% confidence interval [CI]=0.51-0.82, P=0.0004) and angiographic ST (0.5% vs. 1.1%, HR=0.35, 95% CI 0.17-0.72, P=0.004), whereas, the risk of TVR (10.9% vs. 13.5%; HR 0.99, 95% CI 0.84-1.16, P=0.99) and overall MACE was not significantly different (19.2% vs. 22.4%, HR=0.94, 95% CI=0.83-1.07, P=0.35).Our data from a large all-comers multicenter registry confirm that, in comparison with early-generation DES, the use of new-generation DES is associated with similar efficacy and increased long-term safety, because of a reduced risk of ST and MI.

We sought to investigate the relationship between the SYNTAX score (SS) and stent thrombosis (ST) in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).The relationship between the SS and ST is undetermined.We stratified 2,627 patients undergoing PCI in the ACUITY trial by SS tertile according to the current population (true tertiles, SS7, SS = 7-12, and SS12) and by the SYNTAX trial (original SYNTAX tertiles, SS23, SS = 23-32, and SS32). Thirty-day and 1-year rates of definite/probable ST were determined for each tertile.A total 30 (1.1%) and 41 (1.6%) definite/probable ST events occurred by 30 days and 1 year, respectively. When stratified by true tertiles, 30-day and 1-year rates of definite/probable ST were significantly greater in the highest tertile (SS12; 2.0% and 2.8%) compared with the intermediate (SS = 7-12; 0.7% and 1.1%) and lowest tertiles (SS7; 0.6% and 0.7%), P = 0.007 and P = 0.0009, respectively. When stratified by original SYNTAX tertiles, 30-day and 1-year rates of definite/probable ST were significantly greater in the highest (SS32; 6.3% and 8.8%) and intermediate tertiles (SS = 23-32; 2.8% and 3.7%) compared with the lowest tertile (SS22; 0.8% and 1.2%), P0.0001 for both. By multivariable analysis, the SS was an independent predictor for both 30-day and 1-year definite/probable ST.In patients with NSTE-ACS undergoing PCI, the extent and severity of CAD, as assessed by the SS before revascularization, was strongly associated with the occurrence of ST both at 30 days and 1 year. © 2014 Wiley Periodicals, Inc.

To compare the discriminatory value of differing risk scores for predicting clinical outcomes following PCI in routine practice.Various risk scores predict outcomes after PCI. However, these scores consider markedly different factors, from purely anatomical (SYNTAX risk score [SRS]) to purely clinical (ACEF, modified ACEF [ACEFmod], NCDR), while other scores combine both elements (Clinical SYNTAX score [CSS], NY State Risk Score [NYSRS]).Patients with triple vessel and/or LM disease with 12 month follow-up were studied from a single center PCI registry. Exclusion criteria included STEMI presentation, prior revascularization and shock. Clinical events at 12 months were compared to baseline risk scores, according to score tertiles and area under receiver-operating-characteristic curves (AUC).We identified 584 eligible patients (69.8±12.3yrs, 405 males). All scores were predictive of mortality, with the SRS being least predictive (AUC=0.66). The most accurate scores for mortality were the CSS and ACEF (AUC=0.76 for both: P = 0.019 and 0.08 vs. SRS, respectively). For TLR, while the SRS trended toward being positively predictive (P = 0.075), several scores trended towards a negative association, which reached significance for the NCDR (P = 0.045). The SRS and CSS were the only scores predictive of MI (both P0.05). No score was particularly accurate for predicting MACE (death+MI+TLR), with AUCs ranging from 0.53 (NCDR) to 0.63 (SRS).Competing factors influence mortality, MI and TLR after PCI. An increasing burden of comorbidities is associated with mortality, whereas anatomical complexity predicts MI. By combining these outcomes to predict MACE, all scores show reduced utility.

Great strides have been made in improving outcomes for patients with ST-elevation myocardial infarction (STEMI), predominately through initiatives focusing upon improving clinical processes "upstream" of percutaneous coronary intervention (PCI). The actual step-by-step mechanics of diagnostic angiography during STEMI and other aspects of the PCI procedure itself have received relatively little attention.We hypothesized that there would be significant variation in how primary PCI for STEMI is performed in the United States. In order to better understand current US practice, an electronic survey consisting of seven focused questions was forwarded to 2,910 US interventional cardiologists who were members of the Society for Cardiovascular Angiography and Interventions (SCAI).Three hundred sixty-two responses were received (12.4%). Among respondents, the femoral artery was the preferred access site in 83% (vs. 17% radial). The use of a diagnostic catheter to visualize the non-culprit artery prior to using a guiding catheter for the culprit artery was the preferred approach for 58% of respondents, and an additional 23% preferred complete angiography with diagnostic catheters prior to guide insertion. However, a significant minority (19%) preferred starting directly with a guide catheter for the culprit artery and performing PCI prior to contralateral non-culprit artery visualization. Only 9% reported performing routine left ventriculography prior to PCI, with the majority (66%) choosing to perform ventriculography during/after PCI, and 25% reporting rare or no use of left ventriculography. Fewer than half of respondents (49%) reported routine aspiration thrombectomy use, despite a Class IIa ACC/AHA guidelines recommendation.There is significant variability in the self-reported mechanics of primary PCI by US interventional cardiologists. Some of this variability (e.g., sequence of catheters, and performance of left ventriculography prior to reperfusion) is not addressed by current guidelines/consensus documents, and may have clinical implications, reflecting the balance between the desire for timely reperfusion versus a more complete assessment of patient risk.

Objectives To assess the impact of age on safety and efficacy of paclitaxel-eluting stent (PES) implantation during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Background The benefits of paclitaxel-eluting stent (PES) implantation during primary PCI were confirmed by the long-term results of the HORIZONS-AMI trial. Whether the effects of PES are independent of age has not been reported. Methods Data on 3,006 patients from the HORIZONS-AMI study randomized in a 3:1 ratio to PES or bare-metal stent (BMS) in whom at least one stent was implanted were assessed. There were 2,302 (76.6%) patients

To assess the quality of coronary reperfusion and long-term clinical outcomes of patients enrolled in the HORIZONS-AMI trial according to the use of thrombus aspiration (TA).The impact of manual TA on microvascular perfusion and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) is unsettled.In this retrospective, nonrandomized, subgroup analysis, the authors evaluated thrombolysis in myocardial infarction (TIMI) flow, tissue myocardial perfusion grade (TMPG), ST-segment resolution (STR), net adverse clinical events (NACE), and major adverse cardiac events (MACE) in patients undergoing pPCI with or without manual TA.A total of 318 patients had pPCI with upfront TA, and 2,917 patients had pPCI without TA. Patients who had TA were more likely to have TIMI 0/1 flow at baseline (75.1% vs. 63.7%, P0.0001). There was no difference in the rates of final TIMI 3 flow (90.2% vs. 92.3%, P = 0.19) or dynamic TMPG 2-3 (77.4% vs. 76.4%, P = 0.68). STR ≥70% was similar in both groups at 60 minutes but higher in the TA group at discharge (71.8% vs. 64.6%, P = 0.02). After multivariable adjustment, TA did not predict MACE at 30 days (HR 0.96 [0.51-1.80], P = 0.90), 1 year (HR 1.03 [0.68-1.55], P = 0.89), or 3 years (HR 1.13 [0.86-1.48], P = 0.39). Stent thrombosis did not differ at 1 year or 3 years.In STEMI patients undergoing pPCI, the use of manual TA was associated with improved STR at discharge, but not with any difference in final TIMI flow, TMPG, or MACE.

To compare outcomes between US and non-US (OUS) sites in patients with non ST-elevation acute coronary syndromes (NSTEACS) and to evaluate potential reasons for differences in outcomes.There are little data comparing outcomes at US versus OUS sites in patients with NSTEACS managed with an invasive strategy.The ACUITY trial randomized 13,819 patients with NSTEACS in 17 countries to an invasive approach with one of three strategies: (1) heparin plus glycoprotein platelet inhibitors (GPI), (2) bivalirudin plus GPI, or (3) bivalirudin alone.US patients were more often female, were younger, heavier, and had more diabetes, prior myocardial infarction (MI), and prior bypass surgery. US patients were less often treated with percutaneous coronary intervention but had more frequent drug-eluting stent use. US patients had lower mortality and higher MI rates at 30 days and 1 year and higher composite ischemic outcome at 30 days. After adjusting for differences in baseline variables, US patients had higher rates of MI and composite ischemic outcome at 30 days and higher rates of MI at 1 year {HR [95% confidence interval (CI)] = 1.36 [1.18-1.56], P0.0001} with no differences in mortality. There were no differences in treatment effects comparing bivalirudin with the other strategies between US and OUS sites.US versus OUS patients with NSTEACS had higher adjusted rates of MI and ischemia. The reasons for these differences are not clear but may be due to unmeasured confounders, different thresholds for event reporting, or valid differences in systems of care which may impact outcomes.

This study sought to investigate whether there is a differential prognostic effect of successful percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) according to the target vessel the CTO is located in.Between 1998 and 2007, a total of 1,791 patients underwent PCI of a CTO at three tertiary care centers in the US, Italy, and South Korea. Patients with CTOs in multiple target vessels or the left main stem were excluded (n = 57). Of the remaining 1,734 patients, 609 had a CTO in the left anterior descending (LAD, 35.1%), 391 in the left circumflex (LCX, 22.5%), and 734 in the right coronary artery (RCA, 42.3%). Five-year mortality and the need for coronary artery bypass grafting (CABG) were compared between patients with successful vs. unsuccessful PCI stratified by target vessel.Procedural success was obtained in 71.1% of LAD patients, 69.1% of LCX patients, and 65.1% of RCA patients (P = 0.06). The mean follow-up duration was 1,178 days. Kaplan-Meier estimates of long-term mortality were 6.7% vs. 11.0% (P = 0.03), 5.5% vs. 13.9% (P0.01), and 6.6% vs. 4.1% (P = 0.80) in successful vs. unsuccessful LAD, LCX, and RCA patients, respectively. After multivariate analysis, successful CTO PCI remained associated with lower mortality in the LAD (HR 0.41, P = 0.02) and LCX groups (HR 0.32, P0.01). The need for CABG was lower after successful CTO PCI in all three groups (LAD 4.6% vs. 16.0%, P0.01; LCX 2.9% vs. 18.2%, P0.01, RCA 2.3% vs. 8.4%, P0.01).The results from this large contemporary cohort of patients suggest that successful PCI of a CTO in the LAD and the LCX, but not the RCA, is associated with improved long-term survival.

Objectives: To determine the incidence, clinical characteristics, and the coronary angiographic features of patients with apical ballooning syndrome (ABS) among those recruited into a large, prospective, international, multicenter trial. Background: ABS is an important entity in the differential diagnosis of ST-elevation myocardial infarction (STEMI). Current data regarding ABS are limited to single center registries. Methods: Patients with ABS were identified, based on the Mayo Clinic diagnostic criteria, from those enrolled into the HORIZONS-AMI trial. Quantitative angiography was performed by a core laboratory to identify the frequency and severity of coronary artery disease. Results: Among the 2,648 patients who had left ventriculography in addition to coronary angiography, 12 patients were identified with ABS. All patients were female and they were compared to the remaining 571 female patients with STEMI. Compared with patients with STEMI (97.9% of our cohort), patients with ABS (2.1%) had a lower prevalence (42% vs. 100%, P 30% diameter stenosis per patient: 0.58 ± 0.90 vs. 4.13 ± 2.68, P < 0.0001) of coronary artery disease. There were no in-hospital deaths or major adverse cardiovascular events (MACE) in the ABS group vs. 2.1% and 3.7% respectively in the STEMI group, nor at 2-year follow up (death: 0% vs. 5.5%, MACE: 0% vs. 19.4%), but these differences were not statistically significant. Conclusions: In HORIZONS-AMI, ABS was identified exclusively in women (2.1% of female patients, 0.5% of all patients) and MACE were absent in this uncommon but important group of patients. Coronary artery disease was often present in patients with ABS, but its prevalence and severity was significantly less compared with STEMI patients. © 2011 Wiley Periodicals, Inc.

Objectives: The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease. Background: The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States. Methods: This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data. Results: The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%. Conclusions: Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs. © 2011 Wiley Periodicals, Inc.

Objectives We sought to determine the impact of the activated clotting time (ACT) in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with unfractionated heparin (UFH) and a glycoprotein IIb/IIIa inhibitor (GPI). Background UFH+GPI is commonly used during primary PCI for STEMI. UFH anticoagulation is titrated with ACT. Methods Patients randomized to UFH+GPI in HORIZONS-AMI who underwent primary PCI are included (N = 1,624). Initial UFH bolus was 60 IU kg−1 (target ACT: 200–250 sec). Patients were divided into three tertiles of peak ACT (cutoffs 240 and 298 sec). The 30-day rates of major and minor bleeding, major adverse cardiovascular events (MACE), and net adverse clinical events (NACE; MACE or major bleeding) were determined. Results Mortality at 30 days occurred in 2.2, 3.3, and 3.5% of patients in the low to high ACT tertiles, respectively (Ptrend = 0.22). Nor was the peak ACT significantly related to major bleeding, MACE or NACE. However, minor bleeding was increased in the highest ACT tertile (14.7% vs. 14.2% vs. 19.4%, Ptrend = 0.04). By multivariable analysis peak ACT was not significantly related to major bleeding, mortality, MACE, and NACE but was a significant independent predictor of minor bleeding (odds ratio = 1.027 [1.013, 1.042], P < 0.001, for each 10 sec increase in ACT). Conclusions In patients undergoing primary PCI for STEMI treated with UFH+GPI, the peak procedural ACT achieved does not have a substantial effect on major bleeding, mortality, or MACE, although lower peak ACT is associated with less minor bleeding. © 2012 Wiley Periodicals, Inc.

Background: Myocardial infarct size is a strong independent predictor of mortality in patients with ST-elevation myocardial infarction (STEMI). In the Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor reduced cardiac mortality in STEMI patients, which was attributed to reduced major bleeding. Whether a possible reduction in infarct size with bivalirudin may have contributed to the enhanced survival with this agent is unknown. Methods: Cardiac magnetic resonance imaging was performed within 7 days and after 6 months in 51 randomized patients from a single center in HORIZONS-AMI trial (N = 28 bivalirudin, N = 23 heparin plus abciximab). Infarct size, microvascular obstruction (MVO), left ventricular ejection fraction (LVEF), and LV end-diastolic and end-systolic volume indices were evaluated. Results: Infarct size was not significantly different after treatment with bivalirudin compared with heparin plus abciximab either within 7 days (median 9.3% [interquartile range 4.9%, 26.6%] vs. 20.0% [5.9%, 28.2%], P = 0.28) or at 6 months 6.7% [3.8%, 20.0%] vs. 8.2% [1.8%, 16.5%], P = 0.73). MVO was present in 28.6% versus 34.8% of patients respectively (P = 0.63). LVEF and LV volume indices also did not significantly differ between the two groups at either time period, nor were differences in myocardial recovery evident. Conclusions: In conclusion, in the HORIZONS-AMI Cardiac magnetic resonance imaging (CMRI) substudy, cardiac magnetic resonance imaging within 7 days and at 6 months after primary percutaneous coronary intervention (PCI) did not demonstrate significant differences in infarct size, MVO, LVEF, or LV volume indices in patients treated with bivalirudin compared with unfractionated heparin plus abciximab. © 2011 Wiley Periodicals, Inc.

Objectives: To investigate if previously reported gender-based outcome disparities following percutaneous coronary intervention (PCI) are applicable in a large and racially-diverse cohort in the drug eluting stent (DES) era. Background: It is generally believed that women suffer inferior outcomes compared to men after PCI. However, various strategies have evolved that may have mitigated this imbalance, including improved medical therapy, attention to risk-factors, and procedural advances of PCI including DES. Methods: We identified 13,752 patients (4,761 female, 34.6%) with complete follow-up data who underwent de novo lesion PCI from 04/2003 to 04/2009. Relevant data were extracted from an IRB-approved registry. Results: Compared to males, females were significantly older (69.0 vs. 64.8 years) and more frequently from a minority or non-Caucasian background. Females smoked less, but more were hypertensive and/or diabetic. Women had higher HDL, but also higher LDL cholesterol levels. More women presented with an unstable coronary syndrome and required left anterior descending artery PCI. While unadjusted post-PCI mortality rates were higher in females versus males (30 days, 1.3 vs. 0.8%, P = 0.009; 1 year, 6.1 vs. 4.8%, P = 0.001; 3 year, 10.4 vs. 8.4%, P < 0.0001), multivariable regression analyses failed to identify female gender as an independent predictor of mortality. Propensity-adjusted modeling confirmed that females were not at intrinsically higher risk for mortality after PCI. Conclusions: Females undergoing PCI exhibit more comorbidities and adverse prognostic factors than males. However, risk-adjusted analyses identified that gender is not an independent predictor of mortality after PCI in the DES era. © 2011 Wiley Periodicals, Inc.