Significant Differences In Event Rates Research Articles

Abstract 12498: Incidence Of Non-Sustained Ventricular Tachycardia and Arrhythmic Disease Progression During Follow-Up in Hypertrophic Cardiomyopathy Patients

Introduction: One of the most well-established risk markers for sudden cardiac death is non-sustained ventricular tachycardia (NSVT; 3 ventricular beats with a rate of ≥120 bpm, lasting for <30 seconds). Forty-eight-hours Holter monitoring is recommended to identify NSVT in patients with hypertrophic cardiomyopathy (HCM) . Purpose: The study aims to estimate the 48 hour-incidence of NSVT in HCM patients and to analyze arrhythmic disease progression during follow up. Methods: The study retrospectively evaluated HCM patients enrolled in the Registry for Hereditary Cardiovascular Diseases from 2011 to 2020. A total of 145 patients met the inclusions criteria to be a proband with HCM or a relative with left ventricular hypertrophy ≥13mm. A cross sectional analysis was done in 131 patients with at least one available Holter monitoring. A follow-up Holter monitoring was available in 97 patients. Results: Of 145 patients, the mean age was 54±15 years and 98 (68%) were male. The proportion of patients free of NSVT were 66% after 48 hours of Holter monitoring (n=131) (Kaplan-Meier estimates). Fifteen percent of NSVTs occurred from 36 to 48 hours into the Holter monitoring. The mean follow-up time between first and latest Holter (n=97) was 4.3 (±2.5) years and the median Holter monitoring time was both 48 (IQR, 48-48) hours at the first and 48 (IQR, 47-48) hours at the latest Holter. The proportion of patients free of NSVT in the first 48 hour Holter monitoring was 69% compared to 63% in the latest 48 hour Holter monitoring (p=0.17). Wilcoxon signed rank test showed no difference in number of ventricular cycles or the calculated frequency analyzing the first episode of NSVT in each Holter. Cox regressions analysis showed no significant difference in event rates between first and latest Holter (HR 0.84, 95% CI 0.26-2.70, p=0.77) and no association between age and NSVT (HR 1.03, 95% CI 0.83-1.28, p=0.80). Conclusions: NSVT occurred with an incidence rate of 34% per 48-hours Holter monitoring. An important part of NSVTs was identified in the last 12 hours of monitoring. The was no significant progression in the incidence rate of NSVT nor the characteristics of NSVT during follow up. Age had no effect on the incidence of NSVT.

Comparison of Complications and Cost for Transfemoral Versus Transcarotid Stenting of Carotid Artery Stenosis

Options for endovascular treatment of carotid artery disease have been developed to compliment with carotid endarterectomy, transfemoral carotid artery stenting (TFCAS) and a hybrid approach with transcarotid artery revascularization (TCAR). We sought to capture endpoints outside of stroke, myocardial infarction (MI), and death involved with each procedure at our institution as well as evaluate cost. Carotid stent procedures performed from 2014 to 2020 at our institution underwent comparative analysis based upon access site and type of stent procedure performed, TFCAS versus TCAR. Procedural details and outcomes were captured prospectively and included in the National Cardiovascular Data Peripheral Vascular Intervention Registry (NCDR-PVI). Further retrospective review was performed to evaluate endpoints beyond stroke, MI, and death. Total in-hospital cost, including administrative, capital and utilities (fixed cost), and labor and supplies (variable cost) were also evaluated. One hundred thirty-seven patients were reviewed. Seventy-seven were treated with TFCAS and 60 with TCAR. The mean age was 74years, predominantly male (68%) and Caucasian (90%). Patients undergoing TFCAS were more likely to be symptomatic compared to those receiving TCAR (81.8% vs. 50.0%, P = <0.001). There were no statistically significant differences in event rates, including mortality, recurrent cerebrovascular accident / transient ischemic attack, or bleeding. Complications not captured in the NCDR-PVI database were more frequent in the TCAR group (21.7% vs. 5.2%, P=0.004) and included pneumothorax (n=2), neck hematoma (n=8), and common carotid artery stenosis or injury (n=3). Rates of complications in the TFCAS group (n=4) were lower and limited to groin hematoma (n=2), central retinal artery occlusion causing vision loss and a case of postoperative dysphagia. Geographic miss of initial stent placement was identified in 15.0% of TCAR patients and 2.6% (P=0.008) of TFCAS patients. Restenosis rates on duplex ultrasound were similar between the two groups (14.6% of patients) and were not associated with symptoms. The mean follow-up interval was similar for both groups of 31.8months for TCAR and 30.7months for TFCAS (P=0.797). There was a statistically significant difference in total cost with TCAR being more expensive ($22,315 vs. $11,001) driven by direct costs that included devices, imaging, and extended length of stay in the TCAR group (P<0.001). There was no significant difference between stroke free survival (91.1% vs. 88.6%, P=0.69) and mortality (78.1% vs. 85.2%, P=0.677) at 3years follow-up between TCAR and TFCAS, respectively. Both TFCAS and TCAR provide similar 3-year stroke and mortality risk/benefit and are distinctly different procedures. Both should be evaluated independently with analysis of variables beyond stroke, death, and MI. TFCAS is more cost-effective than TCAR in this single institution study.

Influence of Baseline Physical Activity Level on Exercise Training Response and Clinical Outcomes in Heart Failure: The HF-ACTION Trial

ObjectivesThis study sought to evaluate the influence of baseline physical activity (PA) on responses to aerobic exercise training and clinical events in outpatients with chronic systolic heart failure (HF) from the multicenter HF-ACTION (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure) trial. BackgroundThe influence of baseline PA on exercise capacity, responses to exercise training and clinical outcomes in patients with chronic HF is unclear. MethodsOf 2,130 participants who provided consent for this analysis, 1,494 patients (64%) had complete baseline PA data, using a modified version of the International Physical Activity Questionnaire–Short Form questionnaire and were included in the analysis; 742 received usual care and 752 were allocated to the exercise training group. Changes in exercise capacity, all-cause mortality and hospitalization, cardiovascular (CV) mortality and hospitalization, and CV mortality and HF hospitalization were evaluated as a function of baseline PA tertile. ResultsAt baseline, the highest PA tertile showed greater peak oxygen uptake, cardiopulmonary exercise test duration, and 6-min walk test distance than the other 2 PA tertiles, as well as lower New York Heart Association functional class, lower Beck depression score, and lower atrial fibrillation prevalence than the lowest PA tertile. Compared to the lowest PA tertile, the middle tertile had 18% lower risk of CV death/CV hospitalizations, and the upper tertile showed 23% lower risk of CV death/HF hospitalizations. Exercise capacity and clinical outcome responses to training were similar and largely nonsignificant across baseline PA tertiles with significant benefit of training on exercise test duration for all tertiles. ConclusionsIn patients with chronic systolic HF, aerobic exercise training significantly improves exercise test duration to a similar extent across baseline PA tertiles. Although higher baseline PA was associated with lower risk of clinical events, no significant differences in event rates within each PA tertile were seen between subgroups randomized to exercise training versus usual care. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure [HF-ACTION]; NCT00047437)

One-year clinical outcome of percutaneous coronary intervention with very long (≥ 40 mm) drug-eluting stent

ObjectivesThe aim of this study was to assess the clinical outcome of patients with diffuse coronary lesions treated with very long drug-eluting coronary stents (DES) (≥ 40mm) over a period of one year. MethodsThis single-center prospective study enrolled a total of 343 consecutive patients (376 long stents) who underwent percutaneous coronary stent implantation with very long DES. One year clinical outcomes were analyzed. A subgroup analysis of diabetic patients was also performed. ResultsOne year follow up data was available for 314 patients (91.5%). All-cause mortality was 5 (1.6%). Eleven (3.5%) patients had non-ST-elevation myocardial infarction. Definite / probable stent thrombosis was reported in 7 (2.2%) patients. Over one year, 3 (1%) patients underwent target lesion revascularization (TLR). The total number of target lesion failure was 9 (2.9%). The rate of target lesion failure at one year was 2.6% using one vessel per patient analysis. Two patients had ischemic stroke. Any major adverse cardiac event (MACE) was observed in 19 (6%) patients. The event rates between sirolimus and everolimus stent groups were compared - cardiac death (1.7% vs 1.5%; p=0.911), stent thrombosis (2.5% vs 1.7%; p=0.612), TLR (1% vs 0.8%; p=0.878), any MACE (7% vs 4.1%; p=0.284). Exertional dyspnea was reported by 47 (15%) patients at the end of one year. Dual antiplatelet adherence rate was 96% (n=301 of 314). ConclusionUse of very long stents (≥40mm) for diffuse coronary lesions is safe and effective with acceptably low event rates. No significant differences in event rates were observed between the types of DES used in this study (Sirolimus Vs. everolimus).

Efficacy and safety outcomes of recanalisation procedures in patients with acute symptomatic pulmonary embolism: systematic review and network meta-analysis

BackgroundWe aimed to review the efficacy and safety of recanalisation procedures for the treatment of PE.MethodsWe searched PubMed, the Cochrane Library, EMBASE, EBSCO, Web of Science and CINAHL databases from...

Developments in pre-hospital patient transport in ST-elevation myocardial infarction

IntroductionST-elevation myocardial infarction (STEMI) is a medical emergency that benefits from rapid access to specialized care. The objective of this study was to describe developments in patient transport via the pre-hospital emergency medical system (EMS) and its impact on clinical outcomes. MethodsWe retrospectively studied STEMI patients who underwent primary percutaneous coronary intervention between January 2008 and July 2015. Patients were divided according to type of admission. Total ischemic time (TIT), door-to-balloon time (DBT) and in-hospital and one-year clinical outcomes were assessed for each group. ResultsA total of 764 patients were included, of whom 33.5% were transported by the EMS and 45.8% by their own means, 13.7% were transferred from another institution and 6.9% were transported by non-EMS ambulance. There was a trend for more frequent recourse to the EMS over the eight-year period. There was a higher percentage of patients with prior myocardial infarction and Killip class III/IV in the EMS group compared to the non-EMS group. Significant differences were seen between groups in reperfusion times, EMS patients having the shortest TIT and DBT (195 vs. 286 min, p<0.001 and 61 vs. 90 min, p<0.001, respectively), but no significant difference in event rates was observed. Patients presenting to the hospital early had higher rates of effective reperfusion and lower in-hospital mortality (6.9% vs. 33.9%, p<0.001). ConclusionsRecourse to the EMS significantly reduced ischemic times. Although this improvement was not directly associated with significant differences in event rates, it was associated with higher rates of effective reperfusion that were reflected in lower in-hospital mortality.

Evolução e impacto do transporte pré‐hospitalar em doentes com enfarte agudo do miocárdio com elevação do segmento ST

IntroductionST‐elevation myocardial infarction (STEMI) is a medical emergency that benefits from rapid access to specialized care. The objective of this study was to describe developments in patient transport via the pre‐hospital emergency medical system (EMS) and its impact on clinical outcomes. MethodsWe retrospectively studied STEMI patients who underwent primary percutaneous coronary intervention between January 2008 and July 2015. Patients were divided according to type of admission. Total ischemic time (TIT), door‐to‐balloon time (DBT) and in‐hospital and one‐year clinical outcomes were assessed for each group. ResultsA total of 764 patients were included, of whom 33.5% were transported by the EMS and 45.8% by their own means, 13.7% were transferred from another institution and 6.9% were transported by non‐EMS ambulance. There was a trend for more frequent recourse to the EMS over the eight‐year period. There was a higher percentage of patients with prior myocardial infarction and Killip class III/IV in the EMS group compared to the non‐EMS group. Significant differences were seen between groups in reperfusion times, EMS patients having the shortest TIT and DBT (195 vs. 286 min, p<0.001 and 61 vs. 90 min, p<0.001, respectively), but no significant difference in event rates was observed. Patients presenting to the hospital early had higher rates of effective reperfusion and lower in‐hospital mortality (6.9% vs. 33.9%, p<0.001). ConclusionsRecourse to the EMS significantly reduced ischemic times. Although this improvement was not directly associated with significant differences in event rates, it was associated with higher rates of effective reperfusion that were reflected in lower in‐hospital mortality.

Effectiveness of sulphonylureas in the therapy of diabetes mellitus type 2 patients: an observational cohort study.

BackgroundWe compared all-cause mortality, major macrovascular events (MACE) and diabetes-related hospitalizations in T2DM-incident patients newly treated with metformin (MET) versus sulphonylureas (SU) monotherapy and in T2DM-prevalent patients newly treated with MET+SU versus MET+DPP4-inhibitor combination therapy.MethodsWe analysed anonymized data obtained from a German health fund. Patients were included when they had started MET versus SU therapy or MET+SU versus MET+DPP4 therapy between 01/07/2010 and 31/12/2011. Observation started with the first MET/SU prescription or the first prescription of the second agent of a MET+SU/MET+DPP4 combination therapy. Follow-up time lasted until the end of data availability (a minimum of 12 months), death or therapy discontinuation.ResultsIn total, 434,291 T2DM-prevalent and 35,661 T2DM-incident patients were identified. Of the identified T2DM-incident patients, 904/7,874 started SU/MET monotherapy, respectively, with a mean age of 70.1/61.4 years (54.6/50.3 % female; Charlson Comorbidity Index (CCI) 1.4/2.2; 933/7,350 observed SU/MET patient years). 4,157/1,793 SU+MET/DPP4+MET therapy starters had a mean age of 68.1/62.2 years (53.4/50.8 % female; CCI 2.8/2.6; 4,556/1,752 observed SU+MET/ DPP4+MET patient years).In a propensity score matched (PSM) comparison, the HRs (95 % CIs) associated with SU monotherapy compared to MET monotherapy exposure were 1.4 (0.9–2.3) for mortality, 1.4 (0.9–2.2) for MACE, 4.1 (1.5–10.9) for T2DM hospitalizations and 1.6 (1.2–2.3) for composite event risk. In a multivariable Cox regression model, SU monotherapy was associated with higher mortality (aHR 2.0; 1.5–2.6), higher MACE (aHR 1.3; 1.0–1.7) and higher T2DM hospitalizations (aHR 2.8; 1.8–4.4), which corresponded with a higher composite event risk (aHR 1.8; 1.5–2.1).No significant differences in event rates were observed in the PSM comparison between DPP4+MET/SU+MET combination therapy starters and in the multivariable Cox regression analysis.ConclusionsOur results show that SU monotherapy may be associated with increased mortality, MACE and T2DM hospitalizations, compared to MET monotherapy. When considering SU therapy, the associated cardiovascular risk should also be taken into account.Electronic supplementary materialThe online version of this article (doi:10.1186/s40200-016-0251-9) contains supplementary material, which is available to authorized users.

Outpatient Use of Focused Cardiac Ultrasound to Assess the Inferior Vena Cava in Patients With Heart Failure

Accurate assessment of volume status is critical in the management of patients with heart failure (HF). We studied the utility of a pocket-sized ultrasound device in an outpatient cardiology clinic as a tool to guide volume assessment. Inferior vena cava (IVC) size and collapsibility were assessed in 95 patients by residents briefly trained in focused cardiac ultrasound (FCU). Cardiologist assessment of volume status and changes in diuretic medication were also recorded. Patients were followed for occurrence of 30-day events. There was a 94% success rate ofobtaining IVC size and collapsibility, and agreement between visual and calculated IVC parameters was excellent. Most patients were euvolemic by both FCU IVC and clinical bedside assessment (51%) and had no change in diuretic dose. Thirty-two percent had discrepant FCU IVC and clinical volume assessments. In clinically hypervolemic patients, the FCU evaluation of the IVC suggested that the wrong diuretic management plan might have been made 46% of the time. At 30days, 14 events occurred. The incidence of events increased significantly with FCU IVC imaging categorization, from 11% to 23% to 36% in patients with normal, intermediate, and plethoric IVCs. By comparison, when grouped in a binary manner, there was no significant difference in event rates for patients who were deemed to be clinically volume overloaded. Assessment of volume status in an outpatient cardiology clinic using FCU imaging of the IVC is feasible in a high percentage of patients. A group of patients were identified with volume status discordant between FCU IVC and routine clinic assessment, suggesting that IVC parameters may provide a valuable supplement to the in-office physical examination.

The PROMISE study: a clear promise for functional stress testing in patients with suspected coronary artery disease.

Over the years, considerable debate has arisen whether a pure anatomical test would suffice to demonstrate the significance of coronary artery disease (CAD) in patients suspected for CAD, and–more importantly–whether this anatomical information would have a bearing on clinical outcome [1, 2]. In particular, coronary computed tomography angiography (CTA) has been put forward as an optimal non-invasive anatomical imaging test to detect CAD in patients with stable CAD [3]. A number of studies has shown that CTA has a high sensitivity, reasonable specificity and an extremely high negative predictive value [4–10]. Several large-scale studies have shown that a strategy of CTA use in the emergency department is associated with faster discharge, as compared with standard care, without a significant difference in event rates [11–13]. However, the lack of evidence supporting CTA in randomised trials has also been mentioned. As a consequence, the relative impact of data from non-invasive anatomical testing versus functional testing on subsequent management and clinical outcomes is not fully known. At the recently held conference of the American College of Cardiology (ACC), San Diego, California, 14–18 March 2015, the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial was presented by Pamela S. Douglas, MD (Duke University School of Medicine, Durham, North Carolina, USA) and simultaneously published online in The New England Journal of Medicine [14]. The goal of the PROMISE trial was to evaluate anatomical testing using CTA compared with functional testing among low- to intermediate-risk patients with chest pain suspicious for CAD. The primary hypothesis of the study was that the clinical outcomes in patients assigned to anatomical testing with the use of CTA would be superior to those in patients assigned to functional testing. A total of 10,003 low- to intermediate-risk patients with chest pain (mean age 61 years, 53 % female patients, 21 % diabetics) were randomised to evaluation with an anatomical strategy (n = 4996) versus a functional strategy (n = 5007). Patients randomised to an anatomical strategy underwent a 64-slice CTA, while patients randomised to a functional strategy underwent exercise electrocardiography (ECG), exercise imaging or pharmacological stress imaging. Among either group who underwent a functional test, 68 % underwent nuclear stress testing, 22 % underwent stress echocardiography and 10 % underwent exercise ECG. Duration of follow-up was a median of 25 months. The primary outcome, all-cause mortality, myocardial infarction, hospitalisation for unstable angina, or major complication from a cardiovascular procedure occurred in 3.3 % of the anatomical testing group versus 3.0 % of the functional testing group (p = 0.75). Among low- to intermediate-risk patients with chest pain, anatomical testing with coronary CTA was not superior to functional testing. CTA was associated with an increased frequency of cardiac catheterisation; however, it was associated with a lower frequency of invasive catheterisation showing non-obstructive CAD. Anatomical testing was also associated with increased radiation exposure and a non-significant increase in total costs. In conclusion, in symptomatic patients with suspected CAD who required non-invasive testing, an initial strategy of CTA was not associated with better clinical outcomes than functional testing over a median follow-up of 2 years. Simply stated, the PROMISE study suggests therefore that patients, suspected for CAD and undergoing CTA, do not have less risk of heart attack, dying or being hospitalised months later than those who take a simple treadmill test or other functional test. According to W. Douglas Weaver, MD, former president of the ACC, these findings should temper the enthusiastic use of CTA to screen patients with chest pain–it is not worth the added radiation and use of unnecessary heart catheterisations and stent implantations, which did nothing to improve the outcome of patients. Valentin Fuster, MD, current editor-in-chief of the Journal of the American College of Cardiology questioned if there could be a long-term benefit in direct visualisation using CTA. The study author, Pamela S. Douglas, said the research group plans to further investigate outcomes for different subgroups of patients to determine whether different groups might benefit from different testing approaches. In an accompanying Editorial [15], it was stated that the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA; ClinicalTrials.gov number, NCT01471522), in which randomised therapy (invasive versus medical, which is driven by the presence of extensive ischaemia on functional stress testing), will help answer this question. So far, the PROMISE trial offers clear promise that functional stress testing provides at least similar information to CTA and–for economical and safety reasons–might prevail over CTA alone in patients with suspected CAD.

One-year follow-up of patients treated with new-generation polymer-based 38 mm everolimus-eluting stent: the P38 study.

To assess the clinical outcome at 1-year follow-up of real-world patients with long coronary lesions treated with the 38 mm Xience Prime (Abbott Vascular) everolimus-eluting stent (EES). Long-lesions present special challenges to the interventional cardiologists, including increased risk of restenosis, periprocedural injury, geographical miss, and stent deliverability. Indeed, results obtained with shorter stent in the treatment of simpler lesions are of limited applicability to longer stents. Consecutive patients presenting with a long coronary lesion treated by percutaneous coronary intervention with at least one implanted 38 mm EES were enrolled in the study. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, nonfatal myocardial infarction (according to the Universal Definition) and target vessel revascularization. Stent thrombosis was defined according to the Academic Research Consortium criteria. Overall, 203 real-world patients (152 men, 68 ± 9 years) were enrolled in the P38 Study. At 1-year follow-up, 6 (3.0%) patients had died from cardiac causes, 7 (3.4%) had a nonfatal myocardial infarction and 8 (3.9%) underwent target vessel revascularization, yielding a 10.3% cumulative rate of MACE. Two patients had a stent thrombosis (one definite and one probable). No significant differences in event rates were found between patients with and without an additional stent implanted overlapping the 38 mm one. The use of a new-generation polymer-based 38 mm EES in a real-world population with unselected long lesions is associated with excellent procedural results and good clinical outcomes at 12-month follow-up.

Prognosis of patients without perfusion defects with and without rest study in myocardial perfusion scintigraphy.

BackgroundStress myocardial perfusion scintigraphy (MPS) is widely regarded as a useful imaging modality for diagnosing patients with suspected ischemic heart disease. Current European guidelines recommend stress study to be performed first since rest study can be omitted if stress study is interpreted as normal. Thus, a rest study should only be performed in patients with equivocal or abnormal studies. The aim of the present study was to investigate the prognosis of a normal stress-only MPS compared to a normal stress-rest MPS in a retrospective manner and also with regard to normal/abnormal left ventricular function data.MethodsAll 4,820 patients who underwent 99mTc MPS at Skåne University Hospital in Malmö, Sweden, in 2004 to 2007, for suspected or management of known ischemic heart disease were considered. The physician in clinical charge of the investigation decided whether a rest study was necessary or not. Based on the final report according to clinical routine, only patients with a normal perfusion study (no infarction or inducible ischemia) were included. The endpoints were non-fatal acute coronary syndrome or death from ischemic cardiac origin.ResultsA total of 3,426 patients with a normal perfusion study were included. Of these, 2,215 patients had a stress-only study and 1,211 patients had both stress and rest studies. Mean follow-up was 6.2 years. The lowest event rate was found in the normal stress-only group (0.56% for normal stress-only patients vs. 1.42% for normal stress-rest patients; p < 0.0001). When dividing patients according to sex and stress type, the best prognosis was also found in the normal stress-only group (p < 0.0001 for all comparisons). Regarding left ventricular function data, we did not find any significant difference in event rate between normal vs. abnormal ejection fraction (EF), normal vs. abnormal end-diastolic volume (EDV) or normal EF, and EDV vs. abnormal EF or EDV for either the normal stress-only patients or the normal stress-rest patients.ConclusionsPatients with a normal stress-only study had an excellent prognosis over a mean follow-up time of 6 years. Thus, omitting the rest study if the stress study is normal is a safe procedure.

Combined anticoagulation and antiplatelet therapy for high-risk patients with atrial fibrillation: a systematic review

Previous research suggests uncertainty whether or not there is any additional benefit in adding antiplatelet therapy (APT) to anticoagulation therapy (ACT) in patients with high-risk atrial fibrillation (AF) in terms of reduction in vascular events, including stroke. The existing guidelines acknowledge an increased risk of bleeding associated with such a strategy; however, there is no consensus on the treatment pathway. To determine, by undertaking a systematic review, if the addition of APT to ACT is beneficial compared with ACT alone in patients with AF who are considered to be at high risk of thromboembolic events (TEs). Data sources included bibliographic databases {the Cochrane Library [Cochrane Central Register of Controlled Trials (CENTRAL)], MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, ClinicalTrials.gov, National Institute for Health Research (NIHR) Clinical Research Network Portfolio, Current Controlled Trials (CCT) and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)}, reference lists from identified systematic reviews and relevant studies, and contact with clinical experts. Searches were from inception to September 2010 and did not use language restrictions or study design filters. Studies of any design were included to evaluate clinical effectiveness, including randomised controlled trials (RCTs), non-randomised comparisons, cohort studies, case series or registries, longitudinal studies, systematic reviews and meta-analyses, and conference abstracts published after 2008. Inclusion criteria consisted of a population with AF, at high-risk of TEs, aged ≥ 18 years, on combined ACT and APT compared with others on ACT alone or ACT plus placebo. Inclusion decisions, assessment of study quality and data extraction were undertaken using methods to minimise bias. Fifty-three publications were included, reporting five RCTs (11 publications), 18 non-randomised comparisons (24 publications) and 18 publications that reported reviews, which added no further data. There was variation in the population, types and doses of ACT and APT, definitions of outcomes, and length of follow-up between the studies. There was a paucity of directly randomised high-quality RCTs, whereas non-randomised comparisons were found to have significant confounding factors. No studies looked at the effect of ACT plus APT compared with ACT alone on vascular events in patients with AF following acute coronary syndrome (ACS) or percutaneous coronary intervention. In most studies, significant differences in event rates were not seen between the patients on combined therapy compared with those on ACT alone for outcomes such as stroke (including haemorrhagic and ischaemic strokes), rates of transient ischaemic attacks, composite end points of stroke and systemic embolism (SE), SE alone, acute myocardial infarction, mortality (vascular or all cause) or bleeding events. There was conflicting evidence regarding rates of major adverse events consisting of composite end points, although event rates were generally low. An attempt was made to identify all of the available evidence around the subject despite the dearth of directly randomised studies using a robust review methodology. There was a paucity of directly randomised evidence to undertake a meta-analysis for the merits of one technology over another. The selection criteria were kept necessarily broad with regard to the population, intervention and comparator in order to capture all relevant studies. This systematic review suggests that there is still insufficient evidence to advocate a clear benefit of the addition of APT to ACT compared with ACT alone in reducing the risk of vascular events in a population of patients at high risk of TEs resulting from AF. It is recommended that a definitive prospective RCT needs to be undertaken in a population at high risk of atherosclerotic coronary artery and other vascular events in addition to being at high risk of AF-mediated TEs. From the UK context, at the time of writing, any future trial should compare adjusted-dose warfarin [international normalised ratio (INR) 2.0-3.0] plus aspirin (75-325 mg) with adjusted-dose warfarin (INR 2.0-3.0). However, given the emergence of newer anticoagulation agents (dabigatran, rivaroxaban and apixaban) this prioritisation may need to be revisited in the future to reflect current best clinical practice. The National Institute for Health Research Health Technology Assessment programme.

Cardiovascular event rates in atorvastatin patients versus patients switching from atorvastatin to simvastatin

Objective:Statin dose, adherence, and cardiovascular (CV) outcomes are important factors when considering switching statin therapies. The objective of the study was to compare CV event rates and risk in managed care patients receiving atorvastatin versus those switched to simvastatin from atorvastatin.Methods:Patients 18–64 years, with ≥3 continuous pharmacy claims for atorvastatin between 1/1/05–11/30/07 and ≥12 months pre- and ≥3 months post-index continuous eligibility were identified using HealthCore Integrated Research Database (HIRD). Patients were stratified into two cohorts: one continued atorvastatin without interruption and the other switched to simvastatin. Patients were matched 1:10 (continue atorvastatin/switch simvastatin) on five variables, excluding lipid parameters due to limited data availability. Descriptive statistics were reported for sample characteristics. A multivariate Cox proportional hazards model was developed to evaluate adjusted CV risk.Results:In total 73,960 atorvastatin patients and 7396 simvastatin-switch patients were analyzed. The mean age was 54 ± 7 years (both cohorts). Mean follow-up was 440 days for atorvastatin patients and 237 days for simvastatin-switch patients. Mean dose and therapy duration for atorvastatin was 20 mg and 321 days compared with 33 mg and 195 days for simvastatin-switch, respectively. Of the simvastatin-switch patients, 32% were switched to a less potent simvastatin dose (<2× prior atorvastatin dose). After adjusting for demographic/clinical characteristics, no significant differences were found in CV risk between cohorts.Limitations:Limitations include use of administrative claims data without lipid level laboratory results data and the length of follow-up which may not have been sufficient to demonstrate significant differences in event rates between groups.Conclusion:In this managed care population, no significant differences were found in risk of CV events among patients switching to simvastatin compared to patients continuing atorvastatin. Switched patients may differ from controls for reasons not captured in the database.

Abstract TP119: Recurrent Thromboembolic Events After Ischemic Stroke in Patients with Cancer

Background: Cancer often causes hypercoagulability, leading to venous and arterial thromboembolic events such as stroke. The rate and type of recurrent thromboembolic events (RTE) in cancer patients after stroke is unknown. Methods: We retrospectively identified consecutive patients with active cancer diagnosed with acute ischemic stroke by MRI at Memorial Sloan-Kettering Hospital from 2008 to 2010. Study neurologists collected demographic and clinical data using a standardized abstraction tool, and reviewed all electronic records after patients’ index stroke for the primary composite outcome of RTE, defined as any recurrent ischemic stroke, TIA, MI, systemic artery thrombosis, DVT, or PE. Kaplan-Meier statistics were used to calculate the cumulative rate of RTE and recurrent ischemic stroke; follow-up was censored when patients experienced an outcome or died. In an exploratory analysis, bivariate Cox proportional hazard analysis was used to compare rates of RTE on anticoagulation compared with antiplatelet agents. Results: Acute ischemic stroke was diagnosed in 119 patients with active cancer (mean age 66 [SD 13]; 49% women) during the study period. Patients’ underlying cancer was usually a carcinoma (83%) and was advanced (systemic metastases in 74%). Using TOAST criteria, stroke mechanisms were classified as 16% large artery atherosclerosis, 21% cardioembolism, 6% small vessel, 4% of other determined cause, and 53% of undetermined etiology. Despite a very short median survival in these patients (85 days [IQR 24-495 days]), RTE were diagnosed in 37 (31%), consisting of 16 DVTs, 12 recurrent ischemic strokes, 3 PEs, 2 MIs, and 2 systemic artery thromboses. Kaplan-Meier cumulative rates of RTE were 20% at 1 month, 29% at 3 months, and 31% at 6 months, while cumulative rates of recurrent ischemic stroke were 7% at 1 month, 15% at 3 months, and 15% at 6 months. There was no significant difference in event rates on anticoagulation compared with antiplatelet agents (HR=1.2, 95% CI 0.5-2.8). Conclusions: The short-term risk of RTE and recurrent ischemic stroke in patients with active cancer and ischemic stroke is substantial.

Acute and long-term results of carotid stenting under proximal embolic protection using the gore flow reversal system

This study evaluates short- and long-term results of CAS with the Gore Flow Reversal System (GFRS). Embolic protection devices are of fundamental importance in carotid artery stenting (CAS). Proximal protection has potential advantages compared with distal protection. Limited data are available regarding the safety of the proximal GFRS. CAS was performed with the GFRS. Patients' neurological status was assessed during the intervention and at follow-up. Results of patients treated before 2006 were also compared to those of patients treated after 2006 because of changes in device design. CAS was performed in 86 patients with 87 stenoses (symptomatic in 37%). The procedure was technically successful in all cases. In 11 patients a transient periprocedural neurologic deficit occurred related to temporary cerebral flow compromise during balloon occlusion with complete resolution at completion of the procedure. The stroke/death rate at one month was 2.3% with a combined ipsilateral stroke and death rate at one year of 4.6%. There was no significant difference in event rates between the newer and older device version. Overall follow-up time was 484 ± 3.4 patient years with a range of 0 to 119 months. The average yearly ipsilateral stroke rate including the first 30 days was 0.96%. Our results demonstrate that CAS using the GFRS is safe whether the original or new device versions were used. The periprocedural stroke rate is at least as low as the stroke rate reported using distal protection. The long-term stroke rate after CAS is low.

Pregnancy and Delivery in Moyamoya Disease: Results of a Nationwide Survey in Japan

Stroke during pregnancy associated with moyamoya disease (MMD) has been reported sporadically, but no systematic surveys have been undertaken. To reveal the current clinical situation, the authors conducted Japan's first nationwide survey of pregnancy and delivery associated with MMD. A questionnaire was sent to all 270 perinatal medical centers across Japan to survey their experiences with delivery associated with MMD within the preceding 5 years (Survey I); another questionnaire was sent to 554 adult female patients with MMD regarding their experience with childbirth (Survey II). Survey I included 59 deliveries among patients with previously diagnosed MMD. The incidence of perinatal neurological events and morbidity was 5.1% and 1.7%, respectively. In another five cases, newly diagnosed after perinatal attacks, disability was noted in three cases, including one death from intracranial hemorrhage. Survey II included 278 deliveries. The perinatal attack rate was 6.6% in 76 previously diagnosed cases and 2.0% in 202 cases undiagnosed at pregnancy, but neither group reported permanent morbidity. Caesarean section in previously diagnosed cases accounted for 76.3% of deliveries in Survey I and 69.7% in Survey II, but no significant difference in event rate was found between caesarean section and vaginal delivery in either survey. Although the incidence of perinatal neurological events is low when MMD has been diagnosed, careful monitoring is required in light of the potential for stroke. Serious events, especially intracranial hemorrhage, can occur if MMD has not been diagnosed at pregnancy. Further efforts to establish management guidelines are required to ensure safer childbirth in patients with MMD.

Stent implantation in aorto-ostial lesions: long-term follow-up and predictors of outcome

To compare the outcomes of drug-eluting (DES) vs. bare-metal (BMS) stents for stenting of native aorto-ostial lesions (AOL) and to identify predictors of major adverse cardio and cerebrovascular events (MACCE). A total of 181 patients (182 AOL) who underwent stenting of AOL were retrospectively identified: right-coronary artery in 130 (71.4%), left main in 52 (28.6%). In-hospital event rate was 1.1% (two non-Q-wave myocardial infarctions). Follow-up was possible in 98.3%, median time=23.9 months (IQR 12.1-37.7). Event rates and survival MACCE-free were not significantly different between DES and BMS. After multivariate analysis, only the logistic EuroSCORE >10% predicted MACCE (HR=4.66, 95% CI: 2.38-9.12, p<0.001), whereas the predictors for TLR were age (HR=0.96, 95% CI: 0.92-1.00, p=0.039) and the stented artery (RCA vs. LM, HR=10.2, 95% CI: 1.37-75.45, p=0.024). AOL stenting can be performed with high success and low complication rates. At follow-up, no significant differences in event rates were found between DES and BMS; EuroSCORE>10% was the only predictor of MACCE.

Lack of long‐term clinical benefit of thrombus aspiration during primary percutaneous coronary intervention with paclitaxel‐eluting stents or bare‐metal stents: Post‐hoc analysis of the PASSION‐trial

Although current clinical guidelines recommend the use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI), previous studies evaluating TA demonstrated contradictory results. The aim of this study was to evaluate long-term clinical outcome after TA in adjunct to PPCI for acute ST-segment myocardial infarction (STEMI), as compared with conventional treatment, with the use of paclitaxel-eluting stents or bare-metal stents. We analyzed data of the PASSION trial, in which 619 patients with STEMI were randomly assigned to a paclitaxel-eluting stent or a bare-metal stent. TA was performed in 311 patients (50.2%). Clinical endpoints at 2 years were compared between patients who received TA during PPCI with patients who underwent conventional PPCI. The primary outcome of interest was a composite of cardiac death, recurrent myocardial infarction (MI), or target-lesion revascularization (TLR). A propensity score model was made to account for baseline differences that could have affected the probability of performing TA. Complete follow-up was available for 598 patients (96.6%). The cumulative incidence of the combined outcome measure of cardiac death, recurrent MI, or TLR was 40 (13.0%) in the TA group and 41 (13.5%) in the conventional PPCI group (HR 0.96; 95% CI 0.62-1.47; P = 0.84). Also after adjusting for propensity score, no significant difference in event rate was observed between both treatment groups. In this post-hoc analysis of the PASSION trial, TA in adjunct to PPCI did not affect rates of major adverse cardiac events at 2 years follow-up, as compared with conventional PPCI.

Outcomes of patients with left main coronary artery disease undergoing medical or surgical treatment

To evaluate the outcomes of patients with significant (≥ 50%) left main coronary artery disease (LMCAD) undergoing medical treatment (MT) or coronary artery bypass grafting surgery (CABG). A total of 181 patients with significant LMCAD were followed for 4 ± 2 years. MT was done when patients refused CABG or because of either thin native vessels or high clinical risk. Events were defined as all-cause death, myocardial infarction, percutaneous coronary intervention, or subsequent CABG. Logistic regression analysis was used to identify independent predictors of death. A propensity score was created to compare outcomes of patients from the two treatment groups. CABG was performed in 78.5% of the patients. Overall, there were no significant differences in the incidences of death or other events between treatment groups. In patients with normal left ventricular (LV) function (ejection fraction, ≥ 45%), there were no significant differences in event rates with MT or CABG (death, 7.7 vs. 12.1%; myocardial infarction, 0 vs. 1.9%; percutaneous coronary intervention, 3.8 vs. 5.6%). For patients with LV dysfunction, death was more frequent with MT than with CABG (53.8 vs. 22.9%, P<0.001), whereas the incidence of other events was not statistically different. Age and LV dysfunction, but not treatment type, were independent predictors of death. When comparing propensity-matched patients from both treatment groups, there was also no difference in survival. Patients with 50% or more LMCAD and LV dysfunction had increased survival with CABG. However, outcomes of patients with 50% or more LMCAD and normal LV function were not significantly different with either MT or CABG.