Differences In Baseline Variables Research Articles

Propensity Score Analysis Comparing Clinical Outcomes of Drug-Eluting vs Bare Nitinol Stents in Femoropopliteal Lesions

Purpose: To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS). Methods: A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis. Results: The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: –DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: –DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup. Conclusion: These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions.

Everolimus Attenuates Myocardial Hypertrophy and Improves Diastolic Function in Heart Transplant Recipients.

Everolimus (EVL), one of the mammalian targets of rapamycin, is a next generation immunosuppressant that may have accessory anti-proliferative effects in heart transplant (HTx) recipients. However, little is known about the clinical relationship between EVL and regression of cardiac hypertrophy. A total of 42 HTx recipients received EVL therapy at post-HTx 150 days on median and had been followed at our institute for > 1 year between 2008 and 2014 [EVL (+) group]. We also observed 18 patients without EVL from post-HTx 150 days for 1 year [EVL (-) group]. There were no significant differences in baseline variables between the two groups. Left ventricular mass index (LVMI) and the ratio of early transmitral filling velocity to the peak early diastolic mitral annular motion velocity (E/e') decreased significantly during 1-year EVL treatment compared with the EVL (-) group. There were no differences in blood pressure and medications between the 2 groups. Improvement of LVMI and the E/e' ratio was not associated with trough levels of calcineurin inhibitors or EVL, but correlated with each baseline value. In conclusion, this EVL-incorporated immunosuppressant regimen attenuated cardiac hypertrophy as well as diastolic dysfunction in HTx recipients.

Long-Term Adaptive Servo-Ventilator Treatment Prevents Cardiac Death and Improves Clinical Outcome.

Adaptive servo-ventilation (ASV) is a recently developed, noninvasive therapeutic tool for the treatment of heart failure (HF). However, the efficacy of ASV therapy in patients with advanced HF remains uncertain, especially as regards its contribution to freedom from cardiac replacement therapy. A total of 85 patients with advanced HF (New York Heart Association [NYHA] class IV 71%, inotrope infusion-dependent 34%) refractory to guideline-directed medical therapy, received ASV therapy, irrespective of sleep-disordered breathing, at our institute between 2008 and 2014. Among these 85 patients, 46 continued ASV therapy for > 1 month (continued group), whereas 39 discontinued the therapy after < 1 month because of intolerance (discontinued group). There were no significant differences in baseline variables between the two groups. Heart rate indicating sympathetic activity, left ventricular (LV) reverse remodeling assessed by LV diastolic diameter, LV ejection fraction, and the grades of mitral and tricuspid regurgitations, HF severity assessed by NYHA class and plasma level of B-type natriuretic peptide, and end-organ dysfunction, improved significantly at 6 months following the initiation of ASV therapy (P < 0.05 for all). All-cause mortality and cardiac death rate were significantly lower during 2-year follow up in the continued group (P < 0.05 for both). In conclusion, ASV is a novel therapeutic tool prior to cardiac replacement therapy in patients with advanced HF and may prolong the period until cardiac replacement therapy becomes necessary.

Abstract 11478: Excellent Clinical Courses of Autologous Skeletal Myoblast Sheet Transplantation Compared to a Propensity Score-Matched Cardiac Resynchronization Therapy (Best of Basic Science Abstract)

Introduction: We recently reported a multi-center, single-arm, phase II study that evaluated the efficacy and safety of autologous skeletal myoblast sheet (TCD-51073) transplantation. The advantage of this procedure over a control group has not yet been analyzed. Hypothesis: TCD-51073 has better clinical outcome compared with background-matched control group. Methods: Seven patients with advanced heart failure due to ischemic etiology (TCD-51073 group, New York Heart Association [NYHA] class III; left ventricular ejection fraction (LVEF) &lt;35%) refractory to optimal medical and coronary revascularization therapy, received TCD-51073 at 3 study centers between 2012 and 2013 with a 2-year follow-up period. As previously reported, 112 patients received cardiac resynchronization therapy (CRT) with follow-up at the University of Tokyo Hospital between 2007 and 2014. Results: Of them, 21 patients were selected for the control group by propensity score matching. No significant difference in baseline variables between the groups was observed. LVEF and NYHA class improved significantly in the TCD-51073 group during the 6-month study period (p&lt;0.05). During the 2-year follow-up, 7 patients (33%) in the CRT group and no patient in the TCD-51073 group died due to cardiac disease or received VAD implantation (p=0.128 by the log-rank test). Conclusions: Transplantation of TCD-51073 is clinically advantageous in facilitating LV reverse remodeling, improving HF symptoms, and preventing cardiac death in patients with ischemic etiology when compared to background-matched patients receiving CRT.

Efecto de la suplementación con vitamina D en monodosis en niños con parálisis cerebral. Estudio preliminar controlado y aleatorizado

IntroductionChildren with cerebral palsy (CP) have an increased risk of vitamin D (VD) deficiency. Although there are many studies on VD and CP, there is limited information about VD supplementation in these patients. ObjectiveTo evaluate the effect of supplementation with a single dose of VD on the plasma concentrations of 25-hydroxy-vitamin-D (25OHD) in children with CP. Patients and methodProspective-randomised-controlled-trial, including 30 Chilean children (19 males) with CP, median age 9.9 years (6.2-13.5). Clinical and biochemical variables including 25OHD, were recorded (time 0 and 8 weeks). Patients were allocated to the supplemented (S) group receiving 100,000 IU oral D3 at baseline, and compared with the placebo (P) group. ResultsAmong clinical features are highlighted: gastrostomy (60%), underweight (30%), bed-ridden (93.3%), antiepileptic drugs (70%), and 43.3% used VD metabolism inducing antiepileptics. Baseline biochemical measurements were normal. The 25OHD was insufficient in 4/30 and deficient in 6/30. 25OHD levels were not associated with the variables studied. Eight patients completed the study in the S group, and 10 in P group. The placebo and supplementation groups had no significant difference in baseline variables. Serum calcium, phosphate, and alkaline phosphatase levels at 8 weeks were normal in both groups, with no statistically significant differences. 25OHD in the P group was normal in 6/10, and insufficient+deficient in 4/10, and the S group was normal in all (8/8) (exact Fisher test P=.07). ConclusionsA single dose of 100,000 IU VD could normalise the concentrations of 25OHD after 8 weeks of supplementation in Children with CP, but more studies are required to confirm these results.

Improved Clinical Course of Autologous Skeletal Myoblast Sheet Transplantation When Compared to a Propensity Score-Matched Cardiac Resynchronization Therapy Population

We recently reported a multi-center, single-arm, phase II study that evaluated the efficacy and safety of autologous skeletal myoblast sheet (TCD-51073) transplantation. The advantage of this procedure over a control group has not yet been analyzed. Seven patients with advanced heart failure due to ischemic etiology (TCD-51073 group, New York Heart Association [NYHA] class III; left ventricular ejection fraction (LVEF) <35%) refractory to optimal medical and coronary revascularization therapy, received TCD-51073 at 3 study centers between 2012 and 2013 with a 2-year follow-up period. As previously reported, 112 patients received cardiac resynchronization therapy (CRT) with follow-up at the University of Tokyo Hospital between 2007 and 2014. Of them, 21 patients were selected for the control group by propensity score matching. No significant difference in baseline variables between the groups was observed. LVEF and NYHA class improved significantly in the TCD-51073 group during the 6-month study period (p<0.05). During the 2-year follow-up, 7 patients (33%) in the CRT group and no patient in the TCD-51073 group died due to cardiac disease or received VAD implantation (p=0.128 by the log-rank test). Transplantation of TCD-51073 is clinically advantageous in facilitating LV reverse remodeling, improving HF symptoms, and preventing cardiac death in patients with ischemic etiology when compared to background-matched patients receiving CRT.

Improved clinical course of autologous skeletal myoblast sheet (TCD-51073) transplantation when compared to a propensity score-matched cardiac resynchronization therapy population.

We recently reported a multi-center, single-arm, phase II study that evaluated the efficacy and safety of autologous skeletal myoblast sheet (TCD-51073) transplantation. The advantage of this procedure over a control group has not yet been analyzed. Seven patients with advanced heart failure due to ischemic etiology (TCD-51073 group, New York Heart Association (NYHA) class III; left ventricular ejection fraction (LVEF) <35 %) refractory to optimal medical and coronary revascularization therapy, received TCD-51073 at 3 study centers between 2012 and 2013 with a 2-year follow-up period. As previously reported, 112 patients received cardiac resynchronization therapy (CRT) with follow-up at the University of Tokyo Hospital between 2007 and 2014. Of them, 21 patients were selected for the control group by propensity score matching. No significant difference in baseline variables between the groups was observed. LVEF and NYHA class improved significantly in the TCD-51073 group during the 6-month study period (p < 0.05). During the 2-year follow-up, 7 patients (33 %) in the CRT group and no patient in the TCD-51073 group died due to cardiac disease or received VAD implantation (p = 0.128 by the log-rank test). In conclusion, transplantation of TCD-51073 is clinically advantageous in facilitating LV reverse remodeling, improving HF symptoms, and preventing cardiac death in patients with ischemic etiology when compared to background-matched patients receiving CRT.

The porcine valve type predicts obstructive thrombosis beyond the first three postoperative months in bioprostheses in the aortic position

BackgroundObstructive thrombosis of bioprosthetic valves is considered rare but may have dramatic consequences for the individual patient including repeat valve replacement, thrombolysis, or long-term anticoagulation. Whether the risk of obstructive thrombosis is dependent on the type of bioprosthesis (porcine versus bovine pericardial) is uncertain. Methods and resultsBetween 2007 and 2012 a total of 1751 patients received a single stented bioprosthesis in the aortic valve position, 749 (43%) were porcine and 1002 (57%) bovine. During a mean follow-up of 3.4±1.9years, obstructive thrombosis (identified by an increase in mean pressure gradient≥20mm Hg or a decrease in velocity ratio≥0.05 and confirmed by either ECG-gated computer tomography, a return to baseline of stenosis parameters under treatment with a vitamin K antagonist, or histology in case of reoperation) was diagnosed in 17 patients with a porcine (2.3%) and none with a bovine valve (p<0.001). The cumulative probability of developing an obstructive thrombosis was significantly higher in patients with a porcine valve (p<0.001 log-rank test). Adjusting for differences in baseline variables and stratification by the estimated propensity score showed that strata with a high probability of receiving a bovine valve had the highest number of obstructive thrombosis in porcine valves. These findings were further confirmed in a Poisson model and a competing risk model including all-cause mortality. Treatment of obstructive thrombosis with a vitamin K antagonist was safe and effective in 15/17 patients. ConclusionThe porcine valve type is an independent predictor of obstructive thrombosis in bioprostheses in the aortic position.

111 Improved Clinical Outcomes with Multi-Vessel Compared to Culprit only Percutaneous Coronary Intervention in Patients Presenting with Acute ST Elevation Myocardial Infarction

Introduction In patients with acute ST elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) improves survival. Multi-vessel coronary disease is identified in up to two thirds of patients and is associated with poorer outcomes. Historically, registry data and guidelines favoured culprit only PCI in STEMI, although recent data suggest that more complete revascularisation may improve outcomes. To examine this issue locally, we studied clinical outcomes in consecutive patients presenting with STEMI and multivessel disease in SE Scotland stratified according to revascularisation strategy (culprit versus multivessel angioplasty). Methods We retrospectively examined clinical outcomes according to revascularisation strategy (culprit versus multi-vessel) in all patients with multivessel disease (defined as >70% lumen stenosis in at least one non-infarct artery that was suitable for revascularisation) undergoing PCI for STEMI in SE Scotland, October 2013 – August 2014. Patients with significant left main stenosis, cardiogenic shock or previous bypass surgery were excluded. Survival analysis for MACE (death, recurrent myocardial infarction (MI), stroke) was performed using the log-rank test before and after stratification by combined syntax score of the non-culprit vessels. Results One hundred and nineteen patients with multivessel disease at index PCI for STEMI were included in the analysis (mean age 63.8 years (SD 12.8), male 81.5%, diabetes 13.4%, hypertension 35.3%, previous MI 18.5%, previous stroke 5.8%). Eighty-five (71%) patients underwent culprit only PCI and 34 (29%) underwent multivessel PCI. There were no differences in baseline variables between the two groups. Mean duration of follow up was 153.7 days (SD 137.4). MACE occurred in 14 patients from the culprit only PCI group (6 MI, 3 stroke and 6 deaths) while no events occurred in the multivessel PCI group (Figure 1). High syntax score (defined as >median) of the non-infarct vessels predicted increased MACE in the non-culprit PCI group (Figure 2). Conclusions In this single centre, retrospective analysis, multivessel PCI was associated with significantly improved clinical outcomes when compared to culprit only PCI in patients presenting with STEMI and multivessel disease. Our findings provide support for the results of recently published clinical trials.

Is Bridging Necessary? A Pilot Study of Bridging versus Primary Stentriever-Based Endovascular Reperfusion in Large Anterior Circulation Strokes

We aimed to determine whether bridging provides additional benefits over primary stentriever-based endovascular reperfusion (SER) in patients with proximal middle cerebral artery (pMCA) strokes. Clinical and radiologic data from consecutive stroke patients with large anterior circulation infarcts involving the pMCA were analyzed. Stroke subtypes were categorized according to Trial of ORG 10172 in Acute Stroke Treatment criteria. Neurologic deficits were assessed with the National Institutes of Health Stroke Scale (NIHSS), and vessel recanalization was determined using the Thrombolysis in Cerebral Infarction scale at the end of SER. Good outcome was defined as a modified Rankin Scale (mRS) score of 2 or lesser. Fifty-seven patients with a median age of 66 years were included. Of those, 24 received prior systemic tissue plasminogen activator and 33 received primary SER. Atrial fibrillation was more common in patients who underwent SER but there were no other between-group differences in baseline variables, procedure-related variables, or outcome parameters. Six patients died and 27 patients achieved an mRS of 2 or less at 90days. Patients who were treated with tPA before SER needed less stentriever passes to recanalize the occluded vessel, but bridging did not impact the chances for either survival or favorable outcome. Age (odds ratio [OR], .92; 95% confidence interval [CI], .85-.98) and NIHSS score (OR, .12; 95% CI, .02-.78) were the only variables associated with outcome on multivariate analysis. Primary SER and bridging resulted in equally high survival and good outcome rates. Our results suggest that the benefits of primary SER in such critically ill patients may bypass the need for bridging therapy and merit further study.

Clinical outcomes among patients with extreme obesity undergoing elective coronary revascularization: Evaluation of major complications in contemporary practice

Background/objectivesIndividuals with extreme obesity (EO), defined by a body mass index (BMI) ≥40kg/m2, constitute an increasingly prevalent population at higher risk of procedural complications. The implications of increasing weight burdens among this subset of patients in the setting of elective coronary revascularization have yet to be adequately studied. MethodsWe sought to define major complications in this group at one year following contemporary revascularization strategies by retrospectively analysing a cohort of consecutive EO patients undergoing elective percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). The primary endpoint was a composite of peri- and post-procedural complications. Secondary endpoints included a cardiovascular composite and target vessel revascularization (TVR). ResultsAdjusted event-free survival curves for the primary endpoint among 133 patients differed significantly with higher BMI (>43.2kg/m2) associated with greater risk (p=0.02). The primary endpoint occurred more frequently with CABG compared to PCI (24.2% vs. 5.0%, p<0.01), which remained significant after adjusting for differences in baseline variables. Rates of the cardiovascular composite and TVR were comparable. ConclusionsIncreasing BMI was associated with greater risk for major complications among EO patients undergoing elective coronary revascularization. PCI was associated with fewer complications; however, both revascularization strategies demonstrated equivalent rates of death, MI, and/or stroke. Larger studies may permit a better understanding of the associations between increasing BMI and specific outcomes and to evaluate the role for pre-procedural weight loss in this select population.

Long-term clinical and angiographic outcomes in patients with diabetes undergoing coronary artery bypass graft surgery: Results from the PRoject of Ex-vivo Vein graft ENgineering via Transfection IV Trial

There is limited information about the association between diabetes, its treatment, and long-term angiographic and clinical outcomes in patients undergoing coronary artery bypass graft surgery (CABG). We evaluated the association of diabetes and its treatment with 1-year angiographic graft failure and 5-year clinical outcomes in patients undergoing CABG. Using data from 3,014 patients in PREVENT IV, we analyzed angiographic and clinical outcomes in patients with and without diabetes and among those who did and did not receive insulin before CABG. Logistic regression and Cox proportional hazards models were used to adjust for differences in baseline variables. Overall, 1,139 (37.8%) patients had diabetes. Of these, 305 (26.8%) received insulin. One-year rates of vein graft failure were similar in patients with and without diabetes but, among diabetics, tended to be higher in patients who received insulin compared with those who did not. At 5 years, rates of death, myocardial infarction, or revascularization were higher among patients with compared with those without diabetes (adjusted hazard ratio 1.57; 95% CI 1.26-1.96; P < .001) and, among diabetics, higher among those who received insulin (adjusted hazard ratio 1.15; 95% CI 1.02-1.30; P = .02). Patients with diabetes had similar rates of vein graft failure but worse clinical outcomes than patients without diabetes. Patients who received insulin had significantly worse clinical outcomes than patients who did not receive insulin. Further studies to better understand the mechanism behind these findings and to improve the outcomes of patients with insulin-requiring diabetes undergoing CABG surgery are warranted.

Short-term cognitive effects after recovery from a delirium in a hospitalized elderly sample.

The aim of this study was to examine early cognitive performance after a delirium in elderly general hospital patients. Patients were divided into a delirium (n = 47) and a control (n = 25) group. One week before discharge and after delirium had cleared in the first group, all patients completed a neuropsychological test battery (The Cambridge Cognitive Examination-Revised [CAMCOG-R]). Group differences in cognitive performance were analyzed adjusting for differences in baseline sociodemographic and clinical variables. Adjusting for group differences in baseline variables, the delirium group performed significantly worse than the control group on CAMCOG-R; its subdomains language, praxis, and executive functioning; and on Mini Mental State Examination derived from CAMCOG-R. The occurrence of delirium in hospital thus detrimentally affects early cognitive performance.

AB0235 Use of Rituximab Compared to Anti-TNF Agents as Second and Third Line Therapy in Patients with Rheumatoid Arthritis. A Report from the Rhumadata® Clinical Database and Registry

BackgroundThe order of use of biologic agents after failing a TNF inhibitor is still a question for debate. Phase III trial data in TNF-IR patients show comparable efficacy results across...

Abstract W P19: Propensity Scores Facilitate Unbiased Comparison of Endovascular Devices in IMS III

Introduction: The IMS III Trial randomized acute ischemic stroke patients to endovascular (IV tPA + intra-arterial) or IV tPA -only therapy to compare efficacy. However, endovascular subjects were not randomized to a particular approach; interventionalists chose the method. Hence, any statistical comparison of devices must account for potential selection bias. Methods: To compare the efficacy and safety of various endovascular treatment modalities, the multiple propensity score (PS) method was implemented to account for potential bias and achieve balance between groups. The analysis is restricted to subjects with an ICA or M1 vessel treated using a standard microcatheter, the Merci retriever, or the Penumbra system. Propensity scores were estimated via a multinomial regression model that included demographic and clinical variables for which 1) an imbalance between devices was demonstrated (α=0.10) or 2) an association with outcome was established (α=0.10). PS tertiles were included as covariates in a logistic regression model relating outcome to device. Results: The analysis included 167 subjects treated with a standard microcatheter (n=51), the Merci retriever (n=77) or the Penumbra system (n=39). Unadjusted comparison indicated imbalance between devices in the presence of atrial fibrillation, age, systolic blood pressure, onset to IV tPA start time, and IV tPA start to groin puncture time. Additional covariates included in the PS model varied by outcome. After adjustment for PS tertiles, the initial difference in baseline variables between devices was no longer statistically significant and there was insufficient evidence to conclude that the devices differed for any of the outcomes considered. Conclusions: Selection bias was a concern in comparing endovascular approaches in IMS III. The PS method successfully balanced baseline characteristics and facilitated a valid conclusion: major efficacy and safety outcomes did not significantly differ between subjects treated with a standard microcatheter, the Merci retriever, and the Penumbra system. Limitations include small sample size and the possibility of differences in unmeasured baseline characteristics.

Response to the editor: the essential component of clinical trials' reports.

Dear Editor, Referring to the letter you sent to me, I would like to explain more about the research study and its results, “Effects of a three-stage intervention program on the holistic health status of patients with drug addiction after discharge”. I do understand that a well-designed experiment includes design features that allow researchers to eliminate extraneous variables as an explanation of the observed relationship between the independent variable(s) and the dependent variable. In this study, the research design was a quasi-experimental research and a matched pairs design, which is a special case of the randomized block design. It is used when the experiment has only two treatment conditions (control and experimental); and participants can be grouped into pairs, based on some blocking variables. For example, in this study, the researcher manipulated one dependent variable, holistic health status, while holding all other extraneous variables constant. Therefore, the control variable was: being discharged from the institution within six months, and matching variables were: gender, age, level of education, and type of drug addiction, which might have affected the holistic status of the subjects according to the literature reviews (1 - 6). Then, within each pair, subjects were randomly assigned to different treatments for the experimental and the control groups. As with other designs, the matched pairs design uses randomization to control for confounding variables, and the sample size (N) of each group in this study was 45 which is larger than 30. However, it should be noted that, unlike the others, this design explicitly controlled for those extraneous variables that might have occurred, such as being discharged from the institution within 6 months, gender, age, level of education, and type of drug addiction, which were the differences in the baseline variables in the case of no control (Table 1). Table 1. Socio-demographic Characteristics of the Study Samples After the experiment, a t-test was applied to see how the change occurred when compared between the experimental and control groups. Unlike the other designs, a significant level of change was tested, and therefore, a pre-test for baseline was not necessary due to the matched pairs being applied, and the differences in baseline variables were already controlled. In addition, this study tested the change (the differences, D1 and D2 of the experiment and control groups) because it is believed that this method helps to protect against the differences that might have been caused by the history and maturity of the subjects in the pre-post test of both experimental and control groups (7, 8).

Outcome after resection and radiofrequency ablation of liver metastases from small intestinal neuroendocrine tumours

In patients with small intestinal neuroendocrine tumour (SI-NET), liver resection or radiofrequency ablation (RFA) of liver metastases is performed for palliation of carcinoid syndrome, and in an effort to improve survival. Data are generally reported from case series, and no randomized trials have studied these treatments. The aim was to compare outcome after liver resection and/or RFA with that of non-surgical treatment in patients with liver metastases from SI-NET. The study included patients with liver metastases from SI-NET who underwent liver RFA/resection or were treated non-surgically. A propensity score match was performed to reduce bias between groups, using baseline variables such as the Charlson co-morbidity index, age, symptoms, carcinoid heart disease, extent of metastases and proliferation index. Some 103 patients who had RFA and/or liver resection were compared with 273 controls. Propensity score matching resulted in two matched groups, each of 72 patients, with no significant differences in baseline variables. The matched resection/RFA and control groups showed no difference in overall survival (both 74 per cent at 5 years; P = 0·869) or disease-specific survival (74 versus 78 per cent respectively at 5 years; P = 1·000). However, urinary 5-hydroxyindoleacetic acid levels were lower (median 77 versus 120 µmol per 24 h; P = 0·005) and the proportion of patients with progressive disease within the liver was smaller (2 of 18 versus 8 of 18; P < 0·001) in the resection/RFA group after 5 years. These data do not support the use of liver resection and/or RFA in an effort to prolong survival in patients with liver metastases from SI-NET.

Long term outcomes of PCI and CABG for isolated proximal LAD lesions: a real world comparison

Purpose: The clinical prognosis for untreated, high-grade proximal LAD lesions is poor. Previous studies investigating revascularisation strategies in this patient cohort have almost exclusively compared PCI using BMS with CABG in stable patients. We therefore compared clinical outcomes in patient's whom underwent revascularisation for isolated proximal LAD lesions in our institution. Methods: We undertook an observational cohort study of unselected, consecutive patients who underwent single vessel proximal LAD revascularization at a large university hospital from April 2000-August 2011. The clinical database was linked to the administrative Discharge Abstract Database of the Canadian Institute for Health Information and the Registered Persons Database. Due to significant differences in baseline variables between the groups propensity matching of the PCI to CABG cohorts was undertaken at a 2:1 ratio. Results: 1753 patients were included. 1596 had PCI and 157 patients underwent CABG. The mean follow up period was 5.5 years and 7 years respectively. The unadjusted mortality in the PCI group was 11.5% (n=183) and 7% (n=11) in the CABG group. Of the PCI patients 37.8% had DES implanted. The propensity matched PCI (n = 294) and CABG (n=147) cohorts were well balanced with respect to all baseline characteristics including age, diabetes, renal impairment, procedural urgency, presentation and LV impairment. There was no difference in mortality between the PCI group and CABG group: 1 year (0.3% vs. 0.7%), 5 years (3.1% vs. 4.8%; p=0.26). There were higher rates of revascularization in the PCI cohort at 1 year (10.9% vs. 0.7%) and at 5 years (17.3% vs. 1.5%; p<0.001). There was a trend towards higher cardiovascular events in the PCI group: at 5 years (19.7% vs. 10.9%; p=0.06) driven primarily by repeat revascularization. Conclusions: Revascularization by both PCI and CABG provide excellent mortality results in patients with isolated proximal LAD lesions. Repeat revascularization is more frequent in the PCI group.

FRI0225 Use of abatacept in patients with rheumatoid arthritis from the rhumadata® database: experience as first or second line agent compared with adalimumab and etanercept.

BackgroundThe order of use of biologic agents is still a question of debate. Phase III trial data in MTX-IR patients show very similar results across all biologic agents. No head...

Are adverse events following an invasive strategy in patients with non‐ST‐segment elevation acute coronary syndromes more frequent at US sites versus Non‐US sites? analysis from the ACUITY trial

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], P < 0.0001} 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.