Venous thromboembolism in centenarians: Findings from the RIETE registry

BackgroundThe balance between the efficacy and safety of anticoagulant therapy in patients aged ≥ 100 years receiving anticoagulant therapy for venous thromboembolism (VTE) is uncertain.MethodsWe used data from the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to assess the rate of VTE recurrences, bleeding events, and mortality appearing during the course of anticoagulant therapy in VTE patients aged ≥ 100 years.ResultsOf 61,173 patients enrolled in RIETE as of January 2016, 47 (0.08%) were aged ≥ 100 years. Of these, 10 (21%) were men, 21 (45%) presented with pulmonary embolism (PE), and 26 with deep vein thrombosis alone. Overall, 35 patients (74%) had severe renal insufficiency, 14 (30%) chronic heart failure, 30 (64%) anemia, 16 (34%) were taking antiplatelets, and 6 (13%) corticosteroids or non-steroidal anti-inflammatory drugs. Most patients (95%) were treated initially with low-molecular-weight heparin (LMWH) (mean daily dose, 168 ± 42 IU/kg). Then, 14 (30%) switched to vitamin K antagonists and 29 (62%) kept receiving long-term LMWH therapy (mean, 148 ± 51 IU/kg/day). During the course of anticoagulant therapy (mean duration, 139 days), mortality was high (15/47; 32%). Two patients died of PE (initial PE one, recurrent PE one) and 5 (11%) had minor bleeding, but no major bleeding was reported.ConclusionsAmong patients with acute VTE aged ≥ 100 years, the risk of VTE recurrences during the course of anticoagulation outweighed the risk of bleeding. Our data suggest the use of standard anticoagulant therapy in this patient population, even if they have severe renal insufficiency.     

The Japanese experience with sirolimus-eluting stent implantation in the infarct-related artery: Five years of observation from the J-PMS study

BackgroundLong-term outcome and safety concerns regarding drug-eluting stents (DES) for acute myocardial infarction (AMI) treatment is still debated.Methods and resultsWe analyzed data from 1937 patients with complete 5-year follow-up (94.5%) from a multicenter registry of sirolimus-eluting stents (J-PMS). The patients were divided into 2 groups: AMI (n = 133) and non-AMI (n = 1804) by clinical presentation of index procedure, and compared the outcomes. At 5-year follow-up, there were no significant differences in major adverse cardiac events (MACE), death, MI, or stent thrombosis between the groups. However, target vessel related events (TVF; revascularization, cardiac death, MI, thrombosis) were higher in the non-AMI group (p = 0.03). In the early phase (0–6 months), MACE and death/MI were higher in the AMI group (6.0% vs. 3.0%; p = 0.02 and 6.8% vs. 2.1%; p < 0.001). However, in the late phase (6–60 months), there was a difference in TVF between the 2 groups, with a steady increase in the non-AMI group (p = 0.03). Over 60% of patients with AMIs were started on dual antiplatelet therapy after stent implantation or on the same day. However, dual anti-platelet therapy duration was similar (867 ± 18 days in the AMI and 727 ± 57 days in the non-AMI group, p = 0.5). Frequency of bleeding was similar.ConclusionFive-year observation of AMI treatment using drug-eluting stent compared with non-AMI has no clinical disadvantage.     

Aspirin for primary prevention of cardiovascular events in patients with diabetes: A meta-analysis

BackgroundTo systematically review trials concerning the benefit and risk of aspirin therapy for primary prevention of cardiovascular events in patients with diabetes mellitus.MethodsWe searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. Eligible studies were prospective, randomized controlled trials of aspirin therapy for primary cardiovascular prevention in patients with diabetes with follow-up duration at least 12 months.Results7 trials included 11,618 individuals with diabetes. Aspirin therapy was not associated with a statistically significant reduction in major cardiovascular events (relative risk [RR] 0.92, 95% confidence interval [CI] 0.83–1.02, p = 0.11). Aspirin use also did not significantly reduce all-cause mortality (0.95, 95% CI 0.85–1.06; p = 0.33), cardiovascular mortality (0.95, 95% CI 0.71–1.27; p = 0.71), stroke (0.83, 95% CI 0.63–1.10; p = 0.20), or myocardial infarction (MI) (0.85, 95% CI 0.65–1.11; p = 0.24). There was no significant increased risk of major bleeding in aspirin group (2.46, 95% CI 0.70–8.61; p = 0.16). Meta-regression suggested that aspirin agent could reduce the risk of stroke in women and MI in men.ConclusionsIn patients with diabetes, aspirin therapy did not significantly reduce the risk of cardiovascular events without an increased risk of major bleeding, and showed sex-specific effects on MI and stroke.     

Predictors and safety of venous thromboembolism prophylaxis among hospitalized inflammatory bowel disease patients

IntroductionInflammatory bowel disease (IBD) patients are at increased risk of venous thromboembolism (VTE) especially during hospitalization. We assessed the safety and predictors of VTE prophylaxis in this population.MethodsWe conducted a retrospective study of 974 IBD admissions between February 2010 and May 2012. We abstracted data on clinical characteristics, VTE prophylaxis and bleeding events, and conducted multivariate analysis to determine predictors of prophylaxis.ResultsPharmacological VTE prophylaxis was administered to 80% of admissions; 63% were within 24 h of admission. Patients on the surgical service (adjusted OR [aOR], 3.82; 95% CI: 2.00–7.29) and general medicine (aOR, 2.40; 95% CI: 1.39–4.12) were more likely to receive VTE prophylaxis compared to those on the gastroenterology service. Rectal bleeding on admission was associated with lower prophylaxis (aOR, 0.58; 95% CI: 0.35–0.97). The VTE prophylaxis rate increased from 47% to 73% (P < 0.001) on non-surgical services with the introduction of a pharmacist advocate. The rates of major and minor bleeding were similar between patients who did and did not receive VTE prophylaxis (0.26 vs. 0 per 1000 person-days, P = 0.7; 4.18 vs. 2.53 per 1000 person-days, P = 0.4 respectively), and the major bleeding events (n = 2) were post-operative. VTE prophylaxis was not associated with major postoperative bleeding (0.4% vs. 0%, P = 0.96).ConclusionsVTE prophylaxis was more frequent on the surgical service, where standardized protocols exist. The introduction of a pharmacist advocate greatly increased VTE prophylaxis on the non-surgical services. Prophylactic anticoagulation is safe in IBD despite the presence of rectal bleeding on admission.     

Tratamiento antiagregante de muy corta duración tras la ICP y nuevos SLF: metanálisis de 5 estudios aleatorizados

Introduction and objectivesVery early (1-3 months) discontinuation of dual antiplatelet therapy (DAPT) has been recently proposed in percutaneous coronary interventions with modern drug-eluting stents (DES), with contrasting results. The aim of the present meta-analysis was to evaluate the prognostic impact of very short DAPT regimens vs the standard 12-month regimen in patients undergoing percutaneous coronary intervention with new DES.MethodsLiterature and main scientific session abstracts were searched for randomized clinical trials (RCT). The primary efficacy endpoint was mortality, and the primary safety endpoint was major bleeding events. A prespecified analysis was conducted according to the long-term antiplatelet agent.ResultsWe included 5 RCTs, with a total of 30 621 patients; 49.97% were randomized to very short (1-3 months) DAPT, followed by aspirin or P2Y₁₂I monotherapy. Shorter DAPT duration significantly reduced the rate of major bleeding (2% vs 3.1%, OR, 0.62; 95%CI, 0.46-0.84; P = .002; Phet = .02), but did not significantly condition overall mortality (1.3% vs 2%, OR, 0.97; 95%CI, 0.73-1.29; P = .84; Phet = .18). The reduction in bleeding events was even more significant in trials randomizing event-free patients at the time of DAPT discontinuation. The occurrence of myocardial infarction and stent thrombosis was similar between shorter vs standard 12-month DAPT.ConclusionsBased on the current meta-analysis, a very short (1-3 months) period is associated with a significant reduction in major bleeding compared with the standard 12-month therapy, with no increase in major ischemic events and comparable survival.Full English text available from:www.revespcardiol.org/en     

Comparison of outcomes in new-generation versus early-generation heart valve in transcatheter aortic valve implantation: A systematic review and meta-analysis

BackgroundNew-generation (NG) valves for transcatheter aortic valve implantation (TAVI) has recently been widely used in real-world practice, yet its comparative outcomes with early-generation (EG) valves remain under-explored.MethodsAn electronic literature search using PUBMED and EMBASE was conducted from inception to April 2017 for matched-cohort studies. Articles that compared the outcomes of NG vs. EG valves post TAVI with at least one of the following clinical outcome reported were included: all-cause mortality, major or life-threatening bleeding, major vascular complications (MVC), significant (more than moderate) paravalvular regurgitation (PVR), cerebrovascular events, significant (stage 2 or 3) acute kidney injury (AKI) and new permanent pacemaker implantation (PPI) that occurred either in-hospital or within 30-days.ResultsA total of 6 observational matched-cohort studies with 585 and 647 patients included in NG and EG valves, respectively, were included. EG valves were associated with a lower incidence of major or life-threatening bleeding (5.7% vs. 15.7%, p < 0.00001), significant paravalvular regurgitation (5.3% vs. 14.4%, p = 0.001), and significant AKI (4.4% vs. 7.5, p = 0.03). All-cause mortality (3.5% vs. 5.0, p = 0.43), cerebrovascular events (3.4% vs. 2.3%, p = 0.34) and new PPI (11.0% vs. 14.6%, p = 0.52) were similar between the two groups. NG demonstrated lower tendency of MVC (2.5% vs. 7.2, p = 0.09) compared to EG valves.ConclusionsNG demonstrated lower rates of significant AKI, significant PVR and major or life-threatening bleeding while all-cause mortality, new PPI, and cerebrovascular events remained similar compared to EG valves.     

Copy number variations of the F8 gene are associated with venous thromboembolism

BackgroundVenous thromboembolism (VTE) is a complex disease and several inherited and acquired factors are relevant to its occurrence. Among these, an elevated level of plasma coagulation factor VIII (FVIII) is an established risk factor for VTE; copy number variations (CNVs) have also been discovered to be associated with many diseases.ObjectiveTo explore the proposed association between CNV of the F8 gene and the risk of VTE.MethodsA case–control study including 179 VTE patients and 176 healthy individuals were enrolled in this study. Activity of plasma factor VIII was measured. Genomic DNA was extracted for subsequent quantitative real-time PCR analysis of CNVs of the F8 gene.ResultsPlasma factor VIII levels were significantly higher in VTE patients than in healthy controls (251% vs. 99%, p < 0.01). Copy number of the F8 gene in VTE patients was significantly higher than in healthy controls. (male: p = 6.1 × 10^? 14, OR = 12, 95%CI: 6.0–25; female: p = 4.3 × 10^? 10, OR = 9.5, 95%CI: 4.5–20). Plasma factor VIII levels in the samples with high copies of the F8 gene were higher than in those individuals with normal copy number (male: p = 0.023; female: p = 0.036).ConclusionsAmplification of the F8 gene copy number seems to enhance factor VIII activity and was associated with VTE.     

Clinical management and outcome of major bleeding in patients on treatment with vitamin K antagonists

BackgroundThe optimal management of major bleeding associated with vitamin K antagonists remains unclear.ObjectivesThe aim of the study was to assess the determinants of outcome of vitamin K antagonists-associated major bleeding and the outcome of bleeding in relation with the therapeutic management.MethodsPatients hospitalized for major bleeding while on vitamin K antagonists were included in a prospective, cohort study. Major bleeding was defined according to the criteria of the International Society of Thrombosis Haemostasis. The primary study outcome was death at 30 days from major bleeding.Results544 patients were included in this study, of which 282 with intracranial hemorrhage. Prothrombin complex concentrates were used in 51% and in 23% of patients with intracranial hemorrhage or non-intracranial major bleeding, respectively (p < 0.001); fresh frozen plasma was used in 7% and in 17% of patients with intracranial hemorrhage or non-intracranial major bleeding (p < 0.001).Death at 30 days occurred in 100 patients (18%), 72 patients with intracranial hemorrhage and 28 patients with non-intracranial major bleeding. Age over 85 years, low Glasgow Coma Scale score and shock were independent predictors of death at 30 days. Invasive procedures were associated with decreased risk of death.ConclusionsAmong the patients hospitalized for major bleeding while on vitamin K antagonists, the risk for death is substantial. The risk for death is associated with the clinical severity of major bleeding as assessed by the GCS score and by the presence of shock more than with the initial localization of major bleeding (ICH vs other sites).     

Association between red cell distribution width and thromboembolic events in patients with atrial fibrillation

BackgroundWe investigated whether an increase in the value of red cell distribution width (RDW) was associated with thromboembolic outcomes in patients with atrial fibrillation (AF).MethodsWe performed a retrospective analysis of 5082 consecutive patients with non-valvular AF. Thromboembolic events (N = 723, 14.2%) were recorded and analysed according to RDW value.ResultsThe peak RDW value during follow-up was higher in patients with thromboembolic events than in those without thromboembolic events (15.1% vs. 14.2%, p < 0.001). The RDW value showed similar power in predicting thromboembolic outcomes compared with the factor of age. The risk of thromboembolic events was higher in patients with a peak RDW ≥ 13.9% than in patients with a peak RDW < 13.9% (hazard ratio 1.63, p < 0.001), and increased with each quartile increase of RDW. In a subgroup of 739 patients with congestive heart failure (CHF), there were 112 (15.2%) thromboembolic events. The peak RDW value of patients with CHF with thromboembolic events was also significantly higher (16.4% vs. 15.6%, p = 0.019) compared to that of those without thromboembolic events.ConclusionAn increased RDW value during follow-up could be associated with thromboembolic events in patients with non-valvular AF. The suggested cut-off values for RDW used to predict an increased thromboembolic risk in were ≥ 13.9% in patients with AF in general, ≥ 15% in patients with co-existing AF and CHF.     

Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients. A retrospective multicenter study

ObjectiveTo analyze the incidence of VTE in hospitalized medical patients and prophylaxis applied in accordance with the 8th ACCP guidelines and the National PRETEMED guide for thromboprophylaxis.MethodsDischarge lists were reviewed to select the first consecutive 20 patients, aged ≥ 40 years and admitted ≥ 4 days to the Internal Medicine Departments of 79 Spanish hospitals. Exclusion criteria were: admission for diagnostic procedures, VTE or surgical illness, or care during hospitalization provided by the local investigator.ResultsFrom September 2011 to July 2012, 2845 discharge reports were evaluated and 1623 were considered eligible for the study. Overall 930 (57.3%) patients of this group were at risk of VTE according to the ACCP guidelines, 759 (81.6%) received VTE prophylaxis (mechanical or pharmacological) and 159 (17.1%) had at least one risk factor that might contraindicate anticoagulant use. The proportion of patients at VTE risk according to the ACCP and National PRETEMED guidelines with no risk factors of bleeding that did not receive prophylaxis was 16.3% and 17.2%, respectively. During hospitalization, there were 14 (0.9%) episodes of symptomatic VTE, 12 (86%) of which occurred in patients receiving prophylaxis. VTE rate was 1.3% among patients with VTE risk that received prophylaxis and 3.5% in patients that also had one risk factor that might contraindicate anticoagulant use.ConclusionsIn a setting characterized by high thromboprophylaxis compliance most of the episodes occurred in patients receiving pharmacological prophylaxis. Patients with combined VTE and bleeding risk factors showed the highest rate of both symptomatic VTE and prophylaxis failure.     

Riesgo de eventos tromboembólicos en función del manejo de la terapia anticoagulante y antiagregante en pacientes sometidos a colangiopancreatografía retrógrada endoscópica

Background and objectivesThe main clinical practice guidelines recommend adequate periprocedural withdrawal and reintroduction of antithrombotic drugs in case of invasive techniques. The main objective of this study was to assess whether, in patients receiving anticoagulant or antiplatelet therapy, the suppression or reduction of the pharmacological dose for the performance of endoscopic retrograde cholangiopancreatography (ERCP) implies a greater risk of thromboembolic events.Patients and methodsA prospective observational study was carried out, which included 644 ERCP performed with therapeutic intention during 2019 at the Reina Sofía University Hospital with follow-up during the 30 days after the endoscopic intervention.ResultsSix patients presented a thromboembolic event, finding no differences between the incorrect withdrawal/reintroduction of antithrombotic treatment and a higher proportion of thromboembolic or hemorrhagic events after the procedure (P > .05). The incidence of thrombotic events was significantly higher in patients treated with heparin or apixaban (P = .001), as well as with a history of atrial fibrillation (P = .05), rheumatic valve disease (P = .037) and recurrent pulmonary embolism (P = .035), this being also an independent risk factor. Likewise, the incidence of hemorrhage in the 30 days post-sphincterotomy was significantly lower in those with implantation of a biliary prosthesis (P = .04).ConclusionsInadequate periprocedural management of antithrombotic therapy is not associated with a significant increase in the incidence of thromboembolic events in the 30 days after ERCP. However, close follow-up and surveillance during the days after this is essential in those patients with a condition that significantly increases the risk of thrombosis.     

Safety of eptifibatide when added to bivalirudin during ST-segment elevation myocardial infarction

BackgroundPatients presenting with ST-segment elevation myocardial infarction (STEMI) represent a high-risk group for in-hospital adverse events and bleeding. The safety and outcomes of eptifibatide in addition to bivalirudin in this population have not been determined.MethodsOver an 11-year period, we identified 1849 STEMI patients undergoing primary percutaneous coronary intervention (PCI), of which 1639 received bivalirudin monotherapy compared with 210 patients who received both bivalirudin and provisional eptifibatide. Safety of combination therapy was assessed by the occurrence of thrombolysis in myocardial infarction (TIMI) major bleeding. In-hospital event rates of death, Q-wave myocardial infarction (MI), and acute stent thrombosis were evaluated for efficacy. Multivariate analysis was used to adjust for significant differences between groups.ResultsPatients treated with bivalirudin plus eptifibatide, when compared with patients with bivalirudin monotherapy, had increased rates of cardiogenic shock (15.7% vs. 9.4%), aspiration thrombectomy (48.5% vs. 23.7%), pre-TIMI flow ≤ 1 (63.5% vs. 40%), and higher peak troponin I (93.65 ± 92.7 vs. 49.16 ± 81.59; all p < 0.01). These, however, were not associated with differences in the primary end point after adjusting for significant baseline and procedural characteristics (OR: 1.63; 95% CI, 0.90–2.96, p = 0.12). Importantly, TIMI major bleeding was not significantly different between groups (OR 1.78; 95% CI, 0.79–2.95, p = 0.20).ConclusionThe addition of eptifibatide to bivalirudin during primary PCI reflects a high-risk STEMI population. This therapy results in similar in-hospital outcomes without an increase in major bleeding. Therefore, when required, combination therapy may be considered in this population.     

Predictors of outcome in a Spanish cohort of patients with Fabry disease on enzyme replacement therapy

Fabry disease may be treated by enzyme replacement therapy (ERT), but the impact of chronic kidney disease (CKD) on the response to therapy remains unclear. The aim of the present study was to analyse the incidence and predictors of clinical events in patients on ERT.Study designMulticentre retrospective observational analysis of patients diagnosed and treated with ERT for Fabry disease. The primary outcome was the first renal, neurological or cardiological events or death during a follow-up of 60 months (24–120).ResultsIn 69 patients (42 males, 27 females, mean age 44.6 ± 13.7 years), at the end of follow-up, eGFR and the left ventricular septum thickness remained stable and the urinary albumin: creatinine ratio tended to decrease, but this decrease only approached significance in patients on agalsidase-beta (242–128 mg/g (p = 0.05). At the end of follow-up, 21 (30%) patients had suffered an incident clinical event: 6 renal, 2 neurological and 13 cardiological (including 3 deaths). Events were more frequent in patients with baseline eGFR ≤ 60 ml/min/1.73 m² (log Rank 12.423, p = 0.001), and this remained significant even after excluding incident renal events (log Rank 4.086, p = 0.043) and in males and in females. Lower baseline eGFR was associated with a 3- to 7-fold increase the risk of clinical events in different Cox models.ConclusionsGFR at the initiation of ERT is the main predictor of clinical events, both in males and in females, suggesting that start of ERT prior to the development of CKD is associated with better outcomes.     

Angioscopic assessments and clinical outcomes one year after polymer-free biolimus A9-coated coronary stent implantation

BackgroundPolymer-free biolimus A9-coated coronary stent (DCS) has novel features which lead to the expectation of better arterial healing. However, comparisons of intravascular status between DCS and drug-eluting stents (DES), and robust real-word clinical assessments of DCS have been lacking to date.MethodsFrom September 2017 to September 2018, we evaluated the intra-vascular status of 74 DCS implanted in 55 lesions from 43 patients using coronary angioscopy (CAS) approximately one year after implantation from a cohort of 219 lesions in 158 patients. We set 239 second-generation durable-polymer DES (DP-DES) implanted in 211 lesions from 180 patients from a cohort of 2652 lesions in 1914 patients as the control. Angioscopic images were analyzed to determine (1) the dominant degree of neointimal coverage (NIC) over the stent; (2) the heterogeneity of NIC; (3) yellow color grade of the stented segment; and (4) the presence of intra-stent thrombus. The primary outcome was the incidence of thrombus and secondary outcomes were the other CAS findings, and the 1-year clinical outcomes which included target lesion revascularization (TLR) and major adverse cardiac events (MACE). To minimize inter-group differences in baseline characteristics, propensity score matching was performed for clinical outcomes.ResultsIncidence of thrombus adhesion was similar in DCS and DP-DES groups (28.4% versus 22.6%, p = 0.31). However, the dominant NIC grade was significantly higher in DCS (p < 0.001), while NIC was more heterogeneous in DCS than in DP-DES (p = 0.001). Maximum yellow color grade was similar (p = 0.22). After propensity score matching, 202 lesion pairs from 146 patient pairs were retained for analysis. The cumulative incidence of TLR (4.6% versus 3.8%, p = 0.38) and MACE (11.6% versus 11.7%, p = 0.84) was similar for DCS and DP-DES.ConclusionsDCS showed thrombus adhesion and clinical outcomes at 1 year similar to DP-DES. DCS can thus be used with similar safety and efficacy as DP-DES.     

Trends in the treatment and outcomes of elderly patients with acute coronary syndrome: Results from the CZECH registries

BackgroundThe number of elderly patients in the population is rapidly increasing, and little is known about how adherence to recommended treatment strategies in elderly patients with acute coronary syndrome (ACS) has changed over time.AimTo analyze trends in the treatment and outcomes of elderly patients with ACS from two registries conducted in the Czech Republic over 10 years.Methods and resultsData from the CZECH-1 and CZECH-3 registries were used in this study. These registries collected data in autumn 2005 and autumn 2015, and contain data from 1952 and 1754 unselected patients, respectively. All patients had been hospitalized with an initial diagnosis of ACS. There were 490 (25.7%) elderly patients in the CZECH-1 registry and 484 (28.1%) elderly patients in the CZECH-3 registry (p = 0.045) with an average age of 80.6 ± 4 and 82.1 ± 5 years (p < 0.001), respectively. ACS was confirmed in 345 (72%) and 352 (73.6%) elderly patients (p = 0.781), respectively. There was higher use of percutaneous coronary intervention (65.2% and 54.8%; p < 0.001), dual antiplatelet treatment, ACE inhibitors, and statins during treatment in the CZECH-3 compared to the CZECH-1 registry. No differences in hospital mortality of elderly patients with confirmed ACS were observed between registries (8.2% vs. 10.4%; p = 0.790).ConclusionThe proportion of patients with ACS that are elderly is increasing along with their increasing average age. Adherence to guideline-recommended therapy in this subgroup of patients has improved over time, but hospital mortality remains unchanged.     

Association between dyslipidemia and vascular events in patients treated with statins: Report from the UK General Practice Research Database

ObjectiveA retrospective cohort study was conducted to evaluate the association between low high-density lipoprotein cholesterol (HDL-C) and/or elevated triglycerides (TG) and cardiovascular (CV) and/or cerebrovascular (CB) events among patients with elevated low-density lipoprotein cholesterol (LDL-C) despite statin treatment.MethodsPatient demographics, clinical characteristics, laboratory data, and CV/CB events, were collected from the UK General Practice Research Database. Abnormal lipid levels were defined using US and European clinical guidelines. The association between the frequency of CV/CB events among patients with HDL-C/TG abnormalities versus patients with isolated low LDL-C was estimated using multivariate Cox proportional hazards regression.ResultsOf 19,843 statin-treated patients, 6823 had elevated LDL-C despite therapy for a mean follow-up of 1.99 ± 1.06 years. Among these patients, 3115 (45.7%) also had HDL-C/TG abnormalities. A total of 715 patients (10.5%) experienced CV/CB events. In statin-treated patients not at LDL-C goal, the relative risk of a vascular event was 24% higher in patients with HDL-C/TG abnormalities (HR = 1.24, 95% CI: 1.06–1.46, p = 0.006) than in patients without HDL-C/TG abnormalities. Additional variables that were associated with a significantly increased risk of CV/CB events included age (p < 0.0001), gender (p = 0.027), and medication possession ratio (p < 0.0001), while diabetes mellitus (p < 0.0001), hypertension (p < 0.0001), 10-year Framingham risk score > 30% (p = 0.005), statin dose (p < 0.0001), and LDL-C level at baseline (p < 0.0001) were associated with a significantly decreased risk of CV/CB events.ConclusionAmong statin-treated patients with elevated LDL-C from UK clinical practices, reduced HDL-C and/or elevated TGs were associated with a significantly increased relative risk of CV/CB events.     

Trends in use of anti-thrombotic agents and outcomes in patients with non-ST-segment elevation myocardial infarction (NSTEMI) managed with an invasive strategy

ObjectiveTo analyze trends in utilization of anti-thrombotic agents (ATA) and in-hospital clinical outcomes in non-ST-elevation myocardial infarction (NSTEMI) patients managed with an invasive strategy from 2007 to 2010.Methods & resultsUsing ACTION Registry^®-GWTG™ data, we analyzed trends in use of ATA and in-hospital clinical outcomes among 64,199 NSTEMI patients managed invasively between 2007 and 2010. ATA included unfractionated heparin (UFH), low molecular weight heparin (LMWH), glycoprotein IIb/IIIa inhibitors (GPI) and bivalirudin. Although the proportion of NSTEMI patients treated with PCI within 48 h of hospital arrival was similar in 2007 and 2010, percentage use of bivalirudin (13.4–27.3%; p < 0.01) and UFH increased (60.0–67.5%, p < 0.01), and that of GPI (62.3–41.0%; p < 0.01) and LMWH (41.5–36.8%; p < 0.01) declined. Excess dosing of UFH (75.9–59.3%, p < 0.01), LMWH (9.6–5.2%; p < 0.01) and GPI (8.9–5.9%, p < 0.01) was also significantly lower in 2010 compared with 2007. Though in-hospital mortality rates were similar in 2007 and 2010 (2.3–1.9%, p = 0.08), the rates of in-hospital major bleeding (8.7–6.6%, p < 0.01) and non-CABG related RBC transfusion (6.3–4.6%, p < 0.01) were significantly lower in 2010 compared with 2007.ConclusionCompared with 2007, patients with NSTEMI, who were managed invasively in 2010 received GPI and LMWH less often and bivalirudin and UFH more frequently. There were sizeable reductions in the rates of excess dosing of UFH (though still occurred in 67% of patients), GPI and LMWH. In-hospital major bleeding complications and post-procedural RBC transfusion were lower in 2010 compared with 2007.     

Analysis of arterial function in adults with a history of Kawasaki disease

Background and purposeIt remains controversial whether Kawasaki disease (KD) is a risk factor for the early onset of atherosclerosis.The purpose of the present study was to assess endothelial function and arterial stiffness as markers of the early onset of atherosclerosis in adult patients with a history of KD.Methods and subjectsWe compared 14 adult patients with a history of KD with 41 healthy controls. To assess arterial endothelial function, we measured the reactive hyperemia-peripheral arterial tonometry (RH-PAT) index and augmentation index adjusted to 75 bpm (AIx@75) using the Endo-PAT 2000 (Itamar Medical, Caesarea, Israel). In addition, we analyzed medical history, blood pressure, lifestyle habits, and atherosclerosis-related serum biochemical markers [asymmetric dimethylarginine, adiponectin, lipoprotein (a), cholesterols, atherogenic index of plasma].ResultsThere was no difference between the KD and control groups with regard to the RH-PAT index values (2.10 ± 0.43 and 1.84 ± 0.49, respectively; p = 0.19). However, in the KD group, the RH-PAT index values were negatively correlated with the febrile period in the acute phase of disease (r² = 0.458, p = 0.048). In addition, the AIx@75 values were higher in KD patients compared to healthy controls (?7.69 ± 11.86% and ?15.87 ± 8.72%, respectively; p = 0.01). No significant differences existed between the KD and control groups with regard to the serum biomarkers of atherosclerosis.ConclusionsWe speculate that endothelial dysfunction in former KD patients is affected by the febrile period of the acute phase, and antiplatelet drugs may improve endothelial function. The increased arterial stiffness of patients caused by post-inflammatory fibrotic changes in the arterial wall indicates that adults with a history of KD have an increased risk of developing atherosclerosis.     

Combined oral and rectal mesalazine for the treatment of mild-to-moderately active ulcerative colitis: Rapid symptom resolution and improvements in quality of life

Background and aimsMesalazine (5-aminosalicylic acid) is the standard first-line therapy for mild-to-moderate ulcerative colitis. In the PINCE study, remission rates were significantly greater with combined oral/enema vs. oral/placebo treatment at 8 weeks (64% vs. 43%, respectively; p = 0.030). In this analysis, we explored early response, mucosal healing rates, cessation of rectal bleeding, and quality of life in PINCE.MethodsPatients with extensive mild-to-moderately active ulcerative colitis received 8 weeks of oral mesalazine 4 g/day, plus 4 weeks of daily active (1 g mesalazine) or placebo enema. Early response was assessed using the abbreviated ulcerative colitis disease activity index. Mucosal healing was assessed by disease activity index endoscopic mucosal appearance score. Cessation of bleeding (patient diaries), quality of life (EQ-5D), and patient acceptability (questionnaire) were also assessed.ResultsCombined mesalazine oral/enema treatment achieved a significantly higher rate of improvement in abbreviated ulcerative colitis disease activity index (score decrease ≥ 2) within 2 weeks, compared with oral-only treatment (p = 0.032). Bleeding ceased significantly more quickly with combination vs. oral therapy (p = 0.003). More patients showed mucosal healing (disease activity index endoscopic mucosal appearance score 0/1) with combination vs. oral therapy, which was significantly different between groups at week 4 (p = 0.052). Both groups showed quality of life improvements, with a significant benefit for combination vs. oral therapy at week 4 in multiple domains. Most patients reported finding the treatment acceptable.ConclusionsRapid cessation of symptoms was seen with combination therapy, which is particularly important to patients and may improve quality of life.