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Increasing disparity between Society for Vascular Surgery guidelines for infrarenal abdominal aortic aneurysm repair and real-world practice.
Schlieder, I, Kontopidis, I, Blackwood, S, Krol, E, Dietzek, AM
Journal of vascular surgery. 2021;(4):1227-1233.e1
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OBJECTIVE The current Society for Vascular Surgery (SVS) guidelines, based on randomized controlled trials published more than a decade ago, recommend a minimum threshold diameter of 5.5 cm for infrarenal abdominal aortic aneurysm (iAAA) repair. It is unknown whether practice patterns with respect to size of repair have changed since the publication of these guidelines. We aimed to evaluate the real-world practice of vascular surgeons in our region with respect to iAAA size at the time of repair, whether this has changed over the past 12 years and if any changes were associated with the repair type, open vs endovascular. METHODS The Vascular Study Group of New England (VSGNE) database was used to identify all patients who received iAAA repair between 2003 and 2015. The primary end point was to quantify the annual percentage of iAAAs repaired in different size categories (≥5.5 cm; <5.5 cm but ≥5.0 cm; <5.0 cm) over the study time period and by type of repair. The secondary end points were morbidity and mortality in these groups. We excluded nonelective cases (ruptured or symptomatic), patients with coexisting iliac artery aneurysms, and those missing critical data. RESULTS A total of 5314 patients with iAAA repairs (1538 open, 3776 endovascular) were identified in the VSGNE database during the study period. In 40% (2110 of 5314) of patients, repair was performed for aneurysms <5.5 cm, with endovascular aneurysm repair (EVAR) comprising 75% (1581 of 2110) and open 25% (529 of 2110). More EVARs were performed for <5.5 cm in 2015 (46%) compared with 2003 (33%) (P < .05, n - 1 χ2) with an average increase of 1.1%/y. There was also a non-statistically significant increase in open repair of small aneurysms (0.7%/y; P = .759). Overall, 30-day mortality was 1.11% in the EVAR group (0.54% in <5.0 cm, 0.91% in ≥5.0 but <5.5 cm, and 1.55% in ≥5.5 cm), compared with 3% in the open group (2.88%, 1.79%, and 3.77%, respectively) with no significant change in mortality in either group over time. CONCLUSIONS Despite the SVS guidelines suggesting surveillance rather than repair of iAAA <5.5 cm, an increasing proportion of repairs in the VSGNE database were performed below that threshold. The reasons for this are likely multifactorial and might include a lesser complexity and lower operative mortality for smaller aneurysms and markedly improved third- and fourth-generation stent graft technology with possibly better long-term survival. As such, it may be time to re-examine the current guidelines for iAAA repair.
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Loop Diuretics in Severe Bronchopulmonary Dysplasia: Cumulative Use and Associations with Mortality and Age at Discharge.
Bamat, NA, Nelin, TD, Eichenwald, EC, Kirpalani, H, Laughon, MM, Jackson, WM, Jensen, EA, Gibbs, KA, Lorch, SA
The Journal of pediatrics. 2021;:43-49.e3
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OBJECTIVES To measure between-center variation in loop diuretic use in infants developing severe bronchopulmonary dysplasia (BPD) in US children's hospitals, and to compare mortality and age at discharge between infants from low-use centers and infants from high-use centers. STUDY DESIGN We performed a retrospective cohort study of preterm infants at <32 weeks of gestational age with severe BPD. The primary outcome was cumulative loop diuretic use, defined as the proportion of days with exposure between admission and discharge. Infant characteristics associated with loop diuretic use at P < .10 were included in multivariable models to adjust for center differences in case mix. Hospitals were ranked from lowest to highest in adjusted use and dichotomized into low-use centers and high-use centers. We then compared mortality and postmenstrual age at discharge between the groups through multivariable analyses. RESULTS We identified 3252 subjects from 43 centers. Significant variation between centers remained despite adjustment for infant characteristics, with use present in an adjusted mean range of 7.3% to 49.4% of days (P < .0001). Mortality did not differ significantly between the 2 groups (aOR, 0.98; 95% CI, 0.62-1.53; P = .92), nor did postmenstrual age at discharge (marginal mean, 47.3 weeks [95% CI, 46.8-47.9 weeks] in the low-use group vs 47.4 weeks [95% CI, 46.9-47.9 weeks] in the high-use group; P = .96). CONCLUSIONS A marked variation in loop diuretic use for infants developing severe BPD exists among US children's hospitals, without an observed difference in mortality or age at discharge. More research is needed to provide evidence-based guidance for this common exposure.
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Regional Variations in Alirocumab Dosing Patterns in Patients with Heterozygous Familial Hypercholesterolemia During an Open-Label Extension Study.
Langslet, G, Hovingh, GK, Guyton, JR, Baccara-Dinet, MT, Letierce, A, Manvelian, G, Farnier, M
Cardiovascular drugs and therapy. 2020;(4):515-523
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PURPOSE During the alirocumab open-label extension study ODYSSEY OLE (open-label extension; NCT01954394), physicians could adjust alirocumab dosing for enrolled patients, who were diagnosed with heterozygous familial hypercholesterolemia (HeFH) and who had completed previous phase III clinical trials with alirocumab. This post hoc analysis evaluated the differences in physician-patient dosing decisions between the regions of Western Europe, Eastern Europe, North America, and the rest of the world (ROW). METHODS Patients (n = 909) who received starting dose alirocumab 75 mg every 2 weeks (Q2W) during ODYSSEY OLE (patients from FH I, FH II, and LONG TERM parent studies) were included. Low-density lipoprotein cholesterol (LDL-C) levels were blinded until week 8; subsequently, LDL-C values were communicated to physicians. From week 12, dose adjustment from 75 to 150 mg Q2W, or vice versa, was possible. RESULTS Mean LDL-C values used for the decision to increase dose from 75 to 150 mg Q2W were higher in Eastern Europe (3.7 mmol/L; 144.0 mg/dL) and ROW (3.8 mmol/L; 145.2 mg/dL) compared with Western Europe (3.1 mmol/L; 118.6 mg/dL) and North America (3.3 mmol/L; 126.6 mg/dL). Irrespective of region, the mean LDL-C at the time of decision to maintain at 75 mg Q2W was approximately 1.8 mmol/L (70 mg/dL). During ODYSSEY OLE (median treatment duration of 131.7 weeks), alirocumab was shown to have no unexpected long-term safety concerns. CONCLUSIONS In this OLE study, the observed variations in clinical treatment decisions suggest that physicians may perceive the severity of HeFH and/or the treatment of HeFH differently depending on their region.
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Time-trends and treatment gaps in the antithrombotic management of patients with atrial fibrillation after percutaneous coronary intervention: Insights from the CHUM AF-STENT Registry.
Boivin-Proulx, LA, Deneault-Marchand, A, Matteau, A, Mansour, S, Gobeil, F, Camm, JA, Fox, KAA, Potter, BJ
Clinical cardiology. 2020;(3):216-221
Abstract
BACKGROUND The management of atrial fibrillation and flutter (AF) patients undergoing percutaneous coronary intervention (PCI) has undergone a rapid recent evolution. In 2016, the Canadian Cardiovascular Society (CCS) published expert recommendations to help guide clinicians in balancing bleeding and thrombotic risks in these patients. HYPOTHESIS Antithrombotic regimen prescriptions for AF patients undergoing PCI evolved after the publication of the 2016 CCS AF guidelines. METHODS A prospective cohort of AF patients undergoing PCI with placement of a coronary stent from a single tertiary academic center was analyzed for the recommended antithrombotic regimen at discharge. Prescribing behavior was compared between three time periods (Cohort A [2010-2011]; Cohort B [2014-2015]; Cohort C [2017]) using the χ2 test. In addition, antithrombotic management in Cohorts B and C were compared to guideline-recommended therapy. RESULTS A total of 459 patients with AF undergoing PCI were identified. Clinical and procedural characteristics were similar between cohorts, with the exception of an increase in drug-eluting stent (DES) use over time (P < .01). Overall, the rate of oral anticoagulation (OAC) increased over time (P < .01), associated with an increase in nonvitamin K OAC prescription (P < .01) and a concomitant decrease in vitamin K antagonist prescription (P < .01). Despite this, the overall rate of anticoagulation remains below what would be predicted with perfect guideline compliance (75% vs 94%, P < .01). CONCLUSION There has been a dramatic shift in clinical practice for AF patients requiring PCI, with increases in prescription of OAC even in the context of an increase in the use of DES. However, room for further practice optimization still exists.
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Adherence and persistence to direct oral anticoagulants in atrial fibrillation: a population-based study.
Banerjee, A, Benedetto, V, Gichuru, P, Burnell, J, Antoniou, S, Schilling, RJ, Strain, WD, Ryan, R, Watkins, C, Marshall, T, et al
Heart (British Cardiac Society). 2020;(2):119-126
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BACKGROUND Despite simpler regimens than vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), adherence (taking drugs as prescribed) and persistence (continuation of drugs) to direct oral anticoagulants are suboptimal, yet understudied in electronic health records (EHRs). OBJECTIVE We investigated (1) time trends at individual and system levels, and (2) the risk factors for and associations between adherence and persistence. METHODS In UK primary care EHR (The Health Information Network 2011-2016), we investigated adherence and persistence at 1 year for oral anticoagulants (OACs) in adults with incident AF. Baseline characteristics were analysed by OAC and adherence/persistence status. Risk factors for non-adherence and non-persistence were assessed using Cox and logistic regression. Patterns of adherence and persistence were analysed. RESULTS Among 36 652 individuals with incident AF, cardiovascular comorbidities (median CHA2DS2VASc[Congestive heart failure, Hypertension, Age≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category] 3) and polypharmacy (median number of drugs 6) were common. Adherence was 55.2% (95% CI 54.6 to 55.7), 51.2% (95% CI 50.6 to 51.8), 66.5% (95% CI 63.7 to 69.2), 63.1% (95% CI 61.8 to 64.4) and 64.7% (95% CI 63.2 to 66.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. One-year persistence was 65.9% (95% CI 65.4 to 66.5), 63.4% (95% CI 62.8 to 64.0), 61.4% (95% CI 58.3 to 64.2), 72.3% (95% CI 70.9 to 73.7) and 78.7% (95% CI 77.1 to 80.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. Risk of non-adherence and non-persistence increased over time at individual and system levels. Increasing comorbidity was associated with reduced risk of non-adherence and non-persistence across all OACs. Overall rates of 'primary non-adherence' (stopping after first prescription), 'non-adherent non-persistence' and 'persistent adherence' were 3.5%, 26.5% and 40.2%, differing across OACs. CONCLUSIONS Adherence and persistence to OACs are low at 1 year with heterogeneity across drugs and over time at individual and system levels. Better understanding of contributory factors will inform interventions to improve adherence and persistence across OACs in individuals and populations.
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Trends in Atrial Fibrillation and Prescription of Oral Anticoagulants and Embolic Strokes in Germany.
Guelker, JE, Bufe, A, Klues, H, Shin, DI, Blockhaus, C, Gabriel, NH, Haverkamp, W, Kroeger, K
Cardiovascular revascularization medicine : including molecular interventions. 2019;(5):399-402
Abstract
BACKGROUND The aim of the study was to compare trends in frequency of atrial fibrillation (AF) with the prescription rates of oral anticoagulants (OAC) and the incidence of embolic stroke (ES) from 2005 through 2014. METHODS Annual numbers of hospitalized patients with AF and ES were extracted from the Federal Bureau of Statistics. Defined daily doses (DDD) of prescribed OAC among outpatients were extracted from the insurance drug information system. RESULTS The number of cases hospitalized with the diagnosis AF increased continuously by 78.3% (1.25 Million in 2005 to 2.19 Million in 2014, p < 0.001), likewise frequency of ES increased by 89.0% (from 46,068 to 87,050, p < 0.001) and the number of prescribed DDD of OAC almost doubled by 105.4% (from 271,328 to 557,281, p < 0.001). There is an almost linear correlation between occurrence of AF and ES (R2 = 0.9683). In contrast association between prescription rate of OAC and incidence of ES is not linear as there was a disproportional increase in OAC prescriptions beginning in the year 2010 that is not accompanied by a reduction of cases hospitalized with ES. CONCLUSIONS Our analysis of drug treatment rates for OAC in outpatients and hospitalization rates for ES revealed a disproportional increase in prescription of OAC beginning in the year 2010 that does not affect the number of cases hospitalized with ES.
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Medication Discontinuation in the IMPROVE-IT Trial.
Navar, AM, Roe, MT, White, JA, Cannon, CP, Lokhnygina, Y, Newby, LK, Giugliano, RP, Tershakovec, AM, Braunwald, E, Califf, RM, et al
Circulation. Cardiovascular quality and outcomes. 2019;(1):e005041
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BACKGROUND Although cholesterol-lowering medications can reduce the risk of recurrent cardiovascular events, premature discontinuation limits effectiveness. Discontinuation rates have not been systematically reported for lipid-lowering trials. METHODS AND RESULTS We evaluated medication discontinuation in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial), which evaluated placebo+simvastatin versus ezetimibe+simvastatin in patients hospitalized with the acute coronary syndrome and followed longitudinally postdischarge. Reasons for discontinuation were evaluated from randomization through study end (median 71.9 [interquartile range 51.8-85.8] months). Kaplan-Meier (KM) discontinuation rates were evaluated at 30 days, 1 year, and through year 7, and compared by treatment arm and region, with Cox proportional hazards modeling used to evaluate predictors of discontinuation. Overall, 46.7% of subjects discontinued study medication (KM rate by study end 50.9% [95% CI, 50.1%-51.7%]). The risk of discontinuation was highest early in the trial but decreased with increasing time, with a terminal KM rate per 100 person-years of 8.4 (8.2-8.6) from years 1 to 7. Discontinuation was higher in the placebo+simvastatin versus ezetimibe+simvastatin arm (KM rate 52.0% versus 49.8%, P=0.049) and was highest in the United States (7-year KM rate 57.4%). In multivariable modeling, smoking, prior revascularization, hypertension, unstable angina, female sex, nonwhite race, and US location were associated with higher discontinuation rates. CONCLUSIONS Although discontinuation was highest early and stabilized to 8% per year, because of prolonged follow-up, most discontinuation occurred after year 1. Adding ezetimibe to statin therapy did not increase discontinuation risk. Geographic differences and patient-level factors should be considered in trial design and analysis. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT00202878.
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Sex Differences in the Use of Statins in Community Practice.
Nanna, MG, Wang, TY, Xiang, Q, Goldberg, AC, Robinson, JG, Roger, VL, Virani, SS, Wilson, PWF, Louie, MJ, Koren, A, et al
Circulation. Cardiovascular quality and outcomes. 2019;(8):e005562
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BACKGROUND Female patients have historically received less aggressive lipid management than male patients. Contemporary care patterns and the potential causes for these differences are unknown. METHODS AND RESULTS Examining the Patient and Provider Assessment of Lipid Management Registry-a nationwide registry of outpatients with or at risk for atherosclerotic cardiovascular disease-we compared the use of statin therapy, guideline-recommended statin dosing, and reasons for undertreatment. We specifically analyzed sex differences in statin treatment and guideline-recommended statin dosing using multivariable logistic regression. Among 5693 participants (43% women) eligible for 2013 American College of Cardiology/American Heart Association Cholesterol Guideline-recommended statin treatment, women were less likely than men to be prescribed any statin therapy (67.0% versus 78.4%; P<0.001) or to receive a statin at the guideline-recommended intensity (36.7% versus 45.2%; P<0.001). Women were more likely to report having previously never been offered statin therapy (18.6% versus 13.5%; P<0.001), declined statin therapy (3.6% versus 2.0%; P<0.001), or discontinued their statin (10.9% versus 6.1%; P<0.001). Women were also less likely than men to believe statins were safe (47.9% versus 55.2%; P<0.001) or effective (68.0% versus 73.2%; P<0.001) and more likely to report discontinuing their statin because of a side effect (7.9% versus 3.6%; P<0.001). Sex differences in both overall and guideline-recommended intensity statin use persisted after adjustment for demographics, socioeconomic factors, clinical characteristics, patient beliefs, and provider characteristics (adjusted odds ratio, 0.70; 95% CI, 0.61-0.81; P<0.001; and odds ratio, 0.82; 95% CI, 0.73-0.92; P<0.01, respectively). Sex differences were consistent across primary and secondary prevention indications for statin treatment. CONCLUSIONS Women eligible for statin therapy were less likely than men to be treated with any statin or guideline-recommended statin intensity. A combination of women being offered statin therapy less frequently, while declining and discontinuing treatment more frequently, accounted for these sex differences in statin use.
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Use of Non-Vitamin K Antagonist Oral Anticoagulants 2008-2016: A Danish Nationwide Cohort Study.
Haastrup, SB, Hellfritzsch, M, Rasmussen, L, Pottegård, A, Grove, EL
Basic & clinical pharmacology & toxicology. 2018;(4):452-463
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We aimed to provide detailed utilization data on the total use of non-vitamin K antagonist oral anticoagulants (NOACs) since their introduction in 2008. Using the nationwide Danish National Prescription Registry, we identified all individuals filling prescriptions for NOACs 2008-2016. We reported the development in incident and prevalent users and explored baseline characteristics and treatment persistence according to treatment indication. A total of 126,691 NOAC users were identified within the Danish population of 5.7 million inhabitants. The annual incidence and prevalence increased rapidly reaching 10 and 17 per 1000 individuals in 2016. Patients received NOACs due to atrial fibrillation (AF) (43%), venous thromboembolism (VTE) prophylaxis after arthroplastic surgery (17%), VTE (12%) and no registered indication (28%). The most frequently used NOAC was rivaroxaban (n = 52,431), followed by dabigatran (n = 47,067), apixaban (n = 27,116) and edoxaban (n = 77). The proportion of AF and VTE patients initiating low-dose NOACs were between 23% and 50%. Patients treated with NOAC for VTE primarily received rivaroxaban. We observed a trend towards increased use of apixaban and rivaroxaban at the expense of dabigatran. Treatment persistence was highly dependent on treatment indication. Persistence to NOAC after 3 years was only 62% in AF compared to 28% for VTE. We documented an accelerating increase in the use of all four NOACs in the first 8 years after introduction. We have identified areas requiring further attention, including reasons for missing indications, potential inappropriate dosing and low long-term persistence with NOACs in patients with AF.
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Current management and treatment of patients with stable coronary artery diseases presenting to cardiologists in different clinical contexts: A prospective, observational, nationwide study.
De Luca, L, Temporelli, PL, Lucci, D, Gonzini, L, Riccio, C, Colivicchi, F, Geraci, G, Formigli, D, Maras, P, Falcone, C, et al
European journal of preventive cardiology. 2018;(1):43-53
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Background Stable coronary artery disease (CAD) is a leading cause of mortality worldwide. Few studies document the complete sequence of investigation of the overall stable CAD population during outpatient visits or hospitalisation. Aim To obtain accurate and up-to-date information on current management of patients with stable CAD. Methods START (STable coronary Artery diseases RegisTry) was a prospective, observational, nationwide study aimed at evaluating the presentation, management, treatment and quality of life of stable CAD patients presenting to cardiologists during outpatient visits or discharged from cardiology wards. Results Over a 3-month period, 5070 consecutive patients were enrolled in 183 participating centres: 72% managed by a cardiologist during outpatient or day hospital visits and 28% discharged from cardiology wards. The vast majority of patients (87%) received a coronary angiography (86% of patients managed during outpatient visits and 90% during hospitalisation; p < 0.0001). Outpatients more frequently received optimal medical therapy (OMT; i.e. aspirin or thienopyridine, β-blockers and statins) compared to hospitalised patients (70.2% vs 67.1%; p = 0.03). A personalised diet was prescribed in 58% (60.5% in outpatients and 52.9% in those admitted to hospitals; p < 0.0001), physical activity programmes were suggested in 65% (69.4% and 54.3%; p < 0.0001) and smoking cessation was recommended in 71% of currently smoking patients (73.2% and 65.2%; p = 0.02). Conclusions In this large, contemporary registry, patients with stable CAD discharged from cardiology wards more commonly underwent diagnostic imaging procedures and less frequently received OMT or lifestyle modification programmes compared to patients manged by cardiologists during outpatient visits.