Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF.

AIMS: The relationship between outcomes and time after diagnosis for patients with non-valvular atrial fibrillation (NVAF) is poorly defined, especially beyond the first year. METHODS AND RESULTS: GARFIELD-AF is an ongoing, global observational study of adults with newly diagnosed NVAF. Two-year outcomes of 17 162 patients prospectively enrolled in GARFIELD-AF were analysed in light of baseline characteristics, risk profiles for stroke/systemic embolism (SE), and antithrombotic therapy. The mean (standard deviation) age was 69.8 (11.4) years, 43.8% were women, and the mean CHA2DS2-VASc score was 3.3 (1.6); 60.8% of patients were prescribed anticoagulant therapy with/without antiplatelet (AP) therapy, 27.4% AP monotherapy, and 11.8% no antithrombotic therapy. At 2-year follow-up, all-cause mortality, stroke/SE, and major bleeding had occurred at a rate (95% confidence interval) of 3.83 (3.62; 4.05), 1.25 (1.13; 1.38), and 0.70 (0.62; 0.81) per 100 person-years, respectively. Rates for all three major events were highest during the first 4 months. Congestive heart failure, acute coronary syndromes, sudden/unwitnessed death, malignancy, respiratory failure, and infection/sepsis accounted for 65% of all known causes of death and strokes for <10%. Anticoagulant treatment was associated with a 35% lower risk of death. CONCLUSION: The most frequent of the three major outcome measures was death, whose most common causes are not known to be significantly influenced by anticoagulation. This suggests that a more comprehensive approach to the management of NVAF may be needed to improve outcome. This could include, in addition to anticoagulation, interventions targeting modifiable, cause-specific risk factors for death. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation.

OBJECTIVES: To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. DESIGN: The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). PARTICIPANTS: Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. RESULTS: The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). CONCLUSIONS: Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Starch coatings used in food packaging industry

Do przedłużenia trwałości niektórych produktów coraz częściej stosuje się jadalne powłoki skrobiowe. Mają one wiele zalet, wśród których istotne są: biodegradowalność, szeroka dostępność i niska cena. Charakteryzują się dobrymi właściwościami mechanicznymi, optycznymi, sorpcyjnymi, a w połączeniu z innymi składnikami (takimi, jak np. tłuszcze) także właściwościami barierowymi. Są szczególnie przydatne do wprowadzenia substancji dodatkowych do żywności z możliwością ich kontrolowanego uwalniania w czasie spożywania potraw, jak i ich przygotowywania. Powłoki i filmy skrobiowe są wytwarzane najczęściej techniką wylewania. W połączeniu z plastyfikatorem i/lub innymi składnikami tworzą ciągłe struktury nadające się do bezpośredniego powlekania surowców i produktów spożywczych.More and more frequently, edible starch coatings are used to extend storage life of some products. They have many advantages among which the following are essential: biodegradability, wide availability, and low price. They are characterized by good mechanical, optical and sorption properties, and, in combination with other components (such as fats), also by barrier properties. They are particularly useful when incorporating additional substances into food products with an option of monitoring the release thereof during the consumption and preparation of meals. Starch coatings and films are produced using a casting technique. When combined with a plasticiser and/or with other components, they form continuous structures, which are suitable for direct coating of raw materials and food products

Starch as a component of edibl e coatings

Odkryty pod koniec XIX wieku polietylen i jego kopolimery kilkadziesiąt lat później odniosły globalny sukces, jako opakowania do żywności. Podobny sukces zapowiada się w stosunku do jadalnych filmów i powłok ze skrobi. Posiadają one wiele zalet. Powłoki utworzone ze skrobi są bez smaku i zapachu, niealergenne, tanie, szeroko dostępne i biodegradowalne, a wszystko to pozwala na szerokie ich wykorzystanie do powlekania żywności. Powłoki i filmy skrobiowe stosuje się m.in. do produktów nieprzetworzonych, dzięki możliwości chemicznej, fizycznej bądź genetycznej modyfikacji skrobi i łatwości w jej otrzymaniu. Istnieje wiele metod, za pomocą których można uzyskać jadalne i/lub biodegradowalne opakowania ze skrobi. Do najpopularniejszych należy technika wylewania. Aplikacja na produkt odbywa się poprzez zanurzenie, spryskanie lub nanoszenie w postaci jednej lub kilku warstw. Dodatek do struktury filmów i powłok substancji takich jak: woski, aromaty i barwniki powoduje, że produkty spożywcze są atrakcyjne dla konsumenta i docelowo nie stanowią zagrożenia dla środowiska przyrodniczego.Polyethylene and its copolymers were discovered at the end of nineteenth century. Several decades later, when they were used for food packaging, they became worldwidely known. The edible films and food coatings made from starch, show potential to become as popular as copolymers. This is due to many advantages they posses. The coatings formed from starch are tasteless, odorless and they do not cause allergy. Moreover they are cheap to manufacture, comprehensively available and biodegradable. This all means that they can be used for extended spectrum of food coatings. Starch coatings and films are used for example as raw materials. It results in chemical, physical or genetical modification of starch and easiness to their retrieve. There are lots of possibilities that are helpful in obtaining edible and/or biodegradable packagings from starch. One of most popular techniques of acquiring is casting. Aplication on a output consist of either spraying, immersing or coating one or several layers. Waxes, flavors, colors, which include starch, are usually more atractive for customers as well as more environmentally friendly

The effect of rapeseed oil addition on optical properties of starch films

Celem przeprowadzonej pracy badawczej było wyjaśnienie wpływu dodatku oleju rzepakowego na właściwości optyczne filmów ze skrobi natywnej pszennej. Filmy utworzono z 5% wodnych roztworów powłokotwórczych skrobi natywnej pszennej z dodatkiem 50% glicerolu (jako plastyfikatora) względem masy skrobi oraz dodatkiem oleju rzepakowego w ilości 0, 1, 2, 3%. Zmierzono barwę filmów w systemie CIE L*a*b* z zastosowaniem wyróżników barwy takich jak bezwzględna różnica barwy, nasycenie barwy i indeks nasycenia. Policzono również nieprzezroczystość przy długości fali 600 nm. Zaobserwowano zmianę barwy oraz zwiększanie nieprzezroczystości filmów modyfikowanych dodatkiem oleju rzepakowegoThe aim of this work was to analyse the effect of rapeseed oil addition on optical properties of wheat starch films. Films were prepared from 5% of starch film-forming water solutions and 50%glycerol as plasticizer (w/w of starch) and rapeseed oil was added to the solutions at concentration of 0, 1, 2, 3%. Colour in the CIE L*a*b* system was measured and colour discriminants were calculated: total colour difference, colour saturation and saturation index. Moreover the opacity at wavelength of 600 nm was calculated. Changing in colour parameters and discriminants was observed and decreased opacity of starch films with rapeseed oil addition

Diagnostic contribution of cardiac magnetic resonance in patients with acute coronary syndrome and culprit-free angiograms.

BACKGROUND: In spite of robust knowledge about underlying ischemic myocardial damage, acute coronary syndromes (ACS) with culprit-free angiograms raise diagnostic concerns. The present study aimed to evaluate the additional value of cardiac magnetic resonance (CMR) over commonly available non-CMR standard tests, for the differentiation of myocardial injury in patients with ACS and non-obstructed coronary arteries. MATERIAL/METHODS: Patients with ACS, elevated hs-TnT, and a culprit-free angiogram were prospectively enrolled into the study between January 2009 and July 2013. After initial evaluation with standard tests (ECG, echocardiography, hs-TnT) and provisional exclusion of acute myocardial infarction (AMI) in coronary angiogram, patients were referred for CMR with the suspicion of myocarditis or Takotsubo cardiomyopathy (TTC). According to the result of CMR, patients were reclassified as having myocarditis, AMI, TTC, or non-injured myocardium as assessed by late gadolinium enhancement. RESULTS: Out of 5110 patients admitted with ACS, 75 had normal coronary angiograms and entered the study; 69 of them (92%) were suspected for myocarditis and 6 (8%) for TTC. After CMR, 49 patients were finally diagnosed with myocarditis (65%), 3 with TTC (4%), 7 with AMI (9%), and 16 (21%) with non-injured myocardium. The provisional diagnosis was changed or excluded in 23 patients (31%), with a 9% rate of unrecognized AMI. CONCLUSIONS: The study results suggest that the evaluation of patients with ACS and culprit-free angiogram should be complemented by a CMR examination, if available, because the initial work-up with non-CMR tests leads to a significant proportion of misdiagnosed AMI