Portable prothrombin time (PT) monitors offer the potential for both simplifying and improving oral anticoagulation management. It is necessary to evaluate their concordance and correlation with other PT systems. Our objective was to evaluate the concordance and clinical correlation of two portable PT determination systems, ProTime (ITC) and CoaguChek S (Roche Diagnostics). In all, 20 healthy individuals and 60 anticoagulated patients stabilized over 3 months in a therapeutic International Normalized Ratio (INR) range between 2-3.5 were studied. A drop of capillary blood was obtained simultaneously from two different fingers of each patient and applied to the monitor's application zone. The mean INR of the patients' blood samples of the two monitors differed by 0.01 units (2.32+/-0.63 for Pro Time and 2.33+/-0.68 for CoaguChek). The percentage of simple concordance and the kappa index were 88.3 and 75.9%, respectively. The coefficient of correlation was 0.922. The mean difference (bias) between the monitors was 0.01. The portable PT monitors evaluated presented a high percentage of concordance in INR results.

Two models of capillary blood prothrombin time (PT) monitoring systems were evaluated for analytical performance and then compared with two routine PT systems using the reference manual technique and a high-sensitivity thromboplastin. Two sets of 60 and 80 plasmas were analyzed from anticoagulated patients stabilized over 3 months in an INR range 2-3.5 for therapy. Capillary PT determination was performed in two portable monitors, CoaguChek S and CoaguChek PT (Roche Diagnostics), and plasma automatic methods were Neoplastine/STA (Diagnostics Stago) and PT-FibrinogenHsPlus/ACL7000 (Instrumental Laboratories). Thromboplastin Bilbao (TBi), an in-house high-sensitivity rabbit thromboplastin (ISI=1.08), recommended as the reference reagent by an External Spanish Oral Anticoagulant Quality Assessment, was used in the PT manual technique. The two monitors' coefficients of correlation with the reference system were 0.74 for CoaguChek S and 0.81 for CoaguChek PT. The automatic routine systems showed a correlation of 0.92 (Neoplastine/STA) and 0.91 (PT-FbHsPlus/ACL7000). Clinical agreement expressed as the percentage of simple correlation ranged between 75.0% (CoaguChek S) and 88.9% (Neoplastine/STA). The systems having the best kappa index with the manual technique were CoaguChek PT (71.9%) and the Neoplastine/STA system (73%). The routine PT management systems exhibited better correlation and percentage of concordance when using the TBi/manual technique than did the portable monitors, which moreover performed unequally in this regard.

Funding Acknowledgements Type of funding sources: None. Introduction and objectives Sodium-glucose co-transporter type 2 inhibitors (SGLT2i) have proven to reduce risk of cardiovascular outcomes in patients with type 2 diabetes mellitus (T2DM). The aim of this study is to analyse the adverse CV events of acute presentation in a diabetic population with poor control in which treatment with SGLT2i tries to improve it independently of the presence of previous established CV disease. Material and methods Retrospective observational study included 544 patients with inadequately controlled TDM2 from 2 hospitals and 10 primary care centres of reference for the 78,000 population. They received a SGLT2i (Empagliflozin, Dapagliflozin or Canagliflozin) as add-on therapy to other glucose-lowering medications between February 2018 and February 2019. Evolution was monitored until February 2020. We analysed the population"s baseline characteristics and the incidence of acute cardiovascular events during follow-up (stroke, peripheral arterial ischemia, ACS, adverse events and death). Results 544 patients were included, 342 men (63%), with a mean age of 65.94 ± 10.26 years (52.2% > 65 yo). The mean follow-up was 22.62 ± 6.3 months from the start of SGLT2i. Initial HbA1c was 7.95 ± 1.29%, mean BMI 31.39 ± 5.49 kg/m2, preserved renal function with mean GFR of 83.62 ± 0.53 ml/min/1.73 m2 and the duration of diabetes was 12.48 ± 7.75 years. At baseline, 32.5% (N = 177) were on insulin. Prior to the prescription of SGLT2i 11.6% (N = 63) were diagnosed of heart failure and 4.2% (N = 23) had suffered decompensation (during/on/in) the previous year. 23.7% (N = 127) had had previous adverse cardiovascular event: 98 patients injured 1 organ (22 stroke, 57 ischemic heart disease and 19 peripheral arterial ischemia), 24 injured 2 organs and 5 injured 3. A greater proportion of patients (409/544) received Empagliflozin (75.2%) followed by 98 Dapagliflozin (18%) and 37 Canagliflozin (6.8%). Just 16% (N = 87) of the patients discontinued treatment, due to genital infections in 3.1% (N = 17) and 3 drops in GF to < 30 as main causes. Serious complications were rare (2 acidosis, 3 sepsis). No amputations or severe hypoglycaemia were reported. During the follow-up there were 12 deaths (2.2%) because of oncological pathology except for 2 cases of terminal heart failure.  The incidence of acute cardiovascular events was low (N = 19, 3.5%) and they were non-fatal, but unlike the basal affectation in which coronary disease predominated, during the follow-up the new events were 7 strokes (1.3%) and 7 episodes of peripheral arterial ischemia (1.3%), 4 cases of ACS and 1 case of stroke + ACS. 10 patients had had previous events and in 9 cases it was de novo. Conclusions In our diabetic population, the use of SGLT2i is associated with few acute cardiovascular events in the first 1-3 years of follow-up, with good tolerance and low percentages of discontinuation of treatment due to adverse events.

Prothrombin time (PT) is the control test for oral anticoagulant therapy as well as the screening test for defects of the extrinsic pathway of coagulation. Its responsiveness to decreased extrinsic clotting factors depends on the source and type of tissue factor thromboplastin extract. In 1994, a rabbit brain thromboplastin – Thromboplastin Bilbao (TBi) – was introduced as a replacement for a human brain preparation used since 1983, with the aim of establishing a national standard. The purpose of this study was to check the reproducibility, the inter-assay/intra-assay accuracy and the stability of this reagent under temperature changes and over time. A method modified from Frei et al. [World Health Organisation Regional Publications, Eastern Mediterranean Series, Alexandria, 1995] was used for the preparation of thromboplastin extract. Thirty-five batches of human TBi were prepared from 1983 to 1988, while from 1993 to 1999 13 batches of rabbit TBi were produced. The inter-assay reproducibility of rabbit TBi exhibited a coefficient of variation (CV) of 1.07–1.57% for normal plasma and of 1.25–2.56% for anticoagulated plasma. The intra-assay CV was 0.06–1.30% for normal plasma and 1.23–2.66% for anticoagulated plasma. The stability of the reagent to temperature changes and time was also estimated, with similar results for the two thromboplastins. As a result of the Oral Anticoagulant Treatment Quality Assessment Scheme in the Basque Country, an in-house rabbit thromboplastin with good sensitivity and reproducibility was developed.