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

Vitamin K antagonists versus heparin for the treatment of splanchnic vein thrombosis in the ISTH registry: Results of 12-month follow-up and a propensity score analysis

Introduction: Splanchnic vein thrombosis [SVT] is a challenging disease, because of the concurrent increased risk of bleeding and potentially lifethreatening complications. We aimed to explore the actual management of SVT in a large prospective cohort and to report clinical outcomes during follow-up. Methods: Consecutive SVT patients were enrolled in a multicenter international registry, from 2008 to 2012. Clinical outcomes (major bleeding; vascular events, defined as venous or arterial thrombosis; mortality) were collected. A propensity score [PS], created from baseline characteristics of patients receiving the two main treatments (different dosages of parenteral anticoagulants vs vitamin K antagonists [VKAs]), was used to estimate the effect of therapeutic strategies. We here report the results of the 12-month follow-up. Results: 613 patients were enrolled; mean age 53.1±14.8 years; 62.6% males. Initially, 143 patients were not anticoagulated; 175 received parenteral anticoagulants only (mean duration 6.28±4.21 months) and 295 started VKAs (9.67±3.53 months). Major bleeding occurred in 25 patients, 16 on treatment (4.53/100 patientyears [pt-y]) and 9 off treatment (5.45/100 pt-y); vascular events in 47 patients, 27 and 20 (7.93/100 pt-y vs 11.85/100 pt-y); death in 79 patients, 44 and 35 (12.35/100 pt-y vs 20.30/100 pt-y). Solid cancer, ascites, anemia and thrombocytopenia were inversely associated with the prescription of VKAs in a binary logistic regression. Using PS based on these variables, we matched 102 patients treated with VKAs with 102 patients treated with parenteral anticoagulants. Major bleeding occurred in 5.88% vs 0.98% for VKAs and heparin, respectively; vascular events in 2.94% vs 8.82%; mortality in 5.88% vs 18.63%. Conclusions: In our cohort of SVT patients, the incidence of vascular and bleeding events at 1-year follow-up was relevant. Although the PS matching did not allow for a complete balance of heterogeneity, in designated patients VKA treatment appeared to be sufficiently safe