The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701).
Seventy-one patients with peripheral arterial occlusive disease (PAOD) were randomized into two groups of different treatment modalities. The diagnosis of PAOD was established by history of intermittent claudication, clinical examination, and by Doppler pressure assessment or lower extremity arteriography. After a three-month washout period, 35 patients (Group 1) started treatment with indobufen (400 mg per day) and 36 patients (Group 2) with pentoxifylline (600 mg per day). Twenty-nine patients from each group completed six months of treatment. Both of the drugs significantly improved maximal and pain-free walking distances, but the effect of indobufen was more pronounced than that of pentoxifylline. Patients with PAOD exhibited signs of hypercoagulation. Fibrinogen, D-dimer, and b-thromboglobulin concentrations did not change significantly following treatment in both of the groups. The authors observed a decrease of platelet aggregation after treatment with indobufen and a decrease of F1 + 2 fragment and PAI-1 antigen after treatment with pentoxifylline.
Background Direct oral anticoagulants (DOACs) provide a safe, effective alternative to vitamin K antagonists (VKAs) for venous thromboembolism (VTE) treatment, as shown via intention-to-treat comparative effectiveness analysis. However, on-treatment analysis is imperative in observational studies because anticoagulation choice and duration are at investigators' discretion.
Objectives The aim of the study is to compare the effectiveness of DOACs and VKAs on 12-month outcomes in VTE patients using on-treatment analysis.
Methods The Global Anticoagulant Registry in the FIELD - VTE (GARFIELD-VTE) is a world-wide, prospective, non-interventional study observing treatment of VTE in routine clinical practice.
Results In total, 8,034 patients received VKAs (n = 3,043, 37.9%) or DOACs (n = 4,991, 62.1%). After adjustment for baseline characteristics and follow-up bleeding events, and accounting for possible time-varying confounding, all-cause mortality was significantly lower with DOACs than VKAs (hazard ratio: 0.58 [95% confidence interval 0.42–0.79]). Furthermore, patients receiving VKAs were more likely to die of VTE complications (4.9 vs. 2.2%) or bleeding (4.9 vs. 0.0%). There was no significant difference in rates of recurrent VTE (hazard ratio: 0.74 [0.55–1.01]), major bleeding (hazard ratio: 0.76 [0.47–1.24]), or overall bleeding (hazard ratio: 0.87 [0.72–1.05]) with DOACs or VKAs. Unadjusted analyses suggested that VKA patients with active cancer or renal insufficiency were more likely to die than patients treated with DOAC (52.51 [37.33–73.86] vs. 26.52 [19.37–36.29] and 9.97 [7.51–13.23] vs. 4.70 [3.25–6.81] per 100 person-years, respectively).
Conclusion DOACs and VKAs had similar rates of recurrent VTE and major bleeding. However, DOACs were associated with reduced all-cause mortality and a lower likelihood of death from VTE or bleeding compared with VKAs.
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