The elderly with AF had a higher event-rate than the younger patients. A higher severe bleeding event-rate was also registered in elderly patients receiving anticoagulant therapy. Combined, compared with anticoagulant therapy, significantly reduced vascular events and bleeding mortality in elderly patients.
SummaryThis study aims to establish the relative effectiveness and safety of low molecular weight heparin in elderly patients with venous thrombosis in order to find an alternative to oral anticoagulant therapy with less bleeding complications in the long-term treatment of deep venous thrombosis (DVT).One hundred consecutive elderly patients (>75 years old) with venographically demonstrated proximal DVT were included in a randomized trial. All patients were treated for ten days with adjusted doses of intravenous heparin. Informed consent was obtained and on the eight day, patients were randomly allocated to receive acenocoumarol (INR 2.0-3.0) or subcutaneous enoxaparin (4000 anti-Xa units once a day) for three months. All patients were followed-up clinically and venographically for a one year period. The results were analyzed with Fisher’s exact test or chi-square test as appropriate.During the treatment and surveillance period, 6 of the 50 patients (12%) who received acenocoumarol and 8 of the 50 patients (16%) who received enoxaparin had new episodes of venous thromboembolism confirmed by objective testing (p = 0.6; 95% CI for the difference: −19.5 to 11.5). Hemorrhagic complications occurred in six of the 50 patients (12%) who received acenocoumarol and in one (2%) of those on enoxaparin (p = 0.1; 95% CI for the difference: -1.8 to 21.8). Vertebral fractures developed in 2 patients (4%) in the enoxaparin group (p = 0.5; 95% CI for the diference: −11.4 to 3.4).These results show that fixed dose enoxaparin seems to be effective and safe in the long-term treatment of proximal DVT in the elderly. In comparison with oral anticoagulants, the findings are inconclusive due to the wide confidence intervals for differences between outcomes, however they suggest that the former may have less bleeding complications with similar efficacy.
The NASPEAF trial showed that combined anticoagulant plus antiplatelet therapy was more effective than anticoagulant alone at reducing vascular events in atrial fibrillation (AF) patients. We planned both to validate this benefit during a longer follow-up of patients included in that trial and to assess the hypothesis that combination of anticoagulation plus different antiplatelets could be differently effective and/or safe in patients from that trial and new ones followed-up for at least one year. Methods: Five hundred and seventy-four AF patients were included. Anticoagulation alone therapy (INR 2.0 –3.0) was used as control group (g) 1 to compare with anticoagulation (1.9 –2.5) plus either trifusal 600 mg/d (g2), trifusal 300 mg/d (g3) or aspirin 100 mg/d (g4). Median follow-up was 50, 32, 50 and 37 months respectively. The primary outcome was a composite of ischemic/haemorrhagic stroke, systemic/coronary ischemic events and cardiovascular death. The incidence of severe bleeding was also collected. Anticoagulation was regularly controlled in dedicated units. Results: Long-term follow-up showed benefit of combined anticoagulant plus trifusal 600 mg/d vs anticoagulant alone (primary outcome 2.86% pt/years in g1 vs 1.36% in g2, P=0.014). Combined therapy using other antiplatelet strategies was less effective or safe due to higher incidence of ischemic events when using trifusal 300 mg/d (2.44% pt/years in g3 vs 0.61% in g2, P=0.031) as well as more severe bleeding events with aspirin 100 mg/d (6.60% pt/years in g4 vs 1.51% in g2, P=0.008). Groups g1, g3 and g4 had similar primary outcome (2.86% pt/years, 2.67% and 2.83% respectively). Mean INR and other anticoagulation parameters were similar in the three combined therapy groups. Non-gastric severe bleeding incidence during combined therapy with trifusal 600 mg/d (0.3% pt/years) was lower than that observed in either anticoagulant alone therapy (2.1%, P=0.012) or combined with aspirin (6.60%, P=0.008). In conclusion, long-term follow-up of the NASPEAF trial confirmed the benefit of combined antithrombotic therapy over anticoagulant alone therapy. Combined therapy with aspirin 100 mg/d instead of trifusal 600 mg/d caused higher incidence of severe bleeding.
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