Fondaparinux reduced the composite of death, pulmonary embolism, deep-vein thrombosis, or superficial-vein thrombosis extension/recurrence compared to placebo (0.9% vs 5.9%; P<0.001).
RCT (n=3,002)
double-blind
randomized
Does fondaparinux reduce the composite of death, pulmonary embolism, deep-vein thrombosis, extension, or recurrence in patients with acute symptomatic superficial-vein thrombosis?
Fondaparinux 2.5 mg daily for 45 days significantly reduced the risk of symptomatic VTE complications in patients with acute superficial-vein thrombosis without increasing major bleeding.
Effect estimate: Relative risk reduction 85% (95% CI 74 to 92)
Absolute Event Rate: 0.9% vs 5.9%
p-value: p=<0.001
BACKGROUND: The efficacy and safety of anticoagulant treatment for patients with acute, symptomatic superficial-vein thrombosis in the legs, but without concomitant deep-vein thrombosis or symptomatic pulmonary embolism at presentation, have not been established. METHODS: In a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily, or placebo for 45 days. The primary efficacy outcome was a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day 47. The main safety outcome was major bleeding. The patients were followed until day 77. RESULTS: The primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinux group and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux, 85%; 95% confidence interval CI, 74 to 92; P<0.001). The incidence of each component of the primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the placebo group, except for the outcome of death (0.1% in both groups). The rate of pulmonary embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the placebo group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77. A total of 88 patients would need to be treated to prevent one instance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurred in one patient in each group. The incidence of serious adverse events was 0.7% with fondaparinux and 1.1% with placebo. CONCLUSIONS: Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00443053.)
أجرى ديكوس وآخرون (الأربعاء) تجربة عشوائية محكمة في thrombosis السطحية الوريدية الحادة والأعراض في الساقين (عدد=3,002). تم تقييم فوندابارينوكس مقابل الدواء الوهمي على مجموعة من الوفاة من أي سبب أو انسداد رئوي عرضي، أو thrombosis الوريد العميق العرضي، أو تمدد العرضي إلى نقطة تقاطع السافين والفخذي أو تكرار العرضي لـ thrombosis السطحية الوريدية في اليوم 47 (تقليل المخاطر النسبية 85%، فاصل الثقة 95% 74 إلى 92، p=<0.001). قلل فوندابارينوكس من مجموعة الوفاة، والانسداد الرئوي، وthrombosis الوريد العميق، أو تمدد/تكرار thrombosis السطحية الوريدية مقارنة بالدواء الوهمي (0.9% مقابل 5.9%; P<0.001).