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New England Journal of Medicine· 2017Q1

Venöz Tromboembolizmde Uzatılmış Tedavi İçin Rivaroksaban veya Aspirin

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism

Jeffrey I. Weitz, Anthonie W.A. Lensing, Martin H. Prins, Rupert Bauersachs ve diğerleri

Kısa özet

Venöz tromboembolizm (VTE) için uzatılmış tedaviye ihtiyaç duyan hastalarda, günde 100 mg aspirine kıyasla günde 20 mg veya 10 mg rivaroksaban, benzer majör kanama oranlarıyla tekrarlayan VTE'yi %66-74 oranında anlamlı şekilde azaltmıştır.

Yapay zekâ ile başlık ve abstract'tan üretildi; tam metin okunmaz.

Ana noktalar

  • Uzatılmış tedavi gerektiren VTE hastalarında, günde 20 mg veya 10 mg rivaroksaban, günde 100 mg aspirine kıyasla semptomatik tekrarlayan VTE'yi %66-74 oranında azaltmıştır.
  • Primer etkinlik sonucu %1.5 (20 mg rivaroksaban), %1.2 (10 mg rivaroksaban) ve %4.4 (aspirin) hastada görülmüştür.
  • Majör kanama oranları düşüktür ve gruplar arasında benzerdir: %0.5 (20 mg rivaroksaban), %0.4 (10 mg rivaroksaban) ve %0.3 (aspirin).
  • Tüm üç tedavi kolunda advers olay insidansı benzerdi.

Yapay zekâ ile başlık ve abstract'tan üretildi; tam metin okunmaz.

Özet (abstract)

BACKGROUND: Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin. METHODS: In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. RESULTS: A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups. CONCLUSIONS: Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439 .).

Yazarların özeti; kaynağından alınmıştır. New England Journal of Medicine, 2017 · DOI ↗

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