New England Journal of Medicine· 2014Q1· Klinik çalışma
Orta Riskli Pulmoner Emboli Hastalarında Fibrinoliz
Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism
- 1.652atıf
- Q1SCImago
- 2014yıl
Kısa özet
Orta riskli pulmoner emboli hastalarında tenekteplaz artı heparin, plaseboya kıyasla 7 güne kadar ölüm veya hemodinamik dekompansasyonu anlamlı şekilde azalttı (%2,6'ya karşılık %5,6), ancak majör kanama ve inme riskini artırdı.
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Ana noktalar
- Tenekteplaz artı heparin, orta riskli PE hastalarında 7 güne kadar ölüm veya dekompansasyonu %53 oranında azalttı (olasılık oranı 0,44).
- Birincil sonuç tenekteplaz grubunda %2,6, plasebo grubunda ise %5,6 oranında görüldü.
- Majör ekstraserebral kanama tenekteplaz grubunda %6,3, plasebo grubunda ise %1,2 oranında görüldü.
- İnme tenekteplaz grubunda %2,4, plasebo grubunda ise %0,2 oranında görüldü.
Yapay zekâ ile başlık ve abstract'tan üretildi; tam metin okunmaz.
Özet (abstract)
BACKGROUND: The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial. METHODS: In a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization. RESULTS: Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42). CONCLUSIONS: In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; ClinicalTrials.gov number, NCT00639743.).
Yazarların özeti; kaynağından alınmıştır. New England Journal of Medicine, 2014 · DOI ↗
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