Akut pulmoner embolinin uzatılmış tedavisinde direk oral antikoagülanlar (DOAK) ile diğer antikoagülanların mortali başta olmak üzere major komplikasyonlar açısından karşılaştırılması: gerçek yaşam verileri
Küçük Resim Yok
Tarih
2021
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Yayıncı
İnönü Üniversitesi
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
Amaç: Bu çalışmada, akut pulmoner tromboemboli (PTE) tanısı almış seçilmemiş hasta kitlesinde, direk etkili oral antikoagülan (DOAK) grubu ajanların standart tedavi olan VKA(vitamin K antagonisti)-DMAH(düşük molekül ağırlıklı heparin)'lara karşı uzun dönem tedavide, kanama, tromboembolik olaylar ve tüm nedenlere bağlı mortalite üzerindeki etkilerinin rutin klinik uygulamadaki gözlemsel verilerini yansıtmaktır. Gereç ve Yöntem: Çalışmamıza, acil servis başvurularında, başka bir nedenle servis takibi yapıldığı dönemde ve poliklinik başvurularında akut PTE tanısı kesinleşmiş toplam 298 hasta dâhil edilmiştir. Hastaların bir kısmı retrospektif, büyük çoğunluğu ise prospektif gözlemsel olarak değerlendirilmiştir. Tedavi kollarındaki hastalar, PESİ(pulmoner emboli şiddet indeksi) ve sPESİ skorları, kardiyak biyobelirteçler, transtorasik ekokardiyografi(TTE) ile sağ kalp fonksiyonları değerlendirilerek ESC(European Society of Cardiology) risk grupları belirlenip kanama risk ve ek hastalıklarına göre tedavi düzeni oluşturulmuştur. Başlangıç dönem antikoagülan tedavi tamamlanmasından sonra uzun dönem tedavileri takip eden hekim tarafından doz ve tedavi süresi belirlenerek DOAK grubu ajanlardan biri ya da VKA-DMAH'lar ile düzenlenmiştir. Hastalar en az üç ay antikoagülan alacak şekilde en az altı ay süresince hastalar aralıklı takipleri yapılmıştır. Temel değerlendirmede, tedavi süresince ve tedavi kesilmesinden sonraki dönemlerde tedavi kolları arasında tekrarlayan venöz tromboemboli(VTE), kanama ve tüm nedenlere bağlı mortalite oranları arasındaki farklar ortaya koyulmuştur. Veri analizi İBM SPSS 25.0 Windows versiyonu kullanılarak yapıldı. Bulgular: Çalışmada, akut PTE tanısı almış 179'u DOAK kullanan ve 119'u VKA-DMAH kullanan iki grup şeklinde sınıflandırılmak üzere toplam 298 hasta dâhil edilmiştir. DOAK grubundaki hasta yaş ortalaması 60,1 ± 17,1 olup hastaların 102(%57)'sini kadınlar oluştumaktaydı. VKA-DMAH grubunda ise hasta yaş ortalaması 59,0 ± 17,6 olup, hastaların 69(%58)'unu kadın oluşturmaktaydı. PTE tanısı alan DOAK ve VKA-DMAH hasta kollarının her ikisinde de sırasıyla 168 (%93,9) ve 108 (%90,8) hastaya tanı BTPA(Bilgisayarlı tomografi pulmoner anjiografi) ile konulmuştur. DOAK hasta kolunda 72(%40,2)'sinde ve VKA-DMAH hasta kolunda 48(%40,3)'inde akut DVT(derin ven trombozu) tespit edilmiştir. Her iki tedavi kolunda DVT bulgularında istatistiksel fark izlenmedi (p>0,05). Her iki gruptaki hastaların ESC risk sınıflaması açısından değerlendirildiğinde; DOAK grubunda 179 hastanın, 86'sı (%48,1) düşük risk, 33(%18,4)'ü orta-düşük, 45(%25,1)'i orta-yüksek ve 15(%8,4)'i yüksek risk grubunda yer almıştır. VKA/DMAH hasta grubunda 119 hastanın, 48(%40,3)'i düşük risk, 34(%28,6)'ü orta-düşük, 29(%24,4)'u orta-yüksek ve 8(%6,7)'i yüksek risk grubunda yer almıştır. Hasta risk sınıflamasında iki grup açısından istatistiksel olarak anlamlı fark izlenmemiştir( p >0.05 ). Tedavi altında nüks trombüs hiçbir hastada izlenmedi. Tedavi kesildikten sonraki ilk 6-12 aylık dönemde; DOAK tedavi kolunda 21(%11,7) hastada nüks PTE ve 12(%6,7) hastada nüks DVT, VKA-DMAH tedavi kolunda 7(%5,9) hastada nüks PTE ve 8(%6,7) hastada nüks DVT izlenmiştir(p >0,05). Hastane yatış süreleri tedavi kolları arasında sırasıyla ortalama 9,3 gün ve 12,8 gün'dür. DOAK ile antikoagülasyonun hastane yatış sürelerini ortalama 3,5 gün kısalttığı izlenmiştir(p=0,002). DOAK tedavi kolunda uzun dönem majör kanama 3 (%1,67) hastada, VKA-DMAH kolunda 2 (%1,68) hastada (p>0.05), minör kanama DOAK tedavi kolunda 32(%17,9), VKA-DMAH tedavi kolunda 5(%4,2) hastada izlenmiştir(p=0,002). DOAK tedavi kolunda hastane içi genel mortalite 2(%1,1) hastada, VKA-DMAH tedavi kolunda 25(%21) hastada, bir aylık mortalite DOAK tedavi kolunda 4(%2,2) hastada, VKA-DMAH tedavi kolunda 26 (%21,8) hastada, DOAK tedavi kolunda altı aylık genel mortalite 8(%4,5) hastada, VKA-DMAH tedavi kolunda 32(%26,9) hastada izlendi(p<0,001). DOAK tedavi kolunda minör kanama oranları yüksek izlenmiş ancak altı aylık mortalite oranları belirgin düşük bulunmuştur. Sonuç: DOAK grubu antikoagülan ajanların, majör kanama, nüks ve tüm nedenlere bağlı ölüm riskini azaltması açısından en az standart tedavi kadar güvenli olduğu görülmüş, yapılan faz III klinik çalışmalar ve gerçek yaşam verileriyle tutarlı bulunmuştur. Ancak minör kanama oranları istatiksel olarak anlamlı yüksek izlenmiştir. Bu konuda, çok daha fazla hasta sayısını içeren geniş kapsamlı gerçek yaşam verilerini içerecek prospektif çalışmaların yapılması gerekmektedir.
Aim: The purpose of the present study was to reflect the observational data in routine clinical practice in an unselected patient group diagnosed with acute pulmonary thromboembolism (PTE), for direct-acting oral anticoagulant (DOAC) group agents in long-term treatment versus VKA (vitamin K antagonist)-LMWH (low molecular weight heparin), which is the standard treatment, to reflect observational data in routine clinical practice regarding the effects on bleeding, thromboembolic events, and all-cause mortality. Materials and Methods: A total of 298 patients, whose diagnosis of acute PTE was confirmed, at the time of admission to the Emergency Department, during the follow-up period for another reason, and at the time of admission to an outpatient clinic, were included in our study. Some of the patients were evaluated retrospectively, and the majority of them were evaluated prospectively. The ESC (European Society of Cardiology) risk groups were identified by evaluating the patients in the treatment branches, as PESI (Pulmonary Embolism Severity Index) and sPESI scores, cardiac biomarkers, right heart functions evaluated with transthoracic echocardiography (TTE), and a treatment order was established according to the bleeding risk and additional diseases. Once the initial period of anticoagulant treatment was completed, the dose and duration of treatment were determined by the doctor who was following the long-term treatments, and one of the DOAC group agents or VKA-DMAHs was arranged. The patients were followed-up intermittently for at least six months, and they took anticoagulants for at least three months. It was determined in the baseline evaluation that there were differences in the rates of recurrent venous thromboembolism (VTE), bleeding, and all-cause mortality between the treatment branches during the treatment and after the discontinuation of the treatment. The data analysis was made by using IBM SPSS 25.0 Windows version. Results: A total of 298 patients with acute PTE were included in the study as 179 using DOAC and 119 using VKA-DMAH. The mean age of the patients was 60.1 ± 17.1 in the DOAC group, and 102 (57%) of the patients were women. The mean age of the patients was 59.0 ± 17.6 in the VKA-DMAH group, and 69 (58%) of the patients were women. A total of 168 (93.9%) and 108 (90.8%) patients in the DOAC and VKA-DMAH patient groups that were diagnosed with PTE were diagnosed with CTPA (Computed Tomography Pulmonary Angiography), respectively. Acute DVT (Deep Vein Thrombosis) was detected in 72 (40.2%) of the patients in the DOAC branch, and 48 (40.3%) in the VKA-DMAH branch. No statistical differences were detected in DVT findings in the treatment branches (p>0.05). When the patients of the groups were evaluated in terms of ESC risk classification; it was found that, among the 179 patients in the DOAC group, 86 (48.1%) had low risk, 33 (18.4%) moderate-low risk, 45 (25.1%) risk moderate-high, and 15 (8.4%) had high risk. It was found that, among the 119 patients in the VKA/LMWH patient group, 48 (40.3%) had low risk, 34 (28.6%) had moderate-low risk, 29 (24.4%) had moderate-high risk, and 8 (6.7%) had high risk. No statistically significant differences were detected between the two groups in patient risk classification (p >0.05). Relapsing thrombus was not detected in any of the patients under treatment. In the first 6-12 months after the treatment was discontinued, relapsing PTE was detected in 21 (11.7%) patients, relapsing DVT was detected in 12 (6.7%) patients in the DOAC treatment branch, relapsing PTE was detected in 7 (5.9%) patients in the VKA-DMAH treatment branch, and relapsing DVT was detected in 8 (6.7%) patients (p >0.05). The mean length of hospital stay between the treatment branches was found to be 9.3 days and 12.8 days, respectively. It was found that anticoagulation with DOAC shortened the hospitalization times to an average of 3.5 days (p=0.002). In the DOAC treatment branch, long-term major bleeding was detected in 3 (1.67%) patients, and in 2 (1.68%) patients in the VKA-DMAH branch (p>0.05); in the DOAC treatment branch, minor bleeding was detected in 32 (17.9%) patients, and in 5 (4.2%) patients in the VKA-DMAH treatment branch (p=0.002). In the DOAC treatment branch, in-hospital overall mortality was detected in 2 (1.1%) patients, in 25 (21%) patients in the VKA-DMAH treatment branch; one-month mortality was detected in 4 (2.2%) patients in the DOAC treatment branch, and in 26 patients in the VKA-DMAH treatment branch (21.8%). Six-month overall mortality was detected in 8 (4.5%) patients in the DOAC treatment branch and in 32 (26.9%) patients (p<0.001) in the VKA-DMAH treatment branch. Minor bleeding rates were high in the DOAC treatment branch; however, the six-month mortality rates were significantly lower. Conclusion: It was found that DOAC group anticoagulant agents were at least as safe as the standard treatment in terms of reducing the risk of major bleeding, relapse, and all-cause mortality, and were consistent with Phase III clinical studies and real-life data. However, minor bleeding rates were found to be higher at statistically significant levels. Prospective studies which will include large-scale real-life data with a much larger number of patients are required in this respect.
Aim: The purpose of the present study was to reflect the observational data in routine clinical practice in an unselected patient group diagnosed with acute pulmonary thromboembolism (PTE), for direct-acting oral anticoagulant (DOAC) group agents in long-term treatment versus VKA (vitamin K antagonist)-LMWH (low molecular weight heparin), which is the standard treatment, to reflect observational data in routine clinical practice regarding the effects on bleeding, thromboembolic events, and all-cause mortality. Materials and Methods: A total of 298 patients, whose diagnosis of acute PTE was confirmed, at the time of admission to the Emergency Department, during the follow-up period for another reason, and at the time of admission to an outpatient clinic, were included in our study. Some of the patients were evaluated retrospectively, and the majority of them were evaluated prospectively. The ESC (European Society of Cardiology) risk groups were identified by evaluating the patients in the treatment branches, as PESI (Pulmonary Embolism Severity Index) and sPESI scores, cardiac biomarkers, right heart functions evaluated with transthoracic echocardiography (TTE), and a treatment order was established according to the bleeding risk and additional diseases. Once the initial period of anticoagulant treatment was completed, the dose and duration of treatment were determined by the doctor who was following the long-term treatments, and one of the DOAC group agents or VKA-DMAHs was arranged. The patients were followed-up intermittently for at least six months, and they took anticoagulants for at least three months. It was determined in the baseline evaluation that there were differences in the rates of recurrent venous thromboembolism (VTE), bleeding, and all-cause mortality between the treatment branches during the treatment and after the discontinuation of the treatment. The data analysis was made by using IBM SPSS 25.0 Windows version. Results: A total of 298 patients with acute PTE were included in the study as 179 using DOAC and 119 using VKA-DMAH. The mean age of the patients was 60.1 ± 17.1 in the DOAC group, and 102 (57%) of the patients were women. The mean age of the patients was 59.0 ± 17.6 in the VKA-DMAH group, and 69 (58%) of the patients were women. A total of 168 (93.9%) and 108 (90.8%) patients in the DOAC and VKA-DMAH patient groups that were diagnosed with PTE were diagnosed with CTPA (Computed Tomography Pulmonary Angiography), respectively. Acute DVT (Deep Vein Thrombosis) was detected in 72 (40.2%) of the patients in the DOAC branch, and 48 (40.3%) in the VKA-DMAH branch. No statistical differences were detected in DVT findings in the treatment branches (p>0.05). When the patients of the groups were evaluated in terms of ESC risk classification; it was found that, among the 179 patients in the DOAC group, 86 (48.1%) had low risk, 33 (18.4%) moderate-low risk, 45 (25.1%) risk moderate-high, and 15 (8.4%) had high risk. It was found that, among the 119 patients in the VKA/LMWH patient group, 48 (40.3%) had low risk, 34 (28.6%) had moderate-low risk, 29 (24.4%) had moderate-high risk, and 8 (6.7%) had high risk. No statistically significant differences were detected between the two groups in patient risk classification (p >0.05). Relapsing thrombus was not detected in any of the patients under treatment. In the first 6-12 months after the treatment was discontinued, relapsing PTE was detected in 21 (11.7%) patients, relapsing DVT was detected in 12 (6.7%) patients in the DOAC treatment branch, relapsing PTE was detected in 7 (5.9%) patients in the VKA-DMAH treatment branch, and relapsing DVT was detected in 8 (6.7%) patients (p >0.05). The mean length of hospital stay between the treatment branches was found to be 9.3 days and 12.8 days, respectively. It was found that anticoagulation with DOAC shortened the hospitalization times to an average of 3.5 days (p=0.002). In the DOAC treatment branch, long-term major bleeding was detected in 3 (1.67%) patients, and in 2 (1.68%) patients in the VKA-DMAH branch (p>0.05); in the DOAC treatment branch, minor bleeding was detected in 32 (17.9%) patients, and in 5 (4.2%) patients in the VKA-DMAH treatment branch (p=0.002). In the DOAC treatment branch, in-hospital overall mortality was detected in 2 (1.1%) patients, in 25 (21%) patients in the VKA-DMAH treatment branch; one-month mortality was detected in 4 (2.2%) patients in the DOAC treatment branch, and in 26 patients in the VKA-DMAH treatment branch (21.8%). Six-month overall mortality was detected in 8 (4.5%) patients in the DOAC treatment branch and in 32 (26.9%) patients (p<0.001) in the VKA-DMAH treatment branch. Minor bleeding rates were high in the DOAC treatment branch; however, the six-month mortality rates were significantly lower. Conclusion: It was found that DOAC group anticoagulant agents were at least as safe as the standard treatment in terms of reducing the risk of major bleeding, relapse, and all-cause mortality, and were consistent with Phase III clinical studies and real-life data. However, minor bleeding rates were found to be higher at statistically significant levels. Prospective studies which will include large-scale real-life data with a much larger number of patients are required in this respect.
Açıklama
Anahtar Kelimeler
Göğüs Hastalıkları, Chest Diseases
