Frappé Paul, Cogneau Joël, Gaboreau Yoann, Abenhaïm Nathan, Bayen Marc, Calafiore Matthieu, Guichard Claude, Jacquet Jean-Pierre, Lacoin François, Bertoletti Laurent
Department of General Practice, University of Saint-Etienne, Saint-Etienne, France.
Inserm U 1059, Sainbiose DVH, University of Saint-Etienne, Saint-Etienne, France.
PLoS One. 2017 Apr 6;12(4):e0175167. doi: 10.1371/journal.pone.0175167. eCollection 2017.
Real-world studies on anticoagulants are mostly performed on health insurance databases, limited to reported events, and sometimes far from every-day issues in family practice. We assess the presence of data for safe monitoring of oral anticoagulants in general practice, and compare patients' knowledge of taking an anticoagulant between vitamin K antagonists (VKA) and direct anticoagulants (DOAC), and the general practitioner's perception of their adherence to anticoagulation.
The CACAO study is a national cohort study, conducted by general practitioners on ambulatory patients under oral anticoagulant. In the first phase, investigators provided safety data available from medical records at inclusion. They also evaluated patients' knowledge about anticoagulation and graded their perception of patients' adherence.
Between April and December 2014, 463 general practitioners included 7154 patients. Renal and hepatic function tests were respectively unavailable in 109 (7.5%) and 359 (24.7%) DOAC patients. Among patients with atrial fibrillation, 345 patients (6.9%) had a questionable indication of anticoagulant (CHA2DS2-Vasc<2). One hundred and thirty-three VKA patients (2.3%) and 70 DOAC patients (4.9%) answered they took no anticoagulant (p<0.0001). According to general practitioners' perception, 430 patients (6.1%) were classified as "not very" or "not adherent", with no difference between groups.
Our results highlight the efforts needed to improve anticoagulant safety in daily practice: decreasing the rate of unknown biological data in patients with DOACs or the rate of patients with VKA with no strong indication of anticoagulation, and improving patient knowledge with regard to their anticoagulant. Patients' adherence seems highly over-estimated by the general practitioners.
ClinicalTrials.gov NCT02376777.
关于抗凝剂的真实世界研究大多在医疗保险数据库中进行,局限于报告的事件,有时与家庭医疗中的日常问题相差甚远。我们评估了全科医疗中口服抗凝剂安全监测数据的存在情况,并比较了患者对维生素K拮抗剂(VKA)和直接抗凝剂(DOAC)服用抗凝剂的知晓情况,以及全科医生对患者抗凝依从性的看法。
CACAO研究是一项全国性队列研究,由全科医生对口服抗凝剂的门诊患者进行。在第一阶段,研究人员提供了纳入时病历中的安全数据。他们还评估了患者对抗凝的知晓情况,并对患者的依从性看法进行评分。
2014年4月至12月期间,463名全科医生纳入了7154名患者。109名(7.5%)DOAC患者未进行肾功能检查,359名(24.7%)未进行肝功能检查。在房颤患者中,345名患者(6.9%)的抗凝指征存疑(CHA2DS2-Vasc评分<2)。133名VKA患者(2.3%)和70名DOAC患者(4.9%)回答他们未服用抗凝剂(p<0.0001)。根据全科医生的看法,430名患者(6.1%)被归类为“不太”或“不依从”,两组之间无差异。
我们的结果凸显了在日常实践中提高抗凝剂安全性所需的努力:降低DOAC患者未知生物学数据的比例或VKA患者无强烈抗凝指征的比例,并提高患者对抗凝剂的知晓情况。全科医生似乎高估了患者的依从性。
ClinicalTrials.gov NCT02376777