From the Division of Cardiology, Cardiovascular Hospital, Yonsei Health System, Seoul, South Korea (S.P., N.C.).
Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., C.T.R., E.M.A., E.B., R.P.G.).
Hypertension. 2019 Sep;74(3):597-605. doi: 10.1161/HYPERTENSIONAHA.119.13138. Epub 2019 Jul 29.
Hypertension is a risk factor for both stroke and bleeding in patients with atrial fibrillation. Data are sparse regarding the interaction between blood pressure and the efficacy and safety of direct oral anticoagulants. In the ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48), 19,679 patients with atrial fibrillation and hypertension were categorized according to average systolic blood pressure (SBP) and diastolic blood pressure (DBP). The primary efficacy and safety end points were the time to the first stroke or systemic embolic event and the time to the first International Society of Thrombosis and Hemostasis major bleeding event, respectively. Risk was calculated using Cox proportional hazards models based on average SBP and DBP and adjusting for 18 clinical characteristics. The efficacy and safety of a higher dose edoxaban regimen (60/30 mg) versus warfarin were evaluated with stratification by average SBP and DBP. Stroke/systemic embolic event occurred significantly more frequently in patients with elevated average SBP (hazard ratio, 2.01; 95% CI, 1.50-2.70 for SBP ≥150 mm Hg relative to 130-139 mm Hg) or DBP (hazard ratio, 2.36; 95% CI, 1.76-3.16 for DBP ≥90 mm Hg relative to 75-<85 mm Hg). The higher dose edoxaban regimen reduced stroke/systemic embolic event across the full range of SBP (P=0.55) and DBP (P=0.44) compared with warfarin. The higher dose edoxaban regimen reduced the risk of major bleeding events, including intracranial hemorrhage, without modification by average SBP (P=0.29). The relative safety of edoxaban was most pronounced in patients with elevated DBP (P=0.007). The efficacy and safety of edoxaban were consistent across the full range of SBP, while the superior safety of edoxaban was most pronounced among patients with elevated DBP.
高血压是心房颤动患者中风和出血的危险因素。关于血压与直接口服抗凝剂的疗效和安全性之间的相互作用的数据很少。在 ENGAGE AF-TIMI 48 试验（房颤血栓溶栓心肌梗死 48 次有效抗凝因子 Xa 新一代）中，根据平均收缩压（SBP）和舒张压（DBP）将 19679 例心房颤动合并高血压患者进行分类。主要疗效和安全性终点分别为首次中风或全身性栓塞事件的时间以及首次国际血栓和止血协会大出血事件的时间。风险是根据平均 SBP 和 DBP 使用 Cox 比例风险模型计算的，并根据 18 个临床特征进行了调整。评估了较高剂量依度沙班方案（60/30mg）与华法林的疗效和安全性，并按平均 SBP 和 DBP 进行分层。在 SBP 升高（危险比，2.01；95%CI，150-139mm Hg 与 130-139mm Hg 相比，2.70）或 DBP 升高（危险比，2.36；95%CI，176-3.16）的患者中，中风/全身性栓塞事件的发生率明显更高。与华法林相比，较高剂量依度沙班方案降低了 SBP（P=0.55）和 DBP（P=0.44）全范围内的中风/全身性栓塞事件。较高剂量依度沙班方案降低了大出血事件（包括颅内出血）的风险，而不改变平均 SBP（P=0.29）。依度沙班的相对安全性在 DBP 升高的患者中最为明显（P=0.007）。依度沙班的疗效和安全性在 SBP 全范围内一致，而依度沙班的安全性优势在 DBP 升高的患者中最为明显。
Zotero 插件