Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27710, USA
Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27710, USA.
Eur Heart J. 2014 Jul 21;35(28):1873-80. doi: 10.1093/eurheartj/ehu083. Epub 2014 Mar 21.
There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors.
Using data from ROCKET AF, we analysed the management and outcomes of major bleeding overall and according to the randomized treatment. During a median follow-up of 1.9 years, 779 (5.5%) patients experienced major bleeding at a rate of 3.52 events/100 patient-years with a similar event rate in each arm (n = 395 rivaroxaban vs. n = 384 warfarin). The median number of transfused packed red blood cells (PRBC) per episode was similar in both arms [2 (25th, 75th: 2, 4) units]. Overall, few transfusions of whole blood (n = 14), platelets (n = 10), or cryoprecipitate (n = 2) were used. Transfusion of fresh frozen plasma (FFP) was significantly less in the rivaroxaban arm (n = 45 vs. n = 81 units) after adjustment for covariates [odds ratio (OR) 0.43 (95% CI 0.29-0.66); P < 0.0001]. Prothrombin complex concentrates (PCC) were administered less in the rivaroxaban arm (n = 4 vs. n = 9). Outcomes after major bleeding, including stroke or non-central nervous system embolism (4.7% rivaroxaban vs. 5.4% warfarin; HR 0.89; 95% CI 0.42-1.88) and all-cause death (20.4% rivaroxaban vs. 26.1% warfarin; HR 0.69, 95% CI 0.46-1.04) were similar in patients treated with rivaroxaban and warfarin (interaction P = 0.51 and 0.11).
Among high-risk patients with atrial fibrillation who experienced major bleeding in ROCKET AF, the use of FFP and PCC was less among those allocated rivaroxaban compared with warfarin. However, use of PRBCs and outcomes after bleeding were similar among patients randomized to rivaroxaban or to warfarin.
目前尚无关于口服 Xa 因子抑制剂治疗患者发生大出血事件的管理和结局的数据。
利用 ROCKET AF 研究的数据，我们分析了大出血的总体管理和结局，以及按随机治疗进行的分析。在中位随访 1.9 年期间，779 例（5.5%）患者发生大出血，发生率为每 100 患者-年 3.52 例事件，每个治疗组的事件发生率相似（n = 395 例利伐沙班 vs. n = 384 例华法林）。每例大出血事件输注的浓缩红细胞（PRBC）中位数相似[2（25 分位，75 分位：2，4）单位]。总体而言，很少输注全血（n = 14）、血小板（n = 10）或冷沉淀（n = 2）。校正协变量后，利伐沙班组输注新鲜冰冻血浆（FFP）的数量明显减少（n = 45 比 n = 81 单位）[比值比（OR）0.43（95%CI 0.29-0.66）；P < 0.0001]。利伐沙班组给予凝血酶原复合物浓缩物（PCC）的数量也较少（n = 4 比 n = 9）。大出血后的结局，包括卒中或非中枢神经系统栓塞（利伐沙班组 4.7%比华法林组 5.4%；HR 0.89；95%CI 0.42-1.88）和全因死亡（利伐沙班组 20.4%比华法林组 26.1%；HR 0.69，95%CI 0.46-1.04）在接受利伐沙班和华法林治疗的患者中相似（交互 P = 0.51 和 0.11）。
在 ROCKET AF 中发生大出血的高危心房颤动患者中，与华法林相比，接受利伐沙班治疗的患者FFP 和 PCC 的使用率较低。然而，接受利伐沙班或华法林治疗的患者在大出血后的 PRBC 应用和结局相似。
