Duke Clinical Research Institute, Duke University Medical Center, Box 3126, Durham, NC, USA.
Eur Heart J. 2014 Jan;35(4):242-9. doi: 10.1093/eurheartj/eht492. Epub 2013 Dec 2.
Vascular disease is included in a risk scoring system to predict stroke in patients with non-valvular atrial fibrillation (AF). This post hoc analysis of ROCKET AF aimed to determine the absolute rates of stroke and bleeding, and the relative effectiveness and safety of rivaroxaban vs. warfarin in patients with and without peripheral artery disease (PAD). Peripheral artery disease was defined on the case-report form as the presences of intermittent claudication, amputation for arterial insufficiency, vascular reconstruction, bypass surgery, or percutaneous intervention to the extremities, or previously documented abdominal aortic aneurysm.
ROCKET AF was a double-blind, double-dummy, randomized-controlled trial comparing rivaroxaban and warfarin for the prevention of stroke or systemic embolism. A total of 839 (5.9%) patients in ROCKET AF had PAD. Patients with and without PAD had similar rates of stroke or systemic embolism [HR: 1.04, 95% CI (0.72, 1.50), P = 0.84] and major or non-major clinically relevant (NMCR) bleeding [HR: 1.11, 95% CI (0.96, 1.28), P = 0.17], respectively. The efficacy of rivaroxaban when compared with warfarin for the prevention of stroke or systemic embolism was similar in patients with PAD (HR: 1.19, 95% CI: 0.63-2.22) and without PAD (HR: 0.86, 95% CI: 0.73-1.02; interaction P = 0.34). There was a significant interaction for major or NMCR bleeding in patients with PAD treated with rivaroxaban compared with warfarin (HR: 1.40, 95% CI: 1.06-1.86) compared with those without PAD (HR: 1.03, 95% CI: 0.95-1.11; interaction P = 0.037).
Patients with PAD in ROCKET AF did not have a statistically significant higher risk of stroke or systemic embolism than patients without PAD, and there were similar efficacy outcomes in patients treated with rivaroxaban and warfarin. In PAD patients, there was a higher risk of major bleeding or NMCR bleeding with rivaroxaban when compared with warfarin (interaction P = 0.037). Further investigation is warranted to validate this subgroup analysis and determine the optimal treatment in this high-risk cohort of AF patients with PAD.
血管疾病被纳入一种风险评分系统，以预测非瓣膜性心房颤动（AF）患者的中风。这项 ROCKET AF 的事后分析旨在确定中风和出血的绝对发生率，以及利伐沙班与华法林在伴有和不伴有外周动脉疾病（PAD）的患者中的相对有效性和安全性。PAD 在病例报告表中定义为间歇性跛行、动脉功能不全截肢、血管重建、旁路手术或四肢经皮介入治疗，或先前记录的腹主动脉瘤。
ROCKET AF 是一项双盲、双模拟、随机对照试验，比较利伐沙班和华法林预防中风或全身性栓塞。ROCKET AF 共有 839 例（5.9%）患者患有 PAD。有和没有 PAD 的患者中风或全身性栓塞的发生率相似[HR：1.04，95%CI（0.72，1.50），P=0.84]，主要或非主要临床相关（NMCR）出血[HR：1.11，95%CI（0.96，1.28），P=0.17]。与华法林相比，利伐沙班预防 PAD 患者中风或全身性栓塞的疗效相似[HR：1.19，95%CI：0.63-2.22]和无 PAD 患者[HR：0.86，95%CI：0.73-1.02；交互 P=0.34]。与无 PAD 患者相比，接受利伐沙班治疗的 PAD 患者的主要或 NMCR 出血有显著的交互作用[HR：1.40，95%CI：1.06-1.86]，而无 PAD 患者[HR：1.03，95%CI：0.95-1.11；交互 P=0.037]。
在 ROCKET AF 中，患有 PAD 的患者与不患有 PAD 的患者相比，中风或全身性栓塞的风险没有统计学上的显著增加，并且接受利伐沙班和华法林治疗的患者有相似的疗效结果。在 PAD 患者中，与华法林相比，利伐沙班治疗的患者大出血或 NMCR 出血风险更高（交互 P=0.037）。需要进一步的研究来验证这一分组分析，并确定 PAD 高危 AF 患者的最佳治疗方法。
