Intermountain Healthcare Department of Population Health Sciences, Spencer Fox Eccles University of Utah School of Medicine, Salt Lake City.
Institute for Health Research, Kaiser Permanente Colorado, Denver.
JAMA Netw Open. 2023 Jul 3;6(7):e2321971. doi: 10.1001/jamanetworkopen.2023.21971.
Anticoagulation management services (AMSs; ie, warfarin clinics) have evolved to include patients treated with direct oral anticoagulants (DOACs), but it is unknown whether DOAC therapy management services improve outcomes for patients with atrial fibrillation (AF).
To compare outcomes associated with 3 DOAC care models for preventing adverse anticoagulation-related outcomes among patients with AF.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included 44 746 adult patients with a diagnosis of AF who initiated oral anticoagulation (DOAC or warfarin) between August 1, 2016, and December 31, 2019, in 3 Kaiser Permanente (KP) regions. Statistical analysis was conducted from August 2021 through May 2023.
Each KP region used an AMS to manage warfarin but used distinct approaches to DOAC care: (1) usual care (UC) by the prescribing clinician, (2) UC plus an automated population management tool (PMT), or (3) pharmacist-managed AMS care. Propensity scores and inverse probability of treatment weights (IPTWs) were estimated. Direct oral anticoagulant care models were first indirectly compared using warfarin as a common comparator within each region and then directly compared across regions.
Patients were followed up until the first occurrence of an outcome (composite of thromboembolic stroke, intracranial hemorrhage, other major bleeding, or death), discontinuation of KP membership, or December 31, 2020.
Overall, 44 746 patients were included: 6182 in the UC care model (3297 DOAC; 2885 warfarin), 33 625 in the UC plus PMT care model (21 891 DOAC; 11 734 warfarin), and 4939 in the AMS care model (2089 DOAC; 2850 warfarin). Baseline characteristics (mean [SD] age, 73.1 [10.6] years, 56.1% male, 67.2% non-Hispanic White, median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65-74 years, female sex] score of 3 [IQR, 2-5]) were well balanced after IPTW. Over a median follow-up of 2 years, patients who received the UC plus PMT or AMS care model did not have significantly better outcomes than those who received UC. The incidence rate of the composite outcome was 5.4% per year for DOAC and 9.1% per year for warfarin for those in the UC group, 6.1% per year for DOAC and 10.5% per year for those in the UC plus PMT group, and 5.1% per year for DOAC and 8.0% per year for those in the AMS group. The IPTW-adjusted hazard ratios (HRs) for the composite outcome comparing DOAC vs warfarin were 0.91 (95% CI, 0.79-1.05) in the UC group, 0.85 (95% CI, 0.79-0.90) in the UC plus PMT group, and 0.84 (95% CI, 0.72-0.99) in the AMS group (P = .62 for heterogeneity across care models). When directly comparing patients receiving DOAC, the IPTW-adjusted HR was 1.06 (95% CI, 0.85-1.34) for the UC plus PMT group vs the UC group and 0.85 (95% CI, 0.71-1.02) for the AMS group vs the UC group.
This cohort study did not find appreciably better outcomes for patients receiving DOAC who were managed by either a UC plus PMT or AMS care model compared with UC.
抗凝管理服务（AMS；即华法林诊所）已经发展到包括接受直接口服抗凝剂（DOAC）治疗的患者，但尚不清楚房颤（AF）患者的 DOAC 治疗管理服务是否能改善预后。
比较 3 种 DOAC 护理模式在预防 AF 患者抗凝相关不良结局方面的效果。
设计、设置和参与者：这是一项回顾性队列研究，纳入了 2016 年 8 月 1 日至 2019 年 12 月 31 日期间在 3 个 Kaiser Permanente（KP）地区接受口服抗凝剂（DOAC 或华法林）治疗的 44746 名成年 AF 患者。统计分析于 2021 年 8 月至 2023 年 5 月进行。
每个 KP 地区都使用 AMS 管理华法林，但对 DOAC 护理采用不同的方法：（1）由开处方的临床医生提供的常规护理（UC），（2）UC 加自动化人群管理工具（PMT），或（3）药剂师管理的 AMS 护理。使用倾向评分和逆概率治疗权重（IPTW）进行估计。首先在每个地区内间接比较 DOAC 护理模式，将华法林作为共同对照，然后在地区间直接比较。
患者随访至首次出现以下结局之一（血栓栓塞性卒中、颅内出血、其他主要出血或死亡）、终止 KP 会员资格或 2020 年 12 月 31 日。
共有 44746 名患者入组：UC 护理模式组 6182 名（3297 名 DOAC；2885 名华法林），UC 加 PMT 护理模式组 33625 名（21891 名 DOAC；11734 名华法林），AMS 护理模式组 4939 名（2089 名 DOAC；2850 名华法林）。经过 IPTW 后，基线特征（平均[标准差]年龄 73.1[10.6]岁，56.1%男性，67.2%非西班牙裔白人，中位 CHA2DS2-VASc[充血性心力衰竭、高血压、年龄≥75 岁、糖尿病、卒中、血管疾病、年龄 65-74 岁、女性]评分 3[四分位距，2-5]）均衡良好。在中位随访 2 年后，接受 UC 加 PMT 或 AMS 护理模式的患者与接受 UC 的患者相比，结局没有显著改善。DOAC 组和华法林组的复合结局发生率分别为每年 5.4%和 9.1%，UC 加 PMT 组和华法林组分别为每年 6.1%和 10.5%，AMS 组和华法林组分别为每年 5.1%和 8.0%。UC 组 DOAC 与华法林相比的复合结局调整后的危害比（HR）为 0.91（95%置信区间，0.79-1.05），UC 加 PMT 组为 0.85（95%置信区间，0.79-0.90），AMS 组为 0.84（95%置信区间，0.72-0.99）（P=0.62 用于护理模式间的异质性）。当直接比较接受 DOAC 的患者时，UC 加 PMT 组与 UC 组相比，IPTW 调整后的 HR 为 1.06（95%置信区间，0.85-1.34），AMS 组与 UC 组相比，HR 为 0.85（95%置信区间，0.71-1.02）。
这项队列研究没有发现接受 DOAC 治疗且接受 UC 加 PMT 或 AMS 护理模式管理的患者的预后明显优于 UC。
