Goto Shinya, Turpie Alexander G G, Farjat Alfredo E, Weitz Jeffrey I, Haas Sylvia, Ageno Walter, Goldhaber Samuel Z, Angchaisuksiri Pantep, Kayani Gloria, MacCallum Peter, Schellong Sebastian, Bounameaux Henri, Mantovani Lorenzo G, Prandoni Paolo, Kakkar Ajay K
Shinya Goto, Department of Medicine (Cardiology), Tokai University School of Medicine, Japan.
McMaster University, Hamilton, Canada.
Thromb Res. 2021 Jul;203:155-162. doi: 10.1016/j.thromres.2021.05.007. Epub 2021 May 15.
Clinical characteristics and outcomes of venous thromboembolism (VTE) patients with concomitant anemia are unclear. This study compares baseline characteristics, treatment patterns, and 24-month outcomes in patients with and without anemia within GARFIELD-VTE.
GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional registry of real-world treatment practices. Of the 10,679 patients enrolled in GARFIELD-VTE, 7698 were eligible for analysis. Primary outcomes were all-cause mortality, recurrent VTE, and major bleeding in VTE patients with or without concomitant anemia over 24-months after diagnosis. Event rates and 95% confidence intervals were estimated using Poisson regression. Adjusted hazard ratios were calculated using Cox proportional hazard models.
Distribution of VTE events in 2771 patients with anemia and 4927 without anemia was similar (deep-vein thrombosis alone: 61·1% vs. 55·9%, pulmonary embolism ± deep vein thrombosis: 38·9% vs. 44·0%, respectively). Patients with anemia were older (62.6 year vs. 58.9 years) than those without. At baseline, VTE risk factors that were more common in patients with anemia included hospitalization (22·0% vs. 6·8%), surgery (19·2% vs. 8·2%), cancer (20·1% vs. 5·6%) and acute medical illness (8·3% vs. 4·2%). Patients with anemia were more likely to receive parenteral anticoagulation therapy alone than those without anemia (26·6% vs. 11·7%) and less likely to receive a direct oral anticoagulant (38·5% vs. 53·5%). During 24-months of follow-up, patients with anemia had a higher risk (adjusted hazard ratio [95% confidence interval]) of all-cause mortality (1·84 [1·56-2·18]), major bleeding (2·83 [2·14-3·75]). Among anemia patients, the risk of all-cause mortality and major bleeding remained higher in patients with severe anemia than in those with mild/moderate anemia, all-cause mortality: HR 1·43 [95% CI: 1·21-1·77]; major bleeding: HR 2·08 [95% CI: 1·52-2·86]).
VTE patients with concomitant anemia have a higher risk of adverse clinical outcomes compared with those without anemia. Further optimization of anticoagulation therapy for VTE patients with anemia is warranted.
伴有贫血的静脉血栓栓塞症(VTE)患者的临床特征和预后尚不清楚。本研究比较了加菲尔德-VTE研究中伴有和不伴有贫血患者的基线特征、治疗模式及24个月的预后情况。
加菲尔德-VTE研究(ClinicalTrials.gov:NCT02155491)是一项关于真实世界治疗实践的全球前瞻性非干预性注册研究。在加菲尔德-VTE研究纳入的10679例患者中,7698例符合分析条件。主要结局是诊断后24个月内伴有或不伴有贫血的VTE患者的全因死亡率、复发性VTE和大出血。使用泊松回归估计事件发生率和95%置信区间。使用Cox比例风险模型计算调整后的风险比。
2771例贫血患者和4927例非贫血患者的VTE事件分布相似(单纯深静脉血栓形成:分别为61.1%和55.9%,肺栓塞±深静脉血栓形成:分别为38.9%和44.0%)。贫血患者比非贫血患者年龄更大(62.6岁对58.9岁)。基线时,贫血患者中更常见的VTE危险因素包括住院(22.0%对6.8%)、手术(19.2%对8.2%)、癌症(20.1%对5.6%)和急性内科疾病(8.3%对4.2%)。与非贫血患者相比,贫血患者更可能仅接受胃肠外抗凝治疗(26.6%对11.7%),而接受直接口服抗凝剂的可能性较小(38.5%对53.5%)。在24个月的随访期间,贫血患者全因死亡率(调整后的风险比[95%置信区间])、大出血的风险更高(分别为1.84[1.56 - 2.18]、2.83[2.14 - 3.75])。在贫血患者中,重度贫血患者的全因死亡率和大出血风险仍高于轻度/中度贫血患者(全因死亡率:风险比1.43[95%置信区间:1.21 - 1.77];大出血:风险比2.08[95%置信区间:1.52 - 2.86])。
与不伴有贫血的VTE患者相比,伴有贫血的VTE患者发生不良临床结局的风险更高。有必要进一步优化对伴有贫血的VTE患者的抗凝治疗。