Abstract：
BACKGROUND: There is no established risk score for anticoagulant-related bleeding during the acute phase in patients with pulmonary embolism (PE). The Syncope, Anemia, Renal Dysfunction (PE-SARD) bleeding score was developed to predict early major bleeding, but has not yet been fully externally validated.
OBJECTIVE: To externally validate the PE-SARD bleeding score.
METHODS: Using the COMMAND VTE Registry-2 database, which enrolled 5197 consecutive acute symptomatic venous thromboembolism patients among 31 centers in Japan between January 2015 and August 2020, we identified acute PE patients. We divided those into 3 groups by the score: high-risk (>2.5 points), intermediate-risk (1-2.5 points), and low-risk (0 points). The discriminating and calibration performances of the score for 30-day major bleeding were assessed. Subgroup analyses based on active cancer were also performed.
RESULTS: Of 2781 eligible patients, the high-risk group accounted for 557 patients (20%), intermediate-risk group for 1412 (51%), and low-risk group for 812 (29%). Major bleeding occurred in 121 patients within 30 days. The cumulative 30-day incidence of major bleeding substantially increased in the higher risk categories by the score (high-risk group: 8.2% [95%CI, 5.9%-10.5%], intermediate-risk group: 4.6% [95%CI, 3.5%-5.7%], and low-risk group: 1.8% [95%CI, 0.8%-2.7%]). The discriminating power of the score was modest with a C-statistic of 0.65 (95%CI, 0.61-0.70) with a good calibration performance with a score of <4 points except for in active cancer patients.
CONCLUSIONS: The PE-SARD bleeding score had a modest discriminating performance with a limited calibration performance in acute PE patients without active cancer.
OBJECTIVE: To externally validate the PE-SARD bleeding score.
METHODS: Using the COMMAND VTE Registry-2 database, which enrolled 5197 consecutive acute symptomatic venous thromboembolism patients among 31 centers in Japan between January 2015 and August 2020, we identified acute PE patients. We divided those into 3 groups by the score: high-risk (>2.5 points), intermediate-risk (1-2.5 points), and low-risk (0 points). The discriminating and calibration performances of the score for 30-day major bleeding were assessed. Subgroup analyses based on active cancer were also performed.
RESULTS: Of 2781 eligible patients, the high-risk group accounted for 557 patients (20%), intermediate-risk group for 1412 (51%), and low-risk group for 812 (29%). Major bleeding occurred in 121 patients within 30 days. The cumulative 30-day incidence of major bleeding substantially increased in the higher risk categories by the score (high-risk group: 8.2% [95%CI, 5.9%-10.5%], intermediate-risk group: 4.6% [95%CI, 3.5%-5.7%], and low-risk group: 1.8% [95%CI, 0.8%-2.7%]). The discriminating power of the score was modest with a C-statistic of 0.65 (95%CI, 0.61-0.70) with a good calibration performance with a score of <4 points except for in active cancer patients.
CONCLUSIONS: The PE-SARD bleeding score had a modest discriminating performance with a limited calibration performance in acute PE patients without active cancer.
摘要：
背景：肺栓塞（PE）患者急性期抗凝相关出血的风险评分尚未确定。晕厥,贫血,肾功能不全（PE-SARD）出血评分用于预测早期大出血，但尚未完全通过外部验证。
目的：外部验证PE-SARD出血评分。
方法：使用COMMANDVTERegistry-2数据库，在2015年1月至2020年8月期间,我们纳入了日本31个中心的5197例连续急性症状性静脉血栓栓塞患者,我们确定了急性PE患者.我们根据得分将其分为3组：高风险（>2.5分），中等风险(1-2.5分)，低风险（0分）。评估30天大出血评分的辨别和校准性能。还进行了基于活动性癌症的亚组分析。
结果：在2781名符合条件的患者中，高危人群占557例(20%)，中等风险组1412（51%），和低风险组812（29％）。121例患者在30天内发生大出血。在高风险类别中，大出血的累积30天发生率大幅增加（高风险组：8.2％[95CI，5.9％-10.5％]，中等风险组：4.6%[95CI，3.5%-5.7%]，低危组：1.8%[95CI，0.8%-2.7%]）。评分的辨别能力适中，C统计量为0.65（95CI，0.61-0.70），具有良好的校准性能，评分<4分，活跃的癌症患者除外。
结论：在无活动性癌症的急性PE患者中，PE-SARD出血评分具有适度的辨别性能，而校准性能有限。
目的：外部验证PE-SARD出血评分。
方法：使用COMMANDVTERegistry-2数据库，在2015年1月至2020年8月期间,我们纳入了日本31个中心的5197例连续急性症状性静脉血栓栓塞患者,我们确定了急性PE患者.我们根据得分将其分为3组：高风险（>2.5分），中等风险(1-2.5分)，低风险（0分）。评估30天大出血评分的辨别和校准性能。还进行了基于活动性癌症的亚组分析。
结果：在2781名符合条件的患者中，高危人群占557例(20%)，中等风险组1412（51%），和低风险组812（29％）。121例患者在30天内发生大出血。在高风险类别中，大出血的累积30天发生率大幅增加（高风险组：8.2％[95CI，5.9％-10.5％]，中等风险组：4.6%[95CI，3.5%-5.7%]，低危组：1.8%[95CI，0.8%-2.7%]）。评分的辨别能力适中，C统计量为0.65（95CI，0.61-0.70），具有良好的校准性能，评分<4分，活跃的癌症患者除外。
结论：在无活动性癌症的急性PE患者中，PE-SARD出血评分具有适度的辨别性能，而校准性能有限。
