%0 Journal Article
%T External validation of the PE-SARD bleeding score for early major bleeding in patients with acute pulmonary embolism: From the COMMAND VTE Registry-2.
%A Nishimoto Y
%A Yamashita Y
%A Morimoto T
%A Chatani R
%A Kaneda K
%A Ikeda N
%A Kobayashi Y
%A Ikeda S
%A Kim K
%A Inoko M
%A Takase T
%A Tsuji S
%A Oi M
%A Takada T
%A Otsui K
%A Sakamoto J
%A Ogihara Y
%A Inoue T
%A Usami S
%A Chen PM
%A Togi K
%A Koitabashi N
%A Hiramori S
%A Doi K
%A Mabuchi H
%A Tsuyuki Y
%A Murata K
%A Takabayashi K
%A Nakai H
%A Sueta D
%A Shioyama W
%A Dohke T
%A Nishikawa R
%A Sato Y
%A Watanabe T
%A Yamada T
%A Fukunami M
%A Kimura T
%A  
%J J Thromb Haemost
%V 0
%N 0
%D 2024 Jun 27
%M 38944241
%F 16.036
%R 10.1016/j.jtha.2024.06.011
%X <B>BACKGROUND: </B>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.<BR><B>OBJECTIVE: </B>To externally validate the PE-SARD bleeding score.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>The PE-SARD bleeding score had a modest discriminating performance with a limited calibration performance in acute PE patients without active cancer.