TY - JOUR
T1 - Bleeding Risk With Combination Intrapleural Fibrinolytic and Enzyme Therapy in Pleural Infection
T2 - An International, Multicenter, Retrospective Cohort Study
AU - Interventional Pulmonary Outcomes Group
AU - Akulian, Jason
AU - Bedawi, Eihab O.
AU - Abbas, Hawazin
AU - Argento, Christine
AU - Arnold, David T.
AU - Balwan, Akshu
AU - Batra, Hitesh
AU - Uribe Becerra, Juan Pablo
AU - Belanger, Adam
AU - Berger, Kristin
AU - Burks, Allen Cole
AU - Chang, Jiwoon
AU - Chrissian, Ara A.
AU - DiBardino, David M.
AU - Fuentes, Xavier Fonseca
AU - Gesthalter, Yaron B.
AU - Gilbert, Christopher R.
AU - Glisinski, Kristen
AU - Godfrey, Mark
AU - Gorden, Jed A.
AU - Grosu, Horiana
AU - Gupta, Mridul
AU - Kheir, Fayez
AU - Ma, Kevin C.
AU - Majid, Adnan
AU - Maldonado, Fabien
AU - Maskell, Nick A.
AU - Mehta, Hiren
AU - Mercer, Joshua
AU - Mullon, John
AU - Nelson, Darlene
AU - Nguyen, Elaine
AU - Pickering, Edward M.
AU - Puchalski, Jonathan
AU - Reddy, Chakravarthy
AU - Revelo, Alberto E.
AU - Roller, Lance
AU - Sachdeva, Ashutosh
AU - Sanchez, Trinidad
AU - Sathyanarayan, Priya
AU - Semaan, Roy
AU - Senitko, Michal
AU - Shojaee, Samira
AU - Story, Ryan
AU - Thiboutot, Jeffrey
AU - Wahidi, Momen
AU - Wilshire, Candice L.
AU - Yu, Diana
AU - Zouk, Aline
AU - Rahman, Najib M.
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022/12
Y1 - 2022/12
N2 - Background: Combination intrapleural fibrinolytic and enzyme therapy (IET) has been established as a therapeutic option in pleural infection. Despite demonstrated efficacy, studies specifically designed and adequately powered to address complications are sparse. The safety profile, the effects of concurrent therapeutic anticoagulation, and the nature and extent of nonbleeding complications remain poorly defined. Research Question: What is the bleeding complication risk associated with IET use in pleural infection? Study Design and Methods: This was a multicenter, retrospective observational study conducted in 24 centers across the United States and the United Kingdom. Protocolized data collection for 1,851 patients treated with at least one dose of combination IET for pleural infection between January 2012 and May 2019 was undertaken. The primary outcome was the overall incidence of pleural bleeding defined using pre hoc criteria. Results: Overall, pleural bleeding occurred in 76 of 1,833 patients (4.1%; 95% CI, 3.0%-5.0%). Using a half-dose regimen (tissue plasminogen activator, 5 mg) did not change this risk significantly (6/172 [3.5%]; P = .68). Therapeutic anticoagulation alongside IET was associated with increased bleeding rates (19/197 [9.6%]) compared with temporarily withholding anticoagulation before administration of IET (3/118 [2.6%]; P = .017). As well as systemic anticoagulation, increasing RAPID score, elevated serum urea, and platelets of < 100 × 109/L were associated with a significant increase in bleeding risk. However, only RAPID score and use of systemic anticoagulation were independently predictive. Apart from pain, non-bleeding complications were rare. Interpretation: IET use in pleural infection confers a low overall bleeding risk. Increased rates of pleural bleeding are associated with concurrent use of anticoagulation but can be mitigated by withholding anticoagulation before IET. Concomitant administration of IET and therapeutic anticoagulation should be avoided. Parameters related to higher IET-related bleeding have been identified that may lead to altered risk thresholds for treatment.
AB - Background: Combination intrapleural fibrinolytic and enzyme therapy (IET) has been established as a therapeutic option in pleural infection. Despite demonstrated efficacy, studies specifically designed and adequately powered to address complications are sparse. The safety profile, the effects of concurrent therapeutic anticoagulation, and the nature and extent of nonbleeding complications remain poorly defined. Research Question: What is the bleeding complication risk associated with IET use in pleural infection? Study Design and Methods: This was a multicenter, retrospective observational study conducted in 24 centers across the United States and the United Kingdom. Protocolized data collection for 1,851 patients treated with at least one dose of combination IET for pleural infection between January 2012 and May 2019 was undertaken. The primary outcome was the overall incidence of pleural bleeding defined using pre hoc criteria. Results: Overall, pleural bleeding occurred in 76 of 1,833 patients (4.1%; 95% CI, 3.0%-5.0%). Using a half-dose regimen (tissue plasminogen activator, 5 mg) did not change this risk significantly (6/172 [3.5%]; P = .68). Therapeutic anticoagulation alongside IET was associated with increased bleeding rates (19/197 [9.6%]) compared with temporarily withholding anticoagulation before administration of IET (3/118 [2.6%]; P = .017). As well as systemic anticoagulation, increasing RAPID score, elevated serum urea, and platelets of < 100 × 109/L were associated with a significant increase in bleeding risk. However, only RAPID score and use of systemic anticoagulation were independently predictive. Apart from pain, non-bleeding complications were rare. Interpretation: IET use in pleural infection confers a low overall bleeding risk. Increased rates of pleural bleeding are associated with concurrent use of anticoagulation but can be mitigated by withholding anticoagulation before IET. Concomitant administration of IET and therapeutic anticoagulation should be avoided. Parameters related to higher IET-related bleeding have been identified that may lead to altered risk thresholds for treatment.
KW - bleeding
KW - empyema
KW - fibrinolysis
KW - intrapleural
KW - parapneumonic pleural effusion
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U2 - 10.1016/j.chest.2022.06.008
DO - 10.1016/j.chest.2022.06.008
M3 - Article
C2 - 35716828
AN - SCOPUS:85137929564
SN - 0012-3692
VL - 162
SP - 1384
EP - 1392
JO - Chest
JF - Chest
IS - 6
ER -