急性心力衰竭胸腔穿刺术的随机对照试验
A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure.
作者信息
Glargaard Signe, Thomsen Jakob Hartvig, Tuxen Christian, Lindholm Matias Greve, Bang Christian Axel, Schou Morten, Iversen Kasper, Rasmussen Rasmus Vedby, Løgstrup Brian Bridal, Vraa Søren, Stride Nis, Seven Ekim, Barasa Anders, Tofterup Marlene, Høfsten Dan Eik, Rossing Kasper, Køber Lars, Gustafsson Finn, Thune Jens Jakob
机构信息
Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Denmark (S.G., J.H.T., C.T., J.J.T.).
Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.).
出版信息
Circulation. 2025 Apr 22;151(16):1150-1161. doi: 10.1161/CIRCULATIONAHA.124.073521. Epub 2025 Apr 1.
BACKGROUND
TAP-IT (Thoracentesis to Alleviate Cardiac Pleural Effusion-Interventional Trial) investigated the effect of therapeutic thoracentesis in addition to standard medical therapy in patients with acute heart failure and sizeable pleural effusion.
METHODS
This multicenter, unblinded, randomized controlled trial, conducted between August 31, 2021, and March 22, 2024, included patients with acute heart failure, left ventricular ejection fraction ≤45%, and non-negligible pleural effusion. Patients with very large effusions (more than two-thirds of the hemithorax) were excluded. Participants were randomly assigned 1:1 to upfront ultrasound-guided pleural pigtail catheter thoracentesis in addition to standard medical therapy or standard medical therapy alone. The primary outcome was days alive out of the hospital over the following 90 days; key secondary outcomes included length of admission and 90-day all-cause mortality. All outcomes were analyzed according to the intention-to-treat principle.
RESULTS
A total of 135 patients (median age, 81 years [25th; 75th percentile, 75; 83]; 33% female; median left ventricular ejection fraction, 25% [25th; 75th percentile, 20%; 35%]) were randomized to either thoracentesis (n=68) or standard medical therapy (n=67). The thoracentesis group had a median of 84 days (77; 86) alive out of the hospital over the following 90 days compared with 82 days (73; 86) in the control group (=0.42). The mortality rate was 13% in both groups, with no difference in survival probability (=0.90). There were no differences in the duration of the index admission (control group median, 5 days [3; 8]; thoracentesis group median, 5 days [3; 7], =0.69). Major complications occurred in 1% of thoracenteses performed during the study period.
CONCLUSIONS
For patients with acute heart failure and pleural effusion, a strategy of upfront routine thoracentesis in addition to standard medical therapy did not increase days alive out of the hospital for 90 days, all-cause mortality, or duration of index admission. The current findings lay the groundwork for future research to confirm the results.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05017753.
背景
TAP-IT（胸腔穿刺术缓解心脏性胸腔积液干预试验）研究了在标准药物治疗基础上进行治疗性胸腔穿刺术对急性心力衰竭且伴有大量胸腔积液患者的影响。
方法
这项多中心、非盲、随机对照试验于2021年8月31日至2024年3月22日进行，纳入了急性心力衰竭、左心室射血分数≤45%且胸腔积液不可忽视的患者。胸腔积液非常大（超过半侧胸腔的三分之二）的患者被排除。参与者按1:1随机分配，一组在标准药物治疗基础上接受预先的超声引导下胸腔猪尾导管胸腔穿刺术，另一组仅接受标准药物治疗。主要结局是接下来90天内出院后的存活天数；关键次要结局包括住院时间和90天全因死亡率。所有结局均根据意向性分析原则进行分析。
结果
共有135例患者（中位年龄81岁[第25百分位数；第75百分位数，75；83]；33%为女性；中位左心室射血分数25%[第25百分位数；第75百分位数，20%；35%]）被随机分为胸腔穿刺术组（n = 68）或标准药物治疗组（n = 67）。胸腔穿刺术组在接下来90天内出院后的中位存活天数为84天（77；86），而对照组为82天（73；86）（P = 0.42）。两组的死亡率均为13%，生存概率无差异（P = 0.90）。首次住院时长无差异（对照组中位时长5天[3；8]；胸腔穿刺术组中位时长5天[3；7]，P = 0.69）。研究期间进行的胸腔穿刺术中1%发生了严重并发症。
结论
对于急性心力衰竭和胸腔积液患者，在标准药物治疗基础上采用预先常规胸腔穿刺术的策略并未增加90天出院后的存活天数、全因死亡率或首次住院时长。目前的研究结果为未来研究证实这些结果奠定了基础。
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