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Original Research: THROMBOEMBOLISM |

Efficacy and Safety of Low Dose Recombinant Tissue-Type Plasminogen Activator for the Treatment of Acute Pulmonary Thromboembolism: A Randomized, Multicenter, Controlled Trial

Chen Wang, MD, PhD, FCCP; Zhenguo Zhai, MD, PhD; Yuanhua Yang, MD; Qi Wu, MD; Zhaozhong Cheng, MD; Lirong Liang, MD, PhD; Huaping Dai, MD; Kewu Huang, MD; Weixuan Lu, MD; Zhonghe Zhang, MD; Xiansheng Cheng, MD; Ying H. Shen, MD, PhD; for the China Venous Thromboembolism (VTE) Study Group*
Author and Funding Information

From the Beijing Institute of Respiratory Medicine (Drs Wang, Zhai, Yang, Liang, Dai, and Huang), Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Republic of China; Tianjin Medical University General Hospital (Dr Wu), Tianjin, Republic of China; the Affiliated Hospital of the Medical College of Qingdao (Dr Z. Cheng), Shandong, Republic of China; Peking Union Medical College Hospital (Dr Lu), Chinese Academy of Medical Sciences, Beijing, Republic of China; the Affiliated Hospital of Dalian Medical University (Dr Zhang), Liaoning, Republic of China; Beijing Fuwai Hospital (Dr X. Cheng), Chinese Academy of Medical Sciences, Beijing, Republic of China; and Baylor College of Medicine (Dr Shen), Houston, TX.

Correspondence to: Chen Wang, MD, PhD, FCCP, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongtinan Road, Chaoyang District, Beijing 100020, China; e-mail: zhaizhenguo@gmail.com

A complete list of study participants is located in the Appendix.


For editorial comment see page 245

Funding/Support: This study was supported by the China Key Research Projects of the 10th National Five-Year Development Plan (2004BA703B07 to Dr Wang).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).


© 2010 American College of Chest Physicians


Chest. 2010;137(2):254-262. doi:10.1378/chest.09-0765
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Background:  Optimal dosing of the recombinant tissue-type plasminogen activator (rt-PA) is important in treating pulmonary thromboembolism (PTE). The aim of this study was to compare the efficacy and safety of a 50 mg/2 h rt-PA regimen with a 100 mg/2 h rt-PA regimen in patients with acute PTE.

Methods:  A prospective, randomized, multicenter trial was conducted in which 118 patients with acute PTE and either hemodynamic instability or massive pulmonary artery obstruction were randomly assigned to receive a treatment regiment of either rt-PA at 50 mg/2 h (n = 65) or 100 mg/2 h (n = 53). The efficacy was determined by observing the improvements of right ventricular dysfunctions (RVDs) on echocardiograms, lung perfusion defects on ventilation perfusion lung scans, and pulmonary artery obstructions on CT angiograms. The adverse events, including death, bleeding, and PTE recurrence, were also evaluated.

Results:  Progressive improvements in RVDs, lung perfusion defects, and pulmonary artery obstructions were found to be similarly significant in both treatment groups. This is true for patients with either hemodynamic instability or massive pulmonary artery obstruction. Three (6%) patients in the rt-PA 100 mg/2 h group and one (2%) in the rt-PA 50 mg/2 h group died as the result of either PTE or bleeding. Importantly, the 50 mg/2 h rt-PA regimen resulted in less bleeding tendency than the 100 mg/2 h regimen (3% vs 10%), especially in patients with a body weight < 65 kg (14.8% vs 41.2%, P = .049). No fatal recurrent PTE was found in either group.

Conclusions:  Compared with the 100 mg/2 h regimen, the 50 mg/2 h rt-PA regimen exhibits similar efficacy and perhaps better safety in patients with acute PTE. These findings support the notion that optimizing rt-PA dosing is worthwhile when treating patients with PTE.

Trial registration:  clinicaltrials.gov; Identifier: NCT00781378

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