Treatment of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at 3 months: multicenter double-blind, placebo-controlled randomized trial

被引:200
作者
Kline, J. A. [1 ,2 ]
Nordenholz, K. E. [3 ]
Courtney, D. M. [4 ]
Kabrhel, C. [5 ]
Jones, A. E. [6 ]
Rondina, M. T. [7 ]
Diercks, D. B. [8 ]
Klinger, J. R. [9 ]
Hernandez, J. [10 ]
机构
[1] Indiana Univ Sch Med, Dept Emergency Med, Indianapolis, IN 46202 USA
[2] Indiana Univ Sch Med, Dept Cellular & Integrat Physiol, Indianapolis, IN 46202 USA
[3] Univ Colorado, Sch Med, Dept Emergency Med, Aurora, CO USA
[4] Northwestern Univ, Dept Emergency Med, Feinberg Sch Med, Chicago, IL 60611 USA
[5] Massachusetts Gen Hosp, Dept Emergency Med, Boston, MA 02114 USA
[6] Univ Mississippi, Med Ctr, Dept Emergency Med, Jackson, MS 39216 USA
[7] Univ Utah, Dept Internal Med, Salt Lake City, UT 84112 USA
[8] Univ Calif Davis, Dept Emergency Med, Sacramento, CA 95817 USA
[9] Brown Univ, Alpert Med Sch, Dept Internal Med, Providence, RI 02912 USA
[10] Carolinas, Dept Emergency Med, Charlotte, NC USA
基金
美国国家卫生研究院;
关键词
ventricular function; right; quality of life; thrombolytic therapy; pulmonary embolism; randomized controlled trial; QUALITY-OF-LIFE; DEEP VENOUS THROMBOSIS; NORMOTENSIVE PATIENTS; THROMBOLYTIC THERAPY; BOLUS TENECTEPLASE; FOLLOW-UP; QUESTIONNAIRE; MANAGEMENT; DYSFUNCTION; VALIDATION;
D O I
10.1111/jth.12521
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Acute pulmonary embolism (PE) can worsen quality of life due to persistent dyspnea or exercise intolerance. Objective Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE. Methods Normotensive patients with PE and right ventricular (RV) strain (by echocardiography or biomarkers) were enrolled from eight hospitals. All patients received low-molecular-weight heparin followed by random assignment to either a single weight-based bolus of tenecteplase or placebo, administered in a double-blinded fashion. The primary composite outcome included: (i) death, circulatory shock, intubation or major bleeding within 5days or (ii) recurrent PE, poor functional capacity (RV dysfunction with either dyspnea at rest or exercise intolerance) or an SF36((R)) Physical Component (PCS) score Results Eighty-three patients were randomized; 40 to tenecteplase and 43 to placebo. The trial was terminated prematurely. Within 5days, adverse outcomes occurred in three placebo-treated patients (death in one and intubation in two) and one tenecteplase-treated patient (fatal intracranial hemorrhage). At 90days, adverse outcomes occurred in 13 unique placebo-treated patients and five unique tenecteplase-treated patients Thus, 16 (37%) placebo-treated and six (15%) tenecteplase-treated patients had at least one adverse outcome (exact two-sided P=0.017). Conclusions Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome.
引用
收藏
页码:459 / 468
页数:10
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