1/2 Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT Trial)

项目总结 右心亚大面积肺栓塞患者的优化处理 功能障碍但血压正常，尚不确定。除了面临短期糟糕的风险外， 结果，这些患者长期遭受功能能力下降和生活质量下降的痛苦。 虽然全身溶栓可以减少PE的临床恶化，但这一好处被大量的 大出血和颅内出血增多。导管定向治疗(CDT)，溶解肺 动脉血栓溶栓药物剂量小得多，似乎和全身一样有效 溶栓治疗而不会大量增加出血。因此，CDT在美国经常被用来 治疗亚大面积PE。然而，CDT有风险且成本高昂，目前尚不清楚它是否能改善心肺功能 希思，特别是从长远来看。 因此，我们计划进行一项开放标签、评估者盲法的随机试验，即肺栓塞： CDT与非CDT取栓的临床对比研究 亚大面积PE患者500例。我们将使用“自适应样本量”，这可能会导致注册 在中期分析中因疗效较好或无效而被叫停。将有两种主要疗效 结果：氧耗峰值在3个月(短期)，NYHA分级在12个月(长期)。 这些将使用“把关”方法进行顺序分析；对于要比较的NYHA级别，请参见PEAK 首先必须证明CDT增加了氧气消耗(P&lt；0.05)。主要的安全结果将是 随机分组后30天内出现大出血。次要结果包括一般生活质量(QOL)(SF- 36)，6分钟步行距离，临床PE恶化，以及成本效益。探索性分析将 评估：疾病特有的生活质量、其他心肺运动试验参数、复发性静脉 血栓栓塞症和CDT手术的并发症。治疗反应的预测指标也将是 被追寻。PE-Track研究将改变临床实践：如果CDT有效和安全，它将成为 亚大规模PE患者的标准治疗；如果不是，将避免风险和昂贵的治疗。因此， 任何一项研究结果都将改善公共健康，推进NHLBI的使命。

PROJECT SUMMARY The optimal management of patients with submassive pulmonary embolism (PE), who have right heart dysfunction but a normal blood pressure, is uncertain. In addition to being at risk for poor short-term outcomes, these patients suffer from reduced functional capacity and a lower quality of life over the long-term. While systemic thrombolysis reduces clinical deterioration from PE, this benefit is offset by substantial increases in major and intracranial bleeding. Catheter-directed therapy (CDT), which dissolves pulmonary artery thrombus with a much lower dose of thrombolytic drug, appears to be as effective as systemic thrombolytic therapy without substantially increasing bleeding. Consequently, CDT is often used in the U.S. to treat submassive PE. However, CDT has risk and is costly, and it is not known if it improves cardiopulmonary heath, particularly over the long-term. We therefore plan to do an open-label, assessor-blinded, randomized trial, the Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT) Study, to compare CDT with No-CDT in 500 patients with submassive PE. We will use an "adaptive sample size" which could result in enrollment being stopped for superior efficacy or for futility at an interim analysis. There will be two primary efficacy outcomes; peak oxygen consumption at 3 months (short-term) and NYHA class at 12 months (long-term). These will be analyzed sequentially using a "gatekeeping" approach; for NYHA class to be compared, peak oxygen consumption must first be shown to be increased by CDT (P<0.05). The primary safety outcome will be major bleeding within 30 days of randomization. Secondary outcomes include generic quality of life (QOL) (SF- 36), 6-minute walk distance, clinical deterioration from PE, and cost-effectiveness. Exploratory analyses will assess: disease-specific QOL, other cardiopulmonary exercise test parameters, recurrent venous thromboembolism and complications of the CDT procedure. Predictors of therapeutic response will also be sought. The PE-TRACT Study will change clinical practice: if CDT is effective and safe, it will become part of standard therapy for patients with submassive PE; if not, a risky and costly therapy will be avoided. Hence, either study outcome will improve public health and advance the NHLBI’s mission.