Surgical Pulmonary Embolectomy Versus Catheter-directed Thrombolysis in the Treatment of Pulmonary Embolism: A Randomized Phase II Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference in RV/LV ratio by contrast-enhanced chest computed tomography
研究概览
简要总结
Acute pulmonary embolism (PE) is a serious and potentially lethal condition. The clinical spectrum of PE spans from asymptomatic PE to patients with severe hemodynamic compromise. The main determinant of outcome is right ventricular dysfunction caused by the abrupt rise in pulmonary vascular resistance. Patients with hemodynamic compromise are at highest risk of mortality (>15%). Hemodynamic stable patients with imaging and biomarker evidence of right ventricular (RV)- dysfunction are at intermediate-high risk of mortality (3-15%). According to the European Society of Cardiology (ESC) guidelines reperfusion therapy options for patients at high risk and at intermediate-high risk include systemic thrombolysis, catheter-directed therapy or surgical embolectomy.
The University Hospital of Bern is the only tertiary care hospital in Switzerland that has established an interdisciplinary pulmonary embolism response team (PERT since 2010) and has gained expertise in both catheter-directed thrombolysis and surgical embolectomy. Since the introduction of PERT, systemic thrombolysis was no longer performed in Bern due to the high risk of intracranial hemorrhage. Favorable clinical outcomes of the patients managed in Bern have been published for both catheter-directed therapy and surgical embolectomy.
To date, no study has ever compared catheter-directed thrombolysis versus surgical pulmonary embolectomy in the treatment of high and intermediate-high risk PE patients.
详细描述
Background and Study Rationale:
Acute pulmonary embolism (PE) is a serious and potentially lethal condition. The clinical spectrum of PE spans from asymptomatic PE to patients with severe hemodynamic compromise. The main determinant of outcome is right ventricular dysfunction caused by the abrupt rise in pulmonary vascular resistance. Patients with hemodynamic compromise are at highest risk of mortality (>15%). Hemodynamic stable patients with imaging and biomarker evidence of right ventricular (RV)- dysfunction are at intermediate-high risk of mortality (3-15%). According to the European Society of Cardiology (ESC) guidelines reperfusion therapy options for patients at high risk and at intermediate-high risk include systemic thrombolysis, catheter-directed therapy or surgical embolectomy.
The University Hospital of Bern is the only tertiary care hospital in Switzerland that has established an interdisciplinary pulmonary embolism response team (PERT since 2010) and has gained expertise in both catheter-directed thrombolysis and surgical embolectomy. Since the introduction of PERT, systemic thrombolysis was no longer performed in Bern due to the high risk of intracranial hemorrhage. Favorable clinical outcomes of the patients managed in Bern have been published for both catheter-directed therapy and surgical embolectomy.
To date, no study has ever compared catheter-directed thrombolysis versus surgical pulmonary embolectomy in the treatment of high and intermediate-high risk PE patients.
Primary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute symptomatic PE with thrombus located in the pulmonary main trunk or the left and/or right main pulmonary artery
- •High-risk PE defined as PE with sustained systemic arterial hypotension (systolic pressure <90mmHg), cardiogenic shock, or the ongoing need for catecholamine therapy
- •Intermediate-high risk PE: Imaging evidence of RV-Dilatation (right-to-left ventricular diameter ratio >1.0 on echocardiography or chest computed tomography) and biomarker evidence of RV dysfunction (positive Troponin T or I Test).
- •The eligibility for both procedures must be established by the PERT team
- •Signed Informed consent (by subject or legal representative) -
排除标准
- •Age less than 18 years or greater than 80 years.
- •Symptom duration > 14 days suggesting acute-on-chronic pulmonary embolism.
- •Known chronic thromboembolic pulmonary hypertension (CTEPH)
- •Suspected chronic thromboembolic pulmonary hypertension (CTEPH) including RV hypertrophy (RV free wall >5 mm on echocardiography), severe pulmonary hypertension (systolic pulmonary artery pressure > 80 mmHg on echocardiography), or CT findings suggestive of CTEPH including intraluminal webs, bands, strictures, or eccentric filling defects adjacent to the wall of the pulmonary arteries
- •Decompensated cardiogenic shock defined as recent (<48 hours) cardiopulmonary resuscitation therapy or worsening hemodynamic status despite extended fluid and catecholamine support
- •Inability to tolerate catheter procedure or surgical embolectomy due to severe comorbidities.
- •Allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- •Known significant bleeding risk, or known coagulation disorder (including vitamin K antagonists with INR > 2.0 and platelet count < 100 000/mm3)
- •Severe renal impairment (estimated GFR < 30 ml/min).
- •Active bleeding: recent (< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
- •Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
- •History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- •Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
- •Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test in women of childbearing age)
- •Recent (< 1 month) systemic thrombolysis.
- •Life expectancy < 6 months or chronic non-ambulatory status.
- •Participating in any other investigational drug or device study or previous enrollment in this study
- •Inability to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
- •Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
结局指标
主要结局
Difference in RV/LV ratio by contrast-enhanced chest computed tomography
时间窗: 48-72 hours after surgical embolectomy or catheter therapy
次要结局
- Difference in pulmonary occlusion score by contrast-enhanced chest computed tomography(48-72 hours after surgical embolectomy or catheter therapy)