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Life sciences · Journal article
Trials · August 4, 2026
Posted before peer review. The findings may change or fail to hold.
This is a prospective multicenter RCT protocol comparing mechanical thrombectomy combined with anticoagulation versus anticoagulation monotherapy for intermediate–high-risk pulmonary embolism, enrolling 156 patients. The study is currently recruiting and has not yet generated results; it aims to provide evidence in Asian populations where such data are limited.
Prospective multicenter randomized controlled trial. Patients with acute intermediate–high-risk pulmonary embolism stratified by European Society of Cardiology classification criteria.. Intervention: Mechanical thrombectomy with MPA 8F guiding catheter (Cordis Shanghai Medical Device Co., Ltd) combined with anticoagulation. Compared with: Anticoagulation monotherapy. n = 156. China (national multicenter study, Chinese Clinical Trial Registry).
STORM-PE (prior RCT) showed MT combined with anticoagulation resulted in significantly greater reduction in RV/LV diameter ratio at 48 h versus anticoagulation monotherapy, with comparably low rates of major adverse events MT showed lower rates of clinical deterioration and/or bailout and postprocedural ICU use compared with catheter-directed thrombolysis, with no difference in mortality or bleeding
Study is currently enrolling; no efficacy or safety results are reported. Mortality and bleeding outcomes mentioned for prior studies but not specified as endpoints for CAPE.
This protocol describes a planned trial designed to generate evidence for MT combined with anticoagulation in Asian populations, where data are currently limited. Clinicians should await final results rather than using this protocol document for treatment decisions.
This is a study protocol for a currently enrolling RCT with no results reported; it describes planned methodology and rationale but provides no efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
This protocol describes a planned trial designed to generate evidence for MT combined with anticoagulation in Asian populations, where data are currently limited. Clinicians should await final results rather than using this protocol document for treatment decisions.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Treatment of intermediate–high-risk pulmonary embolism is still debated. Interventional therapy is being increasingly widely applied in clinical practice. Numerous studies have confirmed that interventional therapy is effective. Both catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) showed improvement in some efficacy outcomes compared with anticoagulation monotherapy. A recent study showed that MT has lower rates of clinical deterioration and/or bailout and postprocedural intensive care unit use compared with CDT, with no difference in mortality or bleeding, which makes the application of MT in clinical practice increasingly widespread. Recently, STORM-PE, the first randomized controlled trial to test the efficacy and evaluate the safety of MT combined with anticoagulation compared with anticoagulation monotherapy for the treatment of intermediate–high-risk pulmonary embolism, showed that treatment with MT combined with anticoagulation resulted in a significantly greater reduction in right ventricular/left ventricular (RV/LV) diameter ratio at 48 h versus anticoagulation monotherapy, with comparably low rates of major adverse events in both treatment arms. However, whether MT combined with anticoagulation is more effective than anticoagulation monotherapy needs more evidence, especially in Asian populations. The CAPE study is a currently enrolling national multicenter randomized controlled trial (RCT) comparing MT with MPA 8F guiding catheter [Cordis (Shanghai) Medical Device Co., Ltd] combined with anticoagulation vs anticoagulation monotherapy. A total of 156 patients with acute intermediate–high-risk pulmonary embolism stratified by the classification of the latest guideline of European Society of Cardiology (ESC) will be enrolled and randomized in a 1:1 ratio. The primary efficacy endpoint was reduction of RV/LV diameter ratio assessed by computed tomographic angiography (CTPA) at 48 h. The secondary efficacy endpoint was the incidence of chronic thromboembolic pulmonary disease including chronic thromboembolic pulmonary hypertension. The primary safety endpoint was serious adverse events including major bleeding through 3 months visit. CAPE is a RCT to compare the short and long efficacy of MT combined with anticoagulation and anticoagulation monotherapy for acute intermediate-high pulmonary embolism. The result will give more evidence for selection of different strategies for physicians. CAPE study is registered in Chinese Clinical Trial Registry identifier (ChiCTR2500095253, https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=c57630b7-51ec-4b24-83e1-85b9c0a835d6 ). Registered on November 26 2024.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.