Effects of mechanical thrombectomy combined with anticoagulation vs anticoagulation monotherapy for acute intermediate-high risk pulmonary embolism: study protocol for a randomized controlled trial (CAPE study, ChiCTR2500095253, https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=c57630b7-51ec-4b24-83e1-85b9c0a835d6).
17 affiliations
- 1National Center for Respiratory Medicine, Beijing, 100029, China.
- 2State Key Laboratory of Respiratory Health and Multimorbidity, Beijing, 100029, China.
- 3National Clinical Research Center for Respiratory Diseases, National Clinical Research Center for Respiratory Diseases, 100029, China.
- 4Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, 100029, China.
- 5Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, 100029, China.
- 6Evidence-Based Medicine Center, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
- 7Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, 100020, P.R. China.
- 8Beijing Institute of Respiratory Medicine, Beijing, 100020, P.R. China.
- 9Department of Pulmonary and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.
- 10Department of Pulmonary and Critical Care Medicine, The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Wuhan, Hubei, China.
- 11Department of Respiratory Medicine, Haihe Hospital, Tianjin University, Tianjin, China.
- 12Department of Interventional Radiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, P.R. China.
- 13Department of Radiology, Beijing Chao-Yang Hospital, Capital Medical University, Key Lab of Medical Engineering for Cardiovascular Disease, Ministry of Education, Beijing, China. [email protected].
- 14Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, 100020, P.R. China. [email protected].
- 15Beijing Institute of Respiratory Medicine, Beijing, 100020, P.R. China. [email protected].
- 16Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, 100020, P.R. China. [email protected].
- 17Beijing Institute of Respiratory Medicine, Beijing, 100020, P.R. China. [email protected].
Abstract
Background
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.Methods
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.Discussion
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.Trial registration
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.
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BibTeX
@article{huang2026effects,
title = {{Effects of mechanical thrombectomy combined with anticoagulation vs anticoagulation monotherapy for acute intermediate-high risk pulmonary embolism: study protocol for a randomized controlled trial (CAPE study, ChiCTR2500095253, https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=c57630b7-51ec-4b24-83e1-85b9c0a835d6).}},
author = {Qiang Huang and Lin Feng and Lin Liu and Yi-Shan Li and Wei Guo and Fa-Jiu Li and Li Li and Yunong Ren and Chuan-Guo Zhou and Shuai Zhang and Meng Zhang and Cheng-Hong Li and Hong-Wei Li and Qi Yang and Yuan-Hua Yang and Ji-Feng Li},
journal = {Trials},
year = {2026},
month = aug,
doi = {10.1186/s13063-026-09932-9},
url = {https://europepmc.org/article/MED/42958300},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Effects of mechanical thrombectomy combined with anticoagulation vs anticoagulation monotherapy for acute intermediate-high risk pulmonary embolism: study protocol for a randomized controlled trial (CAPE study, ChiCTR2500095253, https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=c57630b7-51ec-4b24-83e1-85b9c0a835d6).
AU - Qiang Huang
AU - Lin Feng
AU - Lin Liu
AU - Yi-Shan Li
AU - Wei Guo
AU - Fa-Jiu Li
AU - Li Li
AU - Yunong Ren
AU - Chuan-Guo Zhou
AU - Shuai Zhang
AU - Meng Zhang
AU - Cheng-Hong Li
AU - Hong-Wei Li
AU - Qi Yang
AU - Yuan-Hua Yang
AU - Ji-Feng Li
PY - 2026
DA - 2026/08/04
JO - Trials
DO - 10.1186/s13063-026-09932-9
UR - https://europepmc.org/article/MED/42958300
AB - Background 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.Methods 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.Discussion 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.Trial registration 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.
SN - 1745-6215
ER -