Catheter-Directed Thrombolysis Versus Anticoagulation Monotherapy in Intermediate-High Risk PE (CANARY)
Pulmonary Embolism, Pulmonary Thromboembolisms, Embolism, Pulmonary
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Intermediate-high risk pulmonary embolism, Catheter-directed thrombolysis, Anticoagulation
Eligibility Criteria
Inclusion Criteria:
- Patients ≥18 years
- Confirmed acute pulmonary emboli by computed tomography pulmonary angiography (CTPA)
- Symptom onset ≤14 day
- Elevated N-terminal-proB-type natriuretic peptide and cardiac troponin
- Right ventricle/left ventricle ratio >0.9 in transthoracic echocardiography
- Less than 48 hours of anticoagulation therapy
- Willingness for participation in the study with signed and dated informed consent form
Exclusion Criteria:
- Pulmonary emboli detected by modalities other than CTPA
- Segmental PE
- High risk (massive)
- Severe renal dysfunction(creatinine clearance [CrCl] below 30 mL/min)
- Terminal illness Surgery within 2 weeks
- Platelet count <50.000 /µL
- Pre and post catheter directed thrombolysis echocardiography exam not possible
- Contraindication to thrombolytic therapy
- Concomitant right heart thrombi
- Allergic reaction to study medications
- Lack or withdrawal of informed consent
Sites / Locations
- Rajaie Cardiovascular Medical and Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Conventional catheter-directed thrombolysis (CDT)
Anticoagulation-only therapy
Conventional catheter-directed thrombolysis (CDT) will be the interventional arm. CDT will be administered using fixed-dose of 24 mg tissue plasminogen activator infusion over 24 hours (0.5 mg/h per catheter if bilateral or 1 mg/h per unilateral catheter) with 500 unit per hour of infusion of unfractionated heparin during the thrombolytic therapy. The therapeutic dose of heparin will immediately be substituted the CDT after termination, and twice-daily subcutaneous enoxaparin (1mg/kg) for the first 48 hours after the thrombolytic therapy will be administered. Direct oral anticoagulation will be in ones with no clinical deterioration.
The anticoagulation-only therapy will be the assigned treatment in the control arm. Control patients will receive subcutaneous enoxaparin (twice-daily, 1mg/kg) in the first 48hours of enrollment. Direct oral anticoagulation will be in ones with no clinical deterioration.