Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High-Risk Pulmonary Embolism - CANARY

Oct 26, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Rajaie Cardiovascular Medical Research Center; Tehran Heart Center
Date Published:
10/19/2022
Original Posted Date:
10/26/2022
References

Contribution To Literature:

The CANARY trial was underpowered; however, showed possible clinical improvement with catheter-directed thrombolysis among patients with intermediate- to high-risk pulmonary embolism.

Description:

The goal of the trial was to evaluate catheter-directed thrombolysis compared with anticoagulation among intermediate- to high-risk individuals with acute pulmonary embolism.

Study Design

  • Randomization
  • Parallel
  • Open-label

Patients with acute intermediate- to high-risk pulmonary embolism were randomized to catheter-directed thrombolysis (n = 48) versus anticoagulation (n = 46).

Among the catheter-directed thrombolysis group, a fixed dose of alteplase was given (0.5 mg/hour), along with unfractionated heparin (500 units/hour) for 24 hours. Among the anticoagulation group, enoxaparin was given (1 mg/kg, subcutaneous, twice daily) for 48 hours. Patient were converted to oral anticoagulation at the discretion of their provider.

  • Total number of enrollees: 94
  • Duration of follow-up: 3 months
  • Mean patient age: 58.4 years
  • Percentage female: 29%
  • Percentage with diabetes: 13%

Inclusion criteria:

  • Patients ≥18 years with acute intermediate- to high-risk pulmonary embolism
  • Presenting within 14 days from symptom onset
  • Simplified pulmonary embolism severity index score ≥1
  • Computed tomography confirmation of pulmonary embolism

Exclusion criteria:

  • Creatinine clearance <30 mL/min
  • Contraindication to fibrinolytic therapy
  • Right heart thrombosis
  • Limited life expectancy

Other salient features/characteristics:

  • The study was prematurely discontinued due to the impact of the COVID-19 pandemic.

Principal Findings:

The primary outcome, right ventricle-to-left ventricle (RV/LV) ratio >0.9 at 3 months, occurred in 4.3% of the catheter-directed group vs. 12.8% of the anticoagulation group (p = 0.24).

Secondary outcomes:

  • All-cause mortality or RV/LV ratio >0.9 at 3 months: 4.3% of the catheter-directed group vs. 17.3% of the anticoagulation group (p = 0.048)
  • Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding: 2.1% of the catheter-directed group vs. 0% of the anticoagulation group (p = 0.86)

Interpretation:

Among patients with intermediate- to high-risk pulmonary embolism, catheter-directed thrombolysis might be effective. Unfortunately, this trial was stopped prematurely due to impact from the COVID-19 pandemic. Possible benefit was an improvement in right ventricle recovery. Major bleeding appeared to be similar between treatment groups. A definitive outcomes trial is warranted.

References:

Sadeghipour P, Jenab Y, Moosavi J, et al. Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High–Risk Pulmonary Embolism: The CANARY Randomized Clinical Trial. JAMA Cardiol 2022;Oct 19:[Epub ahead of print].

Editorial Comment: Hylek EM. Catheter-Directed Treatment of Submassive Pulmonary Embolism—A Cautious Step Closer? JAMA Cardiol 2022;Oct 19:[Epub ahead of print].

Clinical Topics: Anticoagulation Management, COVID-19 Hub, Dyslipidemia, Noninvasive Imaging, Prevention, Vascular Medicine, Lipid Metabolism, Computed Tomography, Nuclear Imaging

Keywords: Anticoagulants, Cardiac Catheters, COVID-19, Enoxaparin, Heart Ventricles, Hemorrhage, Pulmonary Embolism, Risk Factors, Secondary Prevention, Thrombolytic Therapy, Tissue Plasminogen Activator, Tomography, X-Ray Computed, Vascular Diseases, Venous Thrombosis


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