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Published on: February 26, 2013
Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High-risk Pulmonary Embolism:
Parham Sadeghipour1,2, Yaser Jenab3, Jamal Moosavi1
1Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
Insights
Conventional catheter-directed thrombolysis (cCDT) may improve right ventricle function in intermediate-high-risk pulmonary embolism (PE) patients. This study suggests cCDT is a promising treatment option, warranting further investigation in larger trials.
Area of Science:
- Cardiology
- Pulmonary Medicine
- Interventional Radiology
Background:
- The optimal treatment for intermediate-high-risk pulmonary embolism (PE) is not well-established.
- Right ventricular dysfunction is a key predictor of adverse outcomes in PE.
Purpose of the Study:
- To compare conventional catheter-directed thrombolysis (cCDT) plus anticoagulation with anticoagulation alone in patients with acute intermediate-high-risk PE.
- To assess the impact on echocardiographic measures of the right ventricle to left ventricle (RV/LV) ratio.
Main Methods:
- An open-label, randomized clinical trial (CANARY trial) involving 94 patients with intermediate-high-risk PE.
- Patients were assigned to either cCDT (alteplase) plus heparin or anticoagulation monotherapy.
- The primary outcome was the proportion of patients with an RV/LV ratio > 0.9 at 3 months.
Main Results:
- The study was prematurely stopped due to the COVID-19 pandemic.
- While the primary outcome did not reach statistical significance, cCDT showed a trend towards improvement.
- Significantly lower median 3-month RV/LV ratios were observed with cCDT (0.7) compared to anticoagulation (0.8) (P=.01).
- Fewer patients in the cCDT group met the composite endpoint of death or RV/LV > 0.9 at 3 months (4.3% vs 17.3%).
Conclusions:
- This prematurely terminated trial provides hypothesis-generating data for cCDT in intermediate-high-risk PE.
- cCDT demonstrated potential efficacy benefits and an acceptable safety profile regarding major bleeding.
- Further definitive clinical outcomes trials are supported by these findings.
Importance:
The optimal treatment of intermediate-high-risk pulmonary embolism (PE) remains unknown.
Objective:
To assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high-risk PE.
Design, Setting, And Participants:
The Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High-Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high-risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020.
Interventions:
Patients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy.
Main Outcomes And Measures:
The proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes.
Results:
The study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group.
Conclusions And Relevance:
This prematurely terminated randomized clinical trial of patients with intermediate-high-risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05172115.
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