PEERLESS
Trial question
What is the role of large-bone mechanical thrombectomy in patients with intermediate-risk PE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 550
550 patients (259 female, 291 male).
Inclusion criteria: patients with intermediate-risk PE with RV dilatation and additional clinical risk factors.
Key exclusion criteria: right heart clot-in-transit; life expectancy < 30 days; no receipt of therapeutic anticoagulation; intraprocedural systolic pulmonary artery pressure ≥ 70 mmHg on invasive hemodynamic measurement at the start of the index procedure; chronic PE.
Interventions
N=274 large-bore mechanical thrombectomy (aspiration/mechanical thrombectomy by using the FlowTriever® System).
N=276 catheter-directed thrombolysis (thrombolysis treatment per local standard for device selection and thrombolytic dosing).
Primary outcome
Hierarchal win ratio of death, intracranial hemorrhage, major bleeding, clinical deterioration and/or escalation to bailout, postprocedural intensive care unit admission, and length of stay, assessed at sooner of hospital discharge or 7 days post-procedure
52693 wins
10509 wins
52693.0 wins
39519.8 wins
26346.5 wins
13173.3 wins
0.0 wins
Large-bore mechanical
thrombectomy
Catheter-directed
thrombolysis
Significant
increase ▲
Significant increase in hierarchal win ratio of death, ICH, major bleeding, clinical deterioration and/or escalation to bailout, postprocedural ICU admission, and length of stay, assessed at the sooner of hospital discharge or 7 days post-procedure (52693 wins vs. 10509 wins; WR 5.01, 95% CI 3.68 to 6.97).
Secondary outcomes
No significant difference in hierarchal win ratio of death, ICH, major bleeding, clinical deterioration, and/or escalation to bailout, assessed at the sooner of hospital discharge or 7 days post-procedure (7925 wins vs. 5912 wins; WR 1.34, 95% CI 0.78 to 2.35).
No significant difference in major bleeding (6.9% vs. 6.9%; OR 0.99, 99% CI 0.51 to 1.92).
Significant decrease in mMRC Dyspnea Score (13.5% vs. 26.4%; RR 0.51, 95% CI 0.21 to 0.81).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with intermediate-risk PE with RV dilatation and additional clinical risk factors, large-bore mechanical thrombectomy was superior to catheter-directed thrombolysis with respect to hierarchal win ratio of death, ICH, major bleeding, clinical deterioration and/or escalation to bailout, postprocedural ICU admission, and length of stay, assessed at the sooner of hospital discharge or 7 days post-procedure.
Reference
Wissam A Jaber, Carin F Gonsalves, Stefan Stortecky et al. Large-bore Mechanical Thrombectomy Versus Catheter-directed Thrombolysis in the Management of Intermediate-risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial. Circulation. 2024 Oct 29. Online ahead of print.
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