Large-Bore Mechanical Thrombectomy vs. Catheter-Directed Thrombolysis for Treatment of Intermediate-Risk Pulmonary Embolism - PEERLESS

Oct 29, 2024
Font Size
A
A
A
Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Inari Medical
Date Presented:
10/29/2024
Date Published:
10/29/2024
Original Posted Date:
10/29/2024
References

Contribution To Literature:

The PEERLESS trial showed that in patients with intermediate-high risk PE undergoing catheter-based intervention, large-bore mechanical thrombectomy resulted in less frequent clinical deterioration and lower post-procedure ICU utilization with similar bleeding risk to catheter-directed thrombolysis.

Description:

The goal of the trial was to compare the efficacy and safety of large-bore mechanical thrombectomy (LBMT) with catheter-directed thrombolysis (CDT) in the treatment of intermediate-high risk pulmonary embolism (PE).

Study Design

  • Multicenter
  • Randomized
  • Open label

Patients with intermediate-high risk PE who were candidates for catheter-based intervention were randomized in 1:1 fashion to undergo LBMT with the Inari FlowTriever system (n = 274) or CDT (n = 276). The CDT system used was at the institution/operator’s discretion.

  • Total number of enrollees: 550
  • Duration of follow-up: 30 days
  • Mean patient age: 62 years
  • Percentage female: 47%

Inclusion criteria:

  • Age ≥18 years
  • Main or lobar pulmonary artery embolus on echocardiography, computed tomographic (CT) pulmonary angiography, or invasive pulmonary angiography
  • Pulmonary Embolism Severity Index (PESI) class III-IV or simplified PESI ≥1
  • Symptom onset ≤14 days
  • Systolic blood pressure (SBP) >90 mm Hg
  • Right ventricular (RV) dysfunction on echocardiography or CT
  • ≥1 additional risk factor: elevated cardiac troponin or lactate, history of heart failure or chronic lung disease, heart rate ≥110 bpm, SBP <100 mm Hg, respiratory rate ≥30 bpm, oxygen saturation <90%, syncope

Exclusion criteria:

  • Unable to anticoagulate with parenteral agents
  • Hemodynamic instability: cardiac arrest, SBP <90 mm Hg or vasopressor use with evidence of end-organ hypoperfusion, or SBP <90 mm Hg or drop ≥40 mm Hg sustained ≥15 minutes
  • Right heart clot in transit
  • Systolic pulmonary artery (PA) pressure ≥70 mm Hg
  • Life expectancy <30 days

Other salient features/characteristics:

  • Elevated cardiac troponin: 95%
  • Mean PA pressure: 30 mm Hg
  • Saddle PE: 39%
  • Relative contraindication to thrombolytics: 4%
  • CDT with Boston Scientific EKOS system: 60%

Principal Findings:

The primary outcome, 5-component hierarchical win ratio of all-cause mortality, intracranial hemorrhage, major bleeding, clinical deterioration/escalation to bailout, and postprocedural intensive care unit (ICU) admission and length of stay (LOS), at the sooner of hospital discharge or 7 days post-procedure for LBMT vs. CDT, was: 5.01 (95% confidence interval [CI] 3.68-6.97), p < 0.001.

Secondary outcomes for CDT vs. LBMT:

  • Four-component win ratio excluding ICU admission/LOS: 1.34 (95% CI 0.78-2.35), p = 0.30
  • All-cause mortality: 0.4% vs. 0%, odds ratio (OR) 2.99 (95% CI 0.12-73.70), p = 1.0
  • Intracranial hemorrhage: 0.4% vs. 0.7%, OR 0.50 (95% CI 0.04-5.51), p = 0.62
  • Major bleeding: 6.9% vs. 6.9%, OR 0.99 (95% CI 0.51-1.92), p = 1.0
  • Clinical deterioration/bailout therapy: 5.4% vs. 1.8%, OR 3.09 (95% CI 1.11-8.63), p = 0.038
  • Postprocedural ICU admission: 98.6% vs. 41.6%, OR 95.4 (95% CI 34.6-263.6), p < 0.001
  • ICU LOS >24 hours: 65.4% vs. 46.5%, OR 2.18 (95% CI 1.40-3.40), p < 0.001

Additional outcomes for CDT vs. LBMT:

  • Moderate-severe RV dysfunction at 24 hours: 57.9% vs. 42.1%, p = 0.004
  • Hospital LOS: 5.3 vs. 4.5 days, p = 0.002
  • 30-day all-cause readmission: 7.9% vs. 3.2%, p = 0.03
  • All-cause mortality at 30 days: 0.8% vs. 0.4%, p = 0.62
  • New York Heart Association class III or IV symptoms: 27.4% vs. 16.3%, p = 0.002

Procedure characteristics for CDT vs. LBMT:

  • Mean procedure time: 71 vs. 96 minutes
  • Treatment catheter dwell time: 919 vs. 48 minutes
  • Estimated blood loss: 14 vs. 88 mL
  • Internal jugular venous access: 0% vs. 35%

Interpretation:

PEERLESS is the first randomized comparison of catheter-based interventions for intermediate-risk PE. The superiority of LBMT to CDT was driven largely by a reduction in the last components of the hierarchical composite outcome, namely, clinical deterioration/need for bailout therapy or ICU utilization. The authors note that decompensating events such as cardiac arrest or respiratory failure were less frequent and less severe in the LBMT and occurred solely after and not during catheter placement. This may reflect the risk of indwelling catheters during CDT as well as faster time to thrombus resolution with LBMT. RV function and patient symptoms improved to a greater extent with LBMT.

Decreased ICU utilization may have been biased in favor of LBMT due to variability in institutional protocols, which may mandate ICU monitoring for ongoing thrombolysis following CDT. This nevertheless highlights practical considerations for resource utilization with respect to both different catheter-based technologies and post-procedure ICU and hospital costs. Exploratory clinical outcomes at 30 days were in favor of LBMT, though their relevance particularly to risk of future chronic thromboembolic pulmonary hypertension is unclear. This was an unblinded cohort with no anticoagulation-only or anticoagulation with systemic thrombolysis arm, which would best clarify therapeutic benefit versus bleeding and procedural risk in contemporary practice.

References:

Jaber WA, Gonsalves CF, Stortecky S, et al., for the PEERLESS Committees and Investigators. 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:[Epub ahead of print].

Presented by Dr. Wissam A. Jaber at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 29, 2024.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Interventions and Vascular Medicine

Keywords: Pulmonary Embolism, TCT24, Thrombectomy, Thrombolytic Therapy, Transcatheter Cardiovascular Therapeutics


< Back to Listings