RCT of FlowTriever® vs. catheter-directed thrombolytics in pulmonary embolism - Inari Medical

PEERLESS Study

NCT05111613

Outcomes from the PEERLESS RCT comparing FlowTriever^® Retrieval/Aspiration System, large bore mechanical
thrombectomy, to Catheter-Directed Thrombolytics (CDT) in Hemodynamically Stable Intermediate-Risk
Pulmonary Embolism (PE) presented at TCT 2024 by Dr. Wissam Jaber (Co-PI).

First RCT Evaluating FlowTriever
in Treatment of PE

Jump to outcomes

550 Patients Randomized 1:1

Prospective, international, randomized controlled trial of FlowTriever thrombectomy versus CDT in intermediate-risk PE
550 patients (1:1 FlowTriever vs. CDT) at up to 60 sites in the United States and Europe
Up to 150 patients with absolute contraindications to thrombolytics will be enrolled into an independent non-randomized cohort and treated with the FlowTriever thrombectomy system

Primary Endpoint

Win Ratio composite at discharge (7d max):

All-cause mortality
Intracranial hemorrhage
ISTH major bleeding
Clinical deterioration and/or bailout
ICU admission and ICU length of stay (LOS)

Follow-Up

Patients are assessed at 24-hour visit, discharge, and 30-day visit

With superior outcomes,
only FlowTriever
®
moves PE patients

*LOS= length of stay

3X fewer deteriorations or therapy escalations

Better, faster recovery of symptoms and hemodynamics

Less ICU utilization, hospital LOS^*, and readmission burden

First RCT Evaluating
FlowTriever
in
Treatment of PE

As the first major pulmonary embolism RCT in a decade—and the
first ever to evaluate thrombectomy—PEERLESS marks a pivotal
advancement in PE care, setting a new standard for the field.

Baseline characteristics
of randomized patients

FlowTriever
arm
(n=274)

CDT arm
(n=276)

Age, years

63.7 ± 13.0

61.2 ± 14.8

Female sex

125 (45.6)

134 (48.6)

BMI, kg/m²

34.5 ± 8.6

36.3 ± 9.4

Race and ethnicity

White
Black or African American
Other
Hispanic or Latino

184 (72.4)
67 (26.4)
3 (1.2)
13 (5.2)

193 (74.5)
56 (21.6)
10 (3.9)
27 (10.8)

Relative contraindication to
lytics

12 (4.4)

11 (4.0)

Concomitant DVT

178 (65.0)

168 (60.9)

RV/LV ratio (CTPA + echo)

1.27 ± 0.26

1.31 ± 0.27

Saddle PE

104 (38.0)

109 (39.5)

Elevated troponin

256 (93.4)

265 (96.0)

Values are mean ± SD or n (%).

No patients with absolute contraindications to lytics and few with
relative contraindications (~4%) were randomized in PEERLESS.

These patients were treated separately in a contraindication cohort with
FlowTriever (n=142, 20.5% of enrolled patients).
As a result, patients randomized were at lower risk of CDT bleeding events.

Only FlowTriever System Proven
Superior to CDT

Clear win for FlowTriever on the
5-component win ratio
primary endpoint^*

Primary Endpoint

5.01 (3.68-6.97)
(p<0.001)

Favors CDT

Favors FlowTriever

Primary Endpoint:
win ratio favoring
FlowTriever

FlowTriever superiority driven by hard
clinical outcomes and ICU utilization

Components of
Primary Endpoint

FlowTriever
arm, n (%)

CDT arm,
n (%)

P value

All-cause mortality

0 (0.0)

1 (0.4)

1.00

Intracranial hemorrhage

2 (0.7)

1 (0.4)

0.62

Major bleeding

19 (6.9)

1.00

Clinical deterioration
and/or
escalation to
bailout therapy

5 (1.8)

15 (5.4)

0.038

Postprocedural ICU
admission

ICU stay > 24 hours^‡

114 (41.6)

53 (46.5)

272 (98.6)

178 (65.4)

< 0.001

*A win ratio of 5.01 represents 5.01 times more wins for FlowTriever than CDT when every patient in each study arm is compared across the study’s 5 components in hierarchical order: 1. all-cause mortality; 2. intracranial hemorrhage (ICH); 3. major bleeding; 4. clinical deterioration and/or escalation to bailout; and 5. ICU admission and ICU LOS. The win ratio primary endpoint was assessed through discharge or 7 days post-procedure, whichever occurred first.
‡Percentages reported out of patients with post-procedure ICU admission.

FlowTriever Patients Experience 3X Fewer
Clinical Deteriorations and/or Bailouts vs. CDT

Deteriorations in the CDT arm
were also more severe.

FlowTriever arm
n (%)

CDT arm
N (%)

Clinical deterioration and/or escalation

5 (1.8)

15 (5.4)

Patients with clinical
deterioration

Cardiac arrest
High-grade AV block
Respiratory failure

4 (1.5)
0 (0.0)
0 (0.0)
0 (0.0)

10 (3.6)
2 (0.7)
1 (0.4)
3 (1.1)

Increased oxygen
requirement

1 (0.4)

0 (0.0)

Hypotension

3 (1.1)

4 (1.4)

Patients with escalation to
bailout

1 (0.4)

6 (2.2)*

*5 of 6 CDT patients underwent FlowTriever procedure without adverse events, experienced post-procedural improvement, and were discharged without further intervention. 1 patient in each arm had a PE that could not be treated after multiple bailout attempts (systemic tPA, FlowTriever, CDT) and ultimately died after >7 days.

Patients Get Better, Faster
in a
Single-Session
FlowTriever Procedure

Patients felt less short of breath and had better right ventricular (RV)
function after FlowTriever than with CDT.

mMRC Dyspnea Score at 24-hour visit

FlowTriever patients
(n=259)

CDT patients
(n=250)

Scores 3,4
(more severe)

Scores 0,1,2
(less severe)

2X reduction
in severe dyspnea

RV function at 24-hour visit

FlowTriever patients
(n=178)

CDT patients
(n=171)

Moderately or
severely reduced

Normal or
mildly reduced

Significantly
improved
RV function

FlowTriever Patients Recover Faster,
Go Home Sooner—and Stay There

Great for the patient. Great for the hospital.

Triever results (vs. CDT):

~60^%

fewer
ICU
admissions

41.6% FT vs. 98.6% CDT (p<0.001)

day shorter
total
hospital stay

4.5 FT vs. 5.3 CDT (p=0.002)

~60^%

fewer all-cause
30-day
readmissions

3.2% FT vs. 7.9% CD (p=0.028)

Life Awaits After PE

See the Published Results

Indications for Use:
The FlowTriever Retrieval/Aspiration System is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels; and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters are intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters. The FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.

See Instructions for Use for complete Indications for Use, contraindications, warnings, and precautions.

Caution: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician.

For all non-Inari products, please refer to manufacturer Instructions for Use/Intended Purpose for complete indications for use, contraindications, warnings, and precautions.

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