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PREMIER

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

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Year of Publication: 2023

Authors: Ricardo A Hanel, Gustavo M Cortez, Demetrius Klee Lopes, ..., David F Kallmes

Journal: Journal of NeuroInterventional Surgery

Citation: J Neurointervent Surg 2023;15:248–254

Link: https://doi.org/10.1136/neurintsurg-2021-018501

Clinical Question

What are the long-term (3-year) safety and efficacy outcomes of the Pipeline Embolization Device (PED) for the treatment of small- and medium-sized, wide-necked, unruptured intracranial aneurysms?

Bottom Line

At 3 years, the Pipeline Embolization Device (PED) showed high rates of aneurysm occlusion and a low incidence of major neurological events, with no cases of aneurysm rupture, confirming its long-term safety and efficacy in small and medium unruptured intracranial aneurysms.

        Major Points
        PREMIER is a prospective, single-arm, multicenter trial evaluating the PED in 141 patients with unruptured wide-necked aneurysms ≤12 mm.
The primary effectiveness endpoint (complete aneurysm occlusion without significant stenosis or retreatment) was achieved in 78.3% at 3 years.
Complete aneurysm occlusion (Raymond–Roy 1) at 3 years was 83.3%.
Modified Cekirge–Saatci classification (mCSC) identified a 97.1% success rate including occlusion, neck remnant, or size reduction.
The primary safety endpoint (major stroke or neurologic death) occurred in 2.8% over 3 years.
There were no cases of delayed aneurysm rupture.
Functional independence (mRS ≤2) was maintained in 97.7% of patients at 3 years.

      

Design

Study Type: Prospective, single-arm, multicenter interventional study

Randomization:

Blinding: Not applicable; endpoints were independently monitored and adjudicated

Enrollment Period: July 2014 to November 2015

Follow-up Duration: 3 years

Centers: 23

Countries: USA, Canada, Hungary, Switzerland

Sample Size: 141

Analysis: Two-sided 95% exact binomial test, last observation carried forward for imputation, logistic regression; performed using R and SAS

Inclusion Criteria

Unruptured, wide-necked intracranial aneurysms
Aneurysm size ≤12 mm
Location in ICA (up to terminus) or vertebral artery (up to and including PICA origin)

Exclusion Criteria

Clopidogrel resistance
Full exclusion criteria reported in prior publication

Arms

Field	Pipeline Embolization Device (PED)
Intervention	Treatment with the PED for unruptured wide-necked aneurysms ≤12 mm, followed by dual antiplatelet therapy guided by antiplatelet response testing
Duration	3 years

Outcomes

Outcome	Type	Intervention
Complete aneurysm occlusion (Raymond–Roy 1) without significant parent artery stenosis (≤50%) or retreatment	Primary	78.3% (108/138)
Complete aneurysm occlusion (Raymond–Roy 1)	Secondary	83.3% (115/138)
Successful treatment per mCSC	Secondary	97.1%
Functional independence (mRS ≤2)	Secondary	97.7% (127/130)
Primary safety outcome (major stroke or neurologic death)	Adverse	2.8% (4/140)
Aneurysm rupture	Adverse	0%
Target aneurysm recurrence	Adverse	0.7% (1/138)
Target aneurysm retreatment	Adverse	5.0% (7/138)
Significant in-stent stenosis (>50%)	Adverse	3.6% (5/138)

Subgroup Analysis

Subgroup analysis at 3 years was not reported; prior 1-year analysis identified non-smoking and side branch presence as predictors of incomplete occlusion

Criticisms

Single-arm design without a control group limits comparison with other treatments
Long-term imaging follow-up not mandatory for completely occluded aneurysms after 1 year
Results limited to small- and medium-sized unruptured aneurysms in specific anatomical locations

Funding

Medtronic, Inc.

Based on: PREMIER (Journal of NeuroInterventional Surgery, 2023)

Authors: Ricardo A Hanel, Gustavo M Cortez, Demetrius Klee Lopes, ..., David F Kallmes

Citation: J Neurointervent Surg 2023;15:248–254

Content summarized and formatted by NeuroTrials.ai.

PREMIER

(2023)

Objective

To assess long-term safety and effectiveness of the Pipeline Embolization Device (PED) in treating small- and medium-sized intracranial aneurysms over a 3-year follow-up period.

Study Summary

• The PED demonstrated sustained aneurysm occlusion with low rates of retreatment, complications, and morbidity over 3 years.

Intervention

Endovascular treatment using the Pipeline Embolization Device (PED) for unruptured intracranial aneurysms <12 mm in size located along the internal carotid artery, followed for 3 years for durability and safety.

Inclusion Criteria

Patients aged 22–80 years with unruptured, saccular intracranial aneurysms measuring <12 mm in diameter, located along the petrous to superior hypophyseal segment of the internal carotid artery.

Study Design

Arms: Single-arm study using PED (no comparator arm).

Patients per Arm: 141 patients treated with PED; 135 completed 3-year follow-up.

Outcome

• Complete aneurysm occlusion (Raymond-Roy Class I) in 83.5% (111/133) at 3 years; • Retreatment rate: 2.9%; • In-stent stenosis ≥50%: 4.7%; • Major ipsilateral stroke or neurologic death: 2.2%; • Good functional outcome (mRS 0–2): 98.5%; • No new device-related safety signals observed between 1 and 3 years.

Bottom Line

Major Points

PREMIER is a prospective, single-arm, multicenter trial evaluating the PED in 141 patients with unruptured wide-necked aneurysms ≤12 mm.
The primary effectiveness endpoint (complete aneurysm occlusion without significant stenosis or retreatment) was achieved in 78.3% at 3 years.
Complete aneurysm occlusion (Raymond–Roy 1) at 3 years was 83.3%.
Modified Cekirge–Saatci classification (mCSC) identified a 97.1% success rate including occlusion, neck remnant, or size reduction.
The primary safety endpoint (major stroke or neurologic death) occurred in 2.8% over 3 years.
There were no cases of delayed aneurysm rupture.
Functional independence (mRS ≤2) was maintained in 97.7% of patients at 3 years.

Study Design

Study Type: Prospective, single-arm, multicenter interventional study
Randomization: No
Blinding: Not applicable; endpoints were independently monitored and adjudicated
Sample Size: 141
Follow-up: 3 years
Centers: 23
Countries: USA, Canada, Hungary, Switzerland

Primary Outcome

Definition: Complete aneurysm occlusion (Raymond–Roy 1) without significant parent artery stenosis (≤50%) or retreatment

Control	Intervention	HR/OR	P-value
-	78.3% (108/138)	- (70.4% to 84.8%)	-

Limitations & Criticisms

Single-arm design without a control group limits comparison with other treatments
Long-term imaging follow-up not mandatory for completely occluded aneurysms after 1 year
Results limited to small- and medium-sized unruptured aneurysms in specific anatomical locations

Citation

J Neurointervent Surg 2023;15:248–254

View Original Publication →

PREMIER

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Exclusion Criteria

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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