AGENT Subgroups
Name the three sub-analysis groups
Restenosis Risk,
Lesion Preparation, & ACS?
Primary and secondary endpoints for this trial
MSA at site of most calcification (noninferiority)
Procedural cost (superiority)
Stent expansion at max calcium
Primary endpoint for ALLIANCE Registry
TLF at 1 year (4.7%)
What was the primary endpoint difference pursued by Selution4ISR
Thrombosis rate for all AGENT groups treated
ZERO
Name the two differing types of lesion preparation categories utilized for ISR treatment defined in subgroup analysis
CLP Complex lesion prep: atherectomy, specialty balloons, IVL
TBP Typical balloon prep: POBA
Cutting balloon inflations were typically guided based on which previous study
COPS Trial
What percentage of ICI used in registry?
90%
2%
Which trial showed better luminal expansion using wolverine for de novo lesion prep for AGENT
NATURE Trial
Three risk factors used to categorize restenosis risk
What is Insulin-dependent diabetes, RVD ≤3.0 mm, and lesion length ≥30 mm
Average cost savings in total study population
$3600
What was the percentage of AGENT use in the ALLIANCE Registry?
73%
What were the two treatment arms for this trial?
Selution DEB and SOC (DES and POBA)
Primary endpoint for OCVC-BIF trial
>=50% restenosis rate of side branch at 9mo post angiography or symptom driven angiography at 12mo
What was the percentage of ICI was used in all ISR cases in the AGENT PAS
88%
Atherectomy vs Non-atherectomy then further randomized to IVL or wolverine
What were the two most common high risk patient populations included in the registry?
DES over DEB
What number of study patients have been treated with AGENT DCB
16k in studies and 275k total patients treated globally
What outcome holds true across all study populations for patients treated with AGENT
Significant decreases in TLF rates
What was the average number of Wolverine inflations per lesion compared to IVL pulses
3.8 vs 90 pulses
What was the most common lesion type treated?
De novo lesions 97%
What were the major limitations in Selution 4 ISR
Lower risk and less complex patient
population than the AGENT IDE trial
The trial is using a mixed control with 80% DES
randomization that favors a simpler, single-
layer disease
Out of the 12,729 procedures included in the AGENT PAS, what percentage of AGENT balloons were used for off-label indications (range of 5%)?
25-30% (27.2%) through 6/2025