TCT DATA

AGENT Subgroups

100

Name the three sub-analysis groups

Restenosis Risk,
Lesion Preparation, & ACS?

200

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

300

Three risk factors used to categorize restenosis risk

What is Insulin-dependent diabetes, RVD ≤3.0 mm, and lesion length ≥30 mm 

400

What was the percentage of ICI was used in all ISR cases in the AGENT PAS

88%

500

What outcome holds true across all study populations for patients treated with AGENT

Significant decreases in TLF rates

SHORTCUT

100

Primary and secondary endpoints for this trial

MSA at site of most calcification (noninferiority) 

Procedural cost (superiority)

Stent expansion at max calcium

200

Cutting balloon inflations were typically guided based on which previous study

COPS Trial

300

Average cost savings in total study population 

$3600

400

What two study arms were patients assigned in this study before being randomized

Atherectomy vs Non-atherectomy then further randomized to IVL or wolverine

500

What was the average number of Wolverine inflations per lesion compared to IVL pulses

3.8 vs 90 pulses

ALLIANCE

100

Primary endpoint for ALLIANCE Registry

TLF at 1 year (4.7%)

200

What percentage of ICI used in registry?

90%

300

What was the percentage of AGENT use in the ALLIANCE Registry?

73%

400

What were the two most common high risk patient populations included in the registry?

Diabetics and High Bleed Risk populations

500

What was the most common lesion type treated?

De novo lesions 97%

SELUTION

100

What was the primary endpoint difference pursued by Selution4ISR

noninferiority

200

What was the thrombosis rate for both arms of Selution4ISR

2%

300

What were the two treatment arms for this trial?

Selution DEB and SOC (DES and POBA)

400

Data showed that one therapy was favored over the other. Which therapy did the data show favoring?

DES over DEB

500

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

Potpourri

100

Thrombosis rate for all AGENT groups treated

ZERO

200

Which trial showed better luminal expansion using wolverine for de novo lesion prep for AGENT

NATURE Trial

300

Primary endpoint for OCVC-BIF trial

>=50% restenosis rate of side branch at 9mo post angiography or symptom driven angiography at 12mo

400

What number of study patients have been treated with AGENT DCB

16k in studies and 275k total patients treated globally

500

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