e-Ultimaster Bifurcation sub-analysis

Overview

・4,395 patients with Bifurcation lesions treated with Ultimaster™ DES showed acceptable clinical outcomes with TLF 5.1%.
・Ultimaster™ with POT technique improve clinical outcomes.

Study Design

clinical_evidence_e_ultimaster_bifurcation_study_design

Primary Endpoint

Target lesion failure at 1 year

・Cardiac death, target vessel MI or clinically driven target lesion revascularization

Study Outline

Patient background and procedure

Patient characteristicsAll bifurcation
n=4,395
Mean age, year65.6±11.1
Male patients, %76.5
Hypertension, %68.8
Diabetes, %27.2
Hypercholesterolemia, %62.1
Current smoker, %20.5
Renal impairment, %9.1
Present with ACS, %48.4
Lesion/procedure
characteristics
All bifurcation
n=4,395
Radial access, %80.2
Num of lesions treated, n1.5±0.8
Num of stents/pt, n1.9±1.1
Total stent length/pt, mm37.6±24.6
Present with ACS, %48.4
Both main and side branch treated, %51.8
Both main and side branch stented, %23.9

clinical_evidence_e_ultimaster_bifurcation_procedure_background

Result

1 year outcomes in all bifurcation patients

1 year clinical outcomes

clinical_evidence_e_ultimaster_bifurcation_outcome

Procedural differences based on big data by propensity matched analysis

clinical_evidence_e_ultimaster_bifurcation_procedual_difference

One vs Two stent

Both Ultimaster implantation with one-stent technique and that with two-stent technique showed excellent results. These results indicate Ultimaser can shift treatment strategy from one-stent strategy to two-stent strategy without increasing TLF.
1 year clinical outcomes

clinical_evidence_e_ultimaster_bifurcation_one_vs_two_stent.png

POT vs no POT

UltimasterTM implantation with POT technique improved clinical outcomes in treatment of bifurcation lesions. UltimasterTM is the one and only stent that proved the effectiveness of POT technique in bifurcation lesions.
1 year clinical outcomes
clinical_evidence_e_ultimaster_bifurcation_pot_vs_no_pot.png

Final kissing balloon vs No final kissing balloon

Both UltimasterTM implantation with FKB technique and that with No FKB technique showed excellent results. These results indicate that in cases requiring FKB technique not so much, UltimaserTM may be able to skip FKB technique while maintaining low event rate.
1 year clinical outcomes

clinical_evidence_e_ultimaster_bifurcation_kbt_vs_no_kbt

True bifurcation vs other bifurcation

Good performance of UltimasterTM for both true and other bifurcation lesions.
1 year clinical outcomes

clinical_evidence_e_ultimaster_bifurcation_tbf_vs_obf

Reference