Clinical Evidence: e-Ultimaster Bifurcation

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

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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 characteristics	All bifurcation n=4,395
Mean age, year	65.6±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, n	1.5±0.8
Num of stents/pt, n	1.9±1.1
Total stent length/pt, mm	37.6±24.6
Present with ACS, %	48.4
Both main and side branch treated, %	51.8
Both main and side branch stented, %	23.9

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Result

1 year outcomes in all bifurcation patients

1 year clinical outcomes

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Procedural differences based on big data by propensity matched analysis

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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

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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

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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

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