Bóng phủ thuốc cho các tổn thương mạch máu dưới gối Chúng ta đã biết những gì

NOTHING MUCH CHANGED

SINCE

2012

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Why INTEREST in BTK Lesions
“Real-World”

lesions in SEA

“Real-World”

impact for SEA patients

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


60-70% of PVD work is BTK
20-30% at At Ankle

1st Presentation is Tissue Loss
Long healing time is required

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


A Schmidt et al Catheter Cardiovas

Intervent

2010
58 CLI patients 62 limbs
Mean lesion length 183mm
Re-stenosis > 50% after 3 months

68.8%
THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Fernandez et al

J Vas Surg 2010:52 834-42

111 CLI patients
1 year follow up
Duplex patency 33%
Re-intervention rate

<50% re-stenosis
50%
THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Longevity is the main Issue






Stents answer a structural problem
Medications

answer a re-stenosis

problem

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Stents address a structural issue
Role of BMS in BTK post CTO Angioplasty Salvage
situation
Xu G, Tang ZH, Cheng SC ASVS Kyoto 2010
1 year period 12 Limbs (10 patients) out of 130

Limbs

Restenosis >50% on duplex/ DSA/CTA
Restenosis rate 91.2% by one month
follow up
Re-occlusion rate 100% by 4 months

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


YUKON, ACHILLES, DESTINY Trials
•
Short lesions < 3cm
•

Feasibility across joints/Movement

•

Feasibility of “full metal jacket”

•

Stent still remains

points


Deal with long length lesions
No residual inflammatory reaction inciting stents
No concerns across joints and areas of movement
5-10% may still need stents (?DES) for salvage reasons

THE 15 TH NATIONAL CONGRESS

OF CARDIOLOGY

2016


TIMELINE OF EVENTS
2009

0.014 MonoRx Platform

2010

OTW 0.014 Platform Available

2010-2012
2013-Present

DCB Era started withInvatec
Lutonix / Ranger

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


•

Leipzig BTK Registry Schmidt A et al 2011

•

107 patients treated Amphiron DCB

•

60.5% total occlusion Rutherford class V 63.2%

Angiographic evidence of >50%
stenosis at 3 months

BTK POBA

BTK DEB

69%

27%


Medtronic, Inc.
8200 Coral Sea Street NE Mounds View, MN 55112
www.medtronic.com
Urgent Field Safety Notice IN.PACT® Amphirion DrugEluting Balloon (DEB)
November, 2013 Medtronic reference # FA597
Dear Healthcare Professional (Hospital Administrator,
OR Manager, and Risk Manager),
Based on data from the IN.PACT® DEEP clinical study,
Medtronic has decided to voluntarily recall and stop
selling the IN.PACT Amphirion drug-eluting balloon
THE 151HNATIONAL CONGRESS

(DEB). Only the IN.PACT Amphirion DEB is subject to

OF CARDIOLOGY

2016

IN.PACT DEEP Randomized Trial

Zeller et al J Am Coll

Cardio 2014 Oct
Multicenter Prospective

2:1 DEB : POBA

358 CLI patients
End-points CD-TLR LLL

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


CD-TLR

DEB 9.2%

POBA 13.1% p=0.291

LLL DEB 0.61 +/- 0.78mm
p=0.950

POBA

0.62 +/- 0.78mm

A safety signal driven by major amputations through
the IA-DEB arm versus the
12 months was observed in
PTA arm (8.8% vs. 3.6%; p =
0.080).

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


MEANWHILE IN SINGAPORE
2010-2012

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Tan Tock Seng Hospital Registry 2010 Loong TH etal
24 patients agreed to the use of DEB
DEB use after predilatation with uncoated balloon
Patients that need DES or BMS stent salvage not

included in analysis
All started on double antiplatelets for at least 3
months
At ankle and below ankle cases included as well
THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Safety– Acute Re-Thrombosis
Limb Salvage
1 Month 3 Month 6 Month Patency by Duplex

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


DEB Use in BTK Lesions
Age Range

45-94

Mean

67.6

Males

12 ( 57%)

Females

9 (43%)

DM

19 (90%)

HPT

16 (76%)

Hyperlipidaemia

13 (62%)

IHD

8 (38%)

Smoking

2 (10%)

2 patients passed away > 30
days after intervention from
unrelated causes
19 patients 1 BKA- ascending
infection, vessel patent

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Mean lesion length 140mm
Percentage of > 50%

re-

stenosis on duplex
1 Months 0%
3 Months 10%
6 Months 20%
THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016