Vai trò của bóng phủ thuốc với nhồi máu cơ tim có ST chênh lên

DRUG-COATED BALLOON
IN PRIMARY PCI FOR STEMI

Ho Hee Hwa


Background
 Primary percutaneous coronary intervention

(PPCI) is the preferred reperfusion therapy for ST
elevation myocardial infarction (STEMI)
 Associated with higher reperfusion rates (vs lytic)
 ↓ rates of reinfarction, CVA and death

 Started with primary angioplasty (POBA)
Associated with abrupt closure, recurrent ischaemia ; occlusion and
restenosis at 6 mths


PAMI-STENT(1999)

Routine implantation of bare metal stents associated with ↓ TVR
6 mth mortality rate was similar


CADILLAC STUDY (2002)

Routine implantation of bare metal stents associated with ↓ TVR
6 mth mortality rate was similar

Use of DES in PPCI for STEMI
 Trials evaluating use of DES in AMI

(Typhoon, Passion, Sesami,etc)
 Meta-analysis of 7 trials: similar mortality
benefit compared to BMS but ↓TLR in DES
 Recent trial : Comfortable AMI (risk of MACE
at 1 year lower with the biodegradable
polymer BioMatrix stent


Drug-eluting stents in AMI
DES
BMS
(RCTs)
TLR
P =0.006

P <0.001

P <0.001

P =0.23

20.0%

12.6%

11.2%
7.8%

6.0%
3.7%

STRATEGY 8 mo
(n = 175)

TYPHOON 12 mo
(n = 700)

4.3%

SESAMI 12 mo
(n = 320)

5.3%

PASSION 12 mo
(n = 619)


Coronary Stenting
 Stenting generally accepted as routine

revascularisation strategy

ACC/AHA 2013
Recommendation
LOE

ESC 2014

I

I

A

A


Primary PCI in STEMI
Is it feasible to use DEB during PPCI?


Issues with DEB in PPCI
 Is DEB effective in a thrombus-laden

artery?
 Can pt tolerate prolonged balloon
inflation?
 Are we willing to accept a less than perfect
result?


DEB in STEMI
 DEB-AMI (drug eluting balloon in acute ST-segment

elevation myocardial infarction) trial: a multicenter
randomized comparison of DEB + BMS versus BMS

versus DES in PPCI with 6-month angiographic,
intravascular, functional, and clinical outcomes.

X

 In STEMI patients, DEB + BMS implantation failed to show

angiographic superiority to BMS only.
 Angiographic results of DES were superior to both BMS and

DEB.

J Am Coll Cardiol. 2012 Jun 19;59(25):2327-37.


TTSH PPCI-DEB Registry
Clinical Efficacy and Safety of Drug-Coated
Balloon Angioplasty as Primary Therapy
in PPCI


PPCI Strategy for DEB
Aspirate + Predilate
Dissection Type A-B
TIMI 3 flow
Residual stenosis < 30%
TIMI thrombus grade 1-2

DEB

PPCI Strategy for DEB
 Bail-out stenting when there is significant

recoil/dissection ( > type B)


TTSH PPCI DEB Registry





Study Period: Jan 2010 to April 2014
Number of Patients: 97 patients
Number of Lesions: 97 lesions
Male: Female (%) = 83: 17
Mean age : 60 + 12 yrs
Clinical Presentation:
N/(%)
Ant STEMI
50(51)
Inf/post STEMI
47 (49)

LVEF (%) : 42 + 11


TTSH PPCI DEB Registry








CVS Risk Factors:
Smoking
Diabetes mellitus
Hyperlipidemia
Hypertension
Prior MI
Prior PCI

N/(%)
48 (50)
33 (34)
50 (52)
55 (57)
13 (13)
13 (13)


TTSH PPCI DEB Registry
Angiographic and Procedural Variables:
 No. of vessel disease
1VD
2VD
3VD

N/(%)
38 (39)
33 (34)
26 (27)

 Bifurcation

46 (47)

 Glycoprotein IIb/IIIa inhibitors

78 (80)


TTSH PPCI DEB Registry
Target Vessel for PCI
LAD

N/(%)
43 (44)

Proximal LAD (de novo )

12 (12)

RCA
CIRC
Others

23 (24)

14 (14)
17 (17)

* Others include

diagonal, PL/PDA, OM


TTSH PPCI DEB Registry
 PCI details:
Thrombosuction

N/(%)
50 (52)

Predilatation

100 (100)


TTSH PPCI DEB Registry
Baseline Thrombus Grade :

N/(%)

 Grade 5

58 (60)

Thrombus Grade before DEB

N/(%)

 Grade 0
 Grade 1
 Grade 2

45 (46)
45 (46)
7 (7)


TTSH PPCI DEB Registry
 PCI details:

POBA (DEB-only)
Stent (DEB+BMS)
 Post PCI TIMI flow
TIMI 2
TIMI 3
 Residual stenosis (%)

N/(%)
93 (96)
4 (4)

2 (2)
95 (98)
27 + 14

TTSH PPCI DEB Registry
 PCI details:

N/(%)
53 + 21 s
10 + 3 atm

Inflation time
Inflation pressure

Reference diameter ,mm
 Mean number of DEB
 Mean size of DEB, mm
 Length of DEB, mm

:
:
:
:

2.45 + 0.5
1.3 + 0.6
2.6 + 0.5
24 + 11


TTSH PPCI DEB Registry
Clinical Outcomes (1 Month):
All cause mortality

MI
TLR
Lesion thrombosis

N= 97/(%)
4 (4)
0 (0)
0 (0)
0 (0)


TTSH PPCI DEB Registry
Clinical Outcomes (9 Month):
MACE
All cause mortality
MI
TLR
Lesion thrombosis

N=93/(%)
6 (6.4)
1 (1)
2 (2.1)
5 (5.4)
0 (0)


June 2015

CASE EXAMPLES