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oktober 21 2007 DEB for Bifurcations 1
A Paclitaxel-Eluting Balloon for Bifurcation Lesions :
‘ Early Clinical Observations ‘
Pieter R. Stella, MD Director CardioVascular Research University Medical Centre Utrecht The Netherlands [email protected]
“ Innovative Devices : Non Stent Technologies : Drug Eluting Balloons “
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oktober 21 2007 DEB for Bifurcations 2
Disclosure Statement of Financial Interest
I, Pieter Stella, DO NOT have a financial interest/arrangement
or affiliation with one or more organizations that could be
perceived as a real or apparent conflict of interest in the context
of the subject of this presentation.
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Background
• Stents have become very popular and widely used
• DES is more effective in preventing in-stent restenosis
• However : Concern about long term safety of DES
Permanent implant
Live-long dual antiplatelet therapy ?
Not always easy in real challenging anatomy . . .
ic: BIFURCATIONS
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Bifurcations
• Bifurcation lesion intervention is performed in about 8-15% of PCI at most centers
• Most of these lesions are complex (type C of ACC/AHA class)
• Technically challenging with higher learning curve
• PCI of these lesions requires higher number of devices
• Higher MACE and higher restenosis
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Various Techniques for Stenting Bifurcation Lesions
Bifurcation Lesion
Mainvessel
Side-branch
Stent+PTCA Stent+stent(“T stenting”)
Stent+stent(“Y” or “V”)
“V”2
1
1
Stent+stent(“Culotte”)
1 2
Stent+stent(“reverse-T”)
Stent+stent(“Crush”)
2 1
Provisional ‘T’
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oktober 21 2007 DEB for Bifurcations 6
Restenosis following Bifurcation Sirolimus-Eluting Stents for De Novo Narrowings
6-Months Follow-Up (N = 58; 65 Lesions)
Tanabe et al, Am J Cardiol 2004;91:115
0
5
10
15
MACE Death MI TLR Stent thrombosis
10.3
1.7
0 0
8.6
%
Angiographic restenosis (n=44)• Main branch 9.1%• Side branch 13.6%• Overall 22.7%
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oktober 21 2007 DEB for Bifurcations 7
MV and SB Stenting vs. Optional SB Stenting Using Sirolimus-Eluting Stents in Bifurcation Lesions: NORDIC Bifurcation Study
Procedure-Related Biomarker Elevation
Steigen et al, ACC 2006
0
5
10
15
20
25
%
> 3 elevation > 5 elevation > 10 elevation
MV (n = 153)MV + SB (n = 126)
8
P = 0.008
P = 0.011
53
13
4
18
P = NS
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Where would DEB fit in ?
• Ease of the procedure
• No scaffolding of the SB ostium required
• No crushing of DES-material ( polymer / drug )
• Significant decrease in dual antiplatelet therapy
• Dilatation of small diameter coronary artery (SB ) with better long-term results
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DIOR™ Technology:
Paclitaxel loading/ balloon surface: 3 µg/mm²
Coating method: nano porous balloon surface, pacliataxel micro crystals (following dimethilsulfate treatment)
Protection of wash off effect: drug hidden within the balloon folds
Balloon inflation time recommended: 35-45 sec. @ nominal balloon pressure
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Drug Eluting Balloon in bIfUrcation Trial“ DEBIUT “
120 pts
BMS/ POBA DES/POBA BMS/DEB
1. Randomised prospective multi centre , 9 month angiografic FU, 5 Years clincal FU
2. Provisional T stenting technique
3. Dual antiplatelet therapy arm I + III for 3 months
4. Non sponsor driven
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Drug Eluting Balloon in bIfUrcation Trial“ DEBIUT “
Registry: ( june – august 2007 )
20 pts
clinical FU 4 months ( +/- 1 )
sequential predilatation MB / SB
followed by BMS in MB
final kissing with regular balloons
Clopidogrel stopped in all @ 3 months after index procedure
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“ DEBIUT “ - registryCharacteristics Number of patients
(n = 20)
Age (years [range]) 68 (41 – 78)
Male sex, n (%) 14 (70)
Current or ex-smoker, n (%) 15 (75)
Hypercholesterolemia, n (%) 16 (80)
Hypertension, n (%) 14 (70)
Diabetes mellitus, n (%) 6 (30)
Previous myocardial infarction, n (%) 5 (25)
Previous CABG, n (%) 5 (25)
LVEF, % 49
Glycoprotein IIb/IIIa inhibitor use, n (%) 4 (20)
Lesion characteristics
LAD/diagonal, n (%) 17 (85)
LCX/OM, n (%) 1 (5)
LM/LAD/LCX, n (%) 0 (0)
RCA/RCA-PL/RCA-PD, n (%) 2 (10)
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oktober 21 2007 DEB for Bifurcations 13
Drug Eluting Balloon in bIfUrcation Trial“ DEBIUT “
Medina classification type:(proximal main branch, distal main branch, and side branch involvement
Number of patients (n = 20)
(n [%])
1.1.1 12 (60)
1.1.0 2 (10)
1.0.1 4 (20)
0.1.1 2 (10)
QCA Main branch Side branch
Lesion length (mm)
15.5 +/- 5.0 4.2 +/- 2.8
Stent length (mm)
19.0 +/- 6.0 -
Reference vessel
diameter (mm)
3.0 +/- 0.6 2.4 +/- 0.4
100 % successful
No MACE , no SAT
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Conclusions
• Preliminary results look very promising : ‘ safe & easy ‘
• Long term results in de novo unknown
• Indications mainly in difficult anatomy ??
• First results “ DEBIUT “ : TCT 2008
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Some cases if time allows . . .
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Patient Case DEBIUT Registry
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Patient Case DEBIUT Registry
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Patient Case DEBIUT Registry
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Patient Case DEBIUT Registry
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Patient Case DEBIUT Registry
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Patient Case DEBIUT Registry
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oktober 21 2007 DEB for Bifurcations 22
Patient Case DEBIUT Registry
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oktober 21 2007 DEB for Bifurcations 23
Patient Case DEBIUT Registry