Transcript EuroPCR 2009

A Prospective, Randomized Trial Evaluating a
Paclitaxel-Eluting Balloon in Patients TReated
with Endothelial Progenitor Cell CapTuring Stents
for De Novo Coronary Artery Disease
PERfECT Stent Study
Jochen Wöhrle
University of Ulm
Ulm, Germany
TCT 2010 – First Report Investigation
Background
• Treatment of coronary stenosis with drug eluting stents reduce
– the restenosis rate and the need for repeat revascularization,
but
– about 1/3 of restenoses occur proximal or distal to the stent, and
– there is a continuous risk for late stent thrombosis (incomplete
endothelialization, inflammatory response due to coating).
• With a paclitaxel coated balloon the administration of the
antiproliferative drug is homogenous to the vessel wall without peaks
at stent struts (no further need for coating of stent struts).
• Endothelial progenitor cell capturing (EPC) stents with human antiCD34 antibodies on the surface facilitate rapid endothelialization of
the stent struts.
• EPC stents were associated with low rates of stent thrombosis, even
in complex lesions.
120 patients enrolled and
randomized
Age > 18 years
Lesion in native coronary artery
De-novo stenosis
Indication for PCI
Reference diameter 2.5-4.0 mm
Lesion length ≤ 25 mm
Stratified according to
Presence of diabetes mellitus
Paclitaxel coated balloon
plus EPC stent
N=62
EPC stent alone
N=58
6 months
angiographic follow-up
95.2 % (N=59/62)
6 months
angiographic follow-up
96.6 % (N=56/58)
6 months
clinical follow-up
100 % (N=62/62)
6 months
clinical follow-up
100 % (N=58/58)
Late Loss at 6 Months
EPC Stent
Late Loss
(mm)
P = 0.01
Paclitaxel Coated Balloon and EPC Stent
P < 0.001
1.0
1
P = 0.20
P < 0.001
0.88
0.8
0,8
0.61
0.6
0,6
0.34
0.4
0,4
0.2
0,2
0.21
0.04
0.02
0.09
0.16
00
Proximal
In-Stent
primary
endpoint
Distal
Total
Binary Angiographic Restenosis at 6 Months
EPC Stent
Binary
Restenosis
(%)
Paclitaxel Coated Balloon and EPC Stent
P = 0.009
P = 0.005
30
23.2
21.4
20
10
5.1
N=3
5.1
N=12
N=3
N=13
0
In-Stent
Total Segment
Clinical Outcomes at 6 Months
Target lesion
revascularization
Paclitaxel Coated
Balloon plus EPC Stent
EPC Stent
alone
P Value
3 (4.8 %)
9 (15.5 %)
0.05
1 (1.6 %)
1 (1.7 %)
0.96
0 (0 %)
0 (0 %)
--
0 (0%)
1 (1.7 %)
0.30
3 (4.8 %)
10 (17.2 %)
0.03
0 (0 %)
0 (0 %)
--
Myocardial infarction
Non-target vessel
Target vessel
Death
MACE*
Definite / probable stent
thrombosis
* TLR, myocardial infarction not attributable to non-target vessel, cardiac death
Conclusions
• In this prospective, randomized, single-blind, multicenter
study the combined treatment strategy with paclitaxel
coated balloon and EPC stent implantation compared with
EPC stent implantation alone for treatment of de-novo
coronary artery disease showed:
– A significantly lower late loss (primary endpoint)
– A significantly lower binary restenosis rate, percent
diameter stenosis and a significantly larger minimal
lumen diameter at follow-up
– A significantly lower combined clinical endpoint
– No definite / probable stent thrombosis