Transcript The Detrimental Impact of Chronic Renal Insufficiency

KLINIKUM
CO B U R G
A Prospective, Randomized Trial of a
Paclitaxel coated Balloon vs. uncoated
Balloon Angioplasty in Patients with DrugEluting Stent Restenosis
PEPCAD-DES Study
Harald Rittger, MD
University of Erlangen;
Klinikum Coburg
Germany
TCT 2011 – First Report Investigation
Disclosures
• Supported in part by an unrestricted grant by
B.Braun, Melsungen, Germany
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
• Grant/Research Support
• Consulting Fees/Honoraria
• Major Stock Shareholder/Equity
• Royalty Income
• Ownership/Founder
• Intellectual Property Rights
• Other Financial Benefit
Company
• B.Braun, Siemens
• B.Braun, Siemens
• none
• none
• None
• None
• none
Centers
Harald Rittger, MD
Klinikum Coburg
Holger Thiele, MD
Herzzentrum Leipzig
Marc-A. Ohlow, MD
Zentralklinik Bad Berka
Ralf Birkemeyer, MD
Klinikum Villingen-S.
Andreas Brugger, MD
Klinikum Kulmbach
Volker Kurowski, MD
Universität Lübeck
Background
• Drug-eluting stents (DES) significantly reduced the
occurrence of restenosis and the subsequent need for
repeat revascularization.
• Nevertheless, the incidence of DES-restenosis (DES-ISR)
remains frequent due to the continuous increase in DES
implantations.
Background
• Complex lesions with a high restenotic potential are
sufficiently treated with present DES, limiting the use of
bare-metal stents (BMS) to patients not eligible for dual
antiplatelet therapy.
• Paclitaxel coated balloon angioplasty (SeQuent Please,
B.Braun) has been shown to be superior to plain old
balloon angioplasty (POBA) and non-inferior to paclitaxel
eluting stent (PES) implantation for treatment of BMS
restenosis.
Background
• Whether the use of paclitaxel coated balloon angioplasty
is also effective in DES restenosis has not been
sufficiently studied so far.
• We evaluated in a randomized, multicenter, single blinded
trial the efficacy of paclitaxel coated balloon angioplasty
(SeQuent Please, B.Braun, Germany) compared with
plain old balloon angioplasty for DES restenosis in native
coronary arteries.
Inclusion Criteria
•
Age > 18 years
• Lesion in native coronary artery
• DES restenosis of

Sirolimus eluting stents: Cypher, Yukon

Everolimus eluting stents: Xience, Promus

Paclitaxel eluting stents: Taxus
• Indication for PCI (symptoms, ischemia)
• Reference diameter 2.5 – 3.5 mm
• Lesion length ≤ 22 mm
Exclusion Criteria
• thrombus within the target vessel
• side branch ≥ 2 mm in diameter originating within the
•
•
•
•
•
•
•
restenosis or bifurcation lesion
multiple lesions in the target vessel
lesions in bypass grafts
total coronary artery occlusion
lesions within 1 mm of vessel origin or left main
planned surgery within 6 months after the index procedure
women with childbearing potential
contraindication or known hypersensitivity to acetylsalicylic
acid, clopidogrel, paclitaxel or heparin.
Primary Endpoint
• Primary endpoint: six-months late lumen loss at the target
lesion.
• Superiority testing of the primary end point on an intentionto-treat basis.
Primary Endpoint
• With an assumed late lumen loss of 0.20±0.30mm in the
drug coated balloon group and 0.80±0.80mm in the POBA
group the necessary number of patients were 64 in the drug
coated balloon and 34 in the POBA group to achieve 90%
power
• With an assumed dropout rate of 10% the patient numbers
to be recruited were 71 in the drug coated balloon and 38 in
the POBA group.
Secondary Endpoints
• Secondary angiographic endpoints

Binary restenosis, minimal lumen diameter, percent diameter
stenosis (target lesion and total segment)
• Secondary clinical endpoints (definition
according to ARC criteria)




Target lesion revascularization
Myocardial infarction
Death
MACE as a composite of
• cardiac death, myocardial infarction attributable to target vessel, target
lesion revascularization
110 patients enrolled and
randomized (2:1)
predilation
Paclitaxel coated balloon
N=72
6 months
ASS+Clopidogrel
Ballon angioplasty
alone
N=38
6 months
angiographic follow-up
88.9% (N=64/72)
6 months
angiographic follow-up
81.6 % (N=31/38)
6-month
clinical follow-up
100 % (N=72/72)
6-month
clinical follow-up
100 % (N=38/38)
Baseline Characteristics
DCB
POBA
72
38
69.8±10.8 *
52 (72.2%)
64.0±11.3
26 (68.4%)
Diabetes
26 (36.1%)
13 (34.2%)
Hypertension
68 (94.4%)
36 (94.7%)
Hyperlipidemia
59 (81.9%)
27 (71.1%)
History of smoking
11 (15.3%)
6 (15.8%)
BMI – kg/m2
28.1±4.1
27.2±3.5
Number of patients
Age (years)
Male
* p=0.02
Baseline Angiography
DCB
POBA
LAD
24 (33.3%)
16 (39.0%)
CX
23 (32.0%)+
3 (4.9%)
RCA
25 (34.7%)
19 (46.3%)
RVD (mm)
2.29±0.51
2.30±0.52
MLD (mm)
0.66±0.40
0.62±0.44
% DS
72.1±14.5
74.0±16.2
11.2±6.5
12.2±8.2
Lesion location
QCA
Lesion length (mm)
+ p=0.005
Procedural Data
DCB
POBA
Length (mm)
16.0±6.0
16.1±5.5
Diameter (mm)
2.84±0.39
2.76±0.34
Inflation Time (sec)
39.4±26.3
41.9±16.9
Pressure (bar)
15.1±3.8
15.1±3.4
Pre-dilatation balloon
Procedural Data
DCB
POBA
Length (mm)
21.6±6.4*
18.9±6
Diameter (mm)
2.95±0.43
2.92±0.39
Inflation Time (sec)
57.6±16.0
53.2±17.3
Pressure (bar)
14.0±2.5
15.0±5.3
Study Balloon
* p=0.041
Post Procedure QCA
DCB
RD (mm)
POBA
2.47±0.45
2.47±0.58
2.15±0.42
2.14±0.53
12.6±6.2
13.7±6.0
MLD (mm)
Target lesion
Diameter stenosis (%)
Target lesion
Primary Endpoint - Late Loss
100%
POBA
90%
Cumulative frequency
80%
1.03 ± 0.77
70%
60%
50%
40%
30%
20%
10%
0%
-0.5
0.0
0.5
1.0
1.5
Late lumen loss (mm)
2.0
2.5
3.0
Primary Endpoint - Late Loss
P < 0.001
100%
POBA
DCB
90%
Cumulative frequency
80%
0.43 ± 0.61
1.03 ± 0.77
70%
60%
50%
40%
30%
20%
10%
0%
-0.5
0
0.5
1
1.5
Late lumen loss (mm)
2
2.5
3
Late Loss at 6 Months
POBA
P = 0.18
P < 0.001
DCB
P = <0.001
P < 0.001
Follow-up QCA
DCB
POBA
P Value
MLD
1.75±0.70
1.10±0.73
< 0.001
% DS
29.6±24.3
51.1±31.0
< 0.001
MLD
1.65±0.66
1.00±0.68
< 0.001
% DS
32.3±54.7
54.7±29.4
< 0.001
Target lesion
Total segment
Binary Angiographic Restenosis at 6
Months
Binary
Restenosis
(%)
POBA
P < 0.001
DCB
P < 0.001
Clinical Outcomes at 6 Months
DCB
POBA
P Value
11 (15.3 %)
14 (36.8 %)
0.005
Non-target vessel
0 (0%)
0 (0%)
--
Target vessel
0 (0 %)
1 (2.6 %)
0.345
1 (1.4%)
4 (10.5 %)
0.048
Target lesion
revascularization
Myocardial infarction
Cardiac Death
MACE *
12 (16.7 %)
19 (50.0 %) <0.001
*TLR, myocardial infarction attributable to target vessel, cardiac death
Conclusion
• In this prospective, randomized, single-blind, multicenter
study the treatment strategy with paclitaxel coated balloon
(SeQuent Please, B.Braun) compared with balloon
angioplasty alone for treatment of DES restenosis
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
– significantly less MACE
– no definite vessel thrombosis
KLINIKUM
CO B U R G
A Prospective, Randomized Trial of a
Paclitaxel coated Balloon vs. uncoated
Balloon Angioplasty in Patients with
Restenosis of Drug-Eluting Stents
Thank
you very
much
PEPCAD-DES
Study
for your
attention!
Harald Rittger,
MD
University of Erlangen;
Klinikum Coburg
Germany
TCT 2011 – First Report Investigation