M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular Diseases On behalf of the PEPCAD II Investigators The P aclitaxel-E luting P TCA- Balloon Catheter in C oronary A rtery D isease PEPCAD II-ISR
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M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular.
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M.Unverdorben; ACC March 2008
Martin UnverdorbenRotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular
Diseases
On behalf of the PEPCAD II Investigators
The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary
Artery Disease
PEPCAD II-ISR
M.Unverdorben; ACC March 2008 2
Presenter Disclosure Information
PEPCAD II 12-Month Follow-up
The following relationships exist related to this presentation:
M.Unverdorben Nothing to disclose
B.Scheller Consulting and lecture fees from BBraun, co-patent owner of Sequent® Please
M.Unverdorben; ACC March 2008 3
AgendaAgendaThe PACCOCATH technology
PEPCAD II ISR 6-month angiographic and clinical follow-up
PEPCAD II ISR 12-month clinical follow-up
Descriptive statistics: Mean ± SD Inferential statistics: Student’s t-test, Fisher’s
exact test, Logrank test Level of significance: p < 0.05
Total MACE (w/o noncardiac death) 3/64 (4.7%) 11/60 (18.3%)
0.02
fNSTEMI due to side branch occlusion
*1 cardiac, not lesion related 2 non cardiac
** non-cardiac death
M.Unverdorben; ACC March 2008 15
Event Free Survival (ITT/As-Treated)
70
75
80
85
90
95
100
0 2 4 6 8 10
Sub
ject
s [%
]
DES/ I TT DEB/ I TT
DES/AsT DEB/AsT
*p=0.2ITT
*p=0.03As-Treated
Months post PCI *Logrank test
M.Unverdorben; ACC March 2008 16
12-Month Follow-up: As-Treated
60 DES2 with additional
DES
66 DEB56 DEB only6 DEB + BMS4 DEB (cross-
over)
Unknown today
2/60 (3.3%)
Lost to FU1/60 (1.7%)
Follow-up12.3±0.8 months
57/60 (95.0%)
Deaths3/60 (5%)
Unknown today
1/66 (1.5%)
Lost to FU0/60 (0%)
Follow-up12.3±0.7 months
59/60 (98.3%)
Deaths2/66 (3.0%)
M.Unverdorben; ACC March 2008 17
12-Month Event Free Survival (ITT/As-Treated)
70
75
80
85
90
95
100
0 5 10 15
Sub
ject
s [%
]
DES/ I TT DEB/ I TT
DES/AsT DEB/AsT
P*=0.09ITT
P*=0.01As-Treated
Months post PCI *Logrank test
M.Unverdorben; ACC March 2008 18
Events From 6 to 12 Months
DEB
–2 Px with PCI in non-target vessel
–1/66 (1.5%) Px with re-re PCI in target lesion
DES
–2 Px with non-cardiac death
–3/60 (5%) Px with re-re PCI in target lesion
No new patient with MACE
M.Unverdorben; ACC March 2008 19
Summary PEPCAD II
In the treatment of ISR the paclitaxel-eluting balloon catheter Sequent® Please (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate,
–exhibited a significant reduction in 6-month late lumen loss and 6/12-month MACE when compared to the Taxus® stent, and
–was not associated with late thrombosis in 250 patient years.
M.Unverdorben; ACC March 2008 20
The PEPCAD II InvestigatorsF.X. Kleber, Unfallkrankenhaus Berlin
H. Heuer, N. Schulze-Waltrup; St. Johannes Hospital,
Dortmund
C. Vallbracht; Herz- und Kreislaufzentrum, Rotenburg an der
Fulda
B. Scheller; Universitätsklinikum des Saarlandes,
Homburg/Saar
C. Hengstenberg, Universitätsklinikum, Regensburg
M. Leschke; Städtische Kliniken, Esslingen C. Hamm, M. Rau; Kerckhoff Klinik, Bad Nauheim
G. Werner; Städtisches Klinikum, Darmstadt
D. Antoni; Krankenhaus Bogenhausen, MünchenW. Bocksch; Charité Virchow, Berlin
H.Ackermann; Department for Biostatistics, University of Frankfurt/M
M.Boxberger, B.Braun, BerlinR.Degenhardt, M.Unverdorben; Clinical Research Institute,
Rotenburg an der Fulda
M.Unverdorben; ACC March 2008 21
The PEPCAD ProgramPaclitaxel-Eluting PTCA-Catheter in Coronary Artery
Disease Title Design Status PIPEPCAD I SVD
Sequent in ≤2.8mm, 120px, multi-center, GER
6mo-FU 12mo-FU
MU, CRI
PEPCAD II ISR
Sequent vs Taxus in ISR, 131px, multi-center, GER
6mo-FU 12mo-FU
MU, CRI
PEPCAD III Sequent + pre-loaded Coroflex Blue vs Cypher, 600 px, Europe
Q2/07 recruiting
B.SchellerC.Hamm
PEPCAD IV DM
Sequent vs Taxus in DM, 160px, multi-center, Thailand, Malaysia
Q2/07 recruiting
D.Rosli, MU, CRI
PEPCAD V BIF Sequent, 25px, dual-center, GER
Q3/ 07 recruiting
D.Mathey F.Kleber MU, CRI INDICOR Coroflex
Blue+Sequent, Real World, 100px
IRB U.Kaul, MU,CRI
M.Unverdorben; ACC March 2008 22
This is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.