0. Prospective, Randomized Trial of Paclitaxel-Eluting Balloon versus Paclitaxel-Eluting Stent versus Balloon Angioplasty for Treatment of Coronary Restenosis in Limus-Eluting Stents
Robert A. Byrne, Julinda Mehilli, Salvatore Cassese, Franz-Josef Neumann, Susanne Pinieck, Tomohisa Tada, Klaus Tiroch, Christian Valina, Karl-Ludwig Laugwitz, Steffen Massberg, Adnan Kastrati
Deutsches Herzzentrum, Technische Universität, Munich
Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen
1. Medizinische Klinik, Klinikum rechts der Isar, Munich. GERMANY
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

1. Prospective, Randomized Trial of Paclitaxel-Eluting Balloon versus Paclitaxel-Eluting Stent versus Balloon Angioplasty for Treatment of Coronary Restenosis in Limus-Eluting Stents
Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches
ISAR-DESIRE 3
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

2. Disclosure Statement of Financial Interest
I, Robert A. Byrne 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
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

3. Background
The optimal treatment of drug-eluting stent (DES) restenosis remains unknown
Drug-eluting balloon therapy has the advantage of avoiding additional stent layers but its role in the treatment of DES restenosis is poorly defined
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches 3

4. Study Objective To compare the anti-restenotic efficacy of:
paclitaxel-eluting balloon (SeQuent Please)
versus
paclitaxel-eluting stent (Taxus Liberte)
balloon angioplasty alone
in patients with limus-DES restenosis
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches 4

5. Study Organization Design DESIGN:
402 patients with DES-restenosis enrolled between August 2009 and October 2011 in 3 centers in Germany
DESIGN:
Prospective, randomized, active controlled, multicenter clinical trial
INCLUSION CRITERIA:
Stenosis > 50% in “limus”-eluting DES
Symptoms/signs of ischemia
EXCLUSION CRITERIA:
Lesion in left main stem
Acute STEMI
Cardiogenic shock
SPONSOR: Deutsches Herzzentrum
Paclitaxel-eluting stent
(Taxus)
(N=131)
Balloon angioplasty alone
(N=134)
Paclitaxel-eluting balloon
(SeQuent) (N=137)
Angiographic follow-up at 6-8 months in 84.1% (N=338)
Clinical follow-up at 12 months
in 97.5% (N=392)
No significant differences across groups
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

6. Study Organization Design PRIMARY ENDPOINT:
402 patients with DES-restenosis enrolled between August 2009 and October 2011 in 3 centers in Germany
PRIMARY ENDPOINT:
Percent diameter stenosis at follow-up angiography
TEST HYPOTHESES:
PEB non-inferior to PES
%DS 35%; Delta = 7%
alpha = 0.05; Power = 80%
102 Patients/group
PEB and PES superior to balloon angioplasty
%DS 35% vs. 45%
alpha = 0.025; Power 90%
101 Patients/group
Paclitaxel-eluting stent
(Taxus)
(N=131)
Balloon angioplasty alone
(N=134)
Paclitaxel-eluting balloon
(SeQuent) (N=137)
Angiographic follow-up at 6-8 months in 84.1% (N=338)
Clinical follow-up at 12 months
in 97.5% (N=392)
No significant differences across groups
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

7. Baseline Characteristics
Patients
PEB N = 137
PES N = 131 BA
N = 134
Age (years)
67.7
68.8
67.1
Male
76.6
67.2
70.9
Diabetes mellitus
40.9
46.6
37.3
Multivessel disease
94.2
93.1
94.8
ACS (Troponin +)
19.0
16.8
23.1
No significant differences across groups
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

8. Baseline Characteristics
Lesions
PEB N = 172
PES N = 168 BA
N = 160
ISR Morphology, %
Focal
69.2
65.5
65.7
Diffuse
25.6
29.2
28.1
Proliferative
1.7
1.8
0.6
Occlusive
3.5
3.6
5.6
No significant differences across groups
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

9. Baseline Characteristics
Procedures
PEB N = 172
PES N = 168 BA
N = 160
Vessel size (mm)
2.75
2.80
2.72
Lesion length (mm)
12.5
12.7
MLD, pre (mm)*
0.97
0.93
0.88
Stenosis, pre (%)*
64.4
66.7
67.7
No significant differences across groups; *in-stent analysis
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

10. Baseline Characteristics
Procedures
PEB N = 172
PES N = 168 BA
N = 160
Treated per protocol (%)*
93.6
92.9
93.8
Balloon pressure (atm)†
13.7
15.9
15.4
MLD, post (mm)†
2.29
2.53
2.10
Stenosis, post (%)†
18.5
12.8
23.3
*No significant differences across groups
† p<0.001
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

11. Results
ISAR-DESIRE 3
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

12. Primary Endpoint Diameter Stenosis at Follow-up Angiography 100 80 60
Paclitaxel-Eluting Balloon (PEB)
Paclitaxel-Eluting Stent (PES) 80
Balloon Angioplasty (BA) 60
PEB versus BA
PES versus BA
Psuperiority <0.001
PEB 38.0%
Cumulative Frequency (%) 40
PES 37.4%
BA 54.1% 20
PEB versus PES
Pnon-inferiority =0.007 20 40 60 80
100
Diameter Stenosis at Follow-up Angiography (%)
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches

13. Target Lesion Revascularization
Secondary Endpoint
Binary Restenosis
Target Lesion Revascularization
PEB versus BA
PES versus BA
P <0.001
PEB versus BA
PES versus BA
P <0.001 % %
P = .61
P = .09
PEB BA
PES
PEB BA
PES
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches 13

14. Death/Myocardial Infarction
Secondary Endpoint
Death/Myocardial Infarction 50 %
PEB versus PES P =.35
PEB versus BA P =.36
PES versus BA P =.97 40 30 20
Balloon Angioplasty 6.8%
Paclitaxel-Eluting Stent 6.9%
Paclitaxel-Eluting Balloon 4.4% 10 2 4 6 8 10 12
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches 14

15. Target Lesion Thrombosis
Secondary Endpoint
Target Lesion Thrombosis
PEB vs PES P =.97
PEB vs BA P =.33
PES vs BA P =.31
PEB
PES BA %
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches 15

16. Conclusions
In patients presenting with “limus”-DES restenosis, PEB therapy is non-inferior to repeat stenting with PES
Both PEB and PES therapy are superior to balloon angioplasty alone
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches 16

17. Conclusions
By obviating the need for additional stent implantation treatment with a drug-eluting balloon should be the treatment of choice in patients presenting with “limus”-DES restenosis
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches 17

18. Thank You
Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches