Transcript 2. Preliminary 6-months Results of the DESTINY 2

BEC 2014, София
A.Z. Sint-Blasius, Dendermonde
Marc Bosiers
Koen Deloose
Joren Callaert
Imelda Hospital, Bonheiden
Patrick Peeters
Jürgen Verbist
Preliminary 6-months Results
of the DESTINY 2 trial
OLV Hospital, Aalst
Lieven Maene
R.Z. Heilig Hart, Tienen
Koen Keirse
Bart Joos
Koen Deloose, MD
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Level 1 evidence in the coronaries…
Stettler C. et al (2007). Lancet, 370(9591), 937-948.
Roiroin C. et al (2006). Heart, 92, 941-949.
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Transfer the enthousiasm to the BTK…???
?
Tibial vessels
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Randomized trials for DES-BTK
• Achilles
 Sirolimus eluting (Cypher) stent vs. POBA
• Yukon
 Sirolimus eluting (Yukon/no polymer) stent vs. BMS
• Destiny
 Everolimus eluting stent (Xience) vs. BMS (Multilink Vision)
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YUKON, DESTINY & ACHILLES trials (n=515)
overview of 1-year Primary Patency
Rastan A. et al (2011). European Heart Journal, 32, 2274-2281
Bosiers M. et al (2012). Journal of Vascular Surgery, 55, 390-398
Scheinert D. et al (2012). Journal of the American College of Cardiology, 60, 2290-2295
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overview
Primary Patency
100
90
DES-registry
80
BMS-registry
70
DES-RCT
60
50
BMS-RCT
40
30
Linear (DES-Registry)
20
Linear (BMS-Registry)
10
0
0
5 10 15 20 25 30 35 40 45 50 55 60
Time (months)
Biondi-Zoccai G. et al (2009). Journal of Endovascular Therapy, 16(3), 251-260.
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Excellent results…
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…but for very small lesion lengths
Average lesion length: 15.9mm
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…not according to daily reality…
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Real world = Longer lesions
Drug eluting stents: treatment effect
Procedure
PTA only
DES
PTA only
Follow-up
• Long term vessel patency is limited by
patency rate of segment treated with PTA only
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Real world = Longer lesions
• Coronary DES trials showed
– Inadequate lesion coverage may
contribute to edge stenosis
Increased risk for restenosis
if full index lesion is not
completely covered by DES
Sakurai et al. Am J Cardiol 2005;96:1251–1253.
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DESTINY 2 study
Prospective, non-randomized, multi-center study
To evaluate the immediate and long-term (up to 12
months) outcome of the XIENCE PRIME Everolimus-Eluting
Coronary Stent System (Abbott Vascular) in 30 – 100 mm
lesions
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DESTINY 2 study
Device description
XIENCE PRIME Everolimus-Eluting Coronary Stent System
(Abbott Vascular)
• Balloon-expandable stent
• Everolimus-eluting
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DESTINY 2 study
Participating centers
• BELGIUM
–
–
–
–
M. Bosiers, K. Deloose, J. Callaert - AZ Sint-Blasius, Dendermonde
P. Peeters, J. Verbist - Imelda Hospital, Bonheiden
L. Maene, R. Beelen - OLV, Aalst
K. Keirse - RZ Heilig Hart, Tienen
• GERMANY
– D. Scheinert - Herzzentrum Leipzig
– T. Zeller - Herz-zentrum Bad Krozingen
– G. Torsello - St Franziskus Hospital, Münster
• AUSTRALIA
– R. Varcoe - Prince of Wales Private Hospital, Sydney
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DESTINY 2 study
Study design
Main inclusion criteria
• Rutherford classification 4 & 5
• De novo lesion in the infrapopliteal arteries
• Total target lesion length : 30mm - 100mm
Primary endpoint
• Primary patency at 12 months, defined as:
absence of restenosis (≥50% stenosis) or occlusion within the
originally treated lesion based on angiography, verified by
Core Lab.
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DESTINY 2 study
Timeline
proc
disch
1M
6M
12 M
Medication
Physical examination
Rutherford
ABI
Core Lab Angiography
Core Lab Ultrasound
Core Lab X-ray
To date:
Preliminary 6 months results of
1st 30 patients available
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DESTINY 2 study:
Patient demographics
N=30
Male (%)
22 (73.3%)
Age (min – max; ±SD)
74 (48 – 91; ±11.76)
Nicotine abuse (%)
8 (26.7%)
Hypertension (%)
20 (66.7%)
Diabetes mellitus (%)
17 (56.7%)
Renal insufficiency (%)
11 (36.7%)
Hypercholesterolemia (%)
14 (46.7%)
Obesity (%)
11 (36.7%)
Rutherford 4 (%)
14 (46.7%)
Rutherford 5 (%)
15 (50.0%)
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DESTINY 2 study:
Lesion characteristics
N=30
Left/Right limb (%)
Lesion length
14 (46.7%) / 16 (53.3%)
48.6 mm
Reference vessel diameter
Mean lumen diameter
Occlusion (%)
3.1 mm
0.3 mm
11 (36.7%)
Calcified lesion (%)
12 (40.0%)
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DESTINY 2 study:
6 Month Survival – 1st 30 patients
95.0 %
time
baseline
1MFU
6MFU
at risk
30
28
21
%
100
100
95.0
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DESTINY 2 study:
6 Month Primary Patency – 1st 30 patients
93.2 %
time
baseline
1MFU
6MFU
at risk
30
27
20
%
100
93.2
93.2
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DESTINY 2 study:
6 Month Freedom from TLR – 1st 30 patients
92.6 %
time
baseline
1MFU
6MFU
at risk
30
28
20
%
100
96.7
92.6
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DESTINY 2 study:
6 Month Limb salvage – 1st 30 patients
96.7 %
time
baseline
1MFU
6MFU
at risk
30
28
21
%
100
96.7
96.7
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Example case:
screening
• 48 year old male
• Risk factors:
– Previous coronary and cerebrovascular interventions
• Clinics:
– Restpain right leg
– Rutherford 4, ABI: 0.55
– Duplex US: Biphasic signals distally
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Example case:
baseline procedure
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Example case:
baseline procedure
Xience Prime
3.5 x 15 mm
Xience Prime
3.5 x 33 mm
Xience Prime
3.5 x 38 mm
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Example case:
12M follow-up
• No complaints
• Rutherford 0, ABI: 0.89
• Stenosis at 12M: 5%
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Example case:
12M follow-up
RAO
25
RAO
8
LAO
16
No stent fractures
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Conclusion
•We already knew that drug eluting stents work in
focal BTK lesions
•Destiny 2 shows in an preliminary way that also longer
BTK lesions up to 10 cm can successfully be treated
with everolimus DES
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