First time data release2 y results of the Copa Cabana
Study
Gunnar Tepe MDRoMed Rosenheim
Disclosure
Speaker name:
Gunnar Tepe
I have the following potential conflicts of interest to report:
Medrad
study support
Rationale
• The occurrence of SFA in-stent restenosis (ISR) is high
• With stenting increasingly performed in the SFA, an increasing number of patients will require repeat treatment for ISR
• Currently there is no consensus about the treatment of choice
• Registry data indicate superiority of drug-eluting balloons
• 3 prospective randomized trials DCB vs. PTA(FAIR – In.Pact DCB, PEP: RS by DUS (core lab)PACUBA – Eurocor DCB, PEP: RS by diff. measurem. (no CL)COPA – Cotavance DCB, PEP: LLL by DSA (core lab)
• 1 Registry with historic control (DEBATE ISR, In.Pact DCB)
Copa Cabana Trial
Investigator Initiated, Corelab adjudicated,
Prospective, Multicenter, Randomized Trial
Objective: to assess safety and efficacy of PTA with drug-
eluting balloon (Cotavance, Medrad [Medtronic]) vs.
standard PTA for the treatment of symptomatic SFA-ISR
Primary Endpoint: LLL at 6 months by ia DSA
corelab adjudication
Major Inclusion Criteria
1. ISR > 3 months prior to enrollment
2. Rutherford 2 - 5
3. At least one run off vessel to the foot
4. Maximum treated length SFA – POP II: up to 27 cm
DEBPOBA
Major Exclusion Criteria
1. Patients with more than two lesions
2. Not able to cross the lesion
3. Stent fractures 2 - 4
4. Inflow lesion not being successfully treated
5. Acute thrombosis
6. Planned major amputation (above the ankle)
DEBPOBA
Study Organization
Primary endpoint: Late Lumen Loss (difference between angiographic
Minimal Lumen Diameter immediately and 6 months post index procedure
Assessment performed by an independent core lab
Baseline Procedure Discharge 30 Days(-7/+14 days)
6 Months(±30 days)
12 Months(±60 days)
24 Months(±60 days)
In Stent Re-re-
Stenosis
Procedure(>30 days post
index procedure)
6 Months post
In stent Re-re-
Stenosis(±30 days)
EQ-5D
questionnaireX X X X X X
WIQ X X X X X X
Rutherford
classificationX X X X X X X
Ankle Brachial
Index (ABI)X X X X X X X
X-ray of the
stentX X X X X
Laboratory
testsX X X X
Angiogram X X X X X
Duplex
ultrasound
(DUS)
X X* X X* X*
*Conducted when an angiogram is not possible
Enrollment
Rosenheim 26
Berlin-Jewish Hospital 19
Berlin-Neukölln 15
Bad Krozingen 10
Karlsruhe 5
Mannheim 4
Neumünster 4
Tübingen 2
Bern 3
88 patients
in
9 active hospitals
Study flow chart
88 Patients
Rutherford 2-5
POBA
n=41
DCB
n=47
Follow-up
Clinical/Functional: 1, 6, 12, 24 months
DSA: 6 and 24 months with core lab
DSA: any TLR with core lab
DUS: 6,12, 24 months
Double Dose
DCB n=22 In case of TLR
Baseline Characteristics
DCB POBA Clinical
significance
Age [year(s)] 68.3 ± 9.6 67.6 ± 10.2 NS
Male 55.3% (26/47) 63.4% (26/41) NS
Diabetes 42.6% (20/47) 46.3% (19/41) NS
- on Insulin 25% (5/20) 33.3% (6/18) NS
Smoker (current) 29.8% (14/47) 36.6% (15/41) NS
Hyperlipidemia 61.7% (29/47) 78.0% (32/41) NS
Hypertension 80.9% (38/47) 73.2% (30/41) NS
Previous MI 32.3% (10/31) 38.5% (10/26) NS
Cerebrovascular disease (Stroke) 30.8% (4/13) 16.7% (1/16) NS
Continuous data: mean ± SD (n); Categorical data: % of n (n)
(n) = total number of patients in the group for whom the information is available (results of the safety set (SAS))
Number of patients in the SAS: DCB: 47, POBA: 41
Baseline Characteristics
DCB POBA
Calcification within stent
None/Mild 70.2% 72.3%
Moderate/Severe 29.8% 24.4%
missing 2.4%
Total occlusion of the stent 25.5% 36.6%
% maximal stenosis 91.4 ± 9.0 92.0 ± 9.1
Former revascularization 38.3% 19.5%
Stent fracture N=4 N=0
Target lesion length [cm] 15.2 ± 8.5 12.8 ± 8.5
Continuous data: mean ± SD (n); Categorical data: % of n (n)
(n) = total number of patients in the group for whom the information is available (results of the intention-to-treat set (ITT))
Number of patients in the ITT: DCB: 38, POBA: 28
*instent lesions
Baseline Characteristics
DCB POBA
II (moderate claudification) 18.4% (7/38) 11.5% (3/26)
III (severe claudification) 73.7% (28/38) 76.9% (20/26)
IV (ischemic rest pain) 2.6% (1/38) 3.8% (1/26)
V (minor tissue loss) 5.3% (2/38) 7.7% (2/26)Continuous data: mean ± SD (n); Categorical data: % of n (n)
(n) = total number of patients in the group for whom the information is available (results of the intention-to-treat set (ITT))
Number of patients in the ITT: DCB: 38, POBA: 28
Results, LLL
Results, TLR 6 mo
Results, TLR 2y
N=17
N=21
Numbers of patients with
TLR/group
Results, TLR 2y
with Double Dose DCB
N=0
Conclusions
• First prospective randomized DCB study which shows a
reduced benefit of the DCB group after a certain time
• A delayed TLR after DCB might be driven
• By the underlying disease (ISR, calcium burden)
• By the DCB product
(different drug content over time in the vessel wall)
• First DCB study which shows a dose effect of DCB therapy
• Higher dose might be needed especially in complex SFA
lesions with higher chance of restenosis
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