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