Below-the-knee interventions: Is the use of drug-eluting … › media › 1111_Massimiliano... ·...

Below-the-knee interventions: Is the use of drug-eluting technologies

justified?

Massimiliano Fusaro, MD

Interventionelle Kardiologie – Interventionelle Angiologie

Deutsches Herzzentrum München - Technische Universität München

Conflicts of interest

Speaker’s name:

I have the following potential conflicts of interest to report:

Research contracts

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

X I do not have any potential conflict of interest

Why drug elution for BTK disease? Insufficient patency after plain angioplasty…

Is long-term patency needed for ulcer healing?

Multifactorial etiology of diabetic foot

The Journal of Diabetic Foot Complications, 2012; (4) - 2; 26-45

• Drug-eluting stents • Drug-coated balloons • Next future

Fusaro M, J Am Coll Cardiol Intv 2013;6:1284–93

CLI, %

Occlusion, %

Lesion length, mm

Vessel diameter, mm

Meta-analysis

73.5 27.5 26.8 2.86


ARR 15.5% NNT 7

ARR 29.6% NNT 4

ARR 7.5% NNT 13


“On adjusted indirect comparison, the everolimus- versus sirolimus-eluting stents, as well as the polymer-free versus durable-polymer DESs did not affect the risk

estimates for the main outcomes”

From Zeller T, Oral presentation - TCT 2015, San Francisco, USA

…BTK-lesions in the daily practice


According to available evidence DESs have predominantly been tested in: • lesions <30 mm (with only ACHILLES Trial approaching

longer lesions) • relative low number of patients presenting complete

vessel occlusion • relative high number of patients presenting with CLI • complex interventions in proximal BTK-segments but no

foot arteries

…common BTK-lesions have not been fully investigated in RCTs!

Why drug-coated balloons for BTK disease? Because they perform very good in FPA disease…

Conclusions—In FPA disease, PCB therapy is associated with superior antirestenotic efficacy as compared with UCB angioplasty with no evidence of a differential safety profile

Fusaro M, Circ Cardiovasc Interv. 2012;5:582-589

… but do DCBs perform equally in two different arterial districts ?

Trial Patients, n CLI, %

Lesion

length,

mm

Diameter

stenosis,

%

Occlusion,

%

BIOLUX PII 72 78 114.1 72.3 -

DEBATE BTK 132 100 130.0 97.2 80

DEBELLUM 30 52 77.0 86.5 21

IDEAS 50 100 137.5 86.0 17

IN.PACT DEEP 358 100 115.0 85.2 42

CLI, % Lesion length, mm Diameter

stenosis , % Occlusion, %

Meta-analysis

99.6 121 86 31.5

Fusaro M, Submitted

Fusaro M, Submitted

Cumulative TLR

Clinically-driven TLR

Trial

BIOLUX P-II

DEBATE BTK

DEBELLUM

IDEAS

IN.PACT DEEP

Total (95% CI)

Total events

Heterogeneity: Tau² = 0.08; Chi² = 6.51, df = 4 (P = 0.16); I² = 39%

Test for overall effect: Z = 1.57 (P = 0.12)

Events

10

14

3

3

35

65

Total

29

65

13

22

226

355

Events

10

32

8

2

22

74

Total

34

67

16

26

111

254

Weight

21.1%

29.7%

11.6%

5.6%

32.1%

100.0%

M-H, Random, 95% CI

1.17 [0.57, 2.42]

0.45 [0.27, 0.76]

0.46 [0.15, 1.40]

1.77 [0.32, 9.67]

0.78 [0.48, 1.27]

0.71 [0.47, 1.09]

DCB Control Risk Ratio Risk Ratio

M-H, Random, 95% CI

0.01 0.1 1 10 100 Favors DCB Favors control

Trial

BIOLUX P-II

DEBATE BTK

DEBELLUM

IDEAS

IN.PACT DEEP

Total (95% CI)

Total events



Events

9

14

3

3

27

56

Total

29

65

13

22

226

355

Events

9

32

8

2

15

66

Total

34

67

16

26

111

254

Weight

21.0%

31.2%

13.0%

6.5%

28.3%

100.0%

M-H, Random, 95% CI

1.17 [0.54, 2.56]

0.45 [0.27, 0.76]

0.46 [0.15, 1.40]

1.77 [0.32, 9.67]

0.88 [0.49, 1.59]

0.73 [0.46, 1.16]


M-H, Random, 95% CI


Fusaro M, Submitted

Cumulative amputation

Trial

BIOLUX P-II

DEBATE BTK

DEBELLUM

IDEAS

IN.PACT DEEP

Total (95% CI)

Total events



Events

8

18

1

1

20

48

Total

29

65

13

25

227

359

Events

9

21

2

2

4

38

Total

34

67

16

27

111

255

Weight

23.7%

56.1%

3.0%

2.9%

14.3%

100.0%

M-H, Random, 95% CI

1.04 [0.46, 2.35]

0.88 [0.52, 1.50]

0.62 [0.06, 6.05]

0.54 [0.05, 5.59]

2.44 [0.86, 6.98]

1.04 [0.70, 1.54]


M-H, Random, 95% CI


Death

Trial

BIOLUX P-II

DEBATE BTK

DEBELLUM

IDEAS

IN.PACT DEEP

Total (95% CI)

Total events



Events

3

12

1

2

23

41

Total

29

65

13

25

227

359

Events

2

11

2

3

9

27

Total

34

67

16

25

111

253

Weight

7.5%

39.9%

4.2%

7.6%

40.7%

100.0%

M-H, Random, 95% CI

1.76 [0.32, 9.81]

1.12 [0.53, 2.37]

0.62 [0.06, 6.05]

0.67 [0.12, 3.65]

1.25 [0.60, 2.61]

1.14 [0.71, 1.82]


M-H, Random, 95% CI


Incomplete wound healing

Trial

DEBATE BTK

IDEAS

IN.PACT DEEP

Total (95% CI)

Total events



Events

9

7

43

59

Total

65

12

164

241

Events

21

6

21

48

Total

64

12

91

167

Weight

30.8%

29.5%

39.6%

100.0%

M-H, Random, 95% CI

0.42 [0.21, 0.85]

1.17 [0.56, 2.45]

1.14 [0.72, 1.79]

0.84 [0.45, 1.58]

DEB Control Risk Ratio Risk Ratio

M-H, Random, 95% CI

0.01 0.1 1 10 100

Favors DEB Favors control

Fusaro M, Submitted

Late lumen loss

Trial

BIOLUX P-II

DEBATE BTK

DEBELLUM

IDEAS

IN.PACT DEEP

Total (95% CI)

Heterogeneity: Tau² = 0.15; Chi² = 30.36, df = 4 (P < 0.00001); I² = 87%


Mean

0.56

0.91

0.66

1.15

0.51

SD

0.65

1.1

0.9

0.3

0.7

Total

32

80

13

19

125

269

Mean

0.54

2

1.69

1.35

0.6

SD

0.66

1.1

1.5

0.2

1

Total

30

78

17

25

63

213

Weight

21.4%

21.0%

11.0%

24.3%

22.4%

100.0%

IV, Random, 95% CI

0.02 [-0.31, 0.35]

-1.09 [-1.43, -0.75]

-1.03 [-1.89, -0.17]

-0.20 [-0.36, -0.04]

-0.09 [-0.37, 0.19]

-0.41 [-0.79, -0.03]

DCB Control Mean Difference Mean Difference

IV, Random, 95% CI

-2 -1 0 1 2

Favors DCB Favors control

Conclusions—In BTK disease, DCB therapy is associated with superior angiographic performance as compared with control therapy without evidence of

a differential efficacy or safety profile

According to available evidence DCBs have predominantly been tested in: • lesions >100 mm (excluded DEBELLUM Trial) • relative low number of patients presenting complete

vessel occlusion • relative high number of patients presenting with CLI

…without data on angiosome-guided angioplasties and

standardized management of ischemic wounds!


Trial

DEBATE BTK

IDEAS

IN.PACT DEEP

Total (95% CI)

Total events



Events

9

7

43

59

Total

65

12

164

241

Events

21

6

21

48

Total

64

12

91

167

Weight

30.8%

29.5%

39.6%

100.0%

M-H, Random, 95% CI

0.42 [0.21, 0.85]

1.17 [0.56, 2.45]

1.14 [0.72, 1.79]

0.84 [0.45, 1.58]


M-H, Random, 95% CI

0.01 0.1 1 10 100


Liistro F, Circulation. 2013 Aug 6;128(6):615-21


Trial

DEBATE BTK

IDEAS

IN.PACT DEEP

Total (95% CI)

Total events



Events

9

7

43

59

Total

65

12

164

241

Events

21

6

21

48

Total

64

12

91

167

Weight

30.8%

29.5%

39.6%

100.0%

M-H, Random, 95% CI

0.42 [0.21, 0.85]

1.17 [0.56, 2.45]

1.14 [0.72, 1.79]

0.84 [0.45, 1.58]


M-H, Random, 95% CI

0.01 0.1 1 10 100


Zeller T, J Am Coll Cardiol 2014;64:1568–76 Zeller T, ENDOVASCULAR TODAY May 2015

Byrne RA, Nat Rev Cardiol 11, 13–23 (2014)

We have more technology than evidence…

From the largest public health insurance in Germany, all in- and outpatient diagnosis and procedural data were retrospectively obtained from a cohort of 41 882 patients

hospitalized due to PAD during 2009–2011, including a follow-up until 2013

Reinecke H, Eur Heart J. 2015 Apr 14;36(15):932-8

We need more care than technology…

Conclusions

Drug-based technologies have the potential to revolutionize the revascularization of peripheral artery disease involving BTK-segments The established superiority of DESs in comparison with other treatment options for BTK-revascularization is confined to specific lesions and patients subsets The safety and biological efficacy of DCBs still remain to be proved before further investigate a potential superiority in comparison with established treatment options A greater effort is required from scientific authorities and investigators to plan future trials with primary clinical endpoints including amputation, quality of life and wound healing in order to support the daily practice with adequate evidence Importantly, future trials should encourage a standardized treatment for patients with BTK-disease including the wound-care management

Massimiliano Fusaro, MD [email protected]

Deutsches Herzzentrum München

Technische Universität München

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