Neointimal Modification with Scoring-Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients...

Neointimal Modification with Scoring-Balloon and Efficacy of Drug-Coated Balloon Therapy in

Patients with Restenosis in Drug-Eluting Coronary Stents

Deutsches Herzzentrum München & I. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, both Munich; Herzzentrum der Segeberger Kliniken Gruppe, Bad Segeberg;

Krankenhaus Landshut-Achdorf, Medizinische Klinik I, Landshut;

all in GERMANY

Robert A. Byrne, Sebastian Kufner, Michael Joner, Simon Schneider, Ralph Tölg, Janika Repp, Erion Xhepa, Tareq Ibrahim, Salvatore

Cassese, Massimiliano Fusaro, Ilka Ott, Christof Burgdorf, Christian Hengstenberg, Heribert Schunkert, Bernhard Zrenner, Gert Richardt,

Karl-Ludwig Laugwitz, Adnan Kastrati

ISAR-DESIRE 4: Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4

Neointimal Modification with Scoring-Balloon and Efficacy of Drug-Coated Balloon Therapy in

Patients with Restenosis in Drug-Eluting Coronary Stents


Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug

Eluting Stent In-Stent Restenosis 4

ISAR-DESIRE 4

Disclosure Statement of Financial Interest

I, Robert A. Byrne, have received lecture fees from:

B. Braun Melsungen AG

Biotronik

Boston Scientific


Drug-coated balloon therapy

Byrne et al. | Treatment of In-stent RestenosisIn: Interventional Cardiology - A Companion to Braunwald's Heart Disease

Drug-coated balloon angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results and has the advantage of avoiding

additional stent layers in restenotic lesions

Background

• Gold text can be used as a highlight color No text shadows on any text

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• The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the anti-proliferative drug

• Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy


Study Objective

To compare the anti-restenotic efficacy of:

Scoring balloon pre-dilation before paclitaxel-coated balloon therapy

Versus

Standard balloon pre-dilation before paclitaxel-coated balloon therapy

in patients with limus-DES restenosis


Study Devices


Pantera Lux paclitaxel-coated balloon

Angiosculpt scoring balloon

3 µg paclitaxel/mm2

Butyryl-tri-hexyl citrate (BTHC) excipient

Balloon with 3 nitinol spiral “scoring” wires (~0.005”)

Spectranetics

Biotronik

Study Organization

Design252 patients with DES-restenosis enrolled

between June 2012 and December 2014 in 4 centers in Germany

Angiographic follow-up at 6-8 months in 80.4% (N=203)*

Clinical follow-up at 12 months

Standard balloon plus paclitaxel-coated balloon

(N=127)

Scoring balloon plus paclitaxel-coated balloon

(N=125)

*no significant differences across groups


DESIGN: Prospective, randomized, active controlled, multicenter clinical trial

INCLUSION CRITERIA: 1. Stenosis > 50% in “limus”-

eluting DES2. Symptoms/signs of ischemia

EXCLUSION CRITERIA: 3. Lesion in left main stem4. Acute STEMI5. Cardiogenic shock

FUNDING: Biotronik

Study Organization

Design


PRIMARY ENDPOINT: Percent diameter stenosis at follow-up angiography

TEST HYPOTHESES: neointimal modification with scoring balloon pre-dilation before DCB would be superior to standard balloon pre-dilation before DCB

%DS= 26.25% vs. 35% 2-sided α-level = 0.05 power = 80% 101 patients per group

252 patients with DES-restenosis enrolled between June 2012 and December 2014 in 4

centers in Germany

Angiographic follow-up at 6-8 months in 80.4% (N=203)*

Clinical follow-up at 12 months

Standard balloon plus paclitaxel-coated balloon

(N=127)

Scoring balloon plus paclitaxel-coated balloon

(N=125)

*no significant differences across groups

Results

ISAR-DESIRE 4


Baseline Characteristics

Scoring balloonN = 125

ControlN = 127

Age, years 69.4 69.4

Female 20.0 12.6

Diabetes mellitus 40.8 43.3

Multivessel disease 86.4 89.0

ACS 24.8 22.8

Patients

No significant differences across groups




ControlN = 127

ISR Morphology, %

Focal 76.8 75.6

Diffuse 18.4 22.1

Proliferative 1.6 0.8

Occlusive 3.2 1.6

Lesions





ControlN = 127

Stent type, %

biolimus-eluting 11.2 12.6

everolimus-eluting 59.2 60.6

sirolimus-eluting 24.8 19.7

zotarolimus-eluting 4.8 6.3

Lesions





ControlN = 127

Vessel size (mm) 2.96 2.89

Stenosis, pre (%) 65.7 67.2

MLD, pre (mm) 1.01 0.94

Stenosis, post (%) 21.6 22.3

MLD post (mm) 2.37 2.28

Procedure



Primary EndpointDiameter Stenosis at Follow-up Angiography


0 20 40 60 80 100

0

20

40

60

80

100

Diameter Stenosis at Follow-up Angiography (%)

Cu

mu

lati

ve F

req

ue

ncy

(%

)

Scoring-balloonControl

P= 0.047

40.4% ± 21.4

35.0% ± 16.8

Secondary EndpointTarget Lesion RevascularizationBinary Restenosis

Series10

5

10

15

20

25

30

35

18.5

32.0

Series10

5

10

15

20

25

16.8

22.6

P =0.03 P = 0.25

Scoring balloon

Control

% %

Scoring balloon

Control



Secondary EndpointDeath/Myocardial Infarction

Months After Randomization

De

ath

or

My

oca

rdia

l In

farc

tio

n (

%)

0

10

20

30

40

50

0 2 4 6 8 10 12

P> 0.99

Scoring-balloonControl

Scoring Balloon 3.3%Control 3.4%

Secondary EndpointTarget Lesion Thrombosis

-0.5 0.5 1.5

0.0%

0.0%

%

Scoring balloon

Control



Conclusions

In patients presenting with DES restenosis…

• paclitaxel-coated balloon based strategies confirmed a high clinical safety profile out to 1 year

• neointimal modification with scoring-balloon significantly improves the angiographic antirestenotic efficacy of paclitaxel-coated balloon angioplasty

Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4

ISAR-DESIRE 4

Thank You

Neointimal Modification with Scoring-Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients...

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