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A Prospective, Randomized Trial of a Paclitaxel coated Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis PEPCAD-DES Study. Harald Rittger, MD University of Erlangen; Klinikum Coburg Germany TCT 2011 – First Report Investigation. KLINIKUM CO B U R G.

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A Prospective, Randomized Trial of a Paclitaxel coated Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent RestenosisPEPCAD-DES Study

Harald Rittger, MD

University of Erlangen;

Klinikum Coburg

Germany

TCT 2011 – First Report Investigation

KLINIKUM

CO B U R G


Disclosures
Disclosures Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Supported in part by an unrestricted grant by B.Braun, Melsungen, Germany

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship

Company

  • Grant/Research Support

  • Consulting Fees/Honoraria

  • Major Stock Shareholder/Equity

  • Royalty Income

  • Ownership/Founder

  • Intellectual Property Rights

  • Other Financial Benefit

  • B.Braun, Siemens

  • B.Braun, Siemens

  • none

  • none

  • None

  • None

  • none


Centers
Centers Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Harald Rittger, MD

Klinikum Coburg

Marc-A. Ohlow, MD

Zentralklinik Bad Berka

Andreas Brugger, MD

Klinikum Kulmbach

Holger Thiele, MD

Herzzentrum Leipzig

Ralf Birkemeyer, MD

Klinikum Villingen-S.

Volker Kurowski, MD

Universität Lübeck


Background
Background Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Drug-eluting stents (DES) significantly reduced the occurrence of restenosis and the subsequent need for repeat revascularization.

Nevertheless, the incidence of DES-restenosis (DES-ISR) remains frequent due to the continuous increase in DES implantations.


Background1
Background Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Complex lesions with a high restenotic potential are sufficiently treated with present DES, limiting the use of bare-metal stents (BMS) to patients not eligible for dual antiplatelet therapy.

Paclitaxel coated balloon angioplasty (SeQuent Please, B.Braun) has been shown to be superior to plain old balloon angioplasty (POBA) and non-inferior to paclitaxel eluting stent (PES) implantation for treatment of BMS restenosis.


Background2
Background Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Whether the use of paclitaxel coated balloon angioplasty is also effective in DES restenosis has not been sufficiently studied so far.

We evaluated in a randomized, multicenter, single blinded trial the efficacy of paclitaxel coated balloon angioplasty (SeQuent Please, B.Braun, Germany) compared with plain old balloon angioplasty for DES restenosis in native coronary arteries.


Inclusion criteria
Inclusion Criteria Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Age > 18 years

Lesion in native coronary artery

DES restenosis of

Sirolimus eluting stents: Cypher, Yukon

Everolimus eluting stents: Xience, Promus

Paclitaxel eluting stents: Taxus

Indication for PCI (symptoms, ischemia)

Reference diameter 2.5 – 3.5 mm

Lesion length ≤ 22 mm


Exclusion criteria
Exclusion Criteria Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

thrombus within the target vessel

side branch ≥ 2 mm in diameter originating within the restenosis or bifurcation lesion

multiple lesions in the target vessel

lesions in bypass grafts

total coronary artery occlusion

lesions within 1 mm of vessel origin or left main

planned surgery within 6 months after the index procedure

women with childbearing potential

contraindication or known hypersensitivity to acetylsalicylic acid, clopidogrel, paclitaxel or heparin.


Primary endpoint
Primary Endpoint Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Primary endpoint: six-months late lumen loss at the target lesion.

Superiority testing of the primary end point on an intention-to-treat basis.


Primary endpoint1
Primary Endpoint Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

With an assumed late lumen loss of 0.20±0.30mm in the drug coated balloon group and 0.80±0.80mm in the POBA group the necessary number of patients were 64 in the drug coated balloon and 34 in the POBA group to achieve 90% power

With an assumed dropout rate of 10% the patient numbers to be recruited were 71 in the drug coated balloon and 38 in the POBA group.


Secondary endpoints
Secondary Endpoints Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Secondary angiographic endpoints

Binary restenosis, minimal lumen diameter, percent diameter stenosis (target lesion and total segment)

Secondary clinical endpoints (definition according to ARC criteria)

Target lesion revascularization

Myocardial infarction

Death

MACE as a composite of

cardiac death, myocardial infarction attributable to target vessel, target lesion revascularization


110 patients enrolled and Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

randomized (2:1)

predilation

Ballon angioplasty

alone

N=38

Paclitaxel coated balloon

N=72

6 months

ASS+Clopidogrel

6 months

angiographic follow-up

88.9% (N=64/72)

6 months

angiographic follow-up

81.6 % (N=31/38)

6-month

clinical follow-up

100 % (N=72/72)

6-month

clinical follow-up

100 % (N=38/38)


Baseline Characteristics Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

* p=0.02


Baseline Angiography Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

+ p=0.005


Procedural Data Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis


Procedural Data Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

* p=0.041


Post Procedure QCA Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis


Primary Endpoint - Late Loss Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

POBA

1.03 ± 0.77


Primary Endpoint - Late Loss Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

P < 0.001

0.43 ± 0.61

POBA

1.03 ± 0.77

DCB


Late Loss at 6 Months Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

P = <0.001

P = 0.18

P < 0.001

P < 0.001

POBA

DCB


Follow-up QCA Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis


Binary Angiographic Restenosis at 6 Months Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

Binary

Restenosis

(%)

POBA

P < 0.001

P < 0.001

DCB


Clinical Outcomes at 6 Months Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

*TLR, myocardial infarction attributable to target vessel, cardiac death


Conclusion
Conclusion Balloon vs. uncoated Balloon Angioplasty in Patients with Drug-Eluting Stent Restenosis

  • In this prospective, randomized, single-blind, multicenter study the treatment strategy with paclitaxel coated balloon (SeQuent Please, B.Braun) compared with balloon angioplasty alone for treatment of DES restenosis showed:

    • a significantly lower late loss (primary endpoint)

    • a significantly lower binary restenosis rate, percent diameter stenosis and a significantly larger minimal lumen diameter at follow-up

    • significantly less MACE

    • no definite vessel thrombosis


A Prospective, Randomized Trial of a Paclitaxel coated Balloon vs. uncoated Balloon Angioplasty in Patients with Restenosis of Drug-Eluting StentsPEPCAD-DES Study

Harald Rittger, MD

University of Erlangen;

Klinikum Coburg

Germany

TCT 2011 – First Report Investigation

KLINIKUM

CO B U R G

Thank you very much

for your attention!


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