Harald Rittger, MD University of Erlangen; Klinikum Coburg Germany
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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, MDUniversity of Erlangen;
Klinikum CoburgGermany
TCT 2011 – First Report Investigation
KLINIKUMCO B U R G
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DisclosuresDisclosures
• Supported in part by an unrestricted grant by B.Braun, Melsungen, Germany
• 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
Within the past 12 months, I or my spouse/partner have had a financial Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
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CentersCenters
Harald Rittger, MDKlinikum Coburg
Marc-A. Ohlow, MDZentralklinik Bad Berka
Andreas Brugger, MDKlinikum Kulmbach
Holger Thiele, MDHerzzentrum Leipzig
Ralf Birkemeyer, MDKlinikum Villingen-S.
Volker Kurowski, MDUniversität Lübeck
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BackgroundBackground
• 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.
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BackgroundBackground
• 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.
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BackgroundBackground
• 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.
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Inclusion CriteriaInclusion Criteria• 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
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Exclusion CriteriaExclusion Criteria
• 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.
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Primary EndpointPrimary Endpoint
• Primary endpoint: six-months late lumen loss at the target lesion.
• Superiority testing of the primary end point on an intention-to-treat basis.
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Primary EndpointPrimary Endpoint
• 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.
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Secondary EndpointsSecondary Endpoints
• 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
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110 patients enrolled andrandomized (2:1)
Paclitaxel coated balloon
N=72
Ballon angioplastyaloneN=38
6 months angiographic follow-up
88.9% (N=64/72)
6 months angiographic follow-up
81.6 % (N=31/38)
6-month clinical follow-up100 % (N=72/72)
6-month clinical follow-up100 % (N=38/38)
6 monthsASS+Clopidogrel
predilation
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Baseline Characteristics
DCB POBA
Number of patients 72 38
Age (years) 69.8±10.8 * 64.0±11.3 Male 52 (72.2%) 26 (68.4%) Diabetes 26 (36.1%) 13 (34.2%) Hypertension 68 (94.4%) 36 (94.7%) Hyperlipidemia 59 (81.9%) 27 (71.1%) History of smoking 11 (15.3%) 6 (15.8%) BMI – kg/m2 28.1±4.1 27.2±3.5
* p=0.02
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Baseline Angiography
DCB POBA
Lesion locationLAD 24 (33.3%) 16 (39.0%) CX 23 (32.0%)+ 3 (4.9%)RCA 25 (34.7%) 19 (46.3%)
QCARVD (mm) 2.29±0.51 2.30±0.52 MLD (mm) 0.66±0.40 0.62±0.44 % DS 72.1±14.5 74.0±16.2 Lesion length (mm) 11.2±6.5 12.2±8.2
+ p=0.005
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DCB POBA
Pre-dilatation balloon
Length (mm) 16.0±6.0 16.1±5.5
Diameter (mm) 2.84±0.39 2.76±0.34
Inflation Time (sec) 39.4±26.3 41.9±16.9
Pressure (bar) 15.1±3.8 15.1±3.4
Procedural Data
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DCB POBA
Study Balloon
Length (mm) 21.6±6.4* 18.9±6
Diameter (mm) 2.95±0.43 2.92±0.39
Inflation Time (sec) 57.6±16.0 53.2±17.3
Pressure (bar) 14.0±2.5 15.0±5.3
Procedural Data
* p=0.041
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DCB POBA
RD (mm) 2.47±0.45 2.47±0.58
MLD (mm)Target lesion 2.15±0.42 2.14±0.53
Diameter stenosis (%)Target lesion 12.6±6.2 13.7±6.0
Post Procedure QCA
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Primary Endpoint - Late Loss
POBA
1.03 ± 0.77
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Primary Endpoint - Late Loss
POBA DCB
1.03 ± 0.770.43 ± 0.61
P < 0.001
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P = 0.18 P < 0.001 P = <0.001 P < 0.001
Late Loss at 6 MonthsLate Loss at 6 MonthsPOBA DCB
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DCB POBA P Value
Target lesion
MLD 1.75±0.70 1.10±0.73 < 0.001
% DS 29.6±24.3 51.1±31.0 < 0.001
Total segment
MLD 1.65±0.66 1.00±0.68 < 0.001
% DS 32.3±54.7 54.7±29.4 < 0.001
Follow-up QCA
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P < 0.001 P < 0.001
Binary Angiographic Restenosis at 6 Binary Angiographic Restenosis at 6 MonthsMonths
Binary Restenosis
(%)
POBA DCB
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DCB POBA P Value
Target lesion revascularization 11 (15.3 %) 14 (36.8 %) 0.005
Myocardial infarction
Non-target vessel 0 (0%) 0 (0%) --
Target vessel 0 (0 %) 1 (2.6 %) 0.345
Cardiac Death 1 (1.4%) 4 (10.5 %) 0.048
MACE * 12 (16.7 %) 19 (50.0 %) <0.001
Clinical Outcomes at 6 Months
*TLR, myocardial infarction attributable to target vessel, cardiac death
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ConclusionConclusion• 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
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A Prospective, Randomized Trial of a Paclitaxel coated Balloon vs. uncoated
Balloon Angioplasty in Patients with Restenosis of Drug-Eluting Stents
PEPCAD-DES Study
Harald Rittger, MDUniversity of Erlangen;
Klinikum CoburgGermany
TCT 2011 – First Report Investigation
KLINIKUMCO B U R G
Thank you very muchThank you very much for your attention!for your attention!