1M.Unverdorben; TCT 2007

Problem The treatment of stenoses of small

coronary arteries (SVD) and of restenoses after stent deployment (ISR)

still show unsatisfactory long-term results even after drug-eluting stent

deployment

Likely Solution

Using a drug-eluting balloon catheter (B.Braun Melsungen AG, Germany)

2M.Unverdorben; TCT 2007

Paccocath

Hwang, Circulation 2001; 104: 600-5

DES

Scheller, Heart 2007; 2007;93:539-

41

Paclitaxel-eluting stent (DES) vs.Paclitaxel-eluting stent (DES) vs. Paclitaxel-eluting balloon (DEB)Paclitaxel-eluting balloon (DEB)

M.Unverdorben; TCT 2007

The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease

PEPCAD I-SVD

PEPCAD II-ISR

Martin UnverdorbenClinical Research Institute, Center for Cardiovascular

Diseases Rotenburg an der Fulda, Germany

On behalf of the PEPCAD Investigators

4M.Unverdorben; TCT 2007

Primary Variable

6-month late lumen loss

Secondary Variables

Procedural success (≤30% stenosis)6-month binary restenosis rate6-month MACE

MACE at 1 and 3 years

5M.Unverdorben; TCT 2007

Outcome ComparisonDEB ITT

N=120

DEB Only

N=82

Taxus* BMS*

Follow-up [mo]

6.7±2.1 6.7±1.9 9 9

Late loss [mm]

0.3±0.55 0.18±0.38 0.490.61 0.900.63

Restenosis (segment)

15.5% 5.5% 31.2% 49.4%

Total MACE 13.7% 6.1% 18.9% 26.9%

TLR 12% 4.9% 10.4% 21.5%

Myocardial infarction

0.8% 1.2% 5.7% 2.2%

Cardiac death

0% 0% 1.9% 1.1%

*Stone, G JAMA 2005;294:1215-23

6M.Unverdorben; TCT 2007

Summary PEPCAD I

The paclitaxel-eluting balloon catheter Sequent Please (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate in de-novo lesions

–exhibited low late lumen loss after 6 months in SVD

–patients treated w/o additional stenting demonstrated a restenosis rate of 5.5%

7M.Unverdorben; TCT 2007

PEPCAD IIRandomized Comparison to

Taxusin ISR

8M.Unverdorben; TCT 2007

Primary Variable

6-month late lumen loss

Secondary Variables

Procedural success (≤30% stenosis)6-month binary restenosis rate6-month MACE

MACE at 1 and 3 years

9M.Unverdorben; TCT 2007

As-Treated Groups

Treatment w/ DEB70 Subj.

DEB only56 Subj.

DEB + BMS6 Subj.

Crossover from DES 4 Subj.

Violators 4 Subj.

Treatment w/ DES60 Subj.

DES58 Subj.

DES w/ additional DES 2 Subj.

Enrolled 131 Subj. Conventional

balloon 1 Subj. Violator from DES

10M.Unverdorben; TCT 2007

Outcome (N=126) DEB

(N=66)1

DES (N=60)1 P=

Follow-up [months] 6.2 ± 0.8 6.2 ± 0.8 0.7

Follow-up: clinical 62 (93.9%) 59 (98.3%) 0.4

Follow-up: angiographic

54 (81.8%) 53 (83.3%) 0.5

Late lumen loss [mm] 0.19 ± 0.39 0.45 ± 0.69 0.01

Binary restenosis in segment

2/54 (3.7%) 11/53 (20.8%)

0.02

Total MACE 3/62 (4.8%) 13/59 (22.0%)

0.007

TLR 2/62 (3.2%) 11/59 (18.6%)

0.008

Myocardial infarction 0/62 (0.0%) 1/59 (1.7%) 2

1

Death 1/62 (1.6%)3 1/59 (1.6%) 4

1

1 1 protocol violators excluded

2 NSTEMI side branch occlusion4 non-cardiac death3cardiac, not lesion related

11M.Unverdorben; TCT 2007

Event Free Survival (ITT/As Treated)

70

75

80

85

90

95

100

0 2 4 6 8 10

Sub

ject

s [%

]

DES/ I TT DEB/ I TT

DES/AsT DEB/AsT

p=0.07ITT p=0.007

As Treated

Months post PCI

12M.Unverdorben; TCT 2007

Summary PEPCAD II The paclitaxel-eluting balloon catheter

Sequent Please (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate in ISR

–exhibited low late lumen loss after 6 months in ISR

–was superior to the paclitaxel-eluting Taxus stent in ISR after 6 months

–has not been associated with late thrombosis in 200 patient years in SVD and ISR

13M.Unverdorben; TCT 2007

Additional Handouts

14M.Unverdorben; TCT 2007

Abbreviations and TermsAbbreviation/Term

Explanation

BMS Bare metal stent without any active coating

DEB Drug-eluting balloon catheter that delivers (antiproliferative) drugs into the vessel wall

DES Drug-eluting stent that delivers (antiproliferative) drugs into the vessel wall

Follow-up Observation period of a patient following a procedure

In-segment The 5mm of a vessel on either side of a deployed stent

ISR Renarrowing/reocclusion of a stent

Late lumen loss

Renarrowing of a stenosis after PCI [mm]

MACE Major adverse cardiac event; usually incl. heart attack, repeat angioplasty (or bypass) of the stenosis, death

PCI Percutaneous coronary intervention; treating coronary artery stenoses with catheters, incl. balloons, stents, drugs & others

15M.Unverdorben; TCT 2007

Abbreviations and Terms

Abbreviation/Term

Explanation

Restenosis Renarrowing of the target lesion after PCI of at least 50%

Stenosis Narrowing of the coronary artery [%]; considered as relevant when reaching 70% or more of the vessel diameter

Stent Mesh-like devices to scaffold arteries, which are deployed using balloon catheters. Stents may (drug-eluting) or may not (bare metal) deliver drugs to the vessel wall.

SVD Small vessel disease. Coronary artery with diamters 3.0mm

Thrombosis

Renarrowing/reocclusion of a vessel mainly by platelets

TL Target lesion; lesion that has been treated

TLR Target lesion revascularization; lesion that has become narrow again (usually ≥ 70%) and needs „rework“ by PCI or bypass

16M.Unverdorben; TCT 2007

Contact Information

Martin Unverdorben

MD, PhD, Associate Professor of Medicine

+1 804 651 3089 (EST) sbu135@comcast.net