Title: Breaking Through the Restenosis Barrier: DrugEluting Stents
1 American College of Cardiology 53rd Annual
Scientific Session New Orleans, 2004
REDOX Trial Reduced Sirolimus Doses on the Bx
Velocity Stent 4 - Month Results
J. Eduardo Sousa, Alexandre Abizaid, Fausto
Feres, Luis A. Mattos, Luis F. Tanajura, Amanda
Sousa, Jeffrey Popma, Peter Fitzgerald, Joseph
Giorgianni, Roxanne A. Rodney.
2 Presenter Disclosure Information
REDOX Trial
J. Eduardo Sousa No relationships to disclose
Alexandre Abizaid No relationships to
disclose Fausto Feres No relationships to
disclose Luis A. Mattos No relationships to
disclose Luis F. Tanajura No relationships to
disclose Amanda Sousa No relationships to
disclose Jeffrey Popma No relationships to
disclose Peter Fitzgerald No relationships to
disclose Joseph Giorgianni Cordis
enployee Roxanne A. Rodney Cordis enployee
3REDOX Feasibility Study
- Background
- The CYPHERTM Sirolimus-Eluting Coronary Stent has
demonstrated a significant reduction in late
loss and restenosis in 4 randomized trials. - The next generation of drug-eluting stents are
being developed with new materials which have
potentially less surface area. - This study was conducted to test the effect of
reducing the amount of drug on the stent.
4REDOX Feasibility Study
- Objective
- To assess the performance and safety of two
reduced (45 and 70 of current dose) sirolimus
doses on the Bx VELOCITY TM stent in patients
with de novo native coronary lesions
5REDOX Feasibility Study
- Study Design
- Single center, randomized
- Patients randomized 11 to the sirolimus-eluting
Bx VELOCITY containing either 45 or 70 the
current sirolimus dose - Patients followed at 30 days, 4 and 12 months,
and at 2, 3, 4 and 5 years post-procedure, with
all patients undergoing repeat angiography and
IVUS at 4 and 12 months
6REDOX Feasibility Study
- Investigator J. Eduardo Sousa, MD
- Instituto Dante Pazzanese de Cardiologia
- Sao Paolo, Brazil
- Angiographic
- Core Lab Brigham Womens Hospital
- Jeffrey J. Popma, MD
- IVUS Core Lab Sanford University
- Peter Fitzgerald, MD
7REDOX Feasibility Study
- Primary Endpoints - 4 and 12 Months
- Late loss (QCA)
- NIH volume and volumetric plaque burden (IVUS)
- MACE
8REDOX Feasibility Study
- Key Inclusion Criteria
- Male or non-pregnant female gt 18 years of age
- Single de novo lesion in a native coronary artery
- Target lesion lt18mm in length
- Target vessel gt3.0mm to lt3.5mm in diameter
- Target Stenosis gt50 and lt100
- Visual Estimate
9REDOX Feasibility Study
- Key Exclusion Criteria
- MI within 72 hours unless enzymes are back to
norma - Unprotected left main disease with gt50 stenosis
- Angiographic evidence of thrombus
- Ostial lesions
- EFlt30
- Totally occluded vessel
- Target lesion involves bifurcation
10Demographics
Age (Years) Male Gender Diabetes Hypertension Hy
percolesterolemia Unstable Angina Stable Angina /
Assymp
56.5 23 (74.2) 11 (35.5) 25 (80.6) 20
(64.5) 11 (35.5) 20 (64.5)
55.8 26 (89.7) 9 (31) 16 (55.2) 18
(62.1) 11 (37.9) 18 (62.1)
70 SES n 29
11Procedural Characteristics
Procedure Success Device Success Pre-dilatation
Balloon Length Stent Dimeter 3.0
3.5 Pre-dilatation Balloon
length
- 45 SES
- n 31
- 31 (100)
- 31 (100)
- 16 (51.6)
- 13.5 2.3
- 20 (64.5)
- 11 (35.5)
- 22 (71)
- 13.1 3.6
70 SES n 29 29 (100) 29 (100) 13
(44.8) 13.7 2.1 19 (65.5) 10 (34.5) 17
(59) 13.8 2.4
12Vessel / Lesion Characteristics
Vessel Location LAD Lcx RCA Lesion
Classif A / B1 B2 / C
- 45 SES
- 12 (38.7)
- 7 (22.6)
- 11 (35.5)
- 10 (32.3)
- 21 (67.7)
70 SES 13 (44.8) 6 (20.7) 10 (34.5) 9
(31) 20 (69)
13Pre-Procedures QCA
70 SES n 29
p
2.81 0.46 65 9.7 3 0.4 10 0.35 2.84
0.40
2.86 0.44 68 11.5 3 0.3 0.10 0.32 2.75
0.33
0.666
Reference Diameter DS Pre DS Post MLD Pre MLD
Post
14QCA Analysis 4 - Month FU
70 SES n 29
p
In-Stent Binary stenosis MLD Late
Loss In-Lesion Binary Stenosis Proximal
Edge Distal Edge MLD Late Loss
0 (0) 2.74 0.39 0.08 0.27 1 (3.2) 1
(3.2) 0 (0) 2.26 0.53 0.10 0.37
1 (3.6) 2.65 0.48 0.08 0.19 2 (7.1) 2
(7.1) 0 (0) 2.35 0.55 0.10 0.36
0.869 0.433 1.000 0.511 0.511 1.000 0.546 0.77
3
15In-Segment Late Loss
Distal
Proximal
Stent
16IVUS Volumetric Analysis 4 - Month FU
70 SES n 29
p
Vessel Volume (mm3) Stent Volume (mm3) Lumen
Volume (mm3) Intimal Hyperplasia (mm3)
Obstruction ()
289 82 133 36 131 34 3 6.9 2.0 3.6
251 72 122 26 119 29 2.5 5.3 2.6 6.5
0.082 0.207 0.209 0.754 0.684
17IVUS Volumetric Analysis Distribution of
Obstruction
70 SES
18Clinical Events up to 6 - Month
In-Hospital MACE 30-Day MACE 6-Month
MACE Death MI (Q Wave) MI (Non-Q) TLR Stent
Thrombosis
70 SES n 29
0 (0) 0 (0) 1 (3.3) 0 (0) 0 (0) 0 (0) 1
(3.3) 0 (0)
0 (0) 0 (0) 2 (6.7) 0 (0) 1 (3.3) 0 (0) 1
(3.3) 0 (0)
19Diabetic Patients
70 SES n 9
Reference Diameter In-Stent MLD Late
Loss Binary Restenosis In-Lesion MLD Late
Loss Binary Restenosis
2.88 0.5 2.78 0.5 0.01 0.2 0 (0) 2.43
0.5 0.09 0.2 0 (0)
2.83 0.4 2.62 0.4 0.08 0.2 0 (0) 2.31
0.6 0.08 0.4 1 (12.5)
Proximal Edge
20Diabetic Patients IVUS Results at 4 - Month FU
70 SES n 9
Vessel Volume Stent Volume Lumen Volume Intimal
Hyperplasia Obstruction
306 114 134 49 129 35 5.6 11.4 3.2 5.2
247 81 117 25 115 28 2.2 3.6 2.3 3.9
21REDOX Conclusions
- Reducing the normal dose (140 µg/cm2)
- of Sirolimus to 45 and to 70 we observed
- No difference in MACE (3.3 vs. 6.7)
- No difference in QCA late loss (0.08 vs. 0.08mm)
and binary restenosis (3.2 vs. 7.1) - No difference in IVUS of stent obstruction (2
vs 2.6) - Also there was similar inhibition of neointimal
formation in diabetic pts (3.2 vs 2.3). - Changing the SES platform might not
- compromise drug efficacy.