1. TAXUS VI Randomized Trial of Moderate-Rate Release Polymer-Based Paclitaxel-Eluting TAXUS Stent for the Treatment of Longer Lesions
Three Year Clinical Results
Speaker - Grube Eberhard
Keith D. Dawkins MD FRCP FACC
Southampton University Hospital, United Kingdom
on behalf of TAXUS VI Investigators

2. The most complex lesions and procedures of any DES trial
TAXUS VI: Background
Double-blinded, randomized, superiority trial comparing TAXUS MR stent with bare metal controls in complex lesions. The commercially unavailable MR stent releases 3x the amount of Paclitaxel than the SR stent.
Lesion length (mean, mm) ± 7.6
Stented length (mean, mm) 33.4 ± 10.5
Overlapping stents %
Type C lesions (AHA/ACC) 55.6 %
Diabetics 20.0 %
The most complex lesions and procedures of any DES trial

3. Study flow TAXUS MR N=217 Control N=220 Randomized Patients N=446
9-Mo Clinical FU
437/441 (99.0%)
N=214
24-Mo Clinical
F/U 428/434 (98.6%)
TAXUS MR
N=210
Control
36-Mo Clinical
F/U 420/428 (98.1%)

4. Freedom from Target Lesion Revascularization to 3 Years
100%
91.7 %
90.3 %
88.4 %
90%
Freedom of TLR
P=0.005
log rank
80%
TAXUS MR
Control
80.0 %
79.1 %
79.1 %
70%
Days Since Index Procedure
Number Needed to Treat to avoid 1 TLR = 10.75

5. Three Year MACE Composition
Control (N=223)
TAXUS MR (N=217)
P value
TVR %
22.1 (48/217)
17.8 (38/213)
0.27*
TLR %
21.2 (46/217)
11.7 (25/213)
0.0082*
TVR-remote %
3.2 (7/217)
8.0 (17/213)
0.0317*
Q-wave MI %
1.4 (3/217)
2.3 (5/213)
0.50†
Non Q-wave MI %
5.5 (12/217)
7.5 (16/213)
0.41*
Total MACE %
26.3 (57/217)
25.8 (55/213)
0.92*
Cardiac death %
2.3 (5/217)
1.4 (3/213)
0.72†
Total death %
2.3 (5/215)
0.57*
*Chi-Square test
†Fisher’s Test

6. Stent thrombosis at 3 Years
Control (N=223)
TAXUS MR (N=217)
P value
days
0.9% (2/223)
0.5% (1/217)
1.00
days
0% (0/223)
0% (0/217) -
days
0% (0/221)
days
0% (0/212)
0% (0/215)

7. Conclusions:
Numerous studies involving simpler lesions have shown a clinical benefit in treating patients with DES, but TAXUS VI remains the trial that has recruited patients with the most complex lesions
Follow-up rates are exceedingly high, adding confidence to the reliability of the data
The TAXUS TLR benefit extends to the more complex lesions, justifying real world clinical practice
These results confirm the long-term (three year) clinical safety and efficacy of the TAXUS MR stent
20.4% are C and 53.0% are B2/C in ARRIVE I (1 year results)
29.1% are C and 85.7% are B2/C in e-Cypher (1 year results)